no reports of serious adverse events deemed related to the drug.
-- Approximately 120 patients have been enrolled in the trial with
enrollment completed at doses up to 360 mg/day. A total of 73 patients
in the three lowest expanded dose groups (60, 150, and 240 mg/day) have
been followed for more than 24 weeks. Of these 73 patients, 31
patients (42 percent) have received MDV3100 for greater than 24 weeks.
Dose escalation in the trial is continuing; the 360 mg/day expansion
group is completely enrolled, dose escalation is in progress at 480
mg/day, and initial dosing at 600 mg/day has started. Thus far a
maximum tolerated dose (MTD) has not been reached.
-- Medivation expects to seek FDA agreement to begin a pivotal Phase 3
registration study in castration-resistant prostate cancer patients in
Third Quarter 2008 Financial Results
Medivation reported a net loss for the quarter ended September 30, 2008 of $20.5 million, or $0.68 per share, compared with a net loss of $9.4 million, or $0.34 per share, for the same period in 2007. For the nine months ended September 30, 2008, the net loss was $54.5 million, or $1.86 per share, compared with a net loss of $22.2 million, or $0.80 per share, for the same period in 2007.
Total operating expenses for the nine months ended September 30, 2008 were $20.6 million, compared with $9.8 million for the same period in 2007. The increase in operating expenses for the third quarter of 2008 compared with the same period in 2007 is primarily due to increased development costs associated with Dimebon and MDV3100.
For the nine months ended September 30, 2008, total operating expenses
were $55.3 million, compared with total operating expenses of $23.7 million
for the same period in 2007. These figures include non-cash stock-based
|SOURCE Medivation, Inc.|
Copyright©2008 PR Newswire.
All rights reserved