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GTx Inc.

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Mitchell S. Steiner, M.D., CEO, maintained guidance for data from the phase-III programs POWER-1 and POWER-2 for Enobosarm in Cachexia. He stated, "With the last patient being enrolled at the end of December 2012, we expect all subjects to complete the two studies by the end of this month and after taking into account the time required to finalize all patient documentation for both studies at clinical sites in eight countries in order to prepare for data lock, we currently anticipate that we will receive top-line data from the studies in third quarter this year. We intend to share the top-line data for both studies, POWER-1 and POWER-2, at the same time. The top-line data, at a minimum, will include the co-primary end points of lean body mass and physical function, safety, and an update on the survival information available at that time."
Source: Q1 2013 earnings conference call, 5/03/13.

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GTx's Phase III Clinical Studies of Enobosarm (GTx-024) to Continue as Planned Following Planned Safety Review

MEMPHIS, Tenn.--(BUSINESS WIRE)--Apr. 15, 2013-- GTx, Inc. (Nasdaq: GTXI) today announced that a per protocol safety review of unblinded safety data on Friday April 12, 2013, by an independent Data Safety Monitoring Board (DSMB), resulted in a determination that GTx continue as planned its two pivotal Phase III clinical trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer. The DSMB has met regularly every six months to review safety data from the two pivotal Phase III clinical trials and will not meet again until the data is locked and unblinded for a final assessment of safety data from the two studies.

"We are pleased that the DSMB has recommended that GTx continue as planned with our clinical studies of enobosarm under the existing protocols,” said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. “The extensive safety database GTx is compiling from the numerous clinical studies of enobosarm will be a critical component of GTx’s application for marketing approval, which we hope to submit following receipt of topline data from our Phase III clinical trials in the 3rd quarter of 2013."

GTx has completed enrollment of approximately 650 subjects with advanced non-small cell lung cancer in two pivotal Phase III clinical trials, POWER 1 and POWER 2. These international Phase III studies are being conducted in clinical sites in the United States, Europe, Russia and South America. In each of the placebo-controlled, double-blind clinical trials, approximately 325 patients with Stage III or IV non-small cell lung cancer have been randomized to oral daily doses of placebo or enobosarm 3 mg at the time they begin first line standard chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the response rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function assessed by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment. Topline data from the studies should be released during the third quarter of 2013.
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Source: press release, 4/15/13. http://phx.corporate-ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID...

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Enobosarm (Ostarine®, GTx-024), an oral selective androgen receptor modulator, being studied for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer: GTx completed enrollment in late December of subjects with advanced non-small cell lung cancer in two pivotal Phase III clinical trials, POWER 1 and POWER 2. These international Phase III studies are being conducted in approximately 80 clinical sites in the United States, Europe, Russia and South America. In each of the placebo-controlled, double-blind clinical trials, approximately 325 patients with Stage III or IV non-small cell lung cancer have been randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first line standard platinum doublet chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the response rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function assessed by the Stair Climb Test. Durability of the drug effect will be evaluated as a secondary endpoint at five months of treatment. Topline results will be presented for both studies at the same time in the third quarter of this year and will include the co-primary endpoints and safety assessments, as well as an update on survival.
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Source: press release, 2/21/13. http://phx.corporate-ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID...

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GTx Announces FDA’s Grant of Fast Track Designation to Enobosarm For the Prevention and Treatment of Muscle Wasting in patients with Non-Small Cell Lung Cancer

MEMPHIS, Tenn.--(BUSINESS WIRE)--Jan. 8, 2013-- GTx, Inc. (Nasdaq: GTXI) today announced that the U.S. Food and Drug Administration (FDA) has designated enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer as a Fast Track development program. Fast Track status is a process designed by FDA to facilitate the development and expedite the review of new drug candidates that are intended to treat serious diseases and have the potential to fill an unmet medical need. With a Fast Track designation, there is an increased possibility for a priority review of a new drug application (NDA) filed for the drug candidate and more opportunity for more frequent interactions with the FDA both prior to and following the filing of a NDA.

GTx is assessing the ability of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients in two pivotal Phase III clinical trials, POWER 1 and POWER 2. In each of the placebo-controlled, double-blind clinical trials, approximately 300 patients with Stage III or IV non-small cell lung cancer have been randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first line standard platinum doublet chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the responder rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function measured by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment.

“We are very pleased that FDA has recognized enobosarm as a drug candidate with the potential to address the serious and unmet medical need of preventing and treating muscle wasting in non-small cell lung cancer patients,” said Mitchell Steiner, MD, CEO of GTx. “With approximately 650 patients fully enrolled in our two definitive Phase III clinical studies of enobosarm, we expect to receive top line data from these studies this summer. Assuming the data supports our ability to do so, we will move quickly to meet with FDA to discuss the filing of a new drug application for enobosarm.”
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Source: press release, 1/08/13. http://phx.corporate-ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID...

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GTx Attains Enrollment Goal for its Enobosarm POWER 1 and POWER 2 Phase III Clinical Studies

MEMPHIS, Tenn.--(BUSINESS WIRE)--Dec. 17, 2012-- GTx, Inc. (Nasdaq: GTXI) today announced that it has attained its enrollment goal for both of its pivotal Phase III clinical studies of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients.

