GTx, Inc. (Public, NASDAQ:GTXI)

Discussion in 'Men's Economics' started by Michael Scally MD, Aug 12, 2011.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    GTx, Inc. (Public, NASDAQ:GTXI) GTx. Hormone pathways to treat cancer, bone loss, muscle wasting
    INVESTOR RELATIONS: GTx, Inc. - Investor Relations

    GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to prevent and treat cancer, cancer supportive care, and other serious medical conditions.

    GTx's newest product candidate is GTx-758, which is a selective ER alpha agonist being developed for first line treatment of advanced prostate cancer. GTx-758 has the potential to achieve medical castration without causing bone loss or hot flashes.

    GTx is developing Ostarine™ (GTx-024) and other selective androgen receptor modulators, or SARMs, for the prevention and treatment of muscle loss in patients with cancer and for other muscle wasting diseases.


    GOOGLE FINANCE: GTx, Inc.: NASDAQ:GTXI quotes & news - Google Finance
    YAHOO FINANCE: GTXI: Summary for GTx, Inc.- Yahoo! Finance

    SEC: EDGAR Search Results
     
  2. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    SEC Financial Filings: 2010 Annual Report & 2011 2Q.
     

    Attached Files:

  3. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Ostarine™
    GTx. Ostarine™ (MK-2866): Aiming to Build Muscle in the Elderly and in Cancer Patients

    Ostarine™ is an oral selective androgen receptor modulator that GTx is developing for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

    About Muscle Wasting, a Common Cancer Related Symptom

    Muscle wasting is a common cancer related symptom which can begin early in the course of a patient’s malignancy resulting in decline in physical function and other detrimental clinical consequences. Muscle wasting and muscle weakness are also side effects of many chemotherapy drugs. There are no drugs approved for the prevention and treatment of muscle wasting in patients with cancer.

    At diagnosis, approximately 50% of advanced non-small cell lung cancer (NSCLC) patients have severe muscle loss, and approximately 70% of these patients will lose muscle before death. Muscle weakness and functional limitations are highly prevalent, with 88% of NSCLC patients reporting difficulty climbing stairs, lifting and carrying 10 lbs, walking a quarter mile, or stooping, crouching or kneeling. Muscle loss is a predictor of performance status, tolerability to cancer treatment, progression free survival and overall survival. Limitations in physical function predict the ability of a NSCLC patient to tolerate chemotherapy, and patients with functional limitations are less likely to be offered treatment. Functional status is also a predictor of survival.

    To date, GTx has evaluated Ostarine™ in eight clinical trials involving approximately 600 subjects including three efficacy studies. A four month Phase IIb Ostarine™ clinical trial enrolled 159 patients with NSCLC, colorectal cancer, breast cancer, non-Hodgkin’s lymphoma, or chronic lymphocytic leukemia. The study met its primary endpoint of absolute change in total lean body mass (muscle) compared to placebo and the secondary endpoint of muscle function (performance). The incidence of serious adverse events, deaths and tumor progression were similar among placebo and the treatment arms. The most common side effects reported among all subjects in the trial were fatigue, anemia, nausea and diarrhea.


    Chronic Sarcopenia

    Chronic sarcopenia is a disease state of progressive skeletal muscle loss associated with impaired strength and mobility frequently accompanied by disability and a loss of independence. Chronic sarcopenia can exacerbate and be aggravated by comorbid illnesses, such as diabetes, depression and frailty in the elderly. There are currently no FDA approved therapies for chronic sarcopenia.
     
  4. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    GTx-758: The Potential for a “Best in Class” ADT
    GTx 758. An oral LH inhibitor

    GTx is developing Capesaris (GTx-758), a selective estrogen receptor (ER) alpha agonist, for the first-line treatment of men with advanced prostate cancer. GTx-758 rapidly suppresses secretion of luteinizing hormone by feedback inhibition on the pituitary, thereby inhibiting the production of androgens by the testes. Capesaris has the potential to achieve medical castration to control the prostate cancer and to prevent bone loss and hot flashes.

    GTx conducted two Phase I Capesaris clinical trials in 2009. Capesaris was well tolerated. In September 2010, GTx announced that in a Phase II, open label, pharmacokinetic-pharmacodynamic clinical trial, Capesaris suppressed serum total testosterone to castrate levels, increased serum SHBG (sex hormone binding globulin), and markedly reduced serum free testosterone in healthy male volunteers.
     
