Gottfried, Two press releases have come out from ALRIZ already.
On focuses on phase I/II final data for Panretin topical treatment
of KS and the control arm of the phase III topical trial. Final data
show 27% of treatment lesions respond compared to 16% of control.
However, there was evidence that some of the control (non-treated)
lesions had in fact been treated. The phase III trial is double
blind placebo, so patients receiving the placebo will not have the
drug until the study is completed (up to 16 weeks). They have used
an independent group to look at the placebo patients and found that
the response rate was at or below 10%, which was expected. To ensure
that they have a greater than 15% differential they will enroll
approximately 35 additional patients (about 1 per site). They expect
patient accruals to be completed in 2Q, 1997 and and NDA to be filed
this year. They also described the many applications of oral Panretin
in a variety of cancers and skin diseases.
ALRIZ issued a second press release describing 3 compounds that are
finishing advanced pre-clinical testing. At least two of these are expected
to enter clinical trials next year. One compound, ALRT268, is similar
to Targretin. In animal models, it shows promise for treating type II
diabetes. It decreases glucose, triglycerides, and insulin levels,
as a single agent it was as effective as TZD, it synergized with TZD,
and it was well tolertaed. They also described a retinoid antagonist series.
This series would have application for systemic retinoid induced mucocutaneous
toxicity (a problem with treinoin and isotretinoin, the active ingredients
in Retin-A, Renova, Accutane, and Vessanoid). They also discussed an
RAR-specific retinoid which has shown promise for treatment of a wide range
of tumors and doesn't interact with other receptor types associated
with side effects such as mucocutaneous and bone toxicities.
Henry |
