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Aug. 11, 2005:



Subj: Hep-C Drug TARVACIN Enters Ph1

…Attacks ALL Enveloped Viruses, incl. HIV



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@...



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



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:



http://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






Sandra Tara Balduf (Ane)

Frontline Hepatitis Awareness

Support for patients and educational materials

http://frontline-hepatitis-awareness.com

509-888-0587





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