  5. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    AutoZone Billionaire Pumps Fortune Into Cancer Fight
    AutoZone Billionaire Pumps Fortune Into Cancer Fight - Bloomberg

     
  6. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  7. BBC3

    BBC3 Member

    I thought this was the company out of Birmingham (May have that wrong but seems associated) that cant even seem to get Faraston off the gound?? And thought it was some kind of Merck Subsidiary, or bastard child created to experiement. Not that this is a negative...

    So I am not sure. Is this a subcorp of a major pharma recently sold off as public offering??
     
  8. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    EFFECT OF SARM ENOBOSARM
    Abstracts : Journal of Thoracic Oncology

    187P - EFFECT OF ENOBOSARM ON OVERALL SURVIVAL IN A PHASE IIB STUDY IN NSCLC PATIENTS WITH >8% WEIGHT LOSS

    S. Dodson, M. Hancock, M.A. Johnston, M. Steiner Medical Affairs, GTx, Inc., Memphis, TN, UNITED STATES OF AMERICA

    Background: At diagnosis, up to 50% of lung cancer patients have substantial weight loss, increasing to >80% prior to death. Much of this weight loss is attributed to muscle wasting-leading to a decline in physical function and other detrimental effects. Studies show that NSCLC patients with wasting at diagnosis are less able to tolerate chemotherapy, have worse outcomes and shorter survival. The negative impact of wasting underscores the importance of preventing and treating this condition early. We conducted a Phase IIb, randomized, double-blind, placebo-controlled, study to evaluate the effect of enobosarm, a selective androgen receptor modulator, on muscle wasting and physical function in patients with cancer.

    Methods: Subjects (n=159) were randomized to oral enobosarm or placebo for 16 weeks. Subjects were males >45y and postmenopausal females, had experienced ?2% weight loss in the 6 months prior to randomization, and had NSCLC, colorectal cancer, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia or breast cancer. The primary endpoint was change in total lean body mass. We report on overall survival in the entire study population and NSCLC cohort based on weight loss of > or ?8% in the 6 months prior to randomization.

    Results: In placebo subjects (ITT), overall survival was significantly (P=0.003, log rank) reduced in subjects with >8% weight loss compared to subjects with ?8% weight loss. Among NSCLC subjects (n=61) placebo subjects with >8% weight loss demonstrated a similar survival disadvantage (P=0.04); 4 month Kaplan-Meier estimates 100% vs 49% ±14.8%. In enobosarm treated subjects in the ITT and NSCLC groups, baseline weight loss did not negatively affect survival.

    Conclusions: Preceding weight loss among NSCLC patients not treated with enobosarm is predictive of decreased survival. NSCLC subjects randomized to placebo with >8% weight loss at baseline were 2x more likely to die than subjects with ?8% weight loss. In the enobosarm group baseline weight loss was not predictive of survival. These data suggest that enobosarm may overcome the negative prognostic effect of >8% weight loss. Further research is needed to assess the effect of enobosarm on overall survival.

    Disclosure: S. Dodson: I am member of senior leadership and own stock in the GTx. M. Hancock and M.A. Johnston: I am an employee and own stock in GTx, Inc. M. Steiner: I am CEO, on the board and own stock in GTx, Inc.


    188P - EFFECT OF ENOBOSARM, A SELECTIVE ANDROGEN RECEPTOR MODULATOR, ON PHYSICAL FUNCTION IN NSCLC PATIENTS WITH MUSCLE WASTING

    S. Dodson, M. Hancock, M.A. Johnston, M. Steiner Medical Affairs, GTx, Inc., Memphis, TN, UNITED STATES OF AMERICA

    Background: Muscle wasting in cancer patients leads to decline in physical function. At diagnosis, >50% of lung cancer patients have substantial wasting, increasing to >80% prior to death. Data shows that NSCLC patients with muscle wasting are less likely to tolerate chemotherapy, have worse outcomes and shorter survival. This has detrimental consequences early in a patient’s malignancy, underscoring the importance of diagnosing and treating this condition at an early stage. Literature shows that a 10% improvement in physical function is a substantial clinically meaningful benefit. We conducted a randomized, double-blind, placebo-controlled study to evaluate the effect of enobosarm on muscle wasting in physical function in patients with cancer.

