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Purpledawgs I believe it is ours-I posted this several years ago-
2ndstr2thert
Thursday, 02/07/13 01:08:17 PM
Re: None
Post # of 212368
For those who do not know PPHM owns shares in a Chinese company
that is and has been treating patients in China with one of our TNT products ( VIVATUXIN - TNT 3 AND I131 )and LYM 1.
Anyone have any idea how much these shares are currently worth in USA dollars ?
Peregrine Pharmaceuticals, Inc. (the “Company”) entered into a Settlement Agreement and Mutual General Release dated June 4, 2009 (the “Settlement Agreement”) with Cancer Therapeutics Laboratories (“CTL”), Alan Epstein, M.D. (“Dr. Epstein”), Clive Taylor, M.D. and Peisheng Hu, M.D. (collectively, the “CTL Parties”), providing for a settlement and release of all claims with respect to our previously disclosed litigation with the CTL Parties. The dismissal of claims was filed in the Superior Court of the State of California for the County of Orange on June 18, 2009. Medibiotech Co., Inc. (“Medibiotech”) and Shanghai Medipharm Biotech Co., Ltd. were once parties to the litigation but previously settled with us.
Under the Settlement Agreement, we agreed to dismiss with prejudice our claims for breach of contract and interference with contractual relations, as well as all other causes of action, stemming from our 1995 license agreement, as amended, with CTL. CTL agreed to dismiss its breach of contract counterclaim, as well as all other causes of action. In connection with the Settlement Agreement, (1) the Company agreed to pay to CTL the sum of four hundred thousand dollars ($400,000) in eight equal monthly installments of fifty thousand dollars ($50,000) commencing upon execution of the Settlement Agreement and continuing on the first business day of each succeeding month until paid in full, (2) CTL agreed to cause to be issued to the Company 950,000 shares of Medibiotech (which represents fifty percent (50%) of the shares of Medibiotech owned by CTL), and (3) the Company and Dr. Epstein entered into a license agreement, effective as of September 20, 1995, pursuant to which Dr. Epstein granted to the Company (i) a fully paid-up, royalty free, exclusive worldwide license to the murine clone TNT1 and (ii) a fully paid-up, royalty free, non-exclusive worldwide (except in the Peoples Republic of China) license to the murine clones TNT2 and TNT3. The foregoing license grants include our right to grant sublicenses, to make, have made, modify, have modified, use, sell and offer for sale, murine clone TNT1, TNT2 and TNT3 products and derivatives thereof, but not to sell the murine clones. We also granted back to Dr. Epstein a limited, fully paid-up, royalty free, exclusive license to the murine clone TNT1, with the right to grant sublicenses, to make, have made, modify, have modified, offer to sell, sell and use the murine clone TNT1 and its products solely in the Peoples Republic of China effective as of August 29, 2001. In consideration for the foregoing license grants, we paid Dr. Epstein the sum of one thousand dollars ($1,000), which amount was deducted from the initial $50,000 payment.
The Settlement Agreement contains a full general release between the Company and the CTL Parties of all action or actions, causes of action, in law or in equity, suits, debts, liens, contracts agreements, promises, liability, claims, demands, damages, loss, cost or expense, of any nature whatsoever, known or unknown, fixed or contingent, by reason of any act, omission, cause, matter or thing whatsoever from the beginning of time.
Information contained herein shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
PEREGRINE PHARMACEUTICALS, INC.
Date: June 19, 2009
By:
/s/ Paul J. Lytle
Paul J. Lytle
Chief Financial Officer
-------------------------------------------------------------------
I took this post from Terry D ( Silicon Investor ) .
Medipharm seems to be doing Okay. Looks like LYM-1 (AKA Oncolym) is still a go for Medipharm. They also have the TNT fusion protein technology licensed from USC. I wonder just how much of the TNT technology Peregrine still controls or if we get any royalties from the part Medipharm has.
Shanghai MediPharm Biotech is a wholly-owned subsidiary of Medipharm Biotech Biopharmaceutical Ltd (Bermuda) focused on becoming China’s leading oncology biopharma by providing novel, antibody-based, targeted radio immunotherapy for malig-nant cancers. Following 15 years of R&D in antibody related biopharmaceuticals, the company has a strong intellectual prop-erty portfolio, including Vivatuxin®, a chimeric tumor necrosis therapy approved by China’s State Food and Drug Administra-tion for lung cancer and launched in 2007, as well as other can-didates in radio immunotherapy. Through a strategic marketing collaboration study with the Ministry of Health of China currently covering 101 hospitals, the company has agreements to supply 20,000 doses of Vivatuxin®, priced at $3,000 each, used for the treatment of advanced lung cancer patients, who have previ-ously failed at least one course of chemotherapy, and is negotating collaboration with additional 50 hospitals. Furthermore, as the first radio immunotherapy for solid tumors in the world and a potential therapy for all malignant solid tumors,
Vivatuxin® is undergoing Phase III clinical study registrations for glioma and liver cancer, as well as preclinical trials for colorectal and breast cancers.
Finally, the company has two exclusive licenses in radio immunotherapy technology platforms from University of Southern California Cancer Therapeutic Lab, namely Lym-1 for non-Hodgkin lymphoma, which started Phase I clinical trials in 2010, and TNT fusion protein technology for solid tumors. Currently, MediPharm has a staff of 53 professionals, and with 105,000 square feet GMP-approved world class manufacturing facilities, which include a 500L B. Braun bioreactor, the company has the capacity to produce 100,000 drug doses per year.
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An important announcement for Silicon Investor members and an introduction from Craig Longhurst
Biotech / Medical : Peregrine Pharmaceuticals, Inc.( PPHM)
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To: Terry D. who started this subject 1/18/2004 5:25:22 PM
From: cjgaddy of 3711
CHINA TNT Refresher: Interim Lung Results 6-2002
6-19-2002: “INNOVATIVE ADMINISTRATION OF RADIOLABELED TNT SUCCESSFULLY TREATS INOPERABLE LUNG CANCER
TNT Data Presented at Society of Nuclear Medicine’s 49th Annual Meeting”
http://www.peregrineinc.com/prelease.asp?id=6190271436
June 19, 2002 - Peregrine Pharmaceuticals Inc. announced today detailed results from clinical research conducted in China that show 56% efficacy was achieved when patients with inoperable lung cancer were treated with the company's 131iodine labeled chimeric TNT (131I-chTNT) antibody drug using an innovative method of intratumoral injection. Patients treated by this method had a disease control rate of 100%, demonstrating 131I-chTNT can achieve significant therapeutic effects in late stage lung cancer. The results provide substantial validation of Peregrine's proprietary TNT technology, which is a radiolabeled monoclonal antibody that targets the necrotic core of solid tumors. The interim lung cancer data were presented at the Society of Nuclear Medicine's 49th Annual Meeting in Los Angeles. The study was independently designed and conducted by researchers at the Shanghai Tumor Hospital.
The Phase I/II study compared the efficacy of three different methods of administration of 131I-chTNT for patients with inoperable late stage lung cancer: intravenous, intratumoral, and a combination of intravenous plus intratumoral injection. The results demonstrated that the method of intratumoral injection alone achieved a 56% complete and partial tumor remission rate. The combined intravenous plus intratumoral injection method achieved 40% and the intravenous method alone achieved 9% tumor remission rate. The disease control rate for all three methods of treatment, including complete and partial remission and stable disease, was 88% for the 43 patients assessed in the study. The highest therapeutic effect was obtained by using common bronchoscopy and computer tomography (CT) scan instruments in a new technique to directly infuse the tumor with lethal doses of 131I-chTNT.
"Peregrine is reviewing the intratumoral injection techniques used to maximize delivery of radiolabeled TNT to the tumor while minimizing healthy tissue exposure. This will assist us in designing a lung cancer study in the USA," said Edward Legere, CEO of Peregrine Pharmaceuticals. "By using standardized equipment that is routinely used at medical centers around the world, it is possible the treatment could be widely adopted by oncologists treating late stage lung cancer patients."
"This data highlights the promise of TNT for the treatment of late stage lung cancer," said Alan L. Epstein, M.D., Ph.D., co-author of the lung cancer research, inventor of the TNT technology, and Peregrine's scientific consultant. "In this study, intratumoral injection caused substantially higher complete and partial remission rates than the other methods of administration. Given there are no effective treatments for inoperable late stage lung cancer, there is a significant unmet need for new therapies. Directly infusing the drug into the tumor mass may also reduce the systemic toxicity often seen with intravenous administration of radionuclides."
With a population of approximately 1.3 billion, China is a vast market for cancer therapy. Cancer became the main cause of death in China in 1996, with over 7.3 million new cases and just over 3 million deaths annually from cancer in China. The explosion in the number of cases of lung, breast, colon and rectal cancer was caused partly by the aging of China's population. In the USA, there were approximately 170,000 new cases of lung cancer in 1999, making it the most common cancer in the Western world. According to the American Cancer Society and the World Health Organization, since the mid-1990s, about 150,000 Americans have died each year from the disease. Lung cancer is the leading category of cancer death in men, and - since the late 1980s - it has surpassed breast cancer as the leading category of cancer death in women.
Summary of Clinical Study for Lung Cancer:
The poster summarizing the unaudited results of this Phase I/II study can be accessed on Peregrine's web site at:
http://www.peregrineinc.com/Technology.asp?id=Posters+and+Abstracts
As previously announced, a total of 43 patients enrolled in this study had a cytological and histological confirmed diagnosis of stage IIIb (30/43) or IV (13/43) inoperable lung cancer. As confirmed by fine needle biopsy, 24 patients (56%) had a diagnosis of adenocarcinoma, 12 patients (28%) were diagnosed with squamous carcinoma, six patients (14%) with small-cell lung cancer, and one patient (2%) with adeno-squamous carcinoma.
22 patients in the first group were administrated 131I-chTNT by intravenous drug infusion, 16 patients in the second group were administrated by intratumoral injection, and five patients in the third group received both treatments. The dose for each patient was 0.8 mCi/kg, which was repeated two weeks later. Patients receiving intravenous administration were given a total dose of 131I-chTNT delivered in 250 ml of normal saline through a free-flowing intravenous line. For the second group, the intratumoral injection of TNT was directed by thoracic CT guided catheter using a multiple-hole needle. The CT images clearly showed tumor localization, the needle pathway, and the site of administration. In the third group, 75% dosage was given by intratumoral injections and 25% by intravenous infusion.
