YM Biosciences Reports Additional Results From Nimotuzumab Phase III Study In Children With Glioma Presented By Oncoscience Ag
MISSISSAUGA, ON, Oct. 29 /PRNewswire-FirstCall/ -- YM
BioSciences Inc. (NYSE Amex: YMI; TSX: YM), a life sciences product
development company that identifies and advances a diverse
portfolio of promising cancer-related products at various stages of
development, today reported additional results from a completed
phase III study of nimotuzumab in children with diffuse intrinsic
pontine glioma (DIPG). The updates to the preliminary data at ASCO
2008 were presented by Oncoscience AG, YM's licensee for
nimotuzumab in Europe, at the 41st Annual Meeting of the
International Society of Pediatric Oncology (SIOP) held in Sao
Paulo, Brazil from October 5th-9th, 2009.
"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 Ferdinand Bach, CEO of
Oncoscience, the sponsor of the trial. "These additional results
showed that the benefit of nimotuzumab, in combination with
radiotherapy in patients with diffuse intrinsic pontine glioma, was
comparable to the combination of aggressive radio-chemotherapy."
Mr. Bach added, "Based on the results of this trial we intend to
submit a Pediatric Investigation Plan (PIP) to the EMEA forthwith
which, if approved by the Pediatric Committee (PDCO) would support
a submission for marketing authorization."
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. #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 April 2006 and August 2007, with 41
patients evaluable for response. The primary endpoint is reported
to be "probability of a patient surviving progression-free six
months post-diagnosis or median PFS over six months" and secondary
endpoints included overall survival, response rate, toxicity and
quality of life. The principal investigator is Professor Udo Bode
at the University of Bonn, Germany.
"Nimotuzumab continues to demonstrate efficacy in trials
throughout the world while avoiding the severe toxicities of the
currently available EGFR-targeting drugs," said David Allan,
Chairman and CEO of YM BioSciences. "These results underscore the
value of a drug that can deliver benefit while maintaining quality
of life. Adding to the body of safety and efficacy data for
nimotuzumab, 48-month survival data from the randomized 4-arm
"BEST" trial will be presented at ASTRO 2009 which will permit
reviewers to observe the activity and efficacy of nimotuzumab in
the absence of the severe toxicities of the class."
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 Canada and Israel, with
data expected in 2010. The drug is available on a compassionate use
basis in the US for children with pediatric glioma and is
designated an Orphan Drug for adult and pediatric glioma by the FDA
as well as the EMEA for Europe.
ASTRO Presentation
An oral presentation will be delivered at the American Society
for Therapeutic Radiology and Oncology's Annual Meeting on November
2, 2009 reporting on 48 month survival data in "BEST", a randomized
4-arm trial of nimotuzumab with radiation and chemoradiation with
patients with locally advanced head and neck cancer. Scientific
Session D: Head and Neck I - Advances in Targeted Biologic Therapy,
11:20a.m., Room W184.
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.
Source: YM BioSciences Inc.
CONTACT: James Smith, the Equicom Group Inc., Tel. (416)
815-0700 x 229,
Email: jsmith@equicomgroup.com;
Thomas Fechtner, the Trout Group LLC, Tel.
(646) 378-2931, Email: tfechtner@troutgroup.com
Posted: October 2009
