On Wednesday, February 21 GTXI announced that Phase III data from a bone mineral density interim analysis and from a lipid interim analysis will be presented in separate podium sessions on February 23rd at the American Society of Clinical Oncology Prostate Cancer Symposium. Both analyses were conducted in the first 197 men to complete one year of treatment in the Phase III clinical trial evaluating ACAPODENE 80 mg for the treatment of multiple serious side effects of androgen deprivation therapy [ADT] for advanced prostate cancer. GTXI has been notified that these presentations have been selected to be part of an ASCO press briefing the morning of February 23.
In 2006 the company had reported that the interim results were positive but this will be the first time the detailed results will be made public. On Wednesday the stock rose significantly after the 2006 financial results were published showing the loss narrowed on the basis of revenues from collaborations. In addition, management reported an impressive 2006: the company received positive interim data in both the Phase III ADT trial and another Phase III trial with ACAPODENE for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia [PIN]; in the second half of 2006, GTXI licensed ACAPODENE European rights to Ipsen; in the same period GTXI reported successful results from the Phase II proof of concept clinical trial of ostarine for the treatment of muscle wasting and bone loss diseases; and at the end of 2006 the company was successful in raising $57 million from an equity offering, giving it sufficient cash to the first quarter of 2009.
The stock price is at or close to a 52 week high and an all time high since its IPO in early 2004. Investors had punished the stock in 2006 when it was reported that, even though the Phase II study had met all endpoints, a further Phase IIb study for ostarine would be carried out. The stock recovered from this loss and we think 2007 will be a very interesting time for the company. On Friday February 23 the news from the interim analysis will be a good predictor of success in the Phase III trials. If positive, we expect a solid gain in stock price over the next few months.
In addition this could increase the possibilities of a partner for the Asian region for its drug ACAPODENE. It has already partnered the European market, as mentioned above. Its Phase II product for muscle wasting and bone loss, ostarine, will be a strongly supportive catalyst for the stock in 2007. In 2007 GTXI is planning to initiate the Phase IIb ostarine clinical trial for the treatment of cancer muscle wasting and a Phase IIb ostarine clinical trial for the treatment of chronic kidney disease and end stage renal disease muscle wasting by the end of the year.
GTXI 1-yr chart
Disclosure: Author has no position in GTXI.