12-18-2007, 11:35
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#976
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Senior Member
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Streetinvesting.com: Progressive following on Peregrine Pharmaceuticals Inc Tuesday, December 18, 2007; Posted: 09:04 AM
Dec 18, 2007 (M2 PRESSWIRE via COMTEX) -- PPHM | charts | news | PowerRating -- Investors need to turn to the markets these days if even to simply counter the depreciation of their hard earned wealth.
Consumer inflation surged by the largest amount in more than two years in November, led by a huge jump in gasoline prices. Inflation also hit home with big increases in the cost of clothing, airline tickets and prescription drugs. The 0.8 percent rise in consumer prices was worse than the 0.6 percent advance that economists had expected. With one month to go, inflation in 2007 is rising at an annual rate of 4.2 percent! This well outweighed the 2.5 percent increase in 2006. There is worry that the jump in energy costs will leave consumers with less money to spend on other items, worsening the slowdown in economic growth that is already manifesting this nation.
Peregrine Pharmaceuticals Inc. (NASDAQ:PPHM) performance for December 17, 2007, we noticed that the American Market reacted to the contract news. December 17, 2007, the early afternoon trading was down 15 percent on higher than average volume.
Our research resources have been aimed towards the US large caps and the various prospective companies therein. Peregrine Pharmaceuticals Inc. was among those that we have been closely examining
Dec. 14, 2007 -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), today announced the sudden termination of its negotiations to finalize a contract award with the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense (DOD) as a result of Congressional budget cuts. These cuts dramatically reduced the program funds available for grants from DTRA's Transformational Medical Technologies Initiative in the 2008 fiscal year. Peregrine's proposal to investigate bavituximab and other anti-phosphotidylserine (PS) antibodies as potential therapies for hemorrhagic fever virus had been selected for a tentative contract award under the Transformational Medical Technologies Initiative program. The contract was in late stages of negotiation and was expected to be signed in early 2008. In the recently passed H.R. 3222 - Department of Defense Appropriations Act, 2008, Congress eliminated $100 million in funding for the TMTI program, a major portion of its funding available for these types of projects. These cuts were enacted despite the strenuous opposition of the Bush Administration.*
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara . Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers.
With the recent climax remodeling the market temporarily and taking investors on a roller-coaster ride, Streetinvesting.com will keep track of the performance and future news release of this company. Our research team will bring you any news or updates about Peregrine Pharmaceuticals Inc. as they come into the public realm in the coming weeks and months.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
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12-20-2007, 10:23
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#977
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Senior Member
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Peregrine Pharmaceuticals Remains on Track to Advance its Three Lead Clinical Programs in 2008
http://biz.yahoo.com/prnews/071220/lath046.html?.v=101
Thursday December 20, 9:00 am ET
-Five New Clinical Trial Sites Recently Initiated To Support Ongoing Trials-
-Clinical Data Expected in 2008 from Seven Ongoing or Planned Clinical Trials, Including Four Phase II Trials in Major Disease Indications-
-Revenues Plus Cash On-Hand Expected to Provide Sufficient Resources to Advance Programs as Planned-
TUSTIN, Calif., Dec. 20 /PRNewswire-FirstCall/
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today confirmed that its plans for advancing all three of its lead clinical programs in 2008 remain on track. The combination of revenues expected to be generated by Avid, the company's contract manufacturing subsidiary, plus the more than $26 million in cash on- hand reported as of October 31, 2007, should provide sufficient resources to advance these programs. To enhance enrollment rates and accelerate the generation of clinical data, Peregrine recently added additional clinical trial sites to all three of the core clinical programs.
"We believe data from our lead clinical programs will be the key value drivers for Peregrine in 2008, and I am pleased to report that our ambitious clinical plans for advancing all three anti-cancer and antiviral clinical programs in calendar year 2008 are proceeding as planned," said Peregrine president and CEO Steven W. King. "With at least seven clinical studies, including four Phase II trials, slated for 2008, we anticipate that the coming year will provide us with many opportunities to share clinical data with the medical community, potential partners and investors."
In recent months, Peregrine has implemented a number of initiatives to accelerate its three lead clinical programs.
Bavituximab Solid Tumor Clinical Program
In support of the Phase II bavituximab cancer program, Peregrine filed protocols for two breast cancer combination therapy trials and has already received regulatory approval to proceed with one of those protocols, which is assessing bavituximab in combination with docetaxel in patients with breast cancer. Patient enrollment in this trial is expected to begin in early 2008. Regulatory approval for the second breast cancer trial and for a previously filed combination therapy trial in patients with non-small cell lung cancer is expected early in 2008. The company also is taking action to accelerate its Phase I bavituximab cancer trial in the U.S., with the goal of laying the foundation for U.S. Phase II studies. Peregrine recently added a new study site in Charlotte, North Carolina, and a total of five clinical sites are now screening and recruiting patients for this study. Peregrine expects to complete the Phase I trial during 2008. The bavituximab cancer clinical program will be discussed at an important scientific forum when interim clinical data is presented in February 2008 at the 10th Annual International Symposium on Anti-Angiogenic Agents (Angio 2008).