Partial remission (PR) was defined as a greater than 50% reduction in tumor mass in all lesions and complete remission (CR) as no detectable tumor for greater than 10 weeks. Patients receiving intravenous injection alone had two PR (9%), 16 had stable disease (73%), and four progressed (18%). Those receiving intratumoral injection had one CR (6%), 8 PR (50%), seven had stable disease (44%), and zero progressed. Finally, those in the third group had one CR (20%), one PR (20%), two had stable disease (40%), and one progressed (20%). Toxicity was limited to mild and reversible bone marrow suppression in 20 cases.
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You are 2ndstr2thert on WEB4
Anyone know if Cotara ellicts PS or does it incinerate it ?
Chris thank you for your article. You have written the lay-friendly informative PR that PPHM(TCLN)never produced in the 20+ years I have owned this stock.I sincerely hope you have started a retail revolution.IMO shedding a light on the risk vs reward ratio vis a vis PPHM will hopefully attract enough long investors(like many of us on this board )to raise the share price so we can: 1) gain leverage in negotiations
2) increase visibility
3) decrease dilution
4) help cancer patients
5) give all who have supported this co. through the years a profit.I was in my early 40's when I first invested now I just turned 67. I get the "no pain no gain " concept but this is starting to get ridiculous. Father time knocks on everyones door even management's -bring this saga to a succesful conclusion in a reasonable timeframe(< 2018 ).
May I suggest you use your writing skills and scientific knowlege to pen a piece:
1) Explaining why bavi is unique ( upsteam,safety,M1 state inducer,multiple combo possibilities,imaging, non cancer applications)among the current crop of immunostimulatory drugs.
2) Explain why the FDA approved the NSCL phase 3 trial with "fast tract status" inspite of the sabotage of the phase 2 trial.Why many of usbelieve that the statistics involved with the 3 mg. dose vs the revamped control arm indicates that bavituximab is far superior to the soc.
Once again thanks-just the right amount of professionalism and sizzle.
Someone straighten me out. I understood that the MDSC'S could be good or bad. Bad(m2 state) if they are educated( DR. BREKEN'S WORD) by PS but good(m1 state) if educated by BAVI covering PS.
Why ellicit more PS with chemo or radiation if covering it just brings us back to where we would have been without the extra PS ?
The more BAVI covered PS the more MDSC'S are turned into good guys.
Where am I going wrong ?
Anyone know what company is running the phase 3 NSCLC trial ?
Sorry for your loss CJ-Thanks for all you do.
Totally agree-InternetForumUser- "encouraging" sounds weak at best "outstanding" would have been so much better.
When is this company going to present a P.R. that clearly delineates it's products ? A P.R. that captures the imagination of the retail investing public is certainly possible at this point and was possible years ago. Are there any other compounds similar to BAVI that are in trials for both cancer and viral indications ? There are people ( Jerod Swan, Freddie Sanford, Phil Marfuta )that developed brain cancer that should be dead from a statistical stanpoint but were kept alive because of Cotara. Why hasn't our P.R. firm obtained major media coverage for this and the "outstanding" Bavi results of today ? No one should be deceived by false hope---especially cancer patients---but the statistics involved with the phase 2 trials already completed for Oncolym (Yes Oncolym), Cotara, and now Bavi speak for themselves. The F.D.A. has already approved Oncolymn and Cotara for phase 3. Tustin has done a good job advancing the science through trials inspite of their horrid financial management.Advertise now Tustin--get the share price up so if we have to do "whatever" we might be able to get some leverage for product negotiations-some stability through greater institutional ownership. Don't wait till the last minute. Even if our share price eventually goes to 100 there is/was no excuse for our current share price. Longs have shouldered the burden for too long.
I am invested in this company for many reasons---profit certainly being one of them. Eventually I believe we will get to the "Promised Land" (in spite of management because of the science) but pphm sure does lend credence to the "no pain no gain(?) theory."
It's long past due for Tustin to present P.R.'s that are--- lay comprehensible ---that have clear product implications both financial and medical---that make suitable comparisons to our competition---that are worded with the kind of sizzle that shows the company is enthused about it's products ( Say what you want about Ed Legere he at least was animated, openly excited, and more accessible.)
WAKE UP TUSTIN !!!!!
Lost since 1991 in the wilderness that is pphm/tcln. Good luck to us all.
Peregrine Pharmaceuticals (PPHM) Stock Trading Info:
PPHM Stock Quote PPHM Level 2 PPHM Stock Charts PPHM News PPHM Stock Trades PPHM Financial
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Entdoc,Ftm,Sulaco,Mojojo,Cigaddy---If I am reading this correctly the tumor surface as well as it's vasculature exhibits PS.Therefore Bavi should also bind the PS on tumor surfaces. If PS is not exposed on tumor surfaces to any appreciable degree what masks the tumor itself from immune system attack ?
I am a non scientist just trying to somewhat understand the science.
NYAS 5-1-12 Meeting Report - Speaker: Philip Thorpe, UTSW-MC/Dallas
HIGHLIGHTS
• Bavituximab, an antibody drug in development by Peregrine Pharm., targets PS in tumor blood vessels and can reactivate immunity to cancer cells.
• This antibody can serve as both an imaging agent and as an adjuvant treatment with other therapies.
• Bavituximab can induce tumor-specific T-cell immunity in some situations.
TARGETING TUMOR VASCULATURE
Taking advantage of the externalization of PS on tumor cells could provide new treatment strategies for cancer treatments. Philip Thorpe of UT Southwestern MC (Dallas) described preclinical & clinical studies of bavituximab, an antibody drug developed by Peregrine Pharmaceuticals that targets PS in the vasculature of tumors. As tumors develop, they create a stressful, hypoxic cellular environment that results in the formation of reactive oxygen species and the release of inflammatory cytokines. In this environment, the asymmetry of lipid distribution in the membrane of the endothelial cells that line tumor blood vessels breaks down, leading to the externalization of PS. In addition, PS is often exposed on the surface of tumor cells. As a strategy for targeting PS externalization, Peregrine Pharm. initially developed a mouse monoclonal antibody that targets PS by binding to 2 molecules of B2-glycoprotein-I that in turn bind to PS on the surface of cells. With only a single molecule of the protein, binding to the surface of cells is relatively weak, but the affinity increases by a factor of 30,000 with the addition of a second molecule of B2-glycoprotein-I. The researchers have constructed a series of antibodies that targets the tumor vasculature. Two are mouse antibodies, 3G4 & 2aG4. Bavituximab is a chimeric antibody with mouse PS binding regions fused to human IgG. The fully human antibody is known as PGN635. These antibodies localize specifically to the blood vessels in tumors, which makes them useful as imaging agents. Studies with normal tissues and various tumor types reveal that these antibodies show affinity for a range of tumor types but minimal binding to a variety of normal tissues.
It's time for the PR dept to earn their keep. If immunotherapy drugs are the stars of ASCO then our story and what sets us apart from all the other contenders needs to be told and explained in a LAY FRIENDLY WAY. If more retail investors understood BAVI's potential we might be able to raise our share price so that larger financial institutions could buy in and stabilize the share price. We should also expect a better deal for a partnership/buyout if we negotiate from a higher base price.
PR dept it is time to get all your media ducks in a row.
For those who do not know PPHM owns shares in a Chinese company
that is and has been treating patients in China with one of our TNT products ( VIVATUXIN - TNT 3 AND I131 )and LYM 1.
Anyone have any idea how much these shares are currently worth in USA dollars ?
Peregrine Pharmaceuticals, Inc. (the “Company”) entered into a Settlement Agreement and Mutual General Release dated June 4, 2009 (the “Settlement Agreement”) with Cancer Therapeutics Laboratories (“CTL”), Alan Epstein, M.D. (“Dr. Epstein”), Clive Taylor, M.D. and Peisheng Hu, M.D. (collectively, the “CTL Parties”), providing for a settlement and release of all claims with respect to our previously disclosed litigation with the CTL Parties. The dismissal of claims was filed in the Superior Court of the State of California for the County of Orange on June 18, 2009. Medibiotech Co., Inc. (“Medibiotech”) and Shanghai Medipharm Biotech Co., Ltd. were once parties to the litigation but previously settled with us.
Under the Settlement Agreement, we agreed to dismiss with prejudice our claims for breach of contract and interference with contractual relations, as well as all other causes of action, stemming from our 1995 license agreement, as amended, with CTL. CTL agreed to dismiss its breach of contract counterclaim, as well as all other causes of action. In connection with the Settlement Agreement, (1) the Company agreed to pay to CTL the sum of four hundred thousand dollars ($400,000) in eight equal monthly installments of fifty thousand dollars ($50,000) commencing upon execution of the Settlement Agreement and continuing on the first business day of each succeeding month until paid in full, (2) CTL agreed to cause to be issued to the Company 950,000 shares of Medibiotech (which represents fifty percent (50%) of the shares of Medibiotech owned by CTL), and (3) the Company and Dr. Epstein entered into a license agreement, effective as of September 20, 1995, pursuant to which Dr. Epstein granted to the Company (i) a fully paid-up, royalty free, exclusive worldwide license to the murine clone TNT1 and (ii) a fully paid-up, royalty free, non-exclusive worldwide (except in the Peoples Republic of China) license to the murine clones TNT2 and TNT3. The foregoing license grants include our right to grant sublicenses, to make, have made, modify, have modified, use, sell and offer for sale, murine clone TNT1, TNT2 and TNT3 products and derivatives thereof, but not to sell the murine clones. We also granted back to Dr. Epstein a limited, fully paid-up, royalty free, exclusive license to the murine clone TNT1, with the right to grant sublicenses, to make, have made, modify, have modified, offer to sell, sell and use the murine clone TNT1 and its products solely in the Peoples Republic of China effective as of August 29, 2001. In consideration for the foregoing license grants, we paid Dr. Epstein the sum of one thousand dollars ($1,000), which amount was deducted from the initial $50,000 payment.