    Methods: Subjects (n=159) were randomized to oral enobosarm or placebo for 16 weeks. Subjects were males >45y and postmenopausal females, with ?2% weight loss in 6 months prior to randomization and had NSCLC, colorectal cancer, non-Hodgkins lymphoma, chronic lymphocytic leukemia, or breast cancer. The primary endpoint was change in lean body mass and QOL and physical function as secondary endpoints. For this analysis, clinical benefit is defined as 10% improvement in physical function.

    Results: 103 subjects (MITT) had stair climb assessed at baseline and week 16. Enobosarm subjects demonstrated clinical benefit compared to placebo (P=0.03). Among NSCLC subjects, 28 were included in the physical function analysis. 78% treated with enobosarm responded compared to 30% treated with placebo (P=0.02). Physical function was positively correlated with QOL as assessed by the FAACT questionnaire further substantiating clinical benefit (Spearman correlation coefficient = 0.60, P=0.001).

    Conclusions: Enobosarm was well tolerated ad showed statistically significant & clinically relevant improvement in physical function and NSCLC subjects. Clinical benefit in stair climb power correlated with a clinically relevant improvement in quality of life. These data provide evidence that enobosarm may play an important role in management NSCLC by improving physical function & quality of life.

    Disclosure: S. Dodson: I am a member of senior leadership and own stock in GTx, Inc. M. Hancock and M.A. Johnston: I am an employee and own stock in GTx, Inc. M. Steiner: I am the CEO, on the board and own stock in GTx, Inc.
     
  9. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    GTx Announces Presentation on Enobosarm’s Improvement in Physical Function in Cancer Patients with Both Low and Normal testosterone Levels
    GTX, Inc. - News Releases

    MEMPHIS, Tenn.--(BUSINESS WIRE)--Jun. 25, 2012-- GTx, Inc. (Nasdaq: GTXI) announced today that in a Phase IIb clinical study of enobosarm, there was significantly improved physical function after 16 weeks of treatment, compared to placebo, in both hypogonadal (low testosterone) and eugonadal (normal testosterone) subjects. The study met its primary endpoint of absolute change in total lean body mass (muscle) compared to placebo after 16 weeks of treatment. The data were reported by Adrian Dobs, M.D., M.H.S., professor of medicine and oncology, and Vice-Chair of the Department of Medicine, Faculty Development at The Johns Hopkins University Medical School, during the 2012 Annual Meeting ofThe Endocrine Society (ENDO 2012). Enobosarm is currently being evaluated in two pivotal Phase III clinical trials.

    In the presentation, “Prevalence and Impact of Hypogonadism in Cancer Patients with Muscle Wasting in a Phase IIb Enobosarm Trial,” Dr. Dobs reported that enobosarm, a selective androgen receptor modulator (SARM), may play an important role in the management of cancer-related muscle wasting. When correlating baseline testosterone levels with weight loss, hypogonadal male subjects in GTx’s Phase IIb clinical study of enobosarm demonstrated greater weight loss than eugonadal males. Dr. Dobs noted that baseline physical function (stair climb power) of subjects in the study was higher among eugonadal versus hypogonadal males.

    In the Phase IIb clinical study of enobosarm, 159 subjects were randomized to enobosarm or placebo for 16 weeks. The subjects were males greater than 45 years of age and postmenopausal females who had non-small cell lung cancer, colorectal cancer, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia or breast cancer and experienced a 2% or greater weight loss during the 6 months prior to the study’s initiation. Of the 103 male subjects in the study, baseline testosterone levels were available for 93 men. 60% of the males were found to be hypogonadal at randomization, and the distribution of hypogonadism was similar across all forms of the cancers.

    Trial Design

    Enobosarm is a SARM which binds to the androgen receptor and is designed to deliver the beneficial effects of androgens while minimizing unwanted clinical side effects. GTx conducted its Phase IIb clinical study of enobosarm in 159 cancer patients (average age of 66 years) in 35 sites in the United States and Argentina. Participants were randomized to receive placebo, 1 mg or 3 mg oral tablet of enobosarm once daily for 16 weeks. Average reported weight loss prior to entry among all subjects was 8.8%, and subjects were allowed to have standard chemotherapy during the trial. The drop-out rate during the trial was 33%. GTx is conducting two pivotal Phase III clinical trials in the United States, Europe and South America, evaluating a once daily 3 mg dose of enobosarm for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. More information about these two clinical studies can be found at GTx Clinical Trials - The POWER Trials.
     
