In recent conversations I learned:
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.
Scripps moved too slowly. Would have been nice to involve them but more important to complete dosing a.s.a.p. Alamo and Godofsky are commercial centers able to move efficiently.
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.
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.
HCV Phase II
Company is already looking at ways to fund Ph II trial, including NIH grant money and alliances with large investment banking houses.
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.
Even if NIH grant money is obtained, Company will still want to form an alliance now with a major wall street house because you can’t negotiate effectively with BP unless they know you have the deep pockets to finish Phase II/III without them.
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.
Regarding concern that Bavi’s success against HIV could bring great attention to the stock but also put great downward pressure on the ultimate market price of the drug, there are several strategies for dealing with this concern. One of the strategies has to do with the advantage of having three separate molecules: (1) the current Chimeric Bavi which is 70% human, 30% mouse; (2) a Humanized Bavi which is 90% human and 10% mouse; and (3) a Fully Human Bavi, which is 100% human. For example, the Chimeric molecule could be tested and approved just for HIV patients and carry a relatively low price. The Humanized drug could be the one that is tested and approved for co-infected HIV/HCV patients and have a much higher price.
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.
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.
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.”
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.”
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.”
This has not been posted on RB but feel free to do so.