The Settlement Agreement contains a full general release between the Company and the CTL Parties of all action or actions, causes of action, in law or in equity, suits, debts, liens, contracts agreements, promises, liability, claims, demands, damages, loss, cost or expense, of any nature whatsoever, known or unknown, fixed or contingent, by reason of any act, omission, cause, matter or thing whatsoever from the beginning of time.
Information contained herein shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
PEREGRINE PHARMACEUTICALS, INC.
Date: June 19, 2009
By:
/s/ Paul J. Lytle
Paul J. Lytle
Chief Financial Officer
-------------------------------------------------------------------
I took this post from Terry D ( Silicon Investor ) .
Medipharm seems to be doing Okay. Looks like LYM-1 (AKA Oncolym) is still a go for Medipharm. They also have the TNT fusion protein technology licensed from USC. I wonder just how much of the TNT technology Peregrine still controls or if we get any royalties from the part Medipharm has.
Shanghai MediPharm Biotech is a wholly-owned subsidiary of Medipharm Biotech Biopharmaceutical Ltd (Bermuda) focused on becoming China’s leading oncology biopharma by providing novel, antibody-based, targeted radio immunotherapy for malig-nant cancers. Following 15 years of R&D in antibody related biopharmaceuticals, the company has a strong intellectual prop-erty portfolio, including Vivatuxin®, a chimeric tumor necrosis therapy approved by China’s State Food and Drug Administra-tion for lung cancer and launched in 2007, as well as other can-didates in radio immunotherapy. Through a strategic marketing collaboration study with the Ministry of Health of China currently covering 101 hospitals, the company has agreements to supply 20,000 doses of Vivatuxin®, priced at $3,000 each, used for the treatment of advanced lung cancer patients, who have previ-ously failed at least one course of chemotherapy, and is negotating collaboration with additional 50 hospitals. Furthermore, as the first radio immunotherapy for solid tumors in the world and a potential therapy for all malignant solid tumors,
Vivatuxin® is undergoing Phase III clinical study registrations for glioma and liver cancer, as well as preclinical trials for colorectal and breast cancers.
Finally, the company has two exclusive licenses in radio immunotherapy technology platforms from University of Southern California Cancer Therapeutic Lab, namely Lym-1 for non-Hodgkin lymphoma, which started Phase I clinical trials in 2010, and TNT fusion protein technology for solid tumors. Currently, MediPharm has a staff of 53 professionals, and with 105,000 square feet GMP-approved world class manufacturing facilities, which include a 500L B. Braun bioreactor, the company has the capacity to produce 100,000 drug doses per year.
http://www.wallstreetresearch.org/
--------------------------------------------------------------
SiliconInvestor
Advanced Search [ sign in ]
register
An important announcement for Silicon Investor members and an introduction from Craig Longhurst
Biotech / Medical : Peregrine Pharmaceuticals, Inc.( PPHM)
Public Reply | Prvt Reply | Mark as Last Read | File Previous 10 | Next 10 | Previous | Next
To: Terry D. who started this subject 1/18/2004 5:25:22 PM
From: cjgaddy of 3711
CHINA TNT Refresher: Interim Lung Results 6-2002
6-19-2002: “INNOVATIVE ADMINISTRATION OF RADIOLABELED TNT SUCCESSFULLY TREATS INOPERABLE LUNG CANCER
TNT Data Presented at Society of Nuclear Medicine’s 49th Annual Meeting”
http://www.peregrineinc.com/prelease.asp?id=6190271436
June 19, 2002 - Peregrine Pharmaceuticals Inc. announced today detailed results from clinical research conducted in China that show 56% efficacy was achieved when patients with inoperable lung cancer were treated with the company's 131iodine labeled chimeric TNT (131I-chTNT) antibody drug using an innovative method of intratumoral injection. Patients treated by this method had a disease control rate of 100%, demonstrating 131I-chTNT can achieve significant therapeutic effects in late stage lung cancer. The results provide substantial validation of Peregrine's proprietary TNT technology, which is a radiolabeled monoclonal antibody that targets the necrotic core of solid tumors. The interim lung cancer data were presented at the Society of Nuclear Medicine's 49th Annual Meeting in Los Angeles. The study was independently designed and conducted by researchers at the Shanghai Tumor Hospital.
The Phase I/II study compared the efficacy of three different methods of administration of 131I-chTNT for patients with inoperable late stage lung cancer: intravenous, intratumoral, and a combination of intravenous plus intratumoral injection. The results demonstrated that the method of intratumoral injection alone achieved a 56% complete and partial tumor remission rate. The combined intravenous plus intratumoral injection method achieved 40% and the intravenous method alone achieved 9% tumor remission rate. The disease control rate for all three methods of treatment, including complete and partial remission and stable disease, was 88% for the 43 patients assessed in the study. The highest therapeutic effect was obtained by using common bronchoscopy and computer tomography (CT) scan instruments in a new technique to directly infuse the tumor with lethal doses of 131I-chTNT.
"Peregrine is reviewing the intratumoral injection techniques used to maximize delivery of radiolabeled TNT to the tumor while minimizing healthy tissue exposure. This will assist us in designing a lung cancer study in the USA," said Edward Legere, CEO of Peregrine Pharmaceuticals. "By using standardized equipment that is routinely used at medical centers around the world, it is possible the treatment could be widely adopted by oncologists treating late stage lung cancer patients."
"This data highlights the promise of TNT for the treatment of late stage lung cancer," said Alan L. Epstein, M.D., Ph.D., co-author of the lung cancer research, inventor of the TNT technology, and Peregrine's scientific consultant. "In this study, intratumoral injection caused substantially higher complete and partial remission rates than the other methods of administration. Given there are no effective treatments for inoperable late stage lung cancer, there is a significant unmet need for new therapies. Directly infusing the drug into the tumor mass may also reduce the systemic toxicity often seen with intravenous administration of radionuclides."
With a population of approximately 1.3 billion, China is a vast market for cancer therapy. Cancer became the main cause of death in China in 1996, with over 7.3 million new cases and just over 3 million deaths annually from cancer in China. The explosion in the number of cases of lung, breast, colon and rectal cancer was caused partly by the aging of China's population. In the USA, there were approximately 170,000 new cases of lung cancer in 1999, making it the most common cancer in the Western world. According to the American Cancer Society and the World Health Organization, since the mid-1990s, about 150,000 Americans have died each year from the disease. Lung cancer is the leading category of cancer death in men, and - since the late 1980s - it has surpassed breast cancer as the leading category of cancer death in women.
Summary of Clinical Study for Lung Cancer:
The poster summarizing the unaudited results of this Phase I/II study can be accessed on Peregrine's web site at:
http://www.peregrineinc.com/Technology.asp?id=Posters+and+Abstracts
As previously announced, a total of 43 patients enrolled in this study had a cytological and histological confirmed diagnosis of stage IIIb (30/43) or IV (13/43) inoperable lung cancer. As confirmed by fine needle biopsy, 24 patients (56%) had a diagnosis of adenocarcinoma, 12 patients (28%) were diagnosed with squamous carcinoma, six patients (14%) with small-cell lung cancer, and one patient (2%) with adeno-squamous carcinoma.
22 patients in the first group were administrated 131I-chTNT by intravenous drug infusion, 16 patients in the second group were administrated by intratumoral injection, and five patients in the third group received both treatments. The dose for each patient was 0.8 mCi/kg, which was repeated two weeks later. Patients receiving intravenous administration were given a total dose of 131I-chTNT delivered in 250 ml of normal saline through a free-flowing intravenous line. For the second group, the intratumoral injection of TNT was directed by thoracic CT guided catheter using a multiple-hole needle. The CT images clearly showed tumor localization, the needle pathway, and the site of administration. In the third group, 75% dosage was given by intratumoral injections and 25% by intravenous infusion.
Partial remission (PR) was defined as a greater than 50% reduction in tumor mass in all lesions and complete remission (CR) as no detectable tumor for greater than 10 weeks. Patients receiving intravenous injection alone had two PR (9%), 16 had stable disease (73%), and four progressed (18%). Those receiving intratumoral injection had one CR (6%), 8 PR (50%), seven had stable disease (44%), and zero progressed. Finally, those in the third group had one CR (20%), one PR (20%), two had stable disease (40%), and one progressed (20%). Toxicity was limited to mild and reversible bone marrow suppression in 20 cases.
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Thanks Exwannabe for your reply. PPHM already has a conjugated TNT product ( NHS-76 HUMANIZED TNT CONJUGATED WITH MODIFIED HUMANINTERLEUKIN 2-IL-2LT )in cinical trials run by licensee Merck KGaA.
Home > Boards > US Listed > Biotechs > Peregrine Pharmaceuticals (PPHM)
PPHM licensee Merck KGaA adds 2nd Ph.1 trial
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cjgaddy Member Profile cjgaddy
Sunday, May 24, 2009 12:15:21 PM
Re: None
Post # of 110617
PPHM licensee Merck KGaA adds 2nd Ph.1 trial for SELECTIKINE, this one for Selectikine+RAD vs. NSCLC in The Netherlands. Recall that “SELECTIKINE” is the brand name for the TNT-based immunocytokine fusion protein “NHS-IL2-LT (EMD 521873)”, which Merck KGaA licensed from Peregrine in 2000. In Dec.2006, Merck began its 1st Ph.1 trial (Selectikine+Chemo vs. Solids-Tumors or NHL) at 2 sites in Switzerland.
2nd SELECTIKINE PHASE I TRIAL:
“EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)”
Phase I: This study is not yet open for participant recruitment.