Bavituximab Hepatitis C Virus (HCV) Clinical Program
The company's trial of bavituximab in HCV patients co-infected with HIV began enrolling and dosing patients, and with the addition of new clinical sites at The Johns Hopkins Hospital and a private clinic in Orange County, California, a total of three clinical sites are now screening and recruiting patients in this innovative study. The bavituximab HCV clinical program was awarded an oral presentation slot for the second year in a row at the prestigious Annual Meeting of the American Association for the Study of Liver Disease held last November. Final results from the Phase I multiple-dose HCV trial were presented that showed bavituximab was well tolerated and demonstrated encouraging signs of anti-viral activity.
Cotara® Brain Cancer Clinical Program
To help accelerate the ongoing Phase II trial of Cotara in patients with glioblastoma multiforme, one of the most deadly forms of brain cancer, Peregrine recently added two new sites to the study, for a total of seven clinical sites now actively screening and recruiting patients. In addition, Peregrine regained operational responsibility for the ongoing Cotara dosimetry and dose confirmation clinical study and is working closely with the participating academic medical centers to complete patient enrollment and dosing during 2008. Positive results from these two clinical trials are expected to pave the way for Phase III product registration trials for Cotara.
Mr. King concluded, "In 2008 we plan to conduct a number of mid-phase trials for our lead clinical programs, each of which has significant clinical and commercial potential. We have long maintained that positive Phase II clinical data would be the keys to building sustainable shareholder value in the company, and we are optimistic that Peregrine will be able to begin delivering on that promise in the upcoming year."
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.
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__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
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01-22-2008, 14:35
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#978
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Senior Member
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Peregrine Pharmaceuticals Receives Approval to Conduct a Phase II Trial of Bavituximab in Patients With Non-Small Cell Lung Cancer
- Clinical Trial to Evaluate Anti-Tumor Activity of Bavituximab in Combination with Carboplatin and Paclitaxel-
TUSTIN, Calif., Jan. 22 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that its Phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) has been approved by the Drug Controller General of India (DCGI). The primary objective of the multi-center clinical trial is to assess the overall tumor response rate in NSCLC patients treated with the combination of bavituximab and carboplatin plus paclitaxel.
In the trial's two-stage design, up to 21 patients with NSCLC will be enrolled initially. The study will then be expanded up to a total of 49 patients if promising results are observed in the initial cohort. Secondary objectives of the study include time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab as long as the cancer does not progress and side effects are acceptable.
"This phase II trial represents an excellent opportunity for us to evaluate the potential activity of adding bavituximab to a standard regimen of carboplatin plus paclitaxel in NSCLC, a common and deadly cancer that still lacks effective treatment options," said Steven W. King, president and CEO of Peregrine. "With this approval in hand, we can now proceed with final preparations for the trial and look forward to study initiation in the near future."
Tumor response in this study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.
Lung cancer kills more Americans than any other type of cancer. According to the American Cancer Society, in the U.S. lung cancer is the second most commonly diagnosed cancer in men and women and is the leading cause of cancer deaths. It estimates that there were approximately 213,400 new cases of lung cancer and an estimated 160,400 lung cancer deaths in the U.S. in 2007. Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase lb pilot trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients. Peregrine has filed three Phase II cancer protocols to study bavituximab in combination with chemotherapy. In addition to the NSCLC protocol approval announced today, a protocol to study bavituximab in combination with docetaxel in patients with advanced breast cancer has been approved in the Republic of Georgia and is expected to begin shortly, and a second breast cancer protocol to study bavituximab in combination with carboplatin plus paclitaxel is expected to be approved soon in India. Bavituximab is also in Phase I clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com/), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com/.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
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01-23-2008, 10:27
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#979
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Senior Member
Join Date: Nov 2005
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Peregrine Pharmaceuticals Receives Approval to Conduct a Second Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer
-- Peregrine Has Now Received Regulatory Approval for Three Phase II Cancer Trials to Study Bavituximab in Combination with Chemotherapy -- -- New Clinical Trial Will Evaluate Anti-Tumor Activity of Bavituximab in Combination with Carboplatin and Paclitaxel --
TUSTIN, Calif., Jan 23, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that its Phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with advanced breast cancer has been approved by the Drug Controller General of India (DCGI). The primary objective of the multi-center clinical trial is to assess the overall response rate to the combination of bavituximab with carboplatin and paclitaxel, chemotherapy drugs commonly used in the treatment of breast cancer.
In the trial's two-stage design, up to 15 patients with advanced breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 patients if promising results are observed. Secondary objectives of the study include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable.
"We are eager to begin this new trial because we saw encouraging signs of activity against advanced breast cancer in our bavituximab pilot combination therapy study, where two patients treated with bavituximab and these same chemotherapy agents achieved objective tumor responses," said Steven W. King, president and CEO of Peregrine. "We are optimistic that this new trial, along with our other Phase II bavituximab breast cancer trial, will provide us with valuable insights into bavituximab's potential in this important disease. We are now proceeding with final preparations for the trial and look forward to study initiation in the near future."
Tumor response in this study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.
