Avid Bioservices Inc (CDMO)

[eb0783]

“Please provide facts to back up this up and don't cite in-vitro data that may or may not translate to humans. Otherwise, it is just more speculation and pumping.”

Microbe Man, I respect your knowledge and experience and I know it is much better than mine in this area. I also understand that for most past history/experience/drug-development that many/most drugs that work in the lab, and then in animals do not duplicate that in humans. Hence you (and others) rightfully demand proof of efficacy in humans.

I just want to point out [remind] what Phillip Thorpe told us as far back as 2004. On top of the following, ALL of the human data so far has duplicated what we have seen in the animals. …....And This is another big reason I and some others continued to add and stay involved for years.

From the 2005 ASM transcript: Phillip Thorpe response to humans vs. animals question: “All animal species have the same regulation. What I haven’t explained is that PS is one in the same molecule in humans, mice, and all higher species. As far as we know, there is no difference in the regulation of these molecules between humans and other species. If you look in culture, it’s precisely the same.”

"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 are not toxic to mice, even when administered in high doses for prolonged periods of time.”

"....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."
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Also to reiterate what I noted in previous posts, Bavi may just work BETTER in Humans than in animals, unlike most other drugs:

"Peregrine's Bavituximab Shows Promising Anti-Viral Activity and Signs of Prolonged Anti-Viral Effect in Single Dose Monotherapy HCV Trial
TUSTIN, CA, June 7 2006:

Joseph Shan, Peregrine's executive director of clinical and regulatory affairs, added, "These first efficacy results in humans are particularly exciting because researchers did not expect to see much anti-viral activity after a single dose of drug, based on our experience in lethal animal disease models such as Lassa fever. Bavituximab demonstrated good anti-viral activity in these studies, but only after administration of multiple doses. Based on the results reported today, the drug's anti-viral potential may be even more promising in humans than the animal models suggest.""
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Dr. Thorpe also pointed out to us clear back as early as 2005:

"http://abcnews.go.com/Health/wireStory?id=640463

Antibody Fights Hemorrhagic Fever Virus in Animals
Apr 4, 2005 — By Deena Beasley

“In a preclinical trial, half of the guinea pigs lethally infected with the virus that causes Lassa fever, a fatal hemorrhagic fever, survived when also treated with Tarvacin, while none of the untreated animals survived.

The study, funded by the National Institutes of Health and the drug's maker Peregrine Pharmaceuticals Inc., also found that the surviving guinea pigs did not show any signs of viral infection several months after treatment. And they were immune to the virus when reinfected with it, Thorpe said. “
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And then as CP reminded us:
Quote:
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However the most spectacular case was Dr. Brekken's mice dying from old age after being infect with cancer, treated with non-human Bavi and 100% cured, then infected AGAIN and NOT treated and cured again 100% and died from old age. Now that is something because it was a 100% thing, ALL mice died from old age.

Many try to say preclinical data means nothing, and I understand what history has taught us but as Dr. Thorpe stated "there's nothing else like it out there". Well, in light of all of this and of what I heard straight from Dr. Thorpe himself, preclinical results of Bavi mean something to me.