First Received: April 10, 2009, Sponsored by: Merck KGaA
Est. Enrollment: 12
Study Start Date: April 2009
Est. Completion Date: March 2010
Location: Netherlands, Dept. of Thoracic Oncology, Netherlands Cancer Instiute
http://clinicaltrials.gov/ct2/show/NCT00879866
History of the Merck KGaA licensing arrangement:
I. 10-2000 MERCK-KGAA (GERMANY) TNT-BASED “CYTOKINE FUSION PROTEINS” LICENSING AGREEMENT:
$400k upfront plus future milestone payments and royalties on net sales…
10-23-2000 PR: “Techniclone & Merck KGaA Sign Agreement On Use of Tumor Necrosis Therapy Technology”
… Under the agreement, Techniclone will grant Merck the right to use its proprietary TNT antibodies for producing immunocytokines - novel antibody-cytokine fusion proteins used in the treatment of various diseases...
http://tinyurl.com/rbo62u
4-30-2001 10K:
TUMOR NECROSIS THERAPY (COTARA)
“During Oct.2000, the Company entered into a licensing agreement with Merck KGaA to license a segment of its TNT technology for use in the application of cytokine fusion proteins. Under the terms of the licensing agreement, the Company will receive up-front payments of up to $400,000 upon the satisfaction of certain conditions set forth in the agreement, of which, the Company received $50,000 in Nov.1999. The Company will also receive a royalty on net sales, as defined in the agreement, upon the commencement of commercial sales.”
http://tinyurl.com/ostw9a
II. 4-2004: MERCK-KGAA PRESENTS NHS76:IL-2 (SELECTIKINE) AT AACR’04:
AACR 2004 Abstract #654: “Engineering of an IL-2 Immunocytokine with Very Low Toxicity That Retains Potent Anti-Tumor Activity in Immune Competent and Immune Deficient Mouse Tumor Models”
Stephen D. Gillies… Kin-Ming Lo, EMD-Lexigen Research Center [subsidiary of Merck KGaA]
The use of IL-2 for cancer therapy has been limited by its side effect profile that primarily includes effects in the vascular compartment such as vascular leak syndrome and hypotension… In our studies of IL-2 toxicity we have identified a specific IL-2 mutant, D20T, which has little selectivity for high over intermediate affinity IL-2 receptors as a free IL-2 molecule but which has profound selectivity when it is fused to the carboxyl terminus of an antibody to form an immunocytokine… The final molecule was engineered using the V regions from a human antibody, NHS76, with high affinity for the necrotic core of solid tumors, thus allowing for selective targeting of this modified IL-2 to virtually any tumor with necrosis… Studies in several mouse tumor models demonstrate that this immunocytokine, NHS-IL2 (D20T), is extremely well tolerated in immune competent mice and retains most of its anti-tumor activity against established metastases…
http://tinyurl.com/pxl2aa
III. 2-2007: MERCK/GER 1ST PH.1 TRIAL OF SELECTIKINE+CHEMO VS. SOLID-TUMORS OR NHL:
2-22-07 PR: “Peregrine's Licensee Initiates Phase I Clinical Trial in Europe With Novel Tumor Necrosis Therapy Cancer Agent”
http://pphm.client.shareholder.com/releasedetail.cfm?ReleaseID=266050
PH.1 Trial Protocol: Selectikine (EMR 62235-001)
“A Phase 1, Open-Label, Two-Group, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of EMD 521873 Alone and in combination With Fixed Low Doses of Cyclophosphamide in Patients With Metastatic or Locally Advanced Solid Tumors or B-Cell non-Hodgkin Lymphoma”
Sponsor: Merck KGaA, Darmstadt, Germany
Local Principal Investigator: Dr. R. Stupp
http://www.cancer-chuv.ch/ccl_zoom_merck_selectikine.pdf
5-2007: 2nd SELECTIKINE site added, Univ. of Lausanne, Switz: http://tinyurl.com/2l933s
Site1: Oncology Institute of So. Switzerland, Bellinzona, Switzerland
Site2: Multidisciplinary Oncology Center, Univ. of Lausanne Hospital (CHUV), Lausanne, Switzerland http://tinyurl.com/pthokh
IV. 4-2008: LAUSANNE HOSP. (SITE #2) GIVES UPDATE ON SELECTIKINE PH.1 TRIAL:
2007 ANNUAL SCIENTIFIC REPORT – 4-8-08
Prof. C. Ruegg, Head, Div. of Experimental Oncology (DEO)
2. RESEARCH PROJECTS
2.2. Cancer immunotherapy with tumor-specific T lymphocytes
#9: “Characterization Of Cellular Immune-Responses In Cancer Patients Treated With The Immunocytokine Selectikine, An IL2/Anti-DNA Fusion Protein”
J. Laurent, P. Romero, R. Stupp, and D.E. Speiser
Selectikine (EMD 521873) is a fusion protein consisting of a human antibody fused to 2 molecules of a genetically modified human interleukin-2 (hIL2). Preclinical data suggest that immunocytokines exert antitumor-activity via CD8 T cell mediated mechanisms. Experiments in mice with the wild-type-IL2 containing immunocytokine ch.14.18-IL2 demonstrated CD8 T cell responses against tumors. Other experiments with ch14.18.IL2 showed that immunocytokine-treatment induced clonal expansion of T cells. Since 2007, 20 patients have been treated with escalating doses of selectikine from 0.075 mg/kg to 0.6 mg/kg. Analysis of T cell populations revealed an increase of proliferation and activation state of CD8 and CD4 T cells, but no significant effect on natural killer cells as expected. No dose depending effect has been observed between the different groups, showing that T cells react well already at low doses. Analysis of sub-populations of CD4 T cells revealed that T-reg cells are also sensitive to Selectikine, likely due to their expression of the high avidity IL2 receptor CD25. As a consequence, T-reg cells proliferate considerably upon treatment with Selectikine. Functional analysis of T cells, including T-reg cells are ongoing (Study Sponsored by Merck KGaA, Darmstad & EMD Pharmaceuticals Durham, USA).
http://www.cancer-chuv.ch/ccl_home/ccl_recherche/annual_scientific_report.htm
V. 6-2008: MERCK-KGAA PROFILES SELECTIKINE IN FACT SHEET:
Early Stage Products…
• NHS-IL2-LT (EMD 521873) – this immunocytokine delivers a localized high dose of a genetically modified human interleukin 2 (IL-2LT) to the dead and dying cells, which are found in the center of solid tumors. This activates a cellular immune response. The antibody part of the molecule is designed to target DNA, which is released by necrotic cells. The resulting immune response is expected to kill viable tumor cells surrounding the necrotic regions. NHS-IL2-LT is currently in Phase I trials for solid tumors.
ORIG-LINK: http://www.merck.de/servlet/PB/show/1803080/IR_About%2520Merck.pdf
VI. 9-2008: EMD-SERONO (SUBSID. OF MERCK-KGAA) PRESENTS SELECTIKINE:
9-18-08 4-5:30pm: “DF/HCC Pipelines in Oncology: EMD Serono”
Dana-Farber Cancer Institute, Boston
• Jens Oliver Funk, MD, Senior VP, Merck Serono Res.; Global Head TA Oncology
• Frank T Weber, MD, PhD, Senior VP, Merck Serono Res., Head of Exploratory Medicine
• Oscar Kashala, MD, PhD, DSc, Senior Medical Dir., Dev., Head US Oncology Dev.
PROGRAMS/PRODUCTS PRESENTED:
• Erbitux
• Cilengitide - Cyclic RGD peptide integrin inhibitor
• DI17E6 - Anti- Integrin Antibody
• Stimuvax - Therapeutic MUC-1-based cancer vaccine
• Survivac - Therapeutic survivin-based cancer vaccine
• Selectikine - NHS-IL2-LT immunocytokine
• Aurora Multikinase Inhibitor (AS703569)
• MEK Inhibitor (AS703026)
http://tinyurl.com/phmeac
VIi. 4-2009: MERCK-KGAA ADDS 2ND PH.1 SELECTIKINE TRIAL:
“EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)”
First Received: April 10, 2009, Sponsored by: Merck KGaA
Est. Enrollment: 12
Study Start Date: April 2009
Est. Completion Date: March 2010
Location: Netherlands, Dept. of Thoracic Oncology, Netherlands Cancer Instiute
http://clinicaltrials.gov/ct2/show/NCT00879866
= = = = = = = = =
Note: Merch/KGaA vs. Merck & Co. - the similarities in the names of the two companies are a result of common roots in Germany, beginning with the purchase of the pharmacy Engel-Apotheke in Darmstadt in 1668 by Friedrich Jacob Merck. The American subsidiary Merck & Co. was founded in 1891 in the course of expansion. In 1917 Merck & Co. became an independent company with no relations to Merck KGaA.
http://www.merck.de/en/company/history/history.html
Peregrine Pharmaceuticals (PPHM) Stock Trading Info:
PPHM Stock Quote PPHM Level 2 PPHM Stock Charts PPHM News PPHM Stock Trades PPHM Financial
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KT Cotara is armed. The full potential of the TNT platform has barely been scratched. Those who are new to PPHM are only hearing about Cotara in relation to GMB,but Cotara can be used on all solid tumors. Cotara was to be used with VEA technology .
May 19, 2004
Peregrine Pharmaceuticals Announces Patent Grant for Vasopermeation Enhancement Technology
TUSTIN, Calif., May 19 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals (Nasdaq: PPHM) announced today the issuance of U.S. Patent No. 6,737,064, entitled "Method for the diagnosis of neoplastic tissue comprising administering a vasopermeability enhancing peptide of human interleukin-2," which covers methods for using a portion of the cytokine interleukin-2 known as Permeability Enhancing Peptide (PEP) to enhance the diagnosis of cancer. The PEP technology has been exclusively licensed to Peregrine and is part of its Vasopermeation Enhancement Agents (VEA) technology platform which is used to enhance existing cancer therapeutic and diagnostic agents.
"These new method claims extend our coverage to use VEAs for enhancement of diagnostic agents," said Steve King, Peregrine's president and CEO. "We believe there is a significant commercial potential for VEA agents and this patent is a valuable addition to the VEA patent portfolio."
In published reports, scientists have seen an almost 400% increase in the normal amount of chemotherapeutic agent taken up by solid tumors with a VEA pre-treatment. In pre-clinical studies, Peregrine's VEA technology has been shown to significantly improve the effectiveness of chemotherapeutic agents including Doxorubicin, Taxol, Vinblastine, VP-16 and Taxotere in tumor therapy experiments. Data related to the VEA technology platform has been published in a number of peer reviewed journals, including, most recently, the "Journal of the National Cancer Institute" and the technology has been reviewed in "Lancet Oncology" and "Nature Reviews Cancer."