The National Cancer Institute estimates that approximately 178,480 U.S. women were diagnosed with breast cancer in 2007 and 40,460 women died of the disease. According to the World Health Organization, breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase lb trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients. Peregrine has now received regulatory approval for three Phase II clinical trials to study the anti-tumor effects of bavituximab in combination with chemotherapy: A breast cancer protocol in combination with docetaxel, a second breast cancer protocol in combination with carboplatin plus paclitaxel, and a non-small cell lung cancer protocol in combination with carboplatin and paclitaxel. Bavituximab is also in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
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01-29-2008, 10:29
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#980
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Senior Member
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Peregrine Pharmaceuticals Receives Approval to Conduct a Second Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer
*** Peregrine Has Now Received Regulatory Approval for Three Phase II Cancer Trials to Study Bavituximab in Combination with Chemotherapy -- -- New Clinical Trial Will Evaluate Anti-Tumor Activity of Bavituximab in Combination with Carboplatin and Paclitaxel ***
TUSTIN, Calif., Jan 23, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that its Phase II clinical protocol to study bavituximab in combination with chemotherapy in patients with advanced breast cancer has been approved by the Drug Controller General of India (DCGI). The primary objective of the multi-center clinical trial is to assess the overall response rate to the combination of bavituximab with carboplatin and paclitaxel, chemotherapy drugs commonly used in the treatment of breast cancer.
In the trial's two-stage design, up to 15 patients with advanced breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 patients if promising results are observed. Secondary objectives of the study include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable.
"We are eager to begin this new trial because we saw encouraging signs of activity against advanced breast cancer in our bavituximab pilot combination therapy study, where two patients treated with bavituximab and these same chemotherapy agents achieved objective tumor responses," said Steven W. King, president and CEO of Peregrine. "We are optimistic that this new trial, along with our other Phase II bavituximab breast cancer trial, will provide us with valuable insights into bavituximab's potential in this important disease. We are now proceeding with final preparations for the trial and look forward to study initiation in the near future."
Tumor response in this study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.
The National Cancer Institute estimates that approximately 178,480 U.S. women were diagnosed with breast cancer in 2007 and 40,460 women died of the disease. According to the World Health Organization, breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase lb trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients. Peregrine has now received regulatory approval for three Phase II clinical trials to study the anti-tumor effects of bavituximab in combination with chemotherapy: A breast cancer protocol in combination with docetaxel, a second breast cancer protocol in combination with carboplatin plus paclitaxel, and a non-small cell lung cancer protocol in combination with carboplatin and paclitaxel. Bavituximab is also in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
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02-08-2008, 12:27
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#981
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Senior Member
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Clinical Experience With Peregrine's Anti-Cancer Agent Bavituximab Presented at Leading Symposium on Anti-Angiogenic Agents
http://biz.yahoo.com/prnews/080208/laf030.html?.v=101
Friday February 8, 11:00 am ET
- Researcher Participating in Bavituximab U.S. Cancer Trial Presents Data on Novel Anti-PS Monoclonal Antibody to Anti-Angiogenesis Experts
TUSTIN, Calif., Feb. 8 /PRNewswire-FirstCall/
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus infection (HCV), today reported that clinical data on its anti-phosphatidylserine (anti-PS) monoclonal antibody bavituximab was discussed at the 10th Annual International Symposium on Anti-Angiogenic Agents (Angio 2008) in La Jolla, CA.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Peregrine recently initiated its Phase II clinical cancer program for bavituximab.
Alison T. Stopeck, M.D., associate professor of medicine, Department of Medicine, Cancer Center Division at the University of Arizona College of Medicine in Tucson, and team leader of the Breast Cancer Team, Arizona Cancer Center, presented clinical data on bavituximab as part of an Angio 2008 Symposium panel. Dr. Stopeck is an investigator in an ongoing Phase I study that is assessing bavituximab as monotherapy in patients with advanced solid cancers. She also discussed data from a Phase Ib combination therapy cancer trial that was completed last year and from two Phase I clinical trials testing bavituximab in patients with chronic hepatitis C virus infections.
"Bavituximab has a unique anti-vascular mechanism of action and early trials of its use in more than 80 patients as a single agent and in combination therapy cancer studies, and as monotherapy in patients with HCV, have demonstrated a predictable and acceptable safety profile that is consistent with preclinical predictions," said Dr. Stopeck. "I look forward to helping to advance the clinical program for this novel approach to cancer therapy."
Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. Preclinical studies have shown that bavituximab's PS target is upregulated by radiation and chemotherapy, suggesting that anti-PS agents are good candidates for use as part of combination therapy regimens. The approach has demonstrated encouraging anti-tumor activity as part of combination therapy regimens in a number of solid tumor models.
"We are delighted that Dr. Stopeck is presenting early clinical data on bavituximab at this important scientific meeting," said Steven W. King, president and CEO of Peregrine. "As we move to assess bavituximab in Phase II efficacy trials, we are eager to share with the broader scientific and medical communities the growing body of data supporting the positive safety profile and signs of anti-tumor and anti-viral effects demonstrated by this exciting new class of drugs in both single agent and combination therapy studies."
In a Phase Ib pilot trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity in a number of tumor types, achieving objective response or disease stabilization in 50% of the evaluable patients. Peregrine recently received regulatory approval to conduct three Phase II trials to study the anti-tumor effects of bavituximab in combination with chemotherapy. These include two breast cancer protocols and a non-small cell lung cancer (NSCLC) protocol. One of the breast cancer trials has begun enrolling patients and the two other trials are expected to begin soon. Bavituximab is also in clinical trials in the U.S. in patients co-infected with HCV and HIV.
