Research and Markets (http://www.researchandmarkets.com/research/435cv3/gtxs_ostarine) has announced the addition of the "GTX's Ostarine for cancer cachexia - a debilitating condition in need of therapy" report to their offering.
Ostarine is a small molecule, orally available, selective androgen receptor modulator (SARM) in phase III trials for use in cancer cachexia. GTX believes that Ostarine has the ability to build muscle mass and bone in patients with this debilitating condition. In so doing they hope to improve the ability to tolerate chemotherapy and perhaps even survival (although the latter is not a requirement for approval). The two phase III power trials are targeting a population with non-small cell lung cancer (NSCLC) who are about to begin two slightly different regimens of first-line chemotherapy. This report explores the strengths and weaknesses of the phase II data as it relates to the probability of phase III success, regulatory precedents as well as the market for therapies that target this condition.
Key Topics Covered:
1. Cancer cachexia
1. Preclinical data provide a rationale for use
2. What can we learn from the early clinical data?
- Phase IIb cancer cachexia trial
- Other trials
3. Are phase III trials likely to succeed?
1. Precedents give some insight into FDA standards of proof
2. Steroids carry a Class III DEA controlled substance designation - should that apply to ostarine?
3. Are there other safety concerns that will give FDA pause?
3. Competitive issues/summary
- Ligand Pharmaceuticals
- PsiOxus Therapeutics
- Helsinn Therapeutics
For more information visit http://www.researchandmarkets.com/research/435cv3/gtxs_ostarineBusiness Wire
Last updated on: 12/10/2012
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