Peregrine's primary research focus is to develop agents that act on tumor blood vessels for therapeutic and diagnostic purposes. VEAs are agents that make tumor blood vessels selectively leaky, allowing more of an administered therapeutic or diagnostic agent to reach the tumor. Peregrine is currently evaluating VEAs that utilize its human TNT targeting platform linked to the PEP molecule as pre-clinical candidates which may make it possible to use a single VEA as a pre-treatment for a variety of different tumor types and chemotherapeutic agents. Additional information regarding Peregrine's VEA program and other useful information can be found on Peregrine's recently released website at http://www.peregrineinc.com.
About Interleukin-2
Of the numerous biological molecules currently under consideration for development as cancer therapeutics, few have been as severe in side effects as interleukin-2 (IL-2). IL-2 is a naturally occurring cytokine, which is produced by helper T lymphocytes. Cytokines are proteins in the body that stimulate and regulate the immune system. IL-2 is an important cytokine and occupies a central role in the augmentation of cell-mediated immune response. In addition to its cytokine activity, IL-2 has been shown to contain a domain which produces vascular permeability when administered systemically. This phenomenon is known as vascular leak syndrome (VLS). When IL-2 is used in a clinically effective dose for the treatment of cancer, it causes massive leaking of blood, fluids and serum proteins from the vascular network resulting, eventually, in organ failure. This toxic side effect has limited the clinical effectiveness of IL-2 for the treatment of cancer.
About Permeability Enhancing Peptide
The goal of Peregrine's research on IL-2 was to develop a drug compound that had the ability to induce vascular leak syndrome at, and only at, the tumor site. To achieve this, scientists at the University of Southern California identified the region of IL-2 that is responsible for causing vascular leak syndrome. This region was then synthesized and tested for suitability as a vasopermeability agent. Preclinical studies showed this region has 100% of the vasopermeability activity of intact IL-2 but lacked its cytokine activity. This proprietary new compound is called Permeability Enhancing Peptide (PEP) and Peregrine has exclusively licensed it from the University of Southern California. By attaching PEP to a monoclonal antibody (MAB) that targets tumors, Peregrine's scientists are able to localize vascular leak syndrome only at the tumor site.
About Vasopermeation Enhancement Agents
Barriers to Existing Cancer Therapies
Drugs that target cancer cells must overcome a significant number of structural barriers within the tumor in order to be effective. They must first exit the tumor blood vessels, migrate past the support structures that underlie the vessels and eventually make their way to the cancer cells. As a result of these structural barriers, very little drug injected into the blood stream of a patient is able to reach and destroy cancer cells. One potential solution to this problem is to increase the permeability of the blood vessels within the tumor which will permit more therapeutic drug to reach and kill substantially more cancer cells.
Mechanism of Action
Vasopermeation Enhancement Agents (VEAs) are a class of drugs which are designed to increase the uptake of cancer therapeutics and imaging agents at the tumor site, resulting in greater efficacy. VEAs work by using monoclonal antibodies (MABs) to deliver known vasoactive compounds (i.e. molecules that cause tissues to become more permeable) selectively to solid tumors. Once localized at the tumor site, VEAs alter the physiology and the permeability of the vessels and capillaries that supply the tumor. In pre-clinical studies, VEAs have improved drug uptake up to almost 400% in solid tumors. VEAs may be used as either pre-treatments or potentially as part of the therapeutic molecule for therapy and imaging of cancer.
About Peregrine Pharmaceuticals, Inc.
Peregrine's research and development efforts focus on discovering and developing products that affect blood flow to tumors. Peregrine's vascular research programs fall under several different proprietary platforms including Anti-Phospholipid Therapy (APT), Vascular Targeting Agents (VTAs), anti- Angiogenesis and Vasopermeation Enhancement Agents (VEAs). The company has research collaborations with pharmaceutical and biotechnology companies to develop its VTA platform for therapeutic and diagnostic applications and expects to enter its first APT compound into clinical trials for cancer therapy during calendar year 2004.
Peregrine's vascular agents may also have applications in other angiogenesis-dependent diseases besides cancer such as diabetes, arthritis, skin disorders and eye diseases. Peregrine currently has exclusive rights to over 190 U.S. and foreign patents and patent applications that broadly cover its vascular programs. In addition, the company is currently evaluating its proprietary technology for use in treating non-angiogenesis dependent diseases such as viral infections. The company believes that the pre-clinical data generated by the company and the broad nature of its intellectual property may provide many opportunities for product development, partnering and licensing.
Peregrine's most clinically advanced therapeutic program is based on a targeting platform outside vascular biology. This technology platform is known as Tumor Necrosis Therapy (TNT) and targets dead or dying tumor cells that are common to the majority of different tumor types. Cotara™, the most clinically advanced TNT program, is currently in a Phase I clinical trial for the treatment of colorectal carcinoma at Stanford University Medical Center. In addition, we have received protocol approval from the U.S. Food and Drug Administration ("FDA") to initiate a registration clinical study for the treatment of brain cancer. The company is currently seeking a development or funding partner to move the brain cancer program forward. The company believes that continuing the clinical development of Cotara™ in tumor types other than brain cancer will add significant value to the program. The company has a research collaboration to develop immunocytokines based on the TNT platform and a TNT based agent has been developed and approved for the treatment of lung cancer in China under a licensing agreement.
The company also operates a cGMP contract manufacturing facility for monoclonal antibodies and recombinant proteins through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com). Avid produces clinical trial materials to support phase I through phase III clinical trials for biotechnology companies including Peregrine. Copies of Peregrine press releases, SEC filings, current price quotes and other valuable information for investors may be found on the website http://www.peregrineinc.com.
Safe Harbor Statement: This release may contain certain forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the company's expectations as a result of risk factors discussed in Peregrine's reports on file with the U.S. Securities and Exchange Commission, including, but not limited to, Peregrine's report on Form 10-Q for the quarter ended January 31, 2004 and on Form 10-K for the year ended April 30, 2003.
SOURCE Peregrine Pharmaceuticals, Inc.
05/19/2004
CONTACT: Frank Hawkins and Julie Marshall, both of Hawk Associates Inc.
+1-800-987-8256 or info@hawkassociates.com
for Peregrine
Web site: http://www.peregrineinc.com
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Ftm Bavituximab may need BGP21 to bind to PS but pgn632 is BGP21 independent.
re
Genentech studying Imaging using PGN635(Fhu-Bavi): 10-12-12 article...
Genentech studying Imaging using PGN635(Fhu-Bavi) for the potential “detection of tumor response to therapy”. 9 Genentech co-authors of new paper pub. 10-12-2012 in Nuclear Medicine & Biology, which acknowledges Dr. Philip Thorpe & Peregrine, and states in the article, “the presented PS-targeting antibody (89Zr-PGN635) has a potential to become a broadly applicable imaging agent indep. on cancer type since PS is a generic component of the plasma membrane.”… [Thanks, FTM – great find]…
Note: 89Zr-PGN635 is a different imaging agent than used in the ongoing Imaging trial, which uses 124I-PGN650 ( http://clinicaltrials.gov/ct2/show/NCT01632696 ).
…Recall:
• PGN635 is Fully-Human Bavituximab=1N11=AT004 (B2GPI-depen.); Genentech studying 89Zr-PGN635 as a Tumor Imaging Agent, “indep. of cancer type”
• PGN632 is the Duke-PPHM-HIV candidate=11.31=AT005 (B2GPI-indep.); also being studied by PPHM+LSU vs. Ocular Herpes (Acute HSV-1 Keratitis), see http://tinyurl.com/cax9a4p
• PGN650 is a human F(ab’)2 fragment that targets PS expression (1st ref’d in AACR’12 #2452) – see http://tinyurl.com/76nqqkm . 124I-PGN650 is Peregrine’s PS-Imaging candidate, whose IND clinical filing was announced 4-3-12, and whose n=12 trial started 6-2012.
- - - - - - - - -
Note: PGN632 (Duke/HIV preclin’s) binds to PS indep. of B2-glycoprotein I (B2GPI), unlike Bavi & FH-Bavituximab(PGN635) which depend on B2GPI as a binding intermediary.
=
Entdoc I do not post much but I am an avid ( no pun intended )reader of this board. I read an article in New York's Newsday in 1991 about the TNT antibody that was being developed by this little obscure company called Techniclone ( PPHM today ).It caught my imagination so I bought in and have held ever since.
To paraphrase another poster " green at last thank God I'm green at last."
PS Thanks for all that you contribute to the board.
Imagine VEA to prep the way for the targeted radiation of Cotara.PS is then released on a grand scale permitting Bavi to send those cancer cells back to hell where they belong
COTARA-( I131 CH T.N.T.1/B ) is the fusion of a
radioactive particle-( iodine 131 ) and a monoclonal
antibody-( T.N.T. ). Radioactive iodine 131 gives off a
lethal burst of gamma rays within a 300 cell radius. The half life of I131 is approximately 8 days and it does not degrade off the antibody for approximately 10 days.
The Tumor Necrosis Targeting agent-( T.N.T. ) is the vehicle that carries iodine 131 to the cancer cells. because it is a chimeric antibody-( part mouse part human )allergic reactions are minimal. T.N.T. homes in on necrotic tissue found in the core of all solid based tumors. Cancer cells have leaky spots that allows
Cotara entrance-(normal cells do not ). Cotara is too large to fit through the outer membrane of a normal cell-( which also has some but relatively small amounts of necrotic tissue at its core ). Cotara is unique in that it is the only therapeutic agent that will attack ANY solid based tumor large enough to have a necrotic core and leave healthy tissue alone. Other monoclonal antibody therapies are geared for particular cancers - Cotara will seek out and deliver its deadly cargo to ALL solid based tumors.
Many monoclonal antibodies rely on finding and latching
on to specific docking sites found on the surface of cancer cells. If the antibody does not " overwhelm " the tumor then the disease is poised for a comeback. If the docking sites are used up and/or cell surface mutations have altered the sites then what at first appeared to be an effective modality will now be relatively useless. In contrast Cotara becomes more effective with each subsequent dose, since after each application more and more necrotic tissue forms thus presenting a larger and larger target.
