YM BioSciences and CIMAB achieve clinical milestone

 

    - Data for TheraCIM h-R3 in High Grade Malignant Glioma presented at

    ASCO 2005 -

    - Clinical benefit of EGF-R monoclonal antibody demonstrated with absence

    of rash, anaphylaxis or diarrhea -

 

    MISSISSAUGA, ON, May 19 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,

AIM:YMBA), the cancer product development company, today announced data from a

presentation at the American Society of Clinical Oncology 2005 Annual Meeting

for an open label Phase I/II trial in high grade malignant glioma tumors in an

adult population utilizing the EGF receptor humanized monoclonal antibody h-R3

(nimotuzumab) as a combination therapy.

    "TheraCIM continues to demonstrate clinical benefit in a broadening

number of cancer indications. The data from this trial are supportive of the

application by our partner Oncoscience AG for approval to initiate a Phase III

pivotal trial in Europe. These compelling results follow our release of data

in February 2005 demonstrating an overall response rate of 35.3% observed in a

monotherapy trial of TheraCIM h-R3 ("Theraloc" in Europe) in pediatric glioma

where the children had failed all other courses of treatment," said Mr.

David Allan, Chairman of YM BioSciences.

    "We are impressed by the continuing absence of acneiform rash, which is

reported in the literature as being physically and emotionally debilitating

and suffered by many patients treated with the other products being developed

for inhibition of HER1/EGFR. We also continue to see no evidence of

anaphylaxis or severe diarrhea similarly reported in other trials," added

Dr. Normando Iznaga, Global Project Manager for TheraCIM h-R3 at CIMYM Inc.

    The study was conducted in Cuba by CIMAB S.A., YM's partner in its

subsidiary CIMYM Inc. CIMAB S.A. is a company representing the Center of

Molecular Immunology, the originator of TheraCIM h-R3 at CIMYM Inc.

 

    Trial Design and Report Data

 

    Twenty-nine patients were recruited into the trial and 24 are available

for response evaluation. Patients were treated with the humanized EGF-R

monoclonal antibody, nimotuzumab (CIMAher in Latin America, TheraCIM h-R3 in

North America and Theraloc in Europe).

    The trial was an open label, uncontrolled, multi-centric Phase I/II

clinical trial, in which patients received six weekly infusions of h-R3 at the

dose of 200 mg in combination with external beam radiotherapy.

Immunoscintigraphic studies were performed after treatment to evaluate

treatment response.

    Primary tumors corresponded to glioblastoma multiforme (15 patients) and

anaplastic astrocytoma (9 patients). All patients underwent debulking surgery

or biopsy before entering the trial. In this patient set, four subjects

(16.7%) have achieved complete response, five patients (20.8%) have reached

partial response and 12 patients achieved disease stabilization. In total,

21 patients (87.5%) achieved disease stabilization or an objective response.

The product demonstrated clinical benefit in high grade glioma astrocytic

tumors with a mean and median survival for all the patients of 23.7 and

18.1 months and a survival rate at 18 months of 53%.

    No evidence of grade 3/4 adverse events was detected. One patient

developed a serious adverse event that consisted of grade 2 dysphasia and

sensory alteration. No patients presented with acneiform rash.

 

    Additional Information on TheraCIM h-R3 at CIMYM Inc.

 

    In previous clinical trials in head and neck cancer and nasopharyngeal

cancer, TheraCIM h-R3 has been shown to significantly improve the therapeutic

effects of radiation. A report on one of these trials was published in the

Journal of Clinical Oncology (Volume 22, No. 9, May 1, 2004) and other trials

have been described in press releases by YM BioSciences Inc. The licensee for

TheraCIM h-R3 in China received approval for the drug in that country in

April 2005 for the treatment of nasopharyngeal carcinomas in combination with

radiotherapy. TheraCIM h-R3 has also been approved in Argentina, Columbia and

Cuba for head and neck tumors in combination with radiotherapy.

    Application has been made for a randomized trial in adults with glioma

and the positive trial in pediatric glioma announced February 28, 2005 could

also be supportive of that application. A parallel monotherapy trial, also

being conducted in Germany in metastatic pancreatic cancer, was initiated at

the end of November 2004, has enrolled 34 patients to date and is targeted to

complete its first clinical assessment in mid-2005 following the review of the

first 30 patients in that trial.

    Theraloc/TheraCIM h-R3 at CIMYM Inc. has been awarded Orphan Drug

designation by both the European Medicine Evaluation Agency - EMEA - and by

the FDA in the USA for treatment of glioma.

    h-R3 is licensed to YM's subsidiary, CIMYM Inc., for Europe,

North America and the Pacific Rim excluding China, by CIMAB S.A.

 

    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, the Company is developing

TheraCIM hR3, described above, and GnRH anti-cancer vaccine that is in earlier

stage clinical trials. YM BioSciences recently 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 YM proposes to advance AeroLEF(TM) through

a Phase IIb pain trial in 2005.

 

    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; YM BioSciences Inc., Tel. (905) 629-9761, Fax

(905) 629-4959, Email: ir(at)ymbiosciences.com

    (YMBA)

 

 

 



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