Dr. Stopeck's presentation, "Phase I Clinical Studies of the Anti-Tumor Vasculature Antibody, Bavituximab," is part of the Angio 2008 session on Early Drug Development/Clinical Trial Results being held from 8:00 am to 12:00 pm PST at the 10th Annual International Symposium on Anti-Angiogenic Agents at the Hyatt Regency Hotel in La Jolla, CA.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
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02-11-2008, 10:32
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#982
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Senior Member
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Market Review: Review in Progress for Peregrine Pharmaceuticals, Inc
http://new.quote.com/news/story.action?id=MTO042u6956
Monday February 11, 2008 04:28:56 EST
Feb 11, 2008 (M2 PRESSWIRE via COMTEX News Network)
Streetinvesting.com has now resumed our progressive review of Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM), after it traded up 4% Friday, early in the afternoon with above average volume. Based on the Company's most recent news release, we will be progressively reviewing the impact of the markets and the effects of their developments.
Our research resources have been aimed towards the US Large Caps and the various prospective companies therein Peregrine Pharmaceuticals, Inc was among those that we have been closely examining due to their recent news and trading patterns.
Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM), reported on February 8, 2008 that clinical data on its anti-phosphatidylserine (anti-PS) monoclonal antibody bavituximab was discussed at the 10th Annual International Symposium on Anti-Angiogenic Agents (Angio 2008) in La Jolla, CA.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara.
Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers.
Streetinvesting.com will continue to follow the progress of this company following their most recent news announcement. Visit www.streetinvesting.com and signup free for our financial market services.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
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02-12-2008, 09:41
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#983
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Peregrine Pharmaceuticals Doses First Patient in Phase II Clinical Trial of Bavituximab in Patients With Advanced Breast Cancer
http://ih.advfn.com/p.php?pid=nmona&cb=1202823532&article=24700672&sym bol=N%5EPPHM
TUSTIN, Calif., Feb 12, 2008 /PRNewswire-FirstCall via COMTEX/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted therapies for the treatment of cancer and hepatitis C virus infection (HCV), today announced that patient dosing has begun in its clinical trial designed to evaluate the safety and efficacy of bavituximab in combination with chemotherapy in patients with advanced breast cancer. The primary objective of the study is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in breast cancer. The multicenter clinical trial is being conducted in the Republic of Georgia.
"We are now seeing good overall momentum in our bavituximab Phase II cancer program, and we are very pleased that our clinical colleagues in Europe have been so efficient in rapidly moving from protocol approval to trial initiation to patient dosing," said Steven W. King, president and CEO of Peregrine. "We are optimistic that all three bavituximab Phase II cancer trials will proceed well in the coming months and we look forward to reporting on our progress later this year."
In the trial's two-stage design, up to 15 patients with advanced breast cancer will be enrolled initially. The study will then be expanded up to a total of 46 patients if promising results are observed. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable.
"Bavituximab represents a novel strategy for the treatment of cancer that has demonstrated encouraging potential in initial clinical studies," said David Tabagari, M.D., Ph.D., the head of Medulla Immunotherapy and Chemotherapy Clinic and principal investigator of the bavituximab breast cancer trial being conducted in the Republic of Georgia. "We are pleased to have the opportunity to conduct the first Phase II trial of this potentially valuable new approach to treating cancer."
Tumor response in this study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) standards.
The National Cancer Institute estimates that approximately 178,480 U.S. women were diagnosed with cancer of the breast in 2007 and about 40,460 women died of the disease. According to the World Health Organization, breast cancer is the most commonly diagnosed cancer in women, and is second only to lung cancer as a leading cause of female cancer deaths.
Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is usually located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase lb pilot trial in advanced cancer patients, bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the evaluable patients. Peregrine has recently received regulatory approval to conduct three Phase II trials to study the anti-tumor effects of bavituximab in combination with chemotherapy. These include two breast cancer protocols and a non-small cell lung cancer protocol testing bavituximab in combination with chemotherapy. The first bavituximab breast cancer trial is now underway and the two other trials are expected to begin soon. Bavituximab is in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
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03-06-2008, 06:06
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#984
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Senior Member
Join Date: Nov 2005
Location: Sarasota Florida
Posts: 2,635
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Arsenic Aids Tumor Imaging When Joined To Cancer-homing Drug, Researchers Find
http://www.sciencedaily.com/releases...0301214730.htm
(Mar. 5, 2008) — Arsenic linked to a drug that binds to the blood vessels of cancerous tumors provides a powerful imaging agent that could one day allow physicians to detect hard-to-find tumors and more closely monitor cancer's response to therapy, researchers at UT Southwestern Medical Center have found.
The findings, based on animal studies and appearing in the journal Clinical Cancer Research, mark the first time arsenic has been used to label antibodies for the detection of tumors.
Dr. Philip Thorpe, professor of pharmacology at UT Southwestern and senior author of the study, helped create the cancer drug called bavituximab, an antibody that homes in on a specific molecular target on the blood vessels that feed tumors. Bavituximab is being tested in clinical trials to treat solid-tumor cancers in combination with chemotherapy.