Because our docking site is at the core of the tumor the problems associated with the lack of cell surface docking sites and/or mutations are eliminated.
Cotara does not merely interfere with cellular machinery. It is a powerful treatment that will incinerate more and more of the tumor from the inside out -( and send those toxic cells back into hell where they belong ).
According to Dr.Patel there has been some swelling associated with Cotara when used in treating a form of brain cancer. The problem was however manageable when steroids were used.
M.A.T.-( MODIFIED ANTIBODIES TECHNOLOGY) I copied this from an old Yahoo post. This is the "B" in
I131 CH T.N.T./B.
by: ownotshort (64/M/Seattle,WA) 07/19/99 01:20 pm
Msg: 27817 of 256647
" Techniclone scientists discovered that when a small organic molecule like the vitamin biotin is attached to a monoclonal antibody it decreases its electrical charge. Decreasing the electrical charge of the antibody dramatically influences the way the antibody travels in the blood stream. The positive electrical charge of an un-modified antibody gives it a sticky characteristic that causes it to stick to capillary walls as it passes through the blood stream. This stickiness causes delayed antibody circulation, decreased tumor uptake and increased antibody clearance time (time it takes the antibody and toxic payload to clear from the blood stream). Increased clearance time results in higher toxicity.
Decreasing the antibody clearance time may dramatically reduce the toxicity of many, if not most, monoclonal antibody/toxic drug therapies. The increase in monoclonal antibody uptake at the tumor site should result in an increase in drug efficacy. Monoclonal antibodies using TCLN s MAT clear from the bloodstream in half of the time of normal antibodies and produce a 2-3-fold increase in antibody/tumor uptake.
Do we still own the rights to VEA tech ?
TECHNICLONE ISSUED PATENT ON VASOPERMEATION ENHANCEMENT.
Feb, 2000
Biotech Business
Techniclone Corporation (NASDAQ:TCLN), Tustin, Calif., has announced that the U.S. Patent Office has granted a US Patent No. 6007817 for Techniclone's Vasopermeation Enhancement Agent ("VEA") technology. The VEA technology is one of Techniclone's platform technologies, which will be used to enhance drug uptake in solid tumors. This broad patent covers the use of the VEA agents for the treatment of all solid tumors in conjunction with chemotherapeutic agents, monoclonal antibodies, cytokines and other therapeutic agents.
The technology was developed to be administered prior to the administration of most existing cancer therapies. Preclinical studies in animal models have shown that drug uptake can be increased up to 400% in specific instances by using the VEA technology as a pretreatment.
http://www.entrepreneur.com/tradejournals/article/58674378.html
If I am reading this correctly it appears that Bavi has already been coupled with a cytokine. Are we still in an active relationship with Biotecnol? Were they working with humanized Bavi?
O.T. A poster mentioned the company Oragenics because J.Bonofiglio a former CEO of Techniclone(PPHM) is now their CEO.
Oragenics(ORNI.OB)appears to be floundering on the business side but their dental tech is an interesting read if nothing else. Like PPHM.they have game changing tech - one product already at Walgreens (Probiara)is a probiotic that crowds out cavity causing bacteria, but they also have a geneticlly engineered bacteria that with one 5 minute application will eliminate cavities for life.
December 14, 2006
Peregrine Pharmaceuticals and Biotecnol to Collaborate on Development of Immunocytokine Fusion Proteins for Cancer and Anti-Viral Indications
Builds on Peregrine's Recent Preclinical Studies Showing Anti-Phospholipid Immunocytokine Fusion Proteins Can Reduce Tumor Growth By Over 90%
TUSTIN, Calif. and OEIRAS, Portugal, Dec. 14 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted therapeutics for the treatment of cancer and hepatitis C virus (HCV) infection, and Biotecnol SA today announced a collaboration for the development of novel targeted immunocytokine agents for the treatment of cancer and other disease indications. The collaboration will apply technology from Peregrine's Vascular Targeting Agent (VTA) platform with Biotecnol's Tribody™ technology to engineer novel agents that fuse Peregrine's anti-phospholipid targeting agents to one or more cytokines in a Tribody format.
In September 2006 Peregrine reported new research showing that a novel fusion protein combining two proprietary Peregrine technologies--its anti- phospholipid and VTA platforms--with an immunostimulatory cytokine showed significant anti-tumor activity. The fusion protein reduced tumor growth in animal models by more than 90%, without showing evidence of the cytokine- induced toxicity that has limited the widespread therapeutic use of immunostimulatory cytokines such as interferon and interleukin. By fusing these cytokines with Peregrine's anti-phospholipid technology that directly targets tumor blood vessels, the combined fusion protein is expected to reduce both systemic toxicity and dosing frequency, while generating significant anti-tumor effects.
"This collaboration is an important step in developing clinical candidates that capitalize on the striking results we saw in tests of our fusion protein technology in animal cancer models," said Steven W. King, president and CEO of Peregrine. "Our anti-phospholipid platform is an ideal vehicle for targeting tumor blood vessels and delivering a cytokine payload with the goal of producing a very robust immune response while reducing systemic adverse events. We believe that Biotecnol's unique Tribody technology will contribute significantly to our ability to produce fusion protein drug candidates, and we therefore expect this collaboration to further broaden the potential of our proprietary VTA and anti-phospholipid platforms."
Biotecnol's Tribody technology uniquely allows engineering of multifunctional recombinant antibody derivatives, which utilize the natural in vivo heterodimerization of Fd fragments and light chains of a Fab fragment to form a scaffold upon which additional functions can be incorporated, such as additional binders, or cytokines, chemokines, growth factors, enzymes or protein toxins.
"This collaboration has great potential for designing superior immunocytokines based on the characteristics of our unique Tribody antibody engineering platform," said Pedro de Noronha Pissarra Ph.D., CEO of Biotecnol. "We believe that Peregrine has the proprietary technology and expertise to generate several antibody candidates for development as fusion proteins using our platform, with potential applications in oncology and infectious diseases. We are pleased to have the opportunity to contribute to the success of this project by providing a novel way to engineer these fusion protein candidates with unique properties and potentially safer profiles."
Under the collaboration, Biotecnol will engineer novel fusion proteins using one or more of Peregrine's anti-phospholipid antibodies or other targeting agents. The work will be performed as part of a research and development collaboration and is expected to result in a license agreement from Biotecnol to Peregrine for development and commercialization of the resulting agent or agents. Further details of the collaboration were not disclosed.
Peregrine's lead anti-phospholipid agent bavituximab is currently being studied in Phase l clinical trials in the U.S. for the treatment of solid cancers and chronic hepatitis C infection. In clinical data collected to date, bavituximab appears safe and well tolerated, and the company has reported promising signs of anti-viral activity in a Phase I HCV trial. Patient enrollment in a Phase Ib HCV trial has been completed, and a Phase lb solid cancer trial combining bavituximab and commonly-used chemotherapy regimens is now underway in India.
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 five separate clinical trials in cancer and HCV infection in the U.S. and India with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
About Biotecnol SA
Biotecnol SA is a biotechnology company focused on the development of biopharmaceutical products and has a special focus on the development of antibody-based therapeutics to treat life-threatening diseases such as cancer. Biotecnol has three types of proprietary antibody formats in development against various cancer targets. These formats are Tribodies™, Compact Antibodies and Armed Antibodies. Biotecnol is committed in building value by developing a diverse pipeline of antibody products to address unmet healthcare needs. Biotecnol applies its antibody technologies, product development and manufacturing experience to generate, support and potentially license out human antibody products. Biotecnol SA has a presence in the USA and carries out its product development activities via its fully owned subsidiary Biotecnol Inc. Through its facility in Portugal, Biotecnol leverages its business income by establishing in-house partner-led or collaborative programs, which provide Biotecnol a strong client-based activity and an established track record. Biotecnol uses its proprietary expression technology, cell line development capabilities, upstream and downstream processing, analytics and QC experience for delivering GMP/GLP compliant processes for biomanufacturing.
Safe Harbor Statement:
Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that the results of clinical trials involving the fusion protein will not correlate to the results evidenced in the preclinical trials and the risk that the combined fusion protein to be developed in collaboration with Biotecnol will not reduce systemic toxicity and/or dosing frequency, nor generate statistically significant anti-tumor effects. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006, and the quarterly report on Form 10-Q for the quarter ended October 31, 2006. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contacts:
Peregrine Pharmaceuticals Biotecnol SA GendeLLindheim BioCom Partners Dr. Pedro de Noronha Pissarra
Investors Media Chief Executive Officer info@peregrineinc.com Barbara Lindheim www.biotecnol.com (800) 987-8256 (212) 918-4650 +351-21-422-0520
SOURCE Peregrine Pharmaceuticals, Inc. 12/14/2006
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Copyright 2011 Peregrine Pharmaceuticals, Inc.
Wouldn't it be nice if PPHM CLEARLY STATED in lay friendly terms what sets Cotara and Bavituximab apart from their competition.
Wouldn't it be nice if our so called PR dep't. actually found a media outlet that could generate a significant amount of retail interest.
I'M invested in PPHM for many reasons not the least of which is to make money. Eventually I feel that I will profit from my investment-it just should have happened a long time ago.
A word of caution to those who feel they can wait out the companies financial gaffs because the science will conquer all---I have been waiting since 1991 and others longer.
Maybe the big push will start sooner rather than later--- management is starting to age also.
Ysfaconeer had it right in post #55189 we should all try to advertise PPHM.
Perahaps Dr. Garnick can get Tustin to use DNA's PR dep't.
Can someone please explain why we are not giving an oral presentation(s) at Asco if are test results are so stellar ?
I tried to find a stock quote for Medibiotech on the Chinese stock exchanges to no avail. Anyone have any idea what are shares in this company are currently worth in US dollars ?
Thanks 2000 for posting IR's reply (#41908). From their response to you it appears more likely than not that they are going to "effect" a RS.
