YM BioSciences Announces Positive Preliminary Results
September 05 2007 - 3:00AM
UK Regulatory
YM BIOSCIENCES ANNOUNCES POSITIVE PRELIMINARY RESULTS FROM PHASE I/II CANCER
TRIAL OF NIMOTUZUMAB COMBINED WITH RADIATION
Data Presented at the 12th World Conference on Lung Cancer in Seoul, Korea
MISSISSAUGA, ON, Sept. 4 /CNW/ - YM BioSciences Inc. (AMEX: YMI, TSX: YM,
AIM: YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today announced positive
preliminary results from the first two cohorts of the Phase I part of a Phase
I/II trial of nimotuzumab in combination with radiation for the treatment of
non-small-cell lung cancer (NSCLC) patients who are unsuitable for radical
chemotherapy. The data were reported on September 5th in a poster presentation
at the 12th World Conference on Lung Cancer in Seoul, Korea. Nimotuzumab is a
humanized monoclonal antibody that targets the epidermal growth factor
receptor (EGFR).
"While preliminary, these results are compelling because we observed
clinical benefit (Partial Response or Stable Disease) in every one of the 13
patients so far enrolled in this study. A study by The National Cancer
Institute of Canada demonstrated that patients with advanced NSCLC with Stable
Disease as best response for treatment had Overall Survival similar to
patients with Partial Response. The relatively long survival times observed in
the first cohort of this trial are encouraging and are in agreement with the
NCIC observations," said Dr. Igor Sherman, YM's Director of Clinical Research.
"Although nimotuzumab specifically targets the EGF receptor, the reported
absence of side effects, particularly the absence of severe rash, makes
nimotuzumab therapeutically attractive in this setting."
The Phase I component enrolled patients at three centers in Canada and is
evaluating the safety and feasibility of administrating nimotuzumab at three
dose levels (100mg, 200mg and 400mg weekly) with palliative radiation (30 Gy
in 10 fractions). The data will be used to select the optimal effective dose
for the randomized Phase II component of the study, in which Overall Survival
will be the primary endpoint.
Of the six patients enrolled in the 1st cohort (100mg), four Partial
Response (PR) and two Stable Disease (SD) were reported as at August 14, 2007.
Median Overall Survival of the group was 41.5 weeks. All patients ultimately
progressed. Two severe adverse events have been reported, neither causally
attributable to nimotuzumab. A notable absence of grade III/IV rash or
diarrhea in this cohort was reported.
Of the seven patients enrolled in the 2nd cohort (200mg) of the study,
two PR and five SD were reported as at August 14, 2007 Median overall survival
of the group has not been reached but currently exceeds 25 weeks. There has
been a notable absence of grade III/IV rash or diarrhea reported in this
cohort.
Enrolment is now ongoing into the third cohort, to be treated at 400 mg
per dose level, and accrual is anticipated to be completed by the end of 2007.
YM is conducting the trial in Canada and Kuhnil Pharmaceutical Co. is
conducting a parallel trial in Korea with a common protocol. This structure is
designed to accelerate overall recruitment and lower the costs to the
participants. The interim report from Phase I Korean patients is anticipated
early in 2008.
The poster presentation is entitled "Preliminary Results Of An Escalating
Dose (Phase I /II Clinical) Trial Of The Anti EGFR Monoclonal Antibody
Nimotuzumab In Combination With External Radiotherapy In Patients Diagnosed
With Stage IIB, III or IV NSCLC Unsuitable For Radical Therapy" by Gwyn Bebb,
Colum Smith, Anthony Brade, Stewart Rorke and Igor Sherman. The poster, P3 -
023, will be on display on September 5 & 6 at Atlantic Halls 5 - 8 in poster
session 3 - Novel Therapeutics: Molecular Therapeutics.
Nimotuzumab
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR). To date nimotuzumab has been administered to
approximately 900 patients in more than a dozen clinical trials and on a
compassionate basis. It has been approved in several countries and is being
provided on a compassionate basis in certain countries including Canada,
Germany and Australia. The drug continues to demonstrate a significantly
superior side-effect profile compared to all the other EGFR-targeting
antibodies and small molecules targeting the EGF tyrosine kinase signalling
pathway. The absence of any cases of severe rash to date and the very rare
instances of any of the other debilitating side effects holds the prospect for
nimotuzumab to become best-in-class for this important family of
EGFR-targeting agents.
Nimotuzumab global development programs
Nimotuzumab is licensed to YM's majority-owned Canadian subsidiary, CIMYM
BioSciences Inc., by CIMAB, S.A., the corporation representing the Centre for
Molecular Immunology, which was responsible for the discovery and early
development of this unique molecule. Nimotuzumab has been sub-licensed by
CIMYM to Daiichi Sankyo Co., Ltd for Japan, Oncoscience AG in Europe, Kuhnil
Pharmaceutical Co. in South Korea and Innogene Kalbiotech in Southeast Asia.
In the territories for which YM has licensed nimotuzumab, the drug is
currently in varying stages of development in colorectal cancer, adult and
pediatric glioma, non-small-cell lung cancer and pancreatic cancer and YM
expects that the range of indications will continue to broaden in 2008 as the
group's cooperative efforts expand.
In countries outside of YM's territories, nimotuzumab is in development
by seven licensees and is already approved for treatment of cancers of the
head and neck in a number of those including India, China, Cuba, Argentina and
Columbia.
YM anticipates that the licensees will increasingly participate
cooperatively to accelerate the rate of recruitment into trials of common
interest, thereby reducing the costs of development for each participant, and
shortening the time to completion of clinical trials.
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
two late-stage products: nimotuzumab, a humanized monoclonal antibody that
targets the epidermal growth factor receptor (EGFR) and is approved in several
countries for treatment of various types of head and neck cancer; and
AeroLEF(TM), a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain.
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(TM) 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: Thomas Fechtner, the Trout Group LLC, Tel. (212)
477-9007 x31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com; James
Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,
Email: jsmith(at)equicomgroup.com; Nominated Adviser, Canaccord Adams Limited,
Ryan Gaffney, Tel. +44 (0)20 7050 6500
(YM. YMI YMBA)
END
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