"While arsenic has been used as a poison for centuries, the dose of arsenic needed for imaging tumors is about one-millionth of that needed to cause toxicity," Dr. Thorpe said.
"Arsenic-labeled bavituximab appears to be safe."
In the study, Dr. Thorpe and his colleagues injected radioarsenic-labeled bavituximab into rats with prostate tumors. When the bavituximab bound to its target on the the tumor blood vessels, the tag-along arsenic created a "hot spot" that researchers then imaged using positron emission tomography methods. The radioactivity levels produced by the arsenic are comparable to those used in standard, routine imaging procedures in humans. The technique allowed them to locate and capture unusually clear images of the tumors. They also discovered that there was little or no detectable uptake of bavituximab by normal organs, including the liver, a common site where drugs become entrapped.
"We hope to use this technique to detect early tumor deposits that are not visible using other imaging techniques," said Dr. Thorpe. "The images we obtain are so clear that we may be able to see secondary tumors that have spread from the original tumor mass and lodged in distant organs."
The forms of arsenic used in the experiments are called radionuclides, which are radioactive versions, or isotopes, of the element. Several radionuclides currently are used in imaging, but many of the isotopes decay, or breakdown, before they reach the target in the body. The slow rate of decay of arsenic isotopes, together with their stable chemistry, allowed the researchers to couple arsenic to bavituximab and obtain images of the tumors for several days after the drug was given. Optimal tumor imaging in humans is often achieved three days or more after a radio-labeled antibody is administered.
"Long neglected as an awkward Cinderella, arsenic has great potential for new imaging agents and therapeutics based on multiple isotopes with diverse useful characteristics," said Dr. Ralph Mason, professor of radiology, director of the UT Southwestern Cancer Imaging Program and one of the study's authors.
Dr. Mason recently received a grant from the Department of Defense Breast Cancer Initiative to investigate whether arsenic could be used to image breast tumors.
In addition to Drs. Thorpe and Mason, other investigators in UT Southwestern's Harold C. Simmons Comprehensive Cancer Center carried out the research in collaboration with colleagues from UT Austin, Johannes Gutenberg University of Mainz in Germany and the University of Brussels in Belgium. The collaboration included pharmacologists, physicists and chemists.
Other UT Southwestern scientists involved in the study were Dr. Matthew Lewis, assistant professor of radiology; Dr. Dawen Zhao, assistant professor of radiology; Dr. Edward Tsyganov, clinical assistant professor of radiology; Dr. Nikolai Slavine, assistant professor of radiology; Linda Watkins, research scientist in pharmacology; Dr. Vikram Kodibagkar, assistant professor of radiology; and Dr. Peter Antich, professor of radiology.
The research was funded by Gillson Longenbaugh Foundation, National Cancer Institute, Peregrine Pharmaceuticals Inc., Deutsche Forschungsgemeinschaft and the Department of Defense.
Peregrine has exclusively licensed bavituximab from UT Southwestern and has a sponsored research agreement to further explore clinical uses of the drug. Dr. Thorpe is a consultant to and has an equity interest in the company.
Adapted from materials provided by UT Southwestern Medical Center.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
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03-11-2008, 08:55
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#985
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Senior Member
Join Date: Nov 2005
Location: Sarasota Florida
Posts: 2,635
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Peregrine Pharmaceuticals Announces Positive Data From Cotara(R) Brain Cancer Trials
Tuesday March 11, 7:00 am ET
Cotara(R) Appears Safe and Well Tolerated in Dosimetry and Phase II Trials, with Some Patients Already Past the Expected Median Average Survival Time for This Population -
Data From Dosimetry Trial Accepted for Presentation at 2008 ASCO Annual Meeting
TUSTIN, Calif., March 11 /PRNewswire-FirstCall/
[b]Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus infection, today released an update from two clinical trials assessing its targeted therapy Cotara® in the treatment of glioblastoma multiforme (GBM), the most deadly form of brain cancer. The Cotara clinical update covers the first cohort of patients in its dosimetry trial as well as experience to date in an ongoing Phase II safety and efficacy trial. In patients treated in the studies, Cotara appears to be safe and well tolerated, with no dose-limiting adverse events. Patients who are continuing in the trials are being monitored for safety and overall survival, with several surpassing the median expected survival time for relapsed GBM patients.
The recent addition of new clinical sites in both the dosimetry and Phase II trials is expected to help accelerate the pace of patient enrollment going forward.
The company also announced that data from the first patient cohort in the dosimetry trial has been accepted for presentation at the 2008 ASCO Annual Meeting.
"We are encouraged by early results from these two Cotara clinical studies and look forward to presenting data from the dosimetry trial at the upcoming ASCO Annual Meeting," said Steven W. King, president and CEO of Peregrine. "In view of the short expected survival time of approximately six months in this patient population, it is promising that we have early GBM patients in these trials who have survived past the six-month timeframe, with one patient now surviving 15 months post-treatment."
The open-label Phase I dosing and dosimetry study at U.S. brain cancer centers is enrolling GBM patients with recurrent disease. Patients in this trial receive an initial imaging dose of Cotara before receiving the therapeutic dose.
