Clinical study results to be presented at annual meeting
29/05/2009 7:00am
UK Regulatory
TIDMYMB
YM BIOSCIENCES ANNOUNCES RESULTS OF RANDOMIZED NIMOTUZUMAB STUDY TO BE
PRESENTED IN A POSTER AT ASCO ANNUAL MEETING
MISSISSAUGA, ON, May 28 /CNW/ - YM BioSciences Inc. (NYSE Amex:YMI,
TSX:YM, AIM:YMBA), an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide, today announced
that a poster presentation will report results from a randomized trial of
nimotuzumab (aka BIOMAb/TheraCIM/h-R3) in patients with head and neck cancer
conducted by Biocon Limited (Bangalore, India), a licensee of CIMAB SA, YM's
licensor, at the 45th Annual Meeting of the American Society of Clinical
Oncology (ASCO) held in Orlando, Florida from May 29 to June 2, 2009.
The poster entitled "A phase IIb 4-arm open-label randomized study to
assess the safety and efficacy of h-R3 monoclonal antibody against EGFR in
combination with chemoradiation therapy or radiation therapy in patients with
advanced (stage III or IVA) inoperable head and neck cancer (abstract No.
6041)" will be presented in the Head and Neck Cancer general poster session on
Monday, June 1 from 8:00AM until 12:00PM on Level 2 in West Hall C.
About YM BioSciences
YM BioSciences Inc. is a life sciences product development company that
identifies and advances a diverse 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 over 12 countries, In more than 3,500 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 fentanyl because patients can 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.
For further information: James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229, Email: jsmith(at)equicomgroup.com; Thomas Fechtner, the Trout
Group LLC, Tel. (646) 378-2931, Email: tfechtner(at)troutgroup.com; Nominated
Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050 6500
(YM. YMI YMBA)
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