"We are excited to begin exploring another clinical indication for Tarvacin(TM)," said Joseph Shan, senior director of clinical and regulatory affairs. "We anticipate this study will accrue patients rapidly due to the prevalence of chronic Hepatitis C infections in the U.S. and the need for new therapies to treat this disease."
The objectives of the phase 1 clinical protocol are to evaluate safety, pharmacokinetics and viral load in patients chronically infected with HCV who have failed to respond or who have relapsed after the current standard treatment with pegylated interferon plus ribavirin. Up to 50% of patients receiving the combination of pegylated interferon plus ribavirin either relapse or do not respond after treatment.
"Receiving clearance to begin this initial Tarvacin(TM) anti-viral clinical trial is an important milestone for the program," stated Steven King, president and CEO. "We are continuing to evaluate Tarvacin's(TM) potential for the treatment of other enveloped virus infections, including HIV, influenza A, influenza B, avian flu, as well as viruses included on the government's bioterrorism watchlist such as Lassa fever and Marburg virus."
Excerpted
http://www.bio.com/industryanalysis/industryanalysis_news.jhtml?cid=10600034
Luanda, 31/05 - Two tons of bio-security material and 615 kilos of diverse medicines were handed over Tuesday to the Health Ministry, by the Governments of Egypt and France, to fight Marburg haemorrhagic fever.
The charge d`affaires with Egypt embassy to Angola, Alhassam Soliman, said at the act that his Government is always available to aid Angola and that the gesture is a symbol of solidariety to the people.
On his hand, an official with France embassy said the material worth at 50,000 Us dollars and that French people and Government are solidary with the families who have lost their relatives, due to Marburg.
The Angolan Health Minister, Sebastiao Veloso, thanked the gesture and said that Angola needs more as country faces several epidemics, such as malaria and Marburg.
Marburg haemorrhagic fever, which has already killed more than 350 people is under control, said the Minister, explaining that of the 540 contacts which had been followed now exist only 120.
A new antiviral that may help against Marburg is wonderful news, thank you for posting. I'd be for compassionate use trials for those with Marburg in Angola--it certainly couldn't hurt...
Several promising aspects about TARVACIN’s potential as an ANTI-VIRAL (and even Anti-Cancer) treatment (ALL THESE THINGS REMAIN TO BE PROVEN IN HUMAN TRIALS):
IT APPEARS TO BE UNIVERSAL:
Bernard Wolfson in his 7-16-05 O.C.R. “High Hopes” article said, “What if someone told you they had a drug that could fight Cancer and nearly every human Virus from HIV to Hepatitis C, and from Ebola to the common flu? You might be a little surprised, a little curious, a little excited - and more than a little incredulous… The reason Tarvacin appears to have such a broad range of uses is that it targets not any specific cancer or virus, but rather a substance found in the membranes of all cells. When cells become malignant, or are infected by a virus, the substance - known as a phospholipid - moves from the inside of the membrane to the outer surface, allowing Tarvacin to bind with it. The binding marks the cell, raising a red flag that alerts the immune system to the presence of a foreign body. With viral infections, the body's white blood cells attack the viruses. With cancer, the immune system appears to destroy the blood vessels of a tumor, depriving it of the nutrients it needs to grow. ‘The concept is almost so simple it's hard to believe no one picked up on it before,’ says Steven King, Peregrine’s CEO Peregrine.” [http://tinyurl.com/9e6gf ]
###This from Thorpe’s patent app #20040161429 (filed 8-15-03, pub. USPO 8-19-04), titled ‘Compositions for treating Viral Infections using Immunoconjugates to Aminophospholipid’: [0909] “the spectrum of viral treatment for the present invention extends to any virus, whether enveloped or not, DNA or RNA. …the invention is not limited to the treatment of enveloped viruses alone, nor to any particular virus, which is an important advantage. [1302] “the 3G4 antibody has enormous potential as a broad spectrum anti-viral agent.” [ http://tinyurl.com/6pdny ]
###CEO King 6-15-05, “....Examples of enveloped viruses include Marburg virus, Lassa fever, Ebola, HIV, Hepatitis C, Influenza [incl. Avian]. Secondly, as I'll show you later in some preclinical data, Tarvacin has shown the ability to arrest the development of disease even in late stages of infection. And thirdly, Tarvacin is expected to recognize not just the known enveloped viruses that are here today, but new enveloped viruses that will undoubtedly become available and will have mutated and become new viral strains over the next years to come."