The study's main objectives are to confirm the maximum tolerated dose, to determine radiation dosimetry and to assess overall patient survival, progression-free survival and the proportion of patients alive at six months following Cotara administration. In the three GBM patients enrolled in the first cohort, Cotara was safe and well tolerated, with no dose-limiting toxicities. Patients have been followed post-treatment to determine overall survival, with the first treated patient currently surviving 15 months post-treatment and the last treated patient currently surviving four months post-treatment. Dosimetry analysis indicates that Cotara was concentrated only in the tumor in these patients, and not in other organs.
Mr. King added, "With enrollment of the second patient cohort underway, we welcome Dr. William Shapiro of the Barrow Neurological Institute as principal investigator of our newest dosimetry study clinical site. Dr. Shapiro successfully participated in earlier Cotara studies and we are delighted that his center is now participating in the Cotara dosimetry trial."
"We are pleased to join the dosing and dosimetry trial of Cotara for the treatment of recurrent GBM," said Dr. William Shapiro, director, neuro oncology program; Marley chair, neurology; professor of neurology, University of Arizona College of Medicine; and Cotara principal investigator at the Barrow Neurological Institute. "GBM is a deadly disease with very poor survival prospects for relapsed patients, and improved therapies are urgently needed. We are hopeful that the encouraging survival trends seen in previous Cotara studies will be replicated in larger trials going forward, and we view this dosimetry trial as an important step on that path."
Mr. King continued, "We are also pleased to report that we have recently added additional clinical sites to the Cotara Phase II study, increasing the total participating centers from three sites to eight sites. We anticipate enhanced enrollment rates going forward, particularly in view of the quality and enthusiasm of the investigators we have recruited. We look forward to reporting further interim results from the Cotara program as we achieve additional enrollment milestones in the coming months."
The objectives of the open-label Phase II trial are to confirm the safety of the selected dose of Cotara and to obtain estimates of overall patient survival, progression-free survival and the proportion of patients alive at six months in GBM patients at first relapse. Patients in the trial are receiving a single infusion of Cotara by convection-enhanced delivery (CED), a technique that delivers the agent to the tumor with great precision. Patients receive brain scans at eight-week intervals post-treatment.
Total enrollment in the 40-patient trial has reached the 20% completion mark. Patients who are continuing in the trials are being monitored for safety and overall survival, with the first dosed patient having reached eight months of survival post-treatment. Patient screening for the trial will continue until all 40 patients have been enrolled.
About Cotara®
Cotara is an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody. This monoclonal antibody is designed to bind to a type of DNA that is exposed only on dead and dying cells. Solid tumors have many dead and dying cells at their center. Cotara's targeting mechanism enables it to home in on these cells, delivering its radioactive "payload" directly to the center of the tumor mass and thereby destroying it "from the inside out" with minimal radiation exposure to healthy tissue. Cotara is delivered using convection-enhanced delivery (CED), which targets the specific tumor site in the brain. In a previous clinical study, a subset of patients with recurrent glioblastoma treated with Cotara achieved a median survival of 38 weeks, a 58% increase over the median survival time of 24 weeks for patients treated with standard of care therapy. In this study, 25% of 28 recurrent patients survived for more than a year post-treatment and 10% of patients survived for more than three years. These data are considered a promising development in this deadly disease. Cotara has been granted orphan drug status and fast track designation for the treatment of glioblastoma multiforme and anaplastic astrocytoma by the U.S. Food and Drug Administration.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
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03-11-2008, 08:56
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#986
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Senior Member
Join Date: Nov 2005
Location: Sarasota Florida
Posts: 2,635
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Peregrine Pharmaceuticals Reports Financial Results for the Third Quarter of Fiscal Year 2008
http://ir.peregrineinc.com/releaseDe...leaseID=298509
Advances Reported in All Three Clinical Programs, Including Launch of Key Bavituximab Phase II Cancer Program
TUSTIN, Calif., March 11, 2008 /PRNewswire-FirstCall via COMTEX News Network/
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced financial results for the third quarter of fiscal year (FY) 2008 ended January 31, 2008. The company reported a consolidated net loss of $6,154,000, or $0.03 per basic and diluted share, compared to a consolidated net loss of $5,025,000 or $0.03 per basic and diluted share for the same prior year period. The increased net loss primarily reflects increased investments in research and development as the company advanced its clinical programs for bavituximab and Cotara(R).
Total revenues for the current quarter increased to $1,675,000 compared to $363,000 for the comparable quarter last year, and were primarily generated from services provided by Avid Bioservices, the company's wholly owned contract manufacturing subsidiary.
Total costs and expenses increased to $8,077,000 in the third quarter of FY 2008 from $5,643,000 in the same prior year quarter. The increase was primarily related to the increase in the cost of contract manufacturing of $1,066,000 during the quarter resulting from higher reported revenues from external customers, in addition to the increase in research and development expenses of $1,034,000 associated with the advancement of the company's clinical and preclinical product candidates. Research and development expenses were $4,941,000 in the third quarter of FY 2008, compared to $3,907,000 in the third quarter of FY 2007.
At January 31, 2008, the company had $20,063,000 in cash and cash *************************alents compared to $16,044,000 at fiscal year end April 30, 2007.