  10. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    GTx Attains Enrollment Goal for its Enobosarm POWER 1 and POWER 2 Phase III Clinical Studies
    GTx, Inc. - News Releases

    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.
     
  11. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    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
    GTx, Inc. - News Releases

    I can see approval in this set of patients. Off label use will be a concern.
     
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  12. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  13. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Selective Androgen Receptor Modulators In Cancer Cachexia

    [The changes for FDA Approval are far from certain. GTXi is betting on those that will die, no hope of life, NONE, NADA , ZIP. (Also, the attempt to use a SARM that is not tarnished with the name Anabolic Steroid. It is noteworthy that Oxandrolone is approved for wasting.) Therefore, any untoward side-effects will be offset by QoL. The most significant side-effect being hypogonadism after stopping the SARM, which will lead to a condition that only magnifies and exacerbates the cancer cachexia. The plan is they will take the drug until they die. The QoL change measured being at most marginally significant and more likely unimportant in end-of-life planning. Overall, IMO, a bust.]

    Fearon KH. Selective androgen receptor modulators in cancer cachexia? The Lancet Oncology. Selective androgen receptor modulators in cancer cachexia? : The Lancet Oncology

    Although osteoporosis has been a dominant target for novel therapeutics for the past two decades, much interest now surrounds that other component of the musculoskeletal system, namely skeletal muscle. This interest has been spurred by increased understanding of the molecular biology of skeletal muscle fuelled partly by the nascent science of sports medicine. Equally a strong imperative exists for such research in view of the daunting demographics of age-related sarcopenia.

    Adults older than 40 years lose 1% of their muscle mass per year; the number of individuals older than 80 years is projected to double over the next 20 years and in this population age-related muscle loss is predicted to be a major source of physical disability, poor quality of life, and death.

    Most patients with cancer are older than 65 years and therefore many will already have some degree of pre-existent age-related sarcopenia. Equally, modern multimodal cancer therapy often consists of a continuum of months or years of cycles of chemotherapy combined with surgery and radiotherapy. Even a short course of chemotherapy can result in loss of kilograms of skeletal muscle.

    When these effects compound pre-existing age-related sarcopenia and are accompanied by cancer-induced muscle loss a substantial proportion of patients with advanced disease can be rendered profoundly myopenic. Evidence suggests that such crucial loss of skeletal muscle mass is associated with increased chemotoxicity, reduced tolerance of therapy, and reduced overall survival.

    In adults, muscle mass is maintained partly by the anabolic effects of androgens (eg, dehydroepiandrosterone and testosterone). Androgens act via the androgen receptor and increase muscle protein synthesis via several signal transduction pathways. Male hypogonadism is noted frequently in advanced cancer but the epidemiological evidence linking it independently to cachexia or fatigue is awaited. Non-steroidal selective androgen receptor modulators are a class of drug that act mainly on androgen receptors in skeletal muscle and bone and aim to avoid potentially undesirable effects in prostate, skin, and other organs, including liver.

    It is against this background that the phase 2 trial by Adrian Dobs and colleagues of a first-in-class oral selective androgen receptor modulator (enobosarm, GTx-024; GTx, Memphis, TN, USA) should attract much interest. A diverse cohort (n=159) of patients with cancer (lung cancer, colorectal cancer, lymphoma, breast cancer, or chronic lymphocytic leukaemia) with a range of stage of disease (II—IV) were randomly assigned to enobosarm 1 mg, enobosarm 3 mg, or placebo once daily for 16 weeks.

    The drug was well tolerated and resulted in a significant gain of lean body mass (enobosarm 1 mg median 1.5 kg, range ?2.1 to 12.6, p=0•0012; enodosarm 3 mg median 1.0 kg, ?4.8 to 11.5, p=0•046) measured by dual-energy x-ray absorptiometry compared with baseline measurement. Change in total lean body mass within the placebo group was not significant (0•02 kg, ?5•8 to 6•7, p=0•88). The gain in lean muscle was associated with improved physical function as judged by shortened time and increased power in the 12 step stair climb test.

