YM BIOSCIENCES REPORTS ADDITIONAL RESULTS FROM NIMOTUZUMAB PHASE III STUDY IN
CHILDREN WITH GLIOMA PRESENTED BY ONCOSCIENCE AG
MISSISSAUGA, ON,
"These results demonstrate that nimotuzumab continues its long record of differentiated and remarkable safety and that it brings important benefits to children with this disease who are otherwise subject to aggressive chemotherapy," said
Oncoscience reported that patients were able to stay at home or attend school while undergoing treatment with nimotuzumab. After 24 weeks PR and SD was reported in 76% of the children and the median survival of all patients was 9.6 months, with responders having a median survival of 11.4 months. After one year of treatment, 14 of the 41 patients (34%) were reported alive compared to a historical rate of 39.9% (+/- 4.3%) reported for aggressive chemotherapy and radiotherapy by Wolff et al (J Neuro Oncology Vol. 79. No.3, September 2006).
The multi-centre, open-label, single-arm study was completed in 2007 and designed to evaluate the effectiveness of nimotuzumab combined with radiation in children with newly diagnosed DIPG, an inoperable form of brain cancer for which treatment options are severely limited. The study enrolled 42 patients aged 3 to 16 years (median 7 years) between
"Nimotuzumab continues to demonstrate efficacy in trials throughout the world while avoiding the severe toxicities of the currently available EGFR-targeting drugs," said
YM is currently conducting a Phase II study in children suffering from recurrent DIPG at ten of the principal oncology hospitals in the US as well as sites in
ASTRO Presentation
An oral presentation will be delivered at the American Society for Therapeutic Radiology and Oncology's Annual Meeting on
About YM BioSciences
YM BioSciences Inc. is a life sciences product development company that identifies and advances a portfolio of promising cancer-related products at various stages of development. The Company is currently developing two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical trial expertise and a diversified business model designed to reduce risk while advancing clinical products toward international approval, marketing and commercialization.
Nimotuzumab is a humanized monoclonal antibody in development worldwide, targeting multiple tumor types primarily in combination with radiation and chemoradiation. It is significantly differentiated from all other currently marketed EGFR-targeting agents due to its remarkably benign side-effect profile. Nimotuzumab's anti-tumor activity has led to its approval for marketing in 23 countries. In more than 5,000 patients reported as having been treated with nimotuzumab worldwide to date, no Grade IV incidents of radiation dermatitis have been described, severe rash has not been observed and reports of the other severe side-effects that are typical of EGFR-targeting molecules have been rare. Nimotuzumab is licensed to YM's majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and was developed at the Center of Molecular Immunology. YM is developing AeroLEF for the treatment of moderate to severe acute pain. The product is differentiated from other approaches using opioids because patients are able to individually control the analgesia required for their differing intensities of pain. AeroLEF met all endpoints in a randomized Phase II trial and is currently being prepared for late-stage development internationally.
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, 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. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF(R) will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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For further information: James Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Email: [email protected]; Thomas Fechtner, the Trout Group LLC, Tel. (646) 378-2931, Email: [email protected]
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