“More than 600 patients in the United States, Eastern Europe and South America are now participating in our two definitive Phase III clinical studies of enobosarm,” said Mitchell Steiner, MD, CEO of GTx. “After the last patient completes each of the five month studies, we expect to receive top line data during the latter part of our second quarter in 2013. We are excited about the potential of enobosarm to prevent and treat muscle wasting in patients suffering from non-small cell lung cancer.”

GTx is assessing the ability of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients in two pivotal Phase III clinical trials, POWER 1 and POWER 2. In each of the placebo-controlled, double-blind clinical trials, approximately 300 patients with Stage III or IV non-small cell lung cancer have been randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first line standard platinum doublet chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the responder rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function measured by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment.
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Source: press release, 12/17/12. http://phx.corporate-ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID...

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Mitchell S. Steiner, M.D., CEO, gave guidance for data from the POWER 1 and 2 clinical studies. He stated, "With enrollment completing for both the POWER-1 and POWER-2 clinical trials in this quarter, we expect to release top-line data from both these studies during the second quarter of 2013."
Source: Q3 2012 earnings conference call, 11/08/12.

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GTx's Phase III Clinical Development of Enobosarm (GTx-024) for muscle wasting in lung cancer patients on Course Following Planned Safety Review

MEMPHIS, Tenn.--(BUSINESS WIRE)--Oct. 29, 2012-- GTx, Inc. (Nasdaq: GTXI) today announced that a per protocol interim safety review on Friday, October 26, 2012, by an independent Data Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. The DSMB meets every six months to review safety data from the two pivotal Phase III clinical trials, POWER 1 and POWER 2.

“The DSMB reviewed safety data from the subjects enrolled in our two pivotal Phase III clinical trials and recommended that GTx continue with the trials as planned,” said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. “The extensive safety database GTx is compiling from approximately 9 clinical studies of enobosarm will be a critical component of the application for marketing approval we hope to submit following receipt of topline data from our Phase III clinical trials in the 2nd quarter of 2013.”
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Source: press release, 10/29/12. http://phx.corporate-ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID...

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Enobosarm (Ostarine(R), GTx-024), an oral selective androgen receptor modulator, for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer:

GTx is currently enrolling subjects in two pivotal Phase III clinical trials, POWER 1 and POWER 2, in patients with advanced non-small cell lung cancer. After a pre-specified safety review in subjects currently enrolled in these two clinical studies, the independent Data Safety Monitoring Board (DSMB) determined that the studies can continue as planned.

These international pivotal Phase III studies are being conducted in clinical sites in the United States, Europe, and South America. In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage III or IV non-small cell lung cancer are being randomized to oral daily doses of placebo or enobosarm 3 mg at the time they are to begin first line chemotherapy. The studies are evaluating as co-primary endpoints after three months of treatment the effect of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function assessed by the Stair Climb Test. Durability of the drug effect is being assessed as a secondary endpoint after five months of treatment. GTx expects data from the POWER 1 and POWER 2 Phase III clinical studies during the first half of 2013.
Source: press release, 5/08/12. http://phx.corporate-ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID...

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Enobosarm (OstarineTM, GTx-024), an oral selective androgen receptor modulator, for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer: GTx was granted the generic name “enobosarm” for Ostarine as a first in class agent. GTx has recently commenced two pivotal Phase III clinical trials, POWER1 and POWER2 (Prevention and Treatment Of Muscle Wasting in CancER) in patients with advanced non-small cell lung cancer. These clinical trials were designed based on feedback from the United States Food and Drug Administration (FDA). In the fourth quarter, GTx met with representatives of the Medicines and Healthcare Products Regulatory Agency (United Kingdom) and Medical Products Agency (Sweden), who confirmed that the design of the POWER1 and POWER2 clinical trials should be sufficient for the European Medicines Agency to support registration in Europe. These international studies are being conducted in clinical sites in the United States, Europe, and South America. In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage III or IV non-small cell lung cancer will be randomized to placebo or enobosarm 3 mg at the time they are to begin first line chemotherapy. The studies are evaluating as co-primary endpoints after three months of treatment the effect of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry (DXA) and on improvement of physical function assessed by the Stair Climb Test. Durability of the drug effect is being assessed as a secondary endpoint after five months of treatment. GTx expects data from the POWER1 and POWER2 Phase III clinical studies in the first quarter of 2013.
Source: press release, 2/21/12. http://phx.corporate-ir.net/phoenix.zhtml?c=148196&p=irol-newsArticle&ID...

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POWER-1 - Phase III, Randomized, Double-Blind, Placebo Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer on First Line Platinum Plus a Taxane Chemotherapy
Estimated Enrollment: 300
Study Start Date: July 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01355484?term=Ostarine&rank=3

Mechanism of action: Enobosarm (Ostarine, GTX-024) is a SM, promotes muscle formation and many of the benefits of testosterone without the unwanted side effects on prostate and skin by selectively modulating the androgen receptor depending on the tissue type.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2013-07-01 - 2013-09-30

Results: Pending