GTx, Inc. (Nasdaq: GTXI) today provided a company update and reported
financial results for the fourth quarter and full year 2009.
“Following the Complete Response Letter last fall, GTx and our European
partner, Ipsen, met with the FDA in December. We believe that there is a
path forward for the approval of toremifene 80 mg”
“Following the Complete Response Letter last fall, GTx and our European
partner, Ipsen, met with the FDA in December. We believe that there is a
path forward for the approval of toremifene 80 mg,” said Mitchell S.
Steiner, MD, CEO of GTx.
As for the reacquisition of Ostarine™ and the GTx selective androgen
receptor modulator (SARM) program, Dr. Steiner continued: “It was a
difficult decision to dissolve our SARM collaboration with Merck. GTx’s
near term objective is to generate revenue so that we can transition to
a self-sustaining company. Reacquiring Ostarine moves us toward this
objective by allowing us to advance our lead SARM into Phase III
clinical studies in cancer cachexia which is a large commercial
opportunity for our company and a critical unmet medical need for cancer
patients.”
• GTx reacquires full rights to Ostarine and rest of SARM program
and plans to advance Ostarine into Phase III clinical trials
GTx has reacquired full rights to Ostarine and its entire SARM program
following the mutual agreement by GTx and Merck to dissolve their SARM
collaboration. GTx is planning to pursue Phase III clinical development
of Ostarine for the treatment of cancer cachexia. GTx completed a
successful Phase IIb Ostarine clinical trial for cancer cachexia in
October 2008 and now plans to have an End of Phase II meeting with the
United States Food and Drug Administration (FDA) to discuss the Ostarine
Phase III clinical development program.
Ostarine is an oral agent that has demonstrated the ability to increase
lean body mass and improve muscle strength and performance in
postmenopausal women, elderly men, and men and women with cancer
cachexia. Ostarine is GTx’s lead SARM which has been studied in seven
Phase I, Phase II, and Phase IIb clinical trials in 582 subjects.
• GTx provides update on End of Review meeting with FDA
The company announced in November 2009 the receipt of a Complete
Response Letter from the FDA for the toremifene 80 mg New Drug
Application. In December, GTx and its European Partner, Ipsen Biopharm
Limited, met with FDA to better understand the two issues cited in the
Complete Response Letter. Based on this End of Review FDA meeting, GTx
and Ipsen have concluded that there is a path forward to obtain approval
for toremifene 80 mg to reduce fractures in men with prostate cancer on
ADT. GTx will provide additional details following further discussions
with the FDA.
• Toremifene 20 mg Phase III high grade PIN clinical trial results
expected this summer
In late February, the last patient completed the Phase III clinical
trial evaluating toremifene 20 mg for the prevention of prostate cancer
in high risk men with high grade prostatic intraepithelial neoplasia
(PIN). GTx has begun the operational steps to conclude the study and
expects to announce results this summer. If successful, GTx would move
forward with plans to submit a New Drug Application.
• Initiation of the Phase II clinical trial evaluating GTx-758