[ http://tinyurl.com/coomw & http://tinyurl.com/e2hxh ]
###Michael Brush’s 7-28-05 “Envelope Please” article, “Most of the excitement right now surrounds potential treatments of the so-called “envelope” viruses – the ones that envelope themselves with bits the host cell membrane as they exit the host cell. The “envelope” viruses read like a top 10 list of diseases you’re most likely to get, and really don’t want. They range from Influenza and Hepatitis B and C, to Herpes, West Nile, Dengue, HIV, SARS, Avian flu and many of the potential bio-terror “hemorrhagic” viruses, like Ebola. [http://tinyurl.com/9z7yf ]
IT APPEARS TO BE SAFE:
From Thorpe video 10-24-04: “Understanding Tarvacin”, incl. his first-ever public comments about Tarvacin's ANTI-VIRAL capabilities: “That's an extraordinary result, I don't know of any other antiviral agent that is known to protect against Lassa Fever. And we've also shown similar results in cytomegalovirus... at that dose we've never seen any sign of toxicity in mice or monkeys; about 14 species treated with the therapeutic dose. And that's thousands of mice & monkeys. And even if you increase the dose to 10 mg/kg, that's 10x the therapeutic dose. So the conclusions with Tarvacin are that it has a unique mechanism of action, there's nothing else like it out there.”
[http://tinyurl.com/8b6kr & http://tinyurl.com/dou8t ]
###From Thorpe’s APT (AntiPS/3G4/Tarvacin) patent app #20040161429 (pub. USPO 8-19-04):
[1298] “The 3G4 antibody has also been administered to monkeys in safety studies and no side effects have been observed.” [http://tinyurl.com/6pdny ]
###From Thorpe’s Aug03-Jan08 $1.68mm NIH/NIAID grant for research using 3G4 as ‘Novel Anti-Viral Agents for Treating Lassa Fever’, “the phospholipids that they recognize have the same structure and cellular distribution in different mammalian species, simplifying the transition from experimental animals into humans. The antibodies arenot toxic to mice, even when administered in high doses for prolonged periods of time.” [http://tinyurl.com/5ntcm ]
IT APPEARS VIRUSES CAN’T BECOME RESISTANT TO IT:
Again, from the Brush article, “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 CEO Steven King. ‘It is not something the virus can change, to get away from therapy.’” [http://tinyurl.com/9z7yf ]
###From the Wolfson article, “Scientists say Tarvacin could have an advantage over other anti-viral drugs because viruses probably won't be able to evade it by mutating. ‘Mutation won't affect it because it's targeting a substance which is not intrinsic to the virus itself but to the host cell - so that substance will be there no matter what new form the virus takes,’ says Dr. Stephen M. Smith, a paid Peregrine consultant and chief of infectious diseases at the Seton Hall School of Graduate Medical Education in Orange, NJ.” [http://tinyurl.com/9e6gf ]
###CEO King 6-15-05, “Tarvacin recognizes a stable target common to all enveloped viruses that cannot easily be mutated because it is derived from the host, it's not encoded by the genome, but rather it's a stable structure of the virus particle.”
[ http://tinyurl.com/coomw & http://tinyurl.com/e2hxh ]
IT MAY EVEN CONFER VIRAL IMMUNITY:
From Tarvacin.com, “Tarvacin provided significant protection in animals administered lethal viral loads of pichinde virus (a model of Lassa fever) with 50% of the Tarvacin treated animals surviving and none of the animals receiving control treatment surviving. Moreover, Tarvacin treated guinea pigs who survived the infection became immune to subsequent infections with the same viral strain. An interesting hypothesis still to be tested is whether treatment of one virus with APT agents confers protection against infection by other enveloped viruses. [http://tinyurl.com/cvfcm ]
###From BIO2005, “Animals lethally infected with Pichinde virus that survived following Tarvacin therapy had long term immunity to reinfection.” [http://tinyurl.com/dqf9t]
= = = = = = =
Remember, Tarvacin initiated a Ph1 Trial against HEP-C 8-8-2005:
8-8-05: HEP-C Trial Inititates at Bach and Godofsky Infectious Diseases, Bradenton FL:
"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... 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 USA."
http://ir.peregrineinc.com/phoenix.zhtml?c=74236&p=irol-newsArticle&ID=740477
Bach & Godofsky Infectious Diseases in Bradenton, FL
Principle Investigator: Dr. Eliot W. Godofsky
Announcement 8-8-05: http://tinyurl.com/cltum
Tarvacin Trials website: http://www.tarvacin.com
Gov't info: http://clinicaltrials.gov/ct/show/NCT00128271
***Tarvacin HEP-C Trial Contacts:
Peregrine: 800-694-5334, clinicalaffairs@peregrineinc.com
Contact Bach & Godofsky directly: 941-746-2711 x39
To learn more about Thorpe & Tarvacin:
http://tinyurl.com/b9hdq - my amateur compilation of Articles, Quotes, Patents, History, etc.