If it becomes more and more apparent that PPHM is not going to try to avoid the RS I hope there is not a major sell off coupled with extreme shorting BEFORE THE RS IS EVEN ENACTED. Will a greater than 10 to 1 RS then be required ?
I am going to assume that most shareholders agree that the avoidance of a RS and delisting is the most favorable scenario out of all the possibilities. I for one will find it reprehensible if PPHM issues a series of PR's after a RS that could have dispensed beforehand.
I hope I'm wrong and TUSTIN is preparing a major media blitz but the winds do not seem to be blowing that way. Will stay the course but after 19 yrs. I see my goals for this co. will still require more patience.
PPHM FOR ONCE IN A BIG BIG WAY TELL THE WORLD WHAT WE HAVE !!!
Thanks 2000
It certainly appears that anti-ps methodology is a stunning medical achievement. It is troubling however that the means by which many cancers, viruses, and pathogens avoid immune system attack is finally unmasked and PPHM as of 8:48 AM has not utilized this discovery to resolve the RS issue. I'm sure that a series of well crafted PR's would generate sufficient interest to get enough retail investors to push the stock over a dollar for ten consecutive trading days. In general our PR's lack enthusiasm---Unless you are science savvy , have been doing major d.d. ,or are a scientist they do not convey in a lay friendly manner the uniqueness and potential of our anti-ps platform.
Kudos to the team for advancing the science but they so far have dropped the ball as per share price.
Tell us there will be no RS( it would not be the first time our CFO had to reverse himself)---follow that up with consecutive daily pr's that:
1) Give survival data
2) Are lay comprehensible
3) Are written with some sizzle(not hype)--- we do not have to resort to deception but the "stats do NOT speak for themselves" as per the retail investor.
I am troubled that this company has not /can not/ will not rectify the RS issue. I would rather go to the OTC.---we were there before and we should have no trouble getting off---We can raise the share price with retail investors and then have the large institutions buy in at a relatively higher share price.
QUIT THE GAMES TUSTIN IF WE TRULY HAVE WHAT MOST OF US BELIEVE WE HAVE---A MEDICAL BREAKTHROUGH---STATE IT LOUD AND CLEAR AND OUR FINANCIAL WOES WILL BE GONE---THEY WILL COME !!!
If there is a RS I will vote NO on the incentive plan.
PS ---For the “why don’t you sell crowd" I still believe that I along with many others will realize a considerable profit and at the same time help humanity.---IT JUST SHOULD HAVE HAPPENED A LONG TIME AGO AT A MUCH HIGHER PRICE.
Lost in the wilderness that is PPHM/TCLN since 1991.
GOOD LUCK TO US ALL.
Does anyone know what a "close to 5% ownership stake in Medibiotech" is currently worth in U.S. dollars ? Is Medibiotech marketing Vivatuxin ? Are they a profitable company ? Vivatuxin data ? Vivatuxin and possibly VEA data ? " Peregrine will make certain cash payments to C.T.L."---What is that about? Is it the 400,000 that goes to Dr. Epstein ?
For those of us who were waiting years for China to approve and market our T.N.T. product Tustin has again pulled the vail of darkness over the lawsuit settlement.
Thanks K.T. and Slipperypete for responding. I guess I did not form the question properly and/or maybe I did not understand your responses . Let me rephrase.
Exposed P.S. on the inside of tumor vasculature prevents the immune system from recognizing these vessels as a "perversion."
Once Bavi covers the P.S. the cancer vasculature is now exposed as something that should not be there and an antibody attack will now be mounted. My question deals with the tumor itself ---not the vasculature. If P.S. is masking the tumors blood vessels as a bodily threat then what is hiding the tumor itself from being identified as an antibody target ?
T.I.A.
A science question---If ps is masking tumor vasculature from immune system attack then what is cloaking the tumor itself ?
If it is also ps then why doesn't bavi also bind to this ps ( or does it? )and bring forth an antibody reaction ?
If it is not ps providing tumor camouflage then what is it ?
TIA.
Anyone know if either CTL and/or Medipharm obtained a profit from Vivatuxin sales ? Been here since 1991 and it is really hard to swallow the idea that one or both of these companies might be profiting from one of our TNT products and currently WE ARE NOT. Maybe somone with better sleuthing skills can come up with an answer. I tried to google-- Cancer Theraputics Labratories 10k --and got nowhere. Is this information part of what the lawsuit is about?
If this lawsuit comes to a favorable PPHM conclusion and if there are Vivatuxin profits generated by Medipharm and if I haven't died of old age waiting for all this to come to pass is it reasonable to expect a money stream for PPHM ?
TERRY,EZ,CJ,KT ???
-------------------------------------------------------------------
During September 1995, we entered into an agreement with Cancer Therapeutics, Inc., a California corporation, whereby we granted to
Cancer Therapeutics Laboratories, Inc. (“CTL”) the exclusive right to sublicense TNT to a major pharmaceutical company solely in the People’s
Republic of China. In addition, we are entitled to receive 50% of the distributed profits received by Cancer Therapeutics, Inc. from the Chinese
pharmaceutical company. Cancer Therapeutics, Inc. has the right to 20% of the distributed profits under the agreement with the Chinese
pharmaceutical company. During March 2001, we extended the exclusive licensing period granted to Cancer Therapeutics, which now expires
on December 31, 2016. In exchange for this extension, Cancer Therapeutics, Inc. agreed to pay us ten percent (10%) of all other consideration
received by Cancer Therapeutics, Inc. from the Chinese pharmaceutical company, excluding research funding. During January 2007, we filed a
lawsuit against CTL alleging various breaches of contract under the agreement. The lawsuit is currently in the discovery phase as further
discussed in Part I, Item 3 under “Legal Proceedings” of this Annual Report. Through fiscal year ended April 30, 2008, we have not received
any amounts under the agreement.
Date:
July 11, 2008
---------------------------------------------------------------------------
GOOD LUCK TO US ALL.
Realist thanks for the reply. I agree with many of your financial---managerial citicisms but I am betting that the scientific platforms will bear fruit soon enough to alter the present state of affairs.
Paradoxically I believe that your negative opinions would give balance and creedence to an inclusive advertizing package---whose purpose would be to create a dynamic that would hasten and augment a better financial picture.
Whatever your motivation for pointing out the companies flaws I believe you stated that you hope that the company succeeds. Here is your chance to possibly alter the financial picture.
Here is your chance CJ,KT,JMB to possibly alter the financial picture.
COMMENTS???
THE GREATEST STORY NEVER TOLD AGAIN PART 2
A small contribution---
COTARA-( I131 CH T.N.T.1/B ) is the fusion of a
radioactive particle-( iodine 131 ) and a monoclonal
antibody-( T.N.T. ). Radioactive iodine 131 gives off a
lethal burst of gamma rays within a 300 cell radius. The half life of I131 is approximately 8 days and it does not degrade off the antibody for approximately 10 days.
The Tumor Necrosis Targeting agent-( T.N.T. ) is the vehicle that carries iodine 131 to the cancer cells. because it is a chimeric antibody-( part mouse part human )allergic reactions are minimal. T.N.T. homes in on necrotic tissue found in the core of all solid based tumors. Cancer cells have leaky spots that allows
Cotara entrance-(normal cells do not ). Cotara is too large to fit through the outer membrane of a normal cell-( which also has some but relatively small amounts of necrotic tissue at its core ). Cotara is unique in that it is the only therapeutic agent that will attack ANY solid based tumor large enough to have a necrotic core and leave healthy tissue alone. Other monoclonal antibody therapies are geared for particular cancers - Cotara will seek out and deliver its deadly cargo to ALL solid based tumors.
Many monoclonal antibodies rely on finding and latching
on to specific docking sites found on the surface of cancer cells. If the antibody does not " overwhelm " the tumor then the disease is poised for a comeback. If the docking sites are used up and/or cell surface mutations have altered the sites then what at first appeared to be an effective modality will now be relatively useless. In contrast Cotara becomes more effective with each subsequent dose, since after each application more and more necrotic tissue forms thus presenting a larger and larger target.
Because our docking site is at the core of the tumor the problems associated with the lack of cell surface docking sites and/or mutations are eliminated.
Cotara does not merely interfere with cellular machinery. It is a powerful treatment that will incinerate more and more of the tumor from the inside out -( and send those toxic cells back into hell where they belong ).
According to Dr.Patel there has been some swelling associated with Cotara when used in treating a form of brain cancer. The problem was however manageable when steroids were used.
M.A.T.-( MODIFIED ANTIBODIES TECHNOLOGY) I copied this from an old Yahoo post. This is the "B" in
I131 CH T.N.T./B.
by: ownotshort (64/M/Seattle,WA) 07/19/99 01:20 pm
Msg: 27817 of 256647
" Techniclone scientists discovered that when a small organic molecule like the vitamin biotin is attached to a monoclonal antibody it decreases its electrical charge. Decreasing the electrical charge of the antibody dramatically influences the way the antibody travels in the blood stream. The positive electrical charge of an un-modified antibody gives it a sticky characteristic that causes it to stick to capillary walls as it passes through the blood stream. This stickiness causes delayed antibody circulation, decreased tumor uptake and increased antibody clearance time (time it takes the antibody and toxic payload to clear from the blood stream). Increased clearance time results in higher toxicity.
Decreasing the antibody clearance time may dramatically reduce the toxicity of many, if not most, monoclonal antibody/toxic drug therapies. The increase in monoclonal antibody uptake at the tumor site should result in an increase in drug efficacy. Monoclonal antibodies using TCLN s MAT clear from the bloodstream in half of the time of normal antibodies and produce a 2-3-fold increase in antibody/tumor uptake.
Wow, giving antibodies vitamins to pump them up ! A simple but very innovative idea that could be licensed to many companies developing monoclonal antibodies for therapy."
-----------------------------------------------------------
This is but one tiny piece of what PPHM. has to offer.
Surely even this needs to be corrected, it definitely
needs to be augmented and refined. Putting everything together is a huge task but I know that the people on this board are capable of doing it.
That`s about all folks. IF your getting tired and frustrated of just talking and want to do something then maybe by completing this task your needs will be served, our share price might rise, and humanity will be rid of a dreaded disease.
