Key Developments For GTx, Inc.
GTx, Inc. (GTXI.O) (Consolidated Issue listed on NASDAQ Global Market)
GTx, Inc. Receives Complete Response Letter From FDA For Toremifene 80 mg New Drug Application
GTx, Inc. announced that it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT). The FDA identified two deficiencies in the Complete Response Letter and recommended that the following information be provided to the FDA to address these clinical deficiencies: (i) results of a second adequate and well controlled Phase III trial demonstrating the safety and efficacy of toremifene citrate 80mg to reduce fractures in men with prostate cancer on ADT and (ii) results from an adequate and well-controlled clinical trial demonstrating that toremifene treatment to reduce fractures in men with prostate cancer on ADT does not have a detrimental effect on either time-to-disease progression or overall survival.
GTx, Inc. Announces Phase III Clinical Development of Toremifene 20 mg On Course Following Planned Safety Review
GTx, Inc. announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the Company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), a precancerous lesion of the prostate. The trial is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration. The last patient will complete the Phase III high grade PIN clinical trial in the first quarter of 2010.
GTx, Inc. Announces Treatment Of Advanced Prostate Cancer, Advances Into Second Phase I Clinical Trial
GTx, Inc. announced the initiation of a Phase I multiple ascending dose clinical trial evaluating GTx-758, an oral LH inhibitor for first line treatment of advanced prostate cancer. A Phase I single ascending dose clinical trial in 96 subjects was successfully completed in June. In the completed Phase I single ascending dose clinical trial, GTx-758 was well tolerated. GTx-758 demonstrated a pharmacokinetic profile compatible with once daily oral dosing and systemic exposures increasing with dose. The ongoing Phase I multiple ascending dose clinical trial is an open label, single center study of five dose groups of GTx-758, with ten healthy male subjects per group each receiving doses for 10 days. The study will evaluate the safety, tolerability and pharmacokinetic profile of GTx-758. In addition, testosterone and other hormones will be measured to assess the activity of GTx-758 on hormones secreted by the pituitary, hypothalamus, and adrenal glands. GTx expects to complete this Phase I multiple ascending dose clinical trial in the fourth quarter.
GTx, Inc. Presents Phase II Ostarine (MK-2866) Cancer Cachexia Clinical Trial Results At Endocrine Society Annual Meeting
GTx, Inc. announced results of a Phase II clinical trial evaluating Ostarine (MK-2866), an investigational selective androgen receptor modulator (SARM), in patients with cancer induced muscle loss, also known as cancer cachexia. In the study, Ostarine treatment led to statistically significant increase in lean body mass (LBM) and improvement in muscle performance measured by stair climb in patients with cancer cachexia compared to baseline in both the Ostarine 1 mg and 3 mg treatment cohorts. These study results were the subject of an oral podium presentation at the 2009 Annual Meeting of the Endocrine Society in Washington. In the study, Ostarine met the primary endpoint of LBM, measured by a dual energy X-ray absorptiometry (DEXA) scan, by demonstrating statistically significant increases in LBM compared to baseline in both the Ostarine 1 mg and 3 mg treatment cohorts. Specifically, the change from baseline in LBM for the placebo, 1 mg and 3 mg treatment groups was 0.1 kg (p=0.874 compared to baseline), 1.5 kg (p=0.001) and 1.3 kg (p=0.045), respectively, at the end of the 16-week trial.
GTx, Inc.'s Toremifene 80 Mg Increased Bone Mineral Density In Multiple Clinically Relevant Subpopulations of Prostate Cancer Patients on Androgen Deprivation Therapy
GTx, Inc. announced the presentation of data demonstrating that toremifene 80 mg treatment compared to placebo increased bone mineral density (BMD) in multiple clinically relevant subpopulations of men with prostate cancer on androgen deprivation therapy (ADT). The data, an analysis of results of the recent Phase III clinical trial evaluating toremifene 80 mg for the prevention of bone fractures and treatment of other estrogen deficiency side effects of androgen deprivation therapy in men with prostate cancer, were presented May 31, 2009 at the 2009 Annual Meeting of the American Society of Clinical Oncology. Toremifene 80 mg treatment compared to placebo showed higher BMD at the spine and the hip in an analysis of specific subgroups defined by baseline characteristics such as time on ADT (above/below the median 2.3 years), age (above/below 70 years), baseline BMD (normal or low), prevalent fracture, country of origin (United States or Mexico), or use of calcium/vitamin D (Abstract # 5055: The effect of toremifene citrate on BMD in men on ADT: A phase III clinical trial). Additional data from the clinical trial presented at ASCO demonstrated that in a univariate analysis, age greater than 70 years and degree of bone loss are independent predictors of fracture risk in men with prostate cancer on androgen deprivation therapy (Abstract # 9517: Use of age and BMD to predict fracture risk in men on androgen deprivation therapy).
