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Biopharmaceuticals Oncology

 News Release - February 20, 2008

New Breakthrough Treatment for Advanced Kidney Cancer Shows 49 Per Cent Higher Survival Rates

TORISEL(TM) is the First and Only Cancer Therapy Shown to Extend Overall Survival for Patients With Metastatic Renal Cell Carcinoma

TORONTO, Feb. 20 (Healthcare Sales & Marketing Network) - TORISEL(TM) (temsirolimus), a breakthrough therapy shown to extend median overall survival of patients with metastatic (advanced) renal cell carcinoma (RCC), the most common form of kidney cancer,(1,2) has been approved by Health Canada. TORISEL, which received a priority review from Health Canada, works differently than other cancer therapies. TORISEL is the first and only mTOR-based cancer therapy approved by Health Canada. It specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a type of protein that regulates cell production, cell growth and cell survival.(3,4)

"Kidney cancer is a devastating diagnosis since many patients present with advanced disease," says Dr. Georg A. Bjarnason, Associate Professor at The University of Toronto and a Medical Oncologist at The Sunnybrook Odette Cancer Centre. "The diagnosis of advanced stage disease drastically changes the life path of patients, because at that stage kidney cancer is incurable in most patients. Several new drugs have recently shown significant activity in the treatment of this cancer, but so far TORISEL is the only drug where clinical trials have shown a significant increase in median overall survival."

In a three-arm, phase 3 clinical trial of 626 patients with advanced RCC and poor prognosis who had received no prior systemic therapy, TORISEL significantly increased median overall survival by 49 per cent compared with standard of care treatment, interferon-alpha. The trial, the largest in advanced RCC to date, also showed patients on TORISEL had a 77 per cent improvement in progression-free survival - the length of time before advancement or worsening of the disease.

About Renal Cell Carcinoma

In 2007, it was estimated that 4,900 Canadians would be affected by kidney cancer and 1,650 will die from the disease.(6) RCC affects approximately three in 10,000 people and accounts for two per cent of all cancer-related deaths.7 RCC is generally diagnosed between the ages of 50 and 70 and affects more men than women.(8)

Approximately 25 per cent of patients with RCC are initially diagnosed with advanced disease, including locally invasive or metastatic RCC. The five year survival rate for a patient diagnosed with metastatic (cancer that has spread to other parts of the body) RCC is only between five and 10 per cent.(9)

"I know first hand how this cancer profoundly affects patients and their families," said Tony Clark, Chair, Kidney Cancer Canada and also a kidney cancer patient. "New advancements such as TORISEL that can help patients live longer with a good quality of life are very encouraging. I hope that all Canadians in need will have access to this and other new therapies."

Wyeth Pharmaceuticals

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide.

In partnership with the CIHR/Rx&D Collaborative Research Program, Wyeth Canada, has invested in a professional clinical research Chair in Oncology for a five year term. During this term, the Chair will be dedicated to Clinical Research in Oncology, specifically in kidney cancer with the aim of broadening scientific knowledge to address kidney cancer treatment issues in Canada.

References:

(1)Data on file (Temsirolimus CSR-64508, Protocol 3066K1-304, Aug 2006), Wyeth Research.

(2)Cohen HT, McGovern FJ. Renal-Cell Carcinoma. NEJM 2005;353:2477-2490. page 2477.

(3)Bjornsti MA, Houghton PJ. The TOR pathway: a target for cancer therapy. Nat Rev Cancer. 2004;4:335-348.

(4)Janus A, Robak T, Smolewski P. The mammalion target of the rapamycin (mTOR) kinase pathway: its role in tumourigenesis and targeted anti-tumour therapy. Cell Mol BiolLett. 2005;10:479-497.

(6)Canadian Cancer Statistics, 2007. Produced by: Canadian Cancer Society, National Cancer Institute of Canada, Statistics Canada, Provincial / Territorial Cancer Registries, Public Health Agency of Canada (available at www.cancer.ca).

(7)American Accreditation Health Care Commission for Medline Plus Medical Encyclopedia. Renal Cell Carcinoma. Available at: http://www.nlm.nih.gov/Medlineplus/ency/article/000516.htm (Revised December 21, 2005; Accessed January 23, 2007).

(8)Canadian Cancer Society. What causes kidney cancer? Available at: http://www.cancer.ca/ccs/internet/standard/0,3182,3172_10175_269991 _langId-en,00.html

(9)Cancer Care Nova Scotia. Guidelines for the Role of Interferon-Alpha (IFN-a) In Metastatic Renal Cell Carcinoma (RCC). 2001 September. Available at:

http://www.cancercare.ns.ca/documents/Interferon_Alpha_Renal_Cell_dg.pdf (Accessed January 23, 2007).


Source: Wyeth Pharmaceuticals

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