| cjgaddy 2005-08-10, 12:00 pm |
| Anyone interested the fight against HEP-C should be aware of the phase1
study of TARVACIN initiated 8-8-2005 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....ticle&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....236&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
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