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HCV Repeat Dose Trial
If HIV patient is known to have HIV infection, whether positive, active or chronic, patient will not be allowed in this trial. However, the trial sites are not testing for the presence of HIV infection, so it’s quite possible (indeed 40% likely) that many of the HCV patients will be co-infected.
That's my understanding as well. According to the design of the trial as noted on the govt site, only known chronic infections are excluded. (Unlike other trials, - VRTX etc., which specifically list a negative HIV test in the inclusion criteria, PPHM Is not testing folks on thre way in). I can only conclude that they're quite confident (via animal data), that an acute/primary case of HIV will not screw up the drug's effect on the patient's HCV. I'm curious if there would be any way to quantify any potential HIV info from the trial, (perhaps not officially, but still enough to help guide design of future trials), or if- post-trial or better yet during the two weeks of therapy, they'll have patients' blood available to take a look at any change in hypothetical HIV counts.
Public announcement will be made when enrollment completes. This could be early or mid August since Company hopes/expects to present repeat dose data at ASLD conference in Boston on Oct 27-30.
Most data could be reported at ASLD conference even if full 12 week period had not run on all 24 patients.
Some top line preliminary data will be released in August when enrollment completes without waiting full 12 weeks.
good to hear.
Company is not officially tracking any PH 1a patients beyond initial 12 week period but some evidence of SVR will be gathered nonetheless from the doctors who follow these patients.
That's something I've been wondering about- whether we'd ever hear anny more about those folks. The patients are obviously going to be checking their virus on a regular basis via their doctors. Many of the patients in the 1A trial were likely regular clients of Godofsky, and will be going back to him specifically for follow-ups. The drug didn't know it was a 12 week study. The patient's immune system didn't know it was a 12 week study. I'd like to see how long of an effect that ONE SMALL dose had in these folks, just out of curiosity. I think there's a chance of an outright CURE with multi-dose monotherapy bavituximab. It did show CURES in animals given lethal doses of two different viruses, (CMV & Pichinde). The CMV animal experiment had a 100% CURE rate with the Bavi-dosed animals, while 80% of the control animals died. And if in the case of HCV in humans, if the virus is not totally cleared, yet there is more of the same (now well documented in humans) long-term immune response to the virus long after the bavi is gone, then it may become more of an issue of managing the condition via occasional treatments, annual boosters, etc...
re: some evidence of SVR will be gathered nonetheless from the doctors who follow these patients.
I assume you mean data will be gathered, or did you really mean to imply that evidence of Sustained Viral Response will be gathered? Meaning you expect to see SVR from single dose?.....
FINANCE
Board realizes that days of UU funding are over. As recently as this week a major bank confirmed they could not have done the $13 million financing on terms nearly as good as those offered by UU. However, if NIH grant money is not obtained, PH II will require alliance with a major wall street player. Several are interviewing for the job already. More will apply when repeat dose data is released.
Yes. Big banks. Big reputable banks, with big well-known names speculate on far more long-shots than the amount of risk left with this mab now that there is an abundance of flawless animal safety and efficacy data, MOA understanding, single dose viral safety and efficacy data in humans, and soon- human multi-dose viral and multi-dose cancer data.
HIV
The famous collaboration expected to be announced in 1st half 06 has in fact started but cannot be officially announced for political reasons. Why stir up a bunch of jealous enemies in the market before you need to? It’s not good for our collaborator and it’s not good for us. However, if you’ve been listening to recent SK presentations and reading the slides, you already know who it is. Give me a “D” … Give me a “U” … All will be made public quite soon.
You know- that the vast majority (around 25 out of 30 the last time I looked) of HIV studies at Duke are NIAID funded.
Analysts do not get excited about the HIV market on a stand-alone basis, but ANALYSTS LOVE THE NUMBERS THEY SEE FROM A DRUG THAT COULD TREAT CO-INFECTED PATIENTS.
Yes indeed they do.
INFLUENZA / AVIAN FLU
No success in getting clarification of SK remarks during CC. Company confirms that pulmonary delivery mechanism has received “aggressive” attention at multiple centers, and confirms that going after influenza and other respiratory viruses is more a “when” than an “if” question, but won’t confirm that the delivery mechanism issue has been solved.
From WHERE bavi is under investigation for flu and other respiratory infections (RSV), I can only be very optimistic-
DUKE, SRI, UTAH STATE. NIAID funds all those sites to do flu and other respiratory infection work with promising candidates. People sometimes ask how it's ging with NIAID, or where's that "upcoming months" dat etc, etc...
Well, believe it or not, something like 8 out of 10 experiments lately are FLU and H5N1 related at NIAID now! It's a very real and serious and imminent (and impending) issue. NIAID is very aggressively pursuing vaccine and antiviral options against flu and H5N1 flu. THe places where Bavi is under investigation for flu, funded by NIAID, are the tops. and why shouldtn't they be? Look at the animal and human efficacy, safety, and MOA data!
CANCER
Cancer trial is indeed going well. Q: “Why is Company so much more willing to make bold, positive statements about Bavi as a cancer therapy than as an anti-viral therapy?” A: “Because we’ve been working in cancer area for almost seven years now compared to 2-3 in viral arena. Company has huge amounts of preclinical cancer data to compare to current clinical data, which bolsters confidence they know exactly how the drug is working in tumors. Thorpe is convinced PS is the best tumor vasculature target that can be found.”
Thorpe's not alone. "PS as the big bad immunosuppressor", and as THE loop-hole that cancer has been exploiting, (and all other therapies have NOT been addressing!), is being corroborated at the best research institutions world-wide. The research is pointing to exposed PS as THE thing that has been stifling every therapy and allowing cancer to remain, and grow in so many patients despite other therapies.
Q: “In what sense are things going better now at MD Anderson?” A: “Well when the docs see results they are more willing to send patients your direction as compared with competing trials.”
Yes indeed.
Q: “When will we hear results from cancer trial?” A: “As soon as enrollment is complete Company will release top line safety and efficacy data, number of patients who participated in continuation therapy, etc. Company hopes/expects to present hard published data at ASCO in the spring.”
Thank you bigon. That is GREAT to hear- the possibility of hearing how many patients were elligible for the "continuation" therapy, as mentioned in the trial info. I've been curious of the details of the continuation therapy, but I'd expect it to build on the results that made the patient elligible for continuation therapy in the first place....
There are stict objective measurements of efficacy that make the patient elligible for continuation therapy. ("RECIST" it's called. "Response Evaluation Criteria in Solid Tumors"....) If they're seeing that in the phase 1A trial in any patients, it's very very good news.....
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