YM BioSciences Cleared by FDA to Initiate Phase III Registrational Trial for Breast Cancer Drug

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YM Bio. Com Shs	LSE:YMBA	London	Ordinary Share	CA9842381050	COM SHS NPV

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YM BioSciences Cleared by FDA to Initiate Phase III Registrational Trial for Breast Cancer Drug - Pivotal trial to confirm previous positive phase III results for tesmilifene - MISSISSAUGA, ON, Nov. 4 /PRNewswire-FirstCall/ -- YM BioSciences Inc. (AIM:YMBA, TSX:YM), a cancer drug development company with an advanced-stage portfolio, today announced that it has received written confirmation from the U.S. Food and Drug Administration (FDA) that it may initiate a pivotal Phase III, or registrational trial, for its lead small-molecule anti-cancer therapeutic, tesmilifene. "We are extremely pleased the FDA has cleared us to begin this trial and look forward to establishing tesmilifene's ability to enhance traditional chemotherapies and extend the survival time of women with metastatic breast cancer, as the drug has demonstrated in a previous Phase III trial," said David Allan, Chairman and CEO of YM BioSciences. "The incorporation of a sequential design into the protocol creates the possibility of significantly reduced trial time and costs compared with the usual, classic Phase III trial design in this indication." The planned multi-center international trial will compare the overall survival times of advanced metastatic/recurrent breast cancer patients receiving tesmilifene in combination with epirubicin (an anthracycline) and cyclophosphamide versus epirubicin/cyclophosphamide alone. The primary endpoint of this pivotal trial is survival. The FDA has approved the incorporation of a sequential design into the trial protocol, enabling an interim analysis to be made by an independent Data Monitoring Board after 50% of the planned number of events (deaths) have occurred, and if necessary every six months thereafter, without incurring any statistical penalty. If the required survival differential is achieved at the first interim analysis, recruitment for the trial could be completed in approximately two years. This notification also follows the positive Special Protocol Assessment (SPA) by the FDA, approving the trial protocol design and endpoints. About Tesmilifene Tesmilifene is a small molecule anti-cancer drug that enhances traditional chemotherapy agents. It has been administered to over 500 patients in nine clinical trials and has been demonstrated to be safe. Tesmilifene has completed a successful Phase III international trial with 305 patients that compared the combination of tesmilifene and an anthracycline versus anthracycline alone in metastatic breast cancer patients. Results of the trial demonstrated that patients receiving the tesmilifene/anthracycline combination therapy had greater than 50% (23.6 months vs. 15.6 months; p(equal sign)0.03) median survival improvement compared with those receiving anthracycline alone. Further analysis indicated that patients in that trial suffering from aggressive breast cancer, defined as a disease free interval of less than 36 months, showed an even greater median overall survival increase. About YM BioSciences YM BioSciences Inc. is a cancer drug development company that was established in Canada in 1994. Its drug development portfolio includes three different anti-cancer compounds in a number of formulations targeting five different tumours or stages of cancer in clinical development. The products have been licensed principally from academic centres of excellence internationally. Drugs in development include tesmilifene, a small molecule chemopotentiator (for taxanes and anthracyclines) that has completed a Phase III trial with positive results in metastatic breast cancer; an EGFr humanized monoclonal antibody having completed Phase II trials; and a GnRH cancer vaccine also in clinical trials. In addition, the company is supporting the preclinical development of two additional cancer products. Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. DATASOURCE: YM BioSciences Inc. CONTACT: Enquiries: James Smith, The Equicom Group Inc., Tel. +1-416-815-0700 x 229, Email: ; YM BioSciences Inc., Tel. +1-905-629-9761, Fax +1-905-629-4959, Email:

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