"The past quarter was highlighted by a major milestone in our oncology program, as we dosed the first patients in a Phase II trial evaluating bavituximab in combination with chemotherapy in patients with breast cancer," said Steven W. King, president and CEO of Peregrine.
"We also received regulatory approval to initiate two additional bavituximab Phase II cancer trials -- a second breast cancer study and a trial in patients with non-small cell lung cancer, a leading cause of cancer deaths worldwide. Planning for these trials is well underway and we anticipate initiating both studies next month. We also made progress in our Cotara clinical program in patients with glioblastoma multiforme (GBM), today announcing promising data from the ongoing dosimetry and Phase II trials showing that several patients are already surviving longer than the expected six-month median survival time for this patient population, with the longest surviving patient now at 15 months post-treatment. Patients who are continuing in the trials are being monitored for safety and overall survival, and we look forward to providing further updates on these trials going forward. We have also recently expanded the number of clinical sites in the Phase Il study to eight and also added a distinguished brain cancer center and experienced Cotara clinical study site -- the Barrow Neurological Institute -- to our dosimetry study in the U.S."
Mr. King added, "Our initiative to raise awareness for the bavituximab and Cotara programs in the scientific and medical communities scored gains, including an oral presentation covering the clinical experience to date in the bavituximab Phase I cancer program at Angio 2008, an oral presentation of clinical data from our Phase I bavituximab trial in hepatitis C patients at the prestigious 2007 Liver Meeting(R), a recent publication in Clinical Cancer Research highlighting bavituximab's ability to target tumor blood vessels with excellent specificity, and the acceptance last week of an abstract discussing patient data from the Cotara dosimetry trial for presentation at the 2008 ASCO Annual Meeting. We anticipate additional high profile scientific publications and presentations in the coming months while we continue making good progress in advancing our trio of Phase II bavituximab cancer trials, the two ongoing Cotara clinical trials and the trial of bavituximab in HCV patients co-infected with HIV. We look forward to a steady flow of news from these multiple activities in the coming months."
Recent Highlights
Bavituximab Anti-Cancer Program: The company launched the Phase II cancer clinical program for bavituximab during the quarter and achieved a number of other clinical and preclinical advancements.
-- Initiated patient dosing in a Phase II combination therapy trial of bavituximab and docetaxel in patients with advanced breast cancer within 14 days of study initiation.
-- Received regulatory approval to begin two additional Phase II bavituximab combination therapy trials -- one in combination with carboplatin and paclitaxel in patients with advanced breast cancer and another in combination with carboplatin plus paclitaxel in patients with non-small cell lung cancer (NSCLC). Both trials are preparing to begin enrolling patients shortly.
-- A bavituximab cancer investigator presented data at a leading scientific meeting on anti-angiogenic agents -- the 10th Annual International Symposium on Anti-Angiogenic Agents (Angio 2008) --highlighting the positive clinical experience to date with bavituximab.
-- A preclinical study published in Clinical Cancer Research confirmed bavituximab's ability to target tumor blood vessels with excellent specificity. The high degree of selective targeting seen in the study provides additional evidence of bavituximab's therapeutic potential.
Bavituximab Anti-Viral Program:
During the third quarter, the company continued to advance its bavituximab HCV program and presented positive data at a key liver disease meeting.
-- Added The Johns Hopkins Hospital and a private clinic in Orange County, California as additional clinical study sites for the HCV/HIV co-infection study.
-- Presented final results from the Phase I multiple dose HCV trial at the prestigious Annual Meeting of the American Association for the Study of Liver Disease that showed bavituximab was well tolerated and demonstrated encouraging signs of anti-viral activity.
Cotara(R) Glioblastoma Program: Peregrine continued to advance the Cotara brain cancer program.
-- Added additional study sites and continued patient dosing and follow-up in the Cotara Phase II study in patients with glioblastoma multiforme, the most deadly form of brain cancer. Eight sites are now open for patient enrollment.
-- Added an additional site, the Barrow Neurological Institute (BNI) in Phoenix, Arizona, to the ongoing Cotara dosimetry and dose confirmation clinical study. BNI also participated in a previous Cotara Phase II clinical trial.
-- Announced positive results from the first cohort of patients treated in the Cotara dosimetry trial and from the initial patients treated in the Cotara Phase II trial. Cotara appeared safe and well tolerated with no dose-limiting adverse events, with continuing patients being monitored for overall survival. Several patients in these studie have lived longer than the six-month expected median survival time for this patient population.
Other Preclinical Programs:
-- Preclinical data presented at the 5th Annual International Anti-Angiogenesis Conference confirmed that Peregrine's fully human, selective anti-VEGF antibody R84 was as effective as Avastin(R) in inhibiting tumor growth in a model of human breast cancer. Selective anti-VEGF agents may have potential advantages over non-selective approaches.
Avid Bioservices:
-- Wholly owned manufacturing subsidiary Avid Bioservices signed an agreement with ARIUS Research to produce clinical supplies of their lead cancer stem cell anti-CD44 antibody.
