Heat Biologics' Phase II, randomized, placebo-controlled and double-blind incorporates roughly 100 patients and comprise several arms: low dose HS-410 with BCG; high dose HS-410 with BCG, placebo plus BCG, and HS-410 as a monotherapy. The last arm is vitally important to show HS-410 as a monotherapy for bladder cancer and may, if successful, direct the design of a pivotal trial to possibly introduce to the medical community HS-410 as a replacement for BCG - a revolutionary step toward treatment of this expensive and prevalent disease. Patient enrollment is expected to complete by 3Q2015.
Immunotherapy in bladder cancer is spotty; hence, competition is light. Montreal-based Telesta Therapeutics Inc. (TST.TO:Toronto) plans to file a product similar to BCG with the FDA, but the agency has postponed approval due to manufacturing issues, extending decisions until June. Spectrum Pharmaceuticals, Inc. (SPPI:NASDAQ) wants to file an application for EOquin this year for bladder cancer but the drug failed primary endpoints in two previous trials; as an analog of mitomycin C, an antiquated treatment similar to BCG, it is not expected to be accepted by the medical community because side effects mimic chemotherapy.
https://finance.yahoo.com/news/heat-biologics-opportunity-among-soaring-161500153.html
| Estimated Enrollment: |
84 |
| Study Start Date: |
December 2013 |
| Estimated Study Completion Date: |
May 2017 |
| Estimated Primary Completion Date: |
August 2015 (Final data collection date for primary outcome measure) |
https://clinicaltrials.gov/ct2/show/NCT02010203?term=heat+biologics&rank=1