Research Update
March 28 2006 - 8:01AM
UK Regulatory
YM BioSciences' partner, Oncoscience AG, cleared for Phase III trial in
Germanywith nimotuzumab
- Phase II results presented at the 27th Annual German Cancer
Conference -
MISSISSAUGA, ON, March 28 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), the cancer product development company, today announced that its
partner, Oncoscience AG, has been cleared by the German regulatory authority
for biological products, the Paul Ehrlich Institute, to initiate a Phase III
trial of nimotuzumab in combination with radiation in children with inoperable
pontine (brain stem) glioma. The clinical trial was also reviewed with the
EMEA and is designed as a prospectively registrable study on the basis of a
single arm trial because of the absence of treatment options for children
suffering from pontine glioma. It is anticipated that marketing authorization
subsequent to a successful trial would be sought under the EMEA centralized
procedure.
The trial is a single arm study in which 40 children with inoperable
pontine glioma will be treated with radiation concomitant with nimotuzumab.
The primary clinical endpoints in the trial will be Progression-Free Survival
at 3, 6, 12 and 24 months with Median Survival as secondary endpoint. Clinical
sites will be located in Germany, Italy, Belarus and Russia and it is
anticipated that recruitment could be completed within approximately 12 months
after the start of patient enrolment. Based on a historical median survival
for this form of cancer of approximately 8.5 months, the trial could be
completed in the second quarter of 2007.
Additional data from the 40 patient Phase II trial conducted by
Oncoscience AG were presented at the 27th Annual German Cancer Conference in
Berlin on March 25th, 2006. The study reported 8 out of 40 patients were
evaluable for response after consolidation therapy and showed three partial
responses (PR), one Stable Disease (SD) and four progressive disease (PD) in
week 21. Eight patients with consolidation therapy were free of progression
for a median of 4.6 months (1.9-14.5 months). Eight children out of the
40 recruited into the trial were still surviving as of March 25th (2.9-20.6)
months. Non-responders to treatment had a median survival of 1.1 months. No
severe side effects and no rash, diarrhea or conjunctivitis related to the
study medication were observed.
YM BioSciences has previously announced that it and its majority owned
subsidiary, CIMYM Inc., propose to file for authorization to conduct a
Phase III trial in North America following a clearance for such a trial in
Germany. In addition YM proposes to pursue the clinical development of
nimotuzumab in adult glioma as well as the current target of Non-Small Cell
Lung Cancer. YM's licensor, CIMAB SA and its parent, the Center for Molecular
Immunology, are conducting trials with nimotuzumab in glioma, breast,
esophageal, cervical, prostate and head and neck cancer.
Data from trials with nimotuzumab will be presented by Oncoscience AG in
two separate posters: at the AACR meeting in Washington, DC on April 04, 2006
in the late breaking news poster session and at the ASCO meeting in Atlanta,
Georgia on June 05, 2006. YM will also have results disclosed from a
pharmacodynamic/pharmacokinetic study of nimotuzumab conducted by the
University of Torontoat the ASCO meeting.
Analyst Day Announcement
YM BioSciences invites analysts and investment managers to attend a
Research and Development Day on Wednesday, April 5, 2006 from 11:30am to
3:00pm ET, at the Harvard Club of NYC, The Harvard Hall, 27 West 44th Street,
New York, NY. Please RSVP to Thomas Fechtner at (212) 477-9007 x31;
tfechtner(at)troutgroup.com. Unconfirmed attendees may not be accommodated.
About Oncoscience AG
Oncoscience AG is a private biotech company based in Germany and is
focused in Oncology (nimotuzumab), Organ Transplantation (Lifor) and tumor
tissue banking including research in Genomics/Proteomics.
About YM BioSciences
YM BioSciences Inc. is a cancer product development company. Its lead
drug, tesmilifene, is a small molecule chemopotentiator currently undergoing a
700-patient pivotal Phase III trial in metastatic and recurrent breast cancer.
Published results from tesmilifene's first Phase III trial in the same
indication demonstrated a substantial increase in survival for women treated
with the combination of tesmilifene and chemotherapy compared to chemotherapy
alone, demonstrating that tesmilifene significantly enhanced the therapeutic
effect of chemotherapy.
In addition to tesmilifene and nimotuzumab, the Company is also
developing an anti-GnRH anti-cancer vaccine, Norelin(TM), for which Phase II
data have been released. YM's subsidiary DELEX Therapeutics Inc. is developing
AeroLEF(TM), a unique inhalation delivered formulation of the established
drug, fentanyl, to treat acute pain including cancer pain. This product has
completed a Phase IIa trial with positive results and a randomized Phase IIb
pain trial has been initiated. The Company also has a broad portfolio of
preclinical compounds shown to act as chemopotentiators while protecting
normal cells.
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.
For further information: Enquiries: Thomas Fechtner, The Trout Group
LLC, Tel. (212) 477-9007 x31, Fax (212) 460-9028,
Email: tfechtner(at)troutgroup.com; Carolyn McEwen, YM BioSciences Inc.,
Tel. (905) 629-9761, Fax (905) 629-4959, Email: ir(at)ymbiosciences.com;
James Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229,
Fax (416) 815-0080, Email: jsmith(at)equicomgroup.com
(YM. YMI YMBA)
END
YM Bio.'b'ser1 (LSE:YMB)
Historical Stock Chart
From Jul 2024 to Aug 2024
YM Bio.'b'ser1 (LSE:YMB)
Historical Stock Chart
From Aug 2023 to Aug 2024