Research Update
September 28 2005 - 3:03AM
UK Regulatory
YM BioSciences partner, Oncoscience AG, reports update of pediatric
brain cancer data
- Nimotuzumab (Theraloc; TheraCIM h-R3) Phase II results awarded best
poster prize at the 37th congress of the International Society of
Paediatric Oncology -
MISSISSAUGA, ON, Sept. 27 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), the cancer product development company, today announced that
updated data from a Phase II monotherapy trial of nimotuzumab in children with
resistant or relapsed high-grade gliomas (brain cancers) were reported in a
poster presented on September 23rd, 2005 at the 37th Congress of The
International Society of Paediatric Oncology in Vancouver, Canada. Nimotuzumab
produced cytotoxic efficacy and evidence of survival benefit in children with
heavily pretreated relapsed high grade gliomas, especially those with diffuse,
intrinsic pontine glioma.
The presentation updated data originally contained in a press release by
YM BioSciences issued on February 28th, 2005 that described results in 17
evaluable children. The updated data now includes results from 34 children of
which 27 were evaluable at an eight week assessment. The trial design
evaluates the children after eight weeks (induction) of therapy and after week
21 (consolidation) of therapy.
Nine of the 27 patients evaluable following induction had brain-stem
(diffuse intrinsic pontine) glioma, a treatment-resistant tumor. In the nine
evaluable patients with pontine glioma, five demonstrated clinical benefit at
week eight; four with Stable Disease (SD) and one with Partial Response (PR).
At the same time-point, three of the 18 remaining patients diagnosed with high
grade gliomas (grades III/IV) were assessed with clinical benefit (SD) at week
eight.
Of the five patients (all pontine gliomas) who went on to complete the
consolidation period of five months of treatment, two who were evaluated at
induction with SD are now assessed as PR.
Survival in the eight patients who derived clinical benefit post-
induction is as follows:
-------------------------------------------------------------------------
Pontine Glioma Other High-Grade Gliomas
-------------------------------------------------------------------------
Months of Survival 15.5+; 14+; 11; 10; 3+ 11+; 2.5; 8+
-------------------------------------------------------------------------
(+ remains alive)
Median survival of the children who did not respond to nimotuzumab was
1.3 months.
The conclusions of the presentation were:
- Nimotuzumab has cytotoxic efficacy in heavily pretreated relapsed
high grade gliomas, especially in diffuse, intrinsic pontine glioma.
- Repeated application of nimotuzumab is well tolerated and safe; no
severe hematological or non-hematological side effects were reported.
- High quality of life with long intervals of home care, attending the
school or kindergarten.
- A phase III study on the effectiveness of nimotuzumab in newly
diagnosed intrinsic pontine glioma concomitant with radiotherapy in
children and adolescents is planned.
"This study demonstrated the strong anti-tumour activity of nimotuzumab
in the absence of the toxicities, namely rash and diarrhea, normally
associated with other drugs in this class," said Dr. Paul Keane, Director of
Medical Affairs at YM BioSciences.
The poster presentation was awarded best poster prize at the conference
in the section "Experimental Therapeutics". Posters were judged based on
scientific merit, visual presentation and the potential significance of the
clinical research.
About Oncoscience AG
Oncoscience AG is a private biotech company based in Germany and is
focused in Oncology (Theraloc), 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 completing
enrollment in 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,
the Company is developing nimotuzumab, an anti-EGFr humanized monoclonal
antibody in a number of indications. YM BioSciences is also developing its
anti-GnRH, anti-cancer vaccine, Norelin(TM), for which Phase II data have been
released. In May 2005, the Company acquired DELEX Therapeutics Inc., a private
clinical stage biotechnology company 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 randomized a Phase IIb pain trial has been cleared
to start. 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: James Smith, the Equicom Group Inc., Tel.
(416) 815-0700 x 229, Fax (416) 815-0080, Email: jsmith(at)equicomgroup.com;
Carolyn McEwen, YM BioSciences Inc., Tel. (905) 629-9761, Fax (905) 629-4959,
Email: ir(at)ymbiosciences.com
(YM. YMI)
END
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