Enobosarm (GTx-024) 3 mg, an oral selective androgen receptor modulator, is being studied for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer.
“We expect the last patients to complete our two pivotal Phase 3 clinical studies of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer by the end of this month, which should allow us to release topline data from the studies in the third quarter of this year,” said CEO of GTx, Mitchell S. Steiner, MD, in the release.
With the FDA designating enobosarm 3 mg as a fast track development program in January, the drug has an increased possibility for a priority review.
“We are also initiating a new clinical study of enobosarm to treat women with metastatic breast cancer and believe that enobosarm offers the potential of a new hormonal therapy to treat this deadly disease.”
Indeed, this other test, this one announced last week, is to to evaluate enobosarm (GTx-024) 9 mg for the potential treatment of metastatic breast cancer, with an emphasis on rendering the same kind of result currently provided by other therapies without the side effects associated with existing treatments.
“We know from prior studies that women with hormone receptor positive metastatic breast cancer which has progressed following treatment with tamoxifen often respond to androgen [male hormone] therapy,” said Beth A. Overmoyer, M.D., a clinical investigator in the study who is also the director of the Inflammatory Breast Cancer Program at the Dana Farber Cancer Institute, “yet the side effects, such as facial hair growth and deepening of the voice, are not acceptable to most patients.”
“Hopefully, treatment with enobosarm will result in efficacy similar to androgen therapy without the masculinizing side effects.”
The study is planned to randomize 20 post-menopausal women with estrogen receptor (ER) positive metastatic breast cancer, who have previously responded to hormone therapy, who will then receive daily doses of enobosarm until either they show clinical progress or until they have completed 336 days of treatment.
“We believe enobosarm has the potential to selectively treat metastatic breast cancer while minimizing the unwanted side effects associated with steroidal androgens,” said Steiner. “Enobosarm would be the first new targeted hormonal therapy introduced for the treatment of breast cancer in many years.”
Clinical benefit will be assessed six months into the study.
In addition, GTx-758 is being studied by the company for secondary hormonal therapy in men with castration resistant prostate cancer and, potentially, as a primary treatment for advanced prostate cancer.
GTx-758, an oral nonsteroidal selective estrogen receptor alpha agonist, is to be the subject ofan open-label, phase 2 clinical study to evaluate the safety and effectiveness of three lower doses.
The update on its activities came with the release of first quarter financial results, released on Friday, which saw the company report a net loss of $12.6 million for the three months to March 31, compared to a loss of $11.1 million in the year-ago period.
GTx was trading up on the Nasdaq today, with an intraday high of $5.14 from an open of $4.88 per share.