To: JMarcus who wrote (50 ) 2/2/1999 4:38:00 PM From: JMarcus Read Replies (1) | Respond to of 423
Greetings Lonewolf/Braveheart, I finally reached Paul Herron (IR for SUNP) again. He's been fielding lots of phone calls since the Shaman news. I think that I can answer all of your questions now (and some you didn't ask). Targets of the Phase 2 trial of DENSPM: ovarian, melanoma, pancreatic, non-small cell lung, renal cell carcinoma, and colon cancer. Clinical endpoint: tumor shrinkage, as measured by MRI Fast track? Not exactly. My mistake. The FDA has not granted fast-track status, so I should not have used the term "fast track." The trial design, known as an "Ensign design," has been accepted by the FDA for a number of years for cancer therapies. Possible to advance to NDA without P-3 trials: It the statistical results of the P-2 trial are strong enough, this is a real possibility. However, it is too early to get one's hopes up. Warner Lambert has not made an public announcement about how the P-2 trial is going. Herron did not even know which cancer type(s) is/are the one(s) that have advanced to the second stage of this three-stage P-2 trial. He hopes (don't we all?) that Warner Lambert will soon announce which cancer types were the ones that have been advanced to the second stage, but Herron has no way of knowing whether Warner Lambert will choose to do so. Toxicity/Side Effects of DENSPM: Herron reiterated that the side effects are minor: just nausea and vomiting. Chemotherapy patients routinely suffer such side effects, which are treated with anti-emetic drugs. Herron thinks the same anti-emeitc drugs could be used to control these side effects of DENSPM if dosage management fails to eliminate them. The side effects appear to be dose related. DEHOP's safety issues: AIDS patients with refractory diarrhea typically suffer from severe dehydration and electrolite imbalances. The FDA saw some indication that for patients with such complications DEHOP may raise issues of ventricular arhythmia. Herron believes that this issue can be addressed by dosage management, but another Phase 2 trial of 24 patients, who would be administered a slightly lower dose of DEHOP, would be required. Herron says that if SUNP elects to do another Phase 2 trial of DEHOP, enrollment should proceed quickly at one of the centers in either or both San Francisco or New York, where they have conducted prior trials. SUNP is still mulling over the decision whether do the Phase 2 trial of DEHOP or to switch instead to DESPM instead. DESPM appears (in preclinical trials) to have a better safety profile and may be orally available. Shaman: Herron does not know of any other company, besides the late Shaman firm, that is developing a competing drug for refractory diarrhea in AIDS patients. Herron stressed that what distinguishes SUNP from a company like Shaman is that SUNP has a much richer pipeline, whereas Shaman put all of its eggs in the Provir basket. Other indications for DEHOP/DESPM: chemotherapy-induced diarrhea and cholera. These are just possibilities. Institutional shareholders: University of Florida Research Foundation (5%), New York Life, Cross Atlantic Partners (Hambro), some Danish pension funds, Intersouth Partners, and various board members. Originally insiders owned 3.6 million shares, but Herron believes that the Danish pension funds have been buying more shares in the open market. His best information is that the total float (defined as shares not owned by insiders or institutional investors) is 2.5 million shares. The total number of shares outstanding is 6.7 million. I hope this satisfactorily answers your questions. Marc