In recent conversations I learned:
HCV Single Dose Study:
The results of HCV single dose study were remarkable for 3 separate reasons: (1) even a small single dose of Bavi that stays in the body for just 72 hours dramatically reduces the viral count in chronic, hard-to-treat HCV patients; (2) the reduction was durable and sustained over 12 weeks; and (3) the levels of viral reduction actually increased from 0.6 log to 0.8 log over the course of 12 weeks, indicating presence of an adaptive immune response that continued to have therapeutic affect long after the initial Bavi dose had cleared the body.
Bavi is more effective in humans than in animals because it is a chimeric with 70% human material and 30% mouse. Thus, when used in animals, 70% of antibody was seen by animals as foreign matter and had no therapeutic effect. Just the inverse is seen in humans so human clinical results should be consistently better than results in animal studies.
No information collected on condition of liver before and after Bavi treatment.
HCV Repeat Dose Study:
Different cohorts will be treated with different dose levels. Probably the lowest dose level will be dropped but all the other dose levels from Phase Ia study, i.e. 0.3, 1.0 and 3.0 mg/kg, will be tested in the repeat dose study. Doing repeat dosing at 0.3 mg/kg is not a safety issue but rather an economics issue. Why use more Bavi if the drug works just as well at lower doses and can sell in the market at the same price regardless of the dose level. Phase II studies will use a constant dose level determined by Phase Ib results.
There will be hardly any waiting time between Phase Ib cohorts. A total of two or three centers is anticipated. Keep your eye on the Alamo Medical Research Center, where Vertex has done many of its studies. Phase Ib enrollment could be completed by mid-August with 12 week waiting period completed by mid-November.
The combination HCV trial will start soon. Enrollment in combo trial should complete by calendar year end but waiting period may continue into Q1 of 07.
HIV and CMV Trials:
Company is on track to initiate Bavi clinical trials this fall in CMV and HIV, probably in that order. Collaboration with leading HIV institution is in place but may not be announced before June 30, as previously expected, because company does not announce trial centers until enrollment has started at that center. This is why additional HCV Phase Ib centers have not yet been announced. Enrollment of HIV patients is pending completion of additional HIV preclinical data in monkeys, which is an FDA requirement before allowing new HIV clinical tests to start. CMV clinical trial may start before HIV because FDA preclinical work-up does not require primate data. Relationships with Duke Univ. are very much alive and well!
Cancer Trials:
MD Anderson is taking Bavi cancer trial to the next level. Company still expects to complete enrollment by calendar year end. Results may not be published until Q1 of 07. The company is open to releasing interim data from cancer trial as soon as a statistically significant quantum of data has been achieved.
Cancer trials in India are fully negotiated with CRO and will start following green light from Indian FDA.
NABTT Cotara trial is on track for completion by calendar year end.
Relations with NIAID, Avian Flu, other viral testing:
Virtually all of the government’s attention is on Avian Flu these days. Other diseases on the bioterrorism list are getting little attention and there is no way of knowing when we will hear the results of NIAID Bavi testing on the 30 other viral types. Regarding Avian Flu, the company’s collaboration with NIAID is progressing well. The company is working actively with several private and public institutions that are funded by the NIAID’s Avian Flu budget. A go / no-go decision will be announced in the fall before flu season starts.
Government funding of Bavi for Avian Flu could also happen in the fall concurrently with a “go” decision.
Recent Financing / Analyst Coverage:
The company is very pleased to have sold such a large block of stock without warrants or commissions. UU has become a believer in the company’s upside potential and is willing to hold some of its purchase long-term knowing the company won’t create downward pressure on the stock by doing another financing for six months (or below $2.50). UU is acting now more like an investment bank that engages in market stabilization. Company could not have gotten better terms anywhere else. The only down side of the UU financing is the absence of the guaranteed analyst coverage that would have come several months after a traditional banking deal. However, the company is confident Mr. Gendel can generate comparable or better media coverage in the same time frame.
The company continues to meet frequently with analysts. While analyst coverage is not guaranteed, it is still quite likely because several institutions are now buying large blocks of PPHM stock. Soon they will own enough shares to want their “independent” analyst to tell the PPHM story. Analysts like our story because it has the right balance between industry fundamentals and bioterror hype. Many biotech analysts today are skeptical of companies that put all their marbles in the Avian Flu or other bioterror baskets. Analysts like our focus on HCV, HIV and cancer, with Avian Flu as just a wild card that may or may not get played. Note that HCV alone is predicted to be a $9-10 billion market by 2010 while Tamiflu had about $1 billion of sales in the peak of the hype.
PR Policy / Story-Telling Time:
The company has adopted a policy of putting out fewer PRs with more punch per release. All substantive PRs will have large impact and reinforce the market’s understanding of our core platforms and strategies. This is why there was no PR on the 2C3 patent. One advantage of this conservative PR approach is to give the company credibility in PR circles and make it easier for Mr. Gendel to place a major media story in the coming months. Management and Mr. Gendel are on the same page that, following the efficacy results in the June 7 PR, the story is now ready for telling to a much larger audience.
As part of this more aggressive story-telling program, the company will present at the Unterberg Towbin and Canaccord Adams health care conferences as well as Jefferies next week. A fund that learned about the company at the last health care conference is now one of PPHM’s largest institutional holders.
Bottom Line: The Company has received multiple inquiries from pharmaceutical and financial institutions following the June 7 and June 19 PRs. MD Anderson is taking Bavi cancer trial to the next level and the company is open to releasing interim data from this trial. The company is working actively with several private and public institutions that are funded by the NIAID’s Avian Flu budget. Initial results from the first cohort in the repeat-dose HCV trial are in hand. Management and Mr. Gendel are now ready to “beat the drums” and get this story told.
Jazz -- Could you please put a link on RB to this report. For some reason I can’t upload posts to that Board. Thank you.
