Tarvacin Studied for HCV
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Tarvacin(TM) starts with Phase I study against Hepatitis C Virus
Aug 8, 2005, 17:40
“Tarvacin(TM) is truly a novel approach to treating HCV and we are eager to offer patients the opportunity to participate in this trial.”
By Peregrine Pharmaceuticals, Inc., Enrollment Open for Patients Chronically Infected With Hepatitis C Virus (HCV)
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), announced today the initiation of a phase I anti-viral study of Tarvacin(TM), the Company’s first Anti-Phospholipid Therapy candidate. The phase I study is an open-label, dose-escalation study in up to 32 adult patients with chronic hepatitis C virus (HCV) infection who either no longer respond to or failed standard therapy with pegylated interferon and ribavirin combination therapy.
The objectives of the trial are to evaluate safety, pharmacokinetics and viral load following a single intravenous infusion. The study is being conducted at Bach and Godofsky Infectious Diseases, the largest private infectious disease practice specializing in the treatment of viral hepatitis in the United States. Bach & Godofsky is located in Bradenton, FL.
“Tarvacin(TM) is truly a novel approach to treating HCV and we are eager to offer patients the opportunity to participate in this trial,” stated Eliot W. Godofsky, M.D., Principal Investigator and clinical assistant professor of medicine at the University of South Florida in Tampa.
“This study is an important step for our Tarvacin(TM) antiviral program,” said Joseph Shan, Peregrine’s senior director of clinical and regulatory affairs. “Meanwhile, we are continuing our Tarvacin(TM) development efforts for other viral diseases.”
CJ Gaddy Comments:
Anyone interested the fight against HEP-C should be aware of the phase1 study of TARVACIN initiated 8-8-05 at Bach & Godofsky Infectious Diseases in Bradenton, FL., with Dr. Eliot W. Godofsky as principle investigator.
[news: http://tinyurl.com/cltum ]Trial Title: “This phase I study is an open-label, dose-escalation study in up to 32 adult patients with chronic Hepatitis C virus (HCV) infection who either no longer respond to or failed standard therapy with pegylated interferon and ribavirin combination therapy.”
Go to the Tarvacin website to learn about Tarvacin and the HEP-C Trial:
http://www.tarvacin.com – click “Patient Resources” to bring up the TARVACIN overview page. Then click TARVACIN-FOR-VIRUSES how Tarvacin anti-viral works. Note the TARVACIN-FOR-CANCER button – Tarvacin treats both cancer and viruses! Phase I Trial info. (for both Cancer and HEP-C) are further down the left column, including eligibility req’s and Peregrine contact info:
Ph: 800-694-5334, email: clinicalaffairs@peregrineinc.com
Also, ClinicalTrials.gov has more info. on this Tarvacin HEP-C Trial:
http://clinicaltrials.gov/ct/show/NCT00128271
Site Contact: Bach & Godofsky, Bradenton Ph: 941-746-2711 x39
The primary goal of this Phase1 trial is, of course, to prove safety, but read carefully how they worded the trial objectives: “To determine safety and tolerability, characterize blood pharmacokinetics and viral kinetics, define the maximum tolerated dose (MTD) and/or maximum effective dose (MED)”. It SEEMS (my opinion only) the scientists are expecting to see efficacy even at initial low phase1 dosages. To see why they may think so, read about Tarvacin anti-viral animal results presented at BIO2005 6-22-05: http://tinyurl.com/dqf9t
Tarvacin Background:
TARVACIN is a monoclonal targeting antibody drug developed by Dr. Philip Thorpe of UT-SW/Dallas, whose research is funded by Peregrine Pharmaceuticals, the NIH/NIAID (Infectious Diseases), the USAMRIID (BioDefense), and the Susan G. Komen Breast Cancer Foundation. Scientifically, Tarvacin is the chimeric form (mostly human, part mouse) of the Anti-Phosphatidylserine (Anti-PS) antibody “3G4”, the lead product under Thorpe’s Anti-Phospholipid Therapy (APT) platform.
Tarvacin is effective against both CANCER and VIRUSES. A great simple explanation of Tarvacin’s MOA was written by Michael Brush 7-28-05:
“The cells in our bodies are contained by membrane made up of phospholipids which normally know how to position themselves in the right way. But in cancerous cells these phospholipids get confused. Many of them end up on the outside of the cell. That turns them into great targets – if you want to shoot a missile at a cancerous cell inside the body to kill it. A similar thing happens in cells infected by many common viruses. These viruses replicate by entering cells, reproducing in the nucleus, and then exiting the cell. On the way out, however, they get enveloped by parts of the membrane from the host cell. Again, this confuses phospholipids in the membrane of the virus cell, and the phospholipids wind up on the outside of cells. That creates another great target if you want to launch an attack. The key compound that knows how to zero in on target cells is called Tarvacin.”