    Limitations include small sample size, heterogeneity of cancer type, and the issue that a proportion of patients entered into the study might have been disease-free and therefore could not be deemed to have cancer cachexia. Moreover, the nature of other supportive care in both the treatment and control groups was not well defined.

    Importantly, management of cancer-associated muscle loss is unlikely to be optimum without a multimodal approach. A study by Temel and colleagues in advanced lung cancer has emphasised that optimum symptom control by early introduction of palliative care can even translate into a survival advantage. Patients need active management of nutrition-effect symptoms. Nearly 50% of patients with advanced cancer have a daily protein intake below the best level for protein synthesis.

    Equally, clinicians generally recognise that in patients with cancer, systemic inflammation is likely to drive both muscle loss and overall sickness behaviour. Failure to address inflammation could lead to sustained muscle loss and failure to use the muscle that remains. Levels of physical activity are often much reduced in advanced cancer. Exercise is the best physiological intervention for muscle maintenance. A 6 week supervised exercise intervention in advanced cancer is both feasible and effective in reduction of fatigue. However, the effects of this intervention alone on overall quality of life remain difficult to detect. Home-based training is likely to be a more achievable intervention; however, it is probably best focused on keeping people active and targeting physical function, as opposed to fitness or capacity, which require closer supervision.

    The trial by Dobs and colleagues hopefully opens a new era of therapy for the management of muscle loss in patients with cancer. The result of phase 3 trials with this drug (NCT01355484, NCT01355497) and other promising agents are anxiously awaited. The oncology community needs to consider how to optimise the benefits of such treatments. An urgent need exists to establish a validated classification system for cancer cachexia and to establish what is best supportive care (nutrition, exercise, anti-inflammation) so that novel anabolic or anticatabolic agents can be used rationally and to best effect.
     
  14. Michael Scally MD

    Michael Scally MD Doctor of Medicine

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

     
  15. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    GTx Initiating Phase 2, Open-Label Study of Enobosarm to Treat ER Positive Metastatic Breast Cancer
    GTx, Inc. - News Releases

     
  16. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Millard Baker likes this.
  17. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    [FAIL] GTx Reports Results for Enobosarm POWER Trials for the Prevention and Treatment of Muscle Wasting in Patients with Non-Small Cell Lung Cancer
    GTx, Inc. - News Releases

    • Lean body mass (LBM) and stair climb power (SCP) responder analyses were mixed and the trials did not meet the pre-specified criteria

    • Enobosarm demonstrated significant quantitative advantage in LBM compared to placebo in both trials

    • Findings from both trials consistent with published data on the relationship between LBM and survival

    • Company plans to meet with US and European regulatory authorities to discuss path forward

    MEMPHIS, Tenn.--(BUSINESS WIRE)--Aug. 19, 2013-- GTx, Inc. (Nasdaq: GTXI) today announced results of its two Phase 3 enobosarm clinical trials, the POWER trials, in patients with non-small cell lung cancer (NSCLC) receiving chemotherapy. The Company announced that the clinical trials failed to meet the overall criteria for the co-primary responder endpoints of lean body mass and physical function as agreed upon with the United States Food and Drug Administration (FDA); the responder endpoints showed mixed results (for POWER1 and POWER2, p values at Day 84 for LBM were 0.036 and 0.113, respectively; p values at Day 84 for SCP were 0.315 and 0.289, respectively).

    Initial exploratory quantitative (continuous variable) analysis demonstrated that enobosarm had a consistent effect on LBM relative to placebo in both studies at all assessment times (p values were 0.0003 and 0.0227 at Day 84 for POWER1 and POWER2, respectively). Corresponding analyses for SCP were inconsistent between trials (p values were 0.0336 and 0.7923, respectively). Missing data were well balanced between the arms in both trials for both endpoints.

    Across both clinical trials, enobosarm was generally well tolerated, with the occurrence of serious adverse events and overall incidence of adverse events similar across placebo and treatment groups. In POWER1, the four most common adverse events reported (in decreasing order of incidence) were nausea, alopecia, anemia and vomiting. In POWER2, the four most common adverse events reported were anemia, nausea, neutropenia and vomiting. In the safety analysis of survival, there was no evidence of a difference between patients treated with enobosarm and placebo in either clinical trial.

