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Biotech / Medical : Depotech(depo)
DEPO 7.300+1.7%Aug 14 5:00 PM EST
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To: Czechsinthemail who wrote (571)12/19/1997 12:51:00 AM
From: biao luo  Read Replies (2) of 887
 
The control arm for their lymphoma and leukemia trial is cytarabine, if the company's claim is true that Depocyt is an improved version of cytarabine, they may show better results than solid tumor. According to last year's annual report: Clinical Development. In the Phase III clinical trial as originally
designed and initiated in April 1994, patients with one of the three subtypes of
NM selected from multiple centers were randomized to receive either DepoCyt or
standard therapy. Standard therapy for metastases of solid tumors is
methotrexate and the standard therapy for metastases of leukemia and lymphoma is
unencapsulated cytarabine. Within each subtype, at least 20 patients are to
receive DepoCyt and at least 20 patients are to receive standard therapy. A
total of 40 patients are to be treated for each subtype of the disease and a
minimum total of only 120 patients are required to complete all three arms of
the study. Enrollment of patients into the Phase III trial for NM arising from
solid tumors was completed in May 1996 and the data from the trial was analyzed
subsequently based on a data cutoff date of October 1, 1996. Data from the
pivotal Phase III clinical study of DepoCyt in solid tumor patients suggest a
higher complete response rate, extended survival and longer time to disease
progression, compared to the standard treatment.

About their phase IV trial, here is the description of it from the annual report: In the case of DepoCyt, as with all drugs subject to accelerated approval,
the FDA had requested that the Company submit a Phase IV protocol prior to
submission of an NDA. Completion of a Phase IV study is not a prerequisite for
review of an NDA by the FDA. The Company has initiated a multicenter Phase IV
study of DepoCyt for the treatment of NM arising from solid tumors in the United
States and Canada. This study is a non-randomized trial intended to collect
further data relating to safety and efficacy. The study also permits additional
injections of DepoCyt for patients who fail to respond completely during the
initial induction period of the study or who relapse 30 days following
completion of the treatment protocol. See "-- Government Regulation."

I don't know if this will address the efficacy issue.
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