[M.Brush article: http://tinyurl.com/9z7yf ]
You read right: Tarvacin’s universal nature makes it able to attack and destroy ALL SOLID CANCER TYPES, as well as ALL ENVELOPED VIRUSES (ex: Hep/B+C, Influenza, Pneumonia, SARS, HIV/AIDS, Ebola, Marburg, Lassa…).
In addition to the HEP-C trial that is the subject of this email, a Tarvacin phase1 trial to treat ALL-SOLID-CANCERS was initiated 6-10-05 at The Arizona Cancer Center: http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=719219
The U.S. Gov’t is highly interested in the ANTI-VIRAL side: On 4-4-05, following an 8-2003 $1.68mm grant to Thorpe to test 3G4 against Lassa Fever, the NIAID announced their testing labs will screen Peregrine’s APT agents, including Tarvacin, for activity against a “broad spectrum of enveloped viral pathogens” of health and bioterrorism concern, including Herpes viruses, respiratory viruses, pox viruses, HEP B/C, Papillomavirus and viruses of biodefense concern including Pichinde, Yellow Fever, West Nile and Dengue. [NIAID: http://tinyurl.com/5ntcm & http://tinyurl.com/8k9qj ] On 7-21-05, the U.S. Army’s USAMRIID announced they will test Tarvacin against Ebola & Marburg Viruses, under the direction of Dr. Thomas W. Geisbert, Chief, Dept. of Viral Pathology and Ultrastructure at USAMRIID, Fort Detrick, MD.” [Army: http://tinyurl.com/8ny2g ]
Most critically, animal tests suggest Tarvacin is very safe: extensive primate tests have shown no signs of toxicity until dosage is raised to 10x predicted therapeutic dosage. We all know safe Primate testing is a long way from safe Human testing, but Thorpe’s comment here is encouraging, “The phospholipids that 3G4 recognize have the same structure and cellular distribution in different mammalian species, simplifying the transition from experimental animals into humans.” [ http://tinyurl.com/5ntcm ] Well, these two Phase1’s are about to tell us about safety.
On the ANTI-VIRAL side as well, another important statement about Drug Resistance from Michael Brush’s article, “Most of the excitement right now surrounds potential treatments of the so-called “enveloped” viruses – the ones that envelope themselves with bits the host cell membrane as they exit the host cell. The “enveloped” viruses read like a top10 list of diseases you’re most likely to get, and really don’t want. They range from influenza and Hepatitis B+C, to herpes, West Nile, Dengue, HIV, SARS, Avian flu and many of the potential bio-terror “hemorrhagic” viruses, like Ebola. A great thing about Peregrine’s approach is that viruses can’t mutate to fight off the Tarvacin attack. That’s because Tarvacin keys in on anomalies in the cell membrane – the confused phospholipids — that viruses don’t know how to fix. “Since it is not made by the virus, it is not mutable by the virus,” says Peregrine’s CEO Steven King. “It is not something the virus can change, to get away from therapy.”
Virologist Dr. Stephen Smith (Chief of Infectious Diseases, St. Michael’s Medical Center), a Peregrine advisor, said 2-8-05, “this approach represents an entirely new way of combating infectious diseases. Instead of targeting viral proteins, Peregrine’s product attacks altered, endogenous phospholipids. Therefore, drug resistance cannot develop.” [ Dr.Smith: http://tinyurl.com/9qwen ]
In closing, here are a few links that you might find interesting to learn more about Dr. Thorpe’s APTs, beyond the current HEP-C trial:
www.peregrineinc.com – Peregrine Pharmaceuticals website
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-news – Press Releases
http://tinyurl.com/b9hdq – my amateur compilation of Articles, Quotes, etc.
http://tinyurl.com/6yz4x – investment board, but iBox News section up top is accurate
Compiled by:
cjgaddy@earthlink.net
Note: I am a retired computer guy, a follower for years of Phil Thorpe’s discoveries (not just APTs!), as well as an investor in Peregrine. I do these compilations of facts and opinion strictly on my own, and am in no way endorsed or supported by Peregrine or any of Peregrine’s scientists. Everything I put together is factual or the documented opinion of experts, publicly available, and backed by web links to reputable sources. If I make an error, or fail to provide a link, please email me and I’ll correct it immediately.