-- Avid continued to demonstrate strong revenue performance during the third quarter of fiscal year 2008.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
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03-19-2008, 23:01
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#987
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Senior Member
Join Date: Nov 2005
Location: Sarasota Florida
Posts: 2,635
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Principal Investigator: Barton Haynes
Project: Broadly Reactive Neutralizing Antibodies: Novel Strategies for Vaccine Design
Our goal is to acquire proof of concept data that manipulation of the immunoregulatory controls of B cell immune responses to HIV-1 Env, coupled with enhanced immunogen design, can lead to safe induction of broadly reactive neutralizing antibody responses. We are using a two armed approach to the problem of induction of antibodies that broadly neutralize HIV.
The Kelsoe, Haynes and Thorpe laboratories are developing immunogen formulations that trigger B cells normally tolerant to the desired Envelope epitopes and regions. Garnett Kelsoe is determining the origins, development, physiology, and fates of marginal zone, transitional and B1 B cell populations in animal models including mice and non-human primates. Haynes is determining the role of tolerance mechanisms, and TLR signaling on control of broadly reactive B cell activation, and Philip Thorpe is determining the role of lipid binding of anti-HIV antibodies and anti-phosphatidylserine(PS) autoantibodies to protection from HIV infection. With Norm Letvin, a protection trial is being planned to determine if anti-PS antibodies can prevent infection or early viral destruction of the immune system in acute SIV infection.
The Harrison, Alam, Spicer, Shaw, Robinson and Hahn laboratories are developing immunogens that are more “native” and will preferentially induce the desired antibody types. These include HIV Env immunogens with a spectrum of affinities for binding to broadly reactive neutralizing antibodies, and immunogens with low entropic barriers to Mab binding and therefore are thermodynamically stable. Steve Harrison and Bing Chen are expressing and characterizing single-chain Fvs from 4E10, 2F5 and 2G12 Mabs to dissect lipid and protein contributions to binding and Mab neutralization. They will use the Fvs in co-crystallization efforts with trimeric gp120/gp41 constructs. Munir Alam is designing gp41 peptide lipid conjugates using 4E10 and 2F5 epitopes peptides. He is characterizing the binding kinetics, and thermodynamic properties of 4E10 and 2F5 binding to peptide-lipid conjugates. Desaire is characterizing the carbohydrates of HIV-1 Env produced in T cells and macrophages, and Haynes is determining methods for making these “autoantigens” immunogenic. Spicer is studying the lipid-peptide conjugates for their structures by NMR. George Shaw and Beatrice Hahn have constructed HIV-1/HIV-2 chimeras with HIV-2 neutralizing determinants in HIV-1 scaffolds, to study the neutralization of HIV-2.
Interim Report, Submitted on 2/1/08
Our goal is to acquire proof of concept data that manipulation of the immunoregulatory controls of B cell immune responses to HIV-1 Env, coupled with enhanced immunogen design, can lead to safe induction of broadly reactive neutralizing antibody responses. We are using a two armed approach to the problem of induction of antibodies that broadly neutralize HIV.
The Kelsoe, Haynes and Thorpe laboratories are developing immunogen formulations that trigger B cells normally tolerant to the desired Envelope epitopes and regions. Garnett Kelsoe is determining the origins, development, physiology, and fates of marginal zone, transitional and B1 B cell populations in animal models including mice and non-human primates. Haynes is determining the role of tolerance mechanisms, and TLR signaling on control of broadly reactive B cell activation, and Philip Thorpe is determining the role of lipid binding of anti-HIV antibodies and anti-phosphatidylserine (PS) autoantibodies to protection from HIV infection. We have completed the first protection trial to determine if anti-beta-2-glycoprotein-1 antibodies can prevent infection or early viral destruction of the immune system in acute SIV infection.
The Harrison, Alam, Spicer, Shaw, Robinson and Hahn laboratories are developing immunogens that are more native and are being tested for induction of desired antibody types. These include HIV Env immunogens with a spectrum of affinities for binding to broadly reactive neutralizing antibodies, and immunogens with low entropic barriers to Mab binding and therefore are thermodynamically stable. Steve Harrison, Bing Chen and Larry Liao have made single chain Fv 4E10 antibodies and whole IgG1 2F5 Mabs with mutations that selectively eliminate gp41 or lipid reactivity. They have demonstrated that both 2F5 and 4E10 require the capacity to bind to lipids to neutralize HIV-1. They will now use the Fvs and Mabs in co-crystallization efforts with trimeric gp120/gp41 constructs. Munir Alam is designing gp41 peptide lipid conjugates using 4E10 and 2F5 epitopes peptides. He is characterizing the binding kinetics, and thermodynamic properties of 4E10 and 2F5 binding to peptide-lipid conjugates. Heather Desaire is characterizing the carbohydrates of HIV-1 Env produced in T cells and macrophages, and Haynes is determining methods for making these “autoantigens” immunogenic. Spicer is studying the lipid-peptide conjugates for their structures by NMR. George Shaw and Beatrice Hahn have constructed HIV-1/HIV-2 chimeras with HIV-2 neutralizing determinants in HIV-1 scaffolds, to study the neutralization of HIV-2 with James Robinson.
__________________
>>)))*> PL1 <*(((<<
"The Vision that you glorify in your mind, the Ideal that you enthrone in your heart - this you will build your life by, this you will become."
*There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what just happened!*
~To escape criticism: do nothing, say nothing, be nothing~
*Aspire to Inspire before you Expire!*
~~~~~~~~~~~~<*(((<< ~~~~~~~~~~~~
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