Henry,
There are a couple things that I'd like your thoughts on:
1.''Because there are many more KS patients with no available alternative oral
treatments to chemotherapy than there are patients with acute promyelocytic
leukemia (APL), we will restructure our more slowly accruing APL program by
terminating one of our ongoing Phase III studies, and we will channel our
resources into the KS indication with a goal of completing an NDA filing in
1999, our targeted timetable,'' Mr. Robinson said.
Huh? They are dropping a PIII study for APL due to a problem of getting patients. What's up with this?
2. In the studies, Panretin Capsules were administered once daily at doses
increasing from 60 mg/m2 to 100 mg/m2/day
One pill a day sounds good. What is the protocal now with patients who have KS? Ie how are they treated?
3.Drug side effects were generally
manageable, with some patients requiring dose reductions with headache, dry
skin, rash, alopecia, peeling/flaking, and hyperlipidemia as the most common
events.
What are the side effects of existing drugs used to treat this disease?
4. Phase II trials are ongoing in breast, ovarian, pediatric cancers,
and bronchial metaplasia
Do you know where these trial stand? I would think that if Panretin has the same success with just one of the specific cancers above--especially breast cancer--as it has with KS, were looking at a $100 dollar stock IMHO.
5.Two pivotal Phase III trials of Panretin(TM) Gel for topical treatment of KS
have been completed to support an NDA filing in the first quarter of 1998.
The trials showed response rates of 42 and 35 percent respectively at
16-week assessments, and up to 48 percent response with continued treatment
beyond 16 weeks.
What exactly does the "up to 48 percent response with continued treatement beyond 16 weeks" mean? Is that suppose to mean that everyone still showed progress of up to 48 percent after the 16 week trial? The statistic that was thrown in doesn't quite explain itself.
Thanks |
