Each clinical trail we will enroll 300 subjects who have either Stage III or IV non-small cell lung cancer. These subjects are being randomized to daily doses of either 3 mg of enobosarm or placebo at the time they start First Line Platinum Doublet Chemotherapy. More specifically, the chemotherapy regiment for the POWER 1 trial is a Platinum Plus a Taxane and for the POWER 2 trial is a Platinum Plus a Non-Taxane.The primary end point end point for each of these studies is a co-primary end point consisting on a responder analysis of clinical benefit defined as maintaining or improving total lean body mass, assessed by DEXO and improving physical function assessed by the Stair Climb Test. Durability of the drug is being evaluated as a secondary endpoint at five months of treatment and those patients who are determined to have responded at three months. Enrollment is progressing steadily in both studies of randomizing subjects at essentially the same rate. Based on the current enrolment trajectory, we expect to complete enrolment of all 600 subjects during the fourth quarter of this year. We expect to release top line results in both studies during the second quarter of 2013. Early palliative care for the treatment of lung cancer patients is increasingly recognized as a necessary component for effectively providing comprehensive care to address host issues like quality of life, muscle wasting leading to a decline in physical function, fatigue, loss of independence and health care services utilization. This past February ASKO issued a provisional clinical opinion of the integration of palliative care into standard oncology care. Seven published randomized controlled clinical trails have demonstrated early palliative care, given alongside of usual oncology care in patients with advanced cancer that maintains or improves survival and improves quality of life. Based on this strong evidence, patients with metastatic non-small cell lung cancer should be offered concurrent palliative and standard oncology care initial diagnosis. Early palliative care leads to better patient and caregiver outcomes, which include improvement in symptoms, quality of life and patient satisfaction with reduced caregiver burden.
As the ASKO experts observed in their provisional clinical opinion and I quote “therefore is the panels expert consensus that combines standard oncology care and palliative care, should be considered early in the course of illness for any patient with metastatic cancer and/or high symptom burden. Strategies to optimize concurrent palliative care and standard oncology care with evaluation of its impact on important patient and caregiver outcomes for example quality of life, survival, healthcare utilization and cost and on society, should be in an area of intense research.”The ASKO provisional clinical opinions now emphasizing quality of life, their point is, if patents do now survive longer, can they live better. For example if patients with advanced lung cancer had only a medium survival of eight to 12 months, will they spend most of their time at home being active or will they spend the majority of their remaining time requiring skilled nursing care hand or hospice care. Muscle wasting has been shown to correlate with decline in physical function, weakness, fatigue, mobility disability, less tumor response and a potential for higher adverse side effects with chemotherapy, more frequent hospitalizations and shorter survival. If the POWER 1 and POWER 2 clinical trials are successful and enobosarm demonstrates that by preventing and treating muscle wasting, there is an improvement of physical function which allows lung cancer patients to maintain their independence longer with better quality of life, then the avoidance of expensive healthcare services could translate to significant savings for the healthcare system. As for Capesaris, our Capesaris program for advanced prostate cancer, we have clinical sites that are now beginning to screen for patients who have metastatic castration resistant prostate cancer. Approximately 25 clinical sites in the United Sates will participate in our Phase II 712 clinical study of Capesaris, as a secondary hormonal therapy for metastatic castration resistant prostate cancer. Read the rest of this transcript for free on seekingalpha.com