    “While we are disappointed that both studies did not meet the pre-specified responder analyses, we are encouraged by the unambiguous effect of enobosarm on muscle and we are confident that it will translate to clinical benefit and potentially increase survival in patients with non-small cell lung cancer,” said Mitchell Steiner, M.D., CEO of GTx. “We look forward to sharing our clinical data from these and previous trials with FDA and European authorities to discuss the path forward. I would like to personally thank all the employees at GTx for their tremendous effort in conducting two high quality Phase 3 clinical studies and the principal investigators and their staff at over 80 clinical sites in 8 countries for their help recruiting and managing these studies. Most of all, I want to thank the patients with non-small cell lung cancer who participated in the POWER1 and POWER2 clinical trials in order to make it possible for future patients to potentially have access to important therapies.”

    Published observational data suggest that LBM is related to survival outcome. This observational finding has been replicated based on exploratory analysis of current survival data from the POWER studies using landmark analysis and time-dependent covariate Cox regression modeling that includes LBM response and arm as covariates. The effect size and direction were similar in both trials.

    GTx plans to initiate discussions with both the FDA and European regulatory authorities to determine the path forward.

    “Muscle wasting in patients with non-small cell lung cancer is devastating and unfortunately it affects hundreds of thousands of patients worldwide,” said Jeffrey Crawford, M.D., Chief, Division of Medical Oncology at Duke University School of Medicine, and principal investigator for the POWER1 and POWER2 trials. “While some of the pre-specified primary endpoints were not met, I am encouraged by the substantial and consistent effect of enobosarm on muscle in these patients with lung cancer receiving chemotherapy.”

    “Data from the POWER trials provide compelling evidence that enobosarm maintains or increases muscle,” said Carla Prado, Ph.D., Assistant Professor, Nutrition, Food and Exercise Sciences at Florida State University. “Loss of muscle, independent of weight loss, is a common and often occult feature of cancer, and is acknowledged as a remarkable and powerful prognostic indicator of shorter survival.”
     
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  18. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Kim J, Wang R, Veverka KA, Dalton JT. Absorption, distribution, metabolism and excretion of the novel SARM GTx-024 [(S)-N-(4-cyano-3-(trifluoromethyl)phenyl)-3-(4-cyanophenoxy)-2-hydroxy-2-methylp ropanamide] in rats. Xenobiotica 2013;43(11):993-1009. An Error Occurred Setting Your User Cookie

    1. GTx-024, a novel selective androgen receptor modulator, is currently being investigated as an oral treatment for muscle wasting disorders associated with cancer and other chronic conditions.

    2. Absorption of GTx-024 was rapid and complete, with high oral bioavailability. A wide tissue distribution of [(14)C]GTx-024 derived radioactivity was observed. [(14)C]GTx-024-derived radioactivity had a moderate plasma clearance (117.7 and 74.5 mL/h/kg) and mean elimination half-life of 0.6 h and 16.4 h in male and female rats, respectively.

    3. Fecal excretion was the predominant route of elimination, with approximately 70% of total radioactivity recovered in feces and 21-25% in urine within 48 h. Feces of intact rats contained primarily unchanged [(14)C]GTx-024 (49.3-64.6%). Metabolites were identified in urine and feces resulting from oxidation of the cyanophenol ring (M8, 17.6%), hydrolysis and/or further conjugation of the amide moiety (M3, 8-12%) and the cyanophenol ring (M4, 1.3-1.5%), and glucuronidation of [(14)C]GTx-024 at the tertiary alcohol (M6, 3.5-3.7%). There was no quantifiable metabolite in plasma.

    4. In summary, in the rat GTx-024 is completely absorbed, widely distributed, biotransformed through several metabolic pathways, and eliminated in feces primarily as an unchanged drug.
     
  19. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Typically a BAD sign when the CFO resigns.

    "On September 27, 2013, Mark E. Mosteller, the Company’s Vice President, Chief Financial Officer and Treasurer, notified GTx of his intent to resign from the Company, effective December 31, 2013, to pursue other interests. Mr. Mosteller is resigning his position in good standing with GTx, having served as a senior officer of the Company for in excess of twelve years."
    GTx, Inc. - SEC Filings