I don't think anyone knows how effective Cotara can be in treating any and all solid tumors ( maybe the Chinese do ). I understand that trials need parameters but keep in mind that Cotara becomes more effective with each dose. It also has several advantages over Bavi:
1) It does not depend on the immune system for efficacy.
2) Even though Bavi can destroy tumor vasculature the tumor may still feed off the tissue near its periphery ---Cotara destroys tumors from the inside out.
3) Cotara has been approved for phase 3( albeit a different mode of delivery )
4) Cotara hasd been approved for "Orphan Drug and Fast Track " status.
Of course Cotara has radiation complications that Bavi doesn't but the focus should be on the possible synergestic effects achieveable when all of Tustin's tech is used together.
One last comment---I don't know how culpable Dr. Epstein is , but I would be fuming if my lifes work was in Tustin's hands---I HOPE Dr. Thorpe does not become disenchanted.
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
This is but one tiny piece of what PPHM. has to offer.
Surely even this needs to be corrected, it definitely
needs to be augmented and refined. Putting everything together is a huge task but I know that the people on this board are capable of doing it.
That`s about all folks. IF your getting tired and frustrated of just talking and want to do something then maybe by completing this task your needs will be served, our share price might rise, and humanity will be rid of a dreaded disease
THE GREATEST STORY NEVER TOLD --- AGAIN.
SUPRISED---NO---TROUBLED AND DISGUSTED---YES. I am still absorbing the blow engendered by the possibility of a reverse split. Why I am here ?---because I believe that eventually the science will trump the mistakes of management(s).
Four years ago I tried (unsuccessfully)to prod knowlegeable R.B. posters to form an advertizing package, since our p.r. dep't(s)hasen't and/or can't write the kind of p.r.'s that clearly informs the retail investor why our products are unique, groundbreaking, and worth investing in.
Organizing the information already known about our products in a way that is honest, lay comprehensible, and financially worth the risk( not withstanding personal reasons--- isn/t that why we are here ?) is possible and in OUR BEST INTEREST.
C.J. and JBM have accumulated a tremedous amount of information already, we just need a concerted effort by a person(s) to fashion this into a concise, truthfull, interest generating document--- with an ever growing list(kept on I.H.?)of websites to E-mail to.
There has to be some billionaire that is willing to risk capitol for profit and/or philanthropic reasons and/or personal reasons. Somewhere there is a reporter eager to discover the the next possible major medical event. A cash rich company looking for products perhaps.
To make this package beleivable everyone should should have a say. One section could be factually descriptive another filled with positive information and another with negative information.
Here is your chance C.J.--- Jazz---K.T.--- to connect ALL THE DOTS. Here is your chance REALIST to formalize your criticisms.
The reverse split appears to be more and more likely. We probably can not change anything but we can try--- at the very least I or anyone else can fire off a promotional E-mail when frustration levels rise.
Needless to say that I am lacking the skills to coordinate this but many of you are not.
The clock is ticking.
LOST IN THE WILDERNESS THAT IS PPHM SINCE 1991.
GOOD LUCK TO US ALL
If the reverse split is voted down does that affect the 180 day extension period ?
I have 50000 shares and will vote NO for 3 and 4.
It appears to me that Dr. Patel felt that Cotara was superior to the S.O.C. at the time the phase 2 trial was completed.
Am I wrong ?
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Thomson / Gale
Business Services Industry
Peregrine Announces Preliminary Results From Phase II Brain Cancer Trial; Data Presented at the American Society of Clinical Oncology
Business Wire, May 14, 2001
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Business Editors and Health/Medical Writers
TUSTIN, Calif.--(BUSINESS WIRE)--May 14, 2001
Peregrine Pharmaceuticals Inc. (Nasdaq:PPHM) today announced Dr. Sunil Patel, associate professor of neurosurgery at the Medical University of South Carolina, presented preliminary efficacy and safety results from a Phase II brain cancer trial using Cotara(TM), Peregrine's Tumor Necrosis Therapy drug.
Patel presented his findings at the American Society of Clinical Oncology's (ASCO) 37th annual meeting, being held in San Francisco, where he was representing the Cotara brain tumor study consortium.
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The primary objective of the Phase II Cotara study is to determine the median time to progression of treated patients compared with a historical control population. Patel presented data on the first 29 patients in the study.
This group possessed a uniformly poor prognosis, the majority of them having been diagnosed with recurrent glioblastoma multiforme (GBM), which is a form of malignant brain tumor. Primary side effects of the Cotara infusion were well tolerated in this patient population. The overall median time to progression was 13.9 weeks, despite inclusion of many heavily pretreated patients.
By contrast, the median time to progression for the historical control population was eight weeks.
"I am enthusiastic about Cotara, and its potential in the treatment of both newly diagnosed and recurrent malignant gliomas. Compared to current standard therapy, Cotara may offer a promising alternative," said Patel. "I am looking forward to doing further studies with Cotara."
"Glioblastoma multiforme is a deadly disease, and we are pleased to be able to show an impact on this most difficult clinical situation," said Dr. Terrence Chew, Peregrine's vice president of clinical and regulatory affairs.
"Peregrine plans to continue to enroll and treat patients under the Phase II protocol while the final preparations are being made for the Phase III study which will commence later this year. We look forward to moving the Cotara brain cancer program forward."
"We are encouraged by the data from the Phase II study, and we are pleased that Cotara is slowing the progression of these aggressive tumors while having few side effects on the patients," said Edward Legere, Peregrine's president and CEO. "If approved by the FDA, Cotara would be a humane treatment alternative for patients with this aggressive form of cancer."
Cotara is currently being studied in a multi-center Phase II study for brain cancer. Peregrine expects to begin a Phase III study for brain cancer later this year. Cotara is also in Phase I studies for colorectal, pancreatic, biliary and sarcoma cancers at Stanford University and a Phase I liver cancer study at the Mayo Clinic. Peregrine plans to open additional Cotara Phase I studies in the future.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals is a biopharmaceutical company focused on the development, commercialization and licensing of unique technologies for the treatment of cancer, primarily based on its "collateral targeting technologies."
These technologies therapeutically target cell structures and cell types, rather than surface cancer cells, as a means to attack solid tumors, without causing damage to surrounding healthy tissue. The company has three collateral targeting technologies: Tumor Necrosis Therapy (TNT), Vasopermeation Enhancement Agents (VEA), and Vascular Targeting Agents, (VTA).
The company also has a direct tumor-targeting agent called Oncolym(R) for the treatment of advanced non-Hodgkin's B-cell Lymphoma. Oncolym has been licensed to Schering AG, Germany, which is now responsible for all existing and future Oncolym clinical trial programs as well as marketing.
Safe Harbor Statement: This release may contain certain forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the company's expectations as a result of risk factors discussed in Peregrine's reports on file with the U.S. Securities and Exchange Commission, including, but not limited to, the company's report on Form 10K for the year ended April 30, 2000 and Form 10Q for the quarter ended Jan. 31, 2001.
COPYRIGHT 2001 Business Wire
COPYRIGHT 2001 Gale Group
When is this company going to present a P.R. that clearly delineates it's products ? A P.R. that captures the imagination of the retail investing public is certainly possible at this point and was possible years ago. Are there any other compounds similar to BAVI that are in trials for both cancer and viral indications ? There are people ( Jerod Swan, Freddie Sanford, Phil Marfuta )that developed brain cancer that should be dead from a statistical stanpoint but are still alive because of Cotara. Why hasn't our P.R. firm(s) obtained major media coverage for this ? No one should be deceived by false hope---especially cancer patients---but the statistics involved with the phase 2 trials already completed for Oncolym and Cotara speak for themselves. The F.D.A. has already approved Oncolymn and Cotara for phase 3 ( albeit a different mode of delivery for Cotara ).
Conspiracy theories aside I beleive that managerial ineptitude is the root of the problem. Recently Tustin has done a decent job advancing the science through trials inspite of their horrid financial management. The time to overhaul the management has past. At least for now we sink or swim with the current leadership for our nexus is coming soon(there is that "soon" word again).
Advertise now Tustin--get the share price up so if we have to do "whatever" we might be able to get some leverage for product negotiations. Don't wait till the last minute ( we probably already have ). Even if our share price eventually goes to 100 there is/was no excuse for our current share price. Longs have shouldered the burden for too long.
I am invested in this company for many reasons---profit certainly being one of them. Eventually I beleive we will get to the "Promised Land" (inspite of management because of the science) but pphm sure does lend credence to the "no pain no gain(?) theory."
It's long past due for Tustin to present P.R.'s that are--- lay comprehensible ---that have clear product implications both financial and medical---that make suitable comparisons to our competition---that are worded with the kind of sizzle that shows the company is enthused about it's products ( Say what you want about Ed Legere he at least was animated, openly excited, and more accesible.)
WAKE UP TUSTIN !!!!!
Lost since 1991 in the wilderness that is pphm/tcln. Good luck to us all.
Flyingfurter are you saying that PPHM need's enough money in the coffers to conduct one or more phase3 trials to successfuly negotiate a "reasonable" deal with big pharma ?
T.I.A.
I POSTED THIS ON RB--- 5/6/06 A.M.
By: 2ndstr2thert
06 May 2006, 11:32 AM EDT
Msg. 202126 of 202130
Jump to msg. #
I am reprinting post # 201817 written by "Uptomyneck".
I feel he/she raised some serious questions that need to be addressed.
-------------------------------------------------------------
By: uptomyneck
29 Apr 2006, 12:57 PM EDT
Msg. 201817 of 202124
Jump to msg. #
Jazz, I'm trying to explain to my wife, as best I know, the action of Bavituximab, but I keep getting stuck at one point. You've probably explained this somewhere along the line. But I get lost with the Ilg's and some of the other biotechnical terms. My question is why doesn't bavituximab bind to apoptic cells, and if it does why is the immune system not called in and an inflammatory response initiated??
Thanks,
Paul
------------------------------------------------------------
In addition I would like someone to explain why that region of Bavituximab responsible for an immune response dosen`t alert white blood cells to intercept/destroy the antibody in route to its P.S. targets.
T.I.A.---John
(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy)