GTx Meeting Goals on Multiple Levels

The good news keeps coming from Memphis-based GTx. Most recently the company announced that it is being added to the NASDAQ Biotechnology Index(R) (Nasdaq: NBI). Addition to the index means a much more visible platform for the company.

The Nasdaq positioning comes on the heals of the company’s announcement that it has attained its enrollment goal for the pivotal Phase III clinical trial of ACAPODENE(R) for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia, or PIN. This is the largest prospective study to date of high grade PIN. More than 1,260 men, enrolled at approximately 150 clinical sites in the United States, Canada and Argentina, are participating in the placebo-controlled, double blind clinical trial.

Moving through the Phase III clinical trial is huge for this company and this city. The process to reach this point is complicated and lengthy. It begins with pre-clinical research to show biological activity of a compound, a process that can take three to four years. Next, Phase I trials require a year or more of testing. Phase II involves more volunteers to assess a drug’s effectiveness on volunteer patients. Phase III of clinical trials means the pool of test patients is greatly expanded in the clinical and hospital settings, sometimes for as long as three more years. If all goes well, the company moves to market. A city with companies bringing drugs to market is a city with a lot of additional spin-off business opportunity.

GTX also has initiated a proof of concept Phase II clinical trial of ostarine, a first-in-class drug. This clinical trial is designed to evaluate the ability of ostarine, a selective androgen receptor modulator (SARM), to build muscle and to promote bone growth, as well as to assess its safety in both elderly men and postmenopausal women.

GTx is an excellent example of what can happen when science coming from our local universities is matched with the right investors and business opportunities.


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