Posted on: 12/14/2004
December 14, 2004 11:56 AM US Eastern Timezone
Ecopia's Brain Tumour Compound, ECO-4601, Reaches Important Threshold Toward Clinical Trials
BIOWIRE2K
MONTREAL--(BUSINESS WIRE)--Dec. 14, 2004--Ecopia BioSciences Inc. (TSX:EIA) is pleased to announce that it is advancing its lead anticancer compound to treat primary brain tumours into preclinical pharmacology and toxicology trials. The trials are a precursor to the Company's filing of an Investigational New Drug (IND) application with regulatory agencies in North America, expected in the latter part of 2005. Recruitment of patients for a Phase I clinical trial will follow the IND application.
The preclinical trials will be carried out with the assistance of external collaborators and will include rodent and non-rodent animal models. They will focus on ADMET profiling (Absorption, Distribution, Metabolism, Excretion and Toxicity), a set of properties that predict how a drug will behave in the human body, in order to assess the safety of the compound and its efficacy. Results from the trials are expected in the second half of 2005.
Dr. Pierre Falardeau, Ecopia's President and Chief Executive Officer, commented on the remarkable progress of this compound: "Since announcing the discovery of ECO-4601, we have quickly obtained animal data to determine the compound's best indication, we have resolved challenging production issues and we have optimized the formulation, all in less than 24 months. We are very excited about bringing this compound one step closer to treating our first cancer patients."
These pharmacology and toxicology trials come less than two years after the announcement of the discovery of the anticancer compound, using Ecopia's proprietary DECIPHER(R) technology. Advancing a new chemical entity to preclinical testing in such a short period clearly demonstrates the ability of the Company's platform to originate valuable potential drugs that can be quickly directed towards the clinic.
About ECO-4601
ECO-4601 represents a new class of anticancer drugs discovered using Ecopia's proprietary DECIPHER(R) technology. Animal tests have shown significant inhibition of tumour growth in an aggressive form of brain cancer. More recently, the Company released data showing that ECO-4601 can cross the blood-brain barrier, demonstrating the compound's potential for easy delivery to the brain by intravenous infusion. In addition to its activity in brain cancer, earlier tests revealed the compound's selectively against other specific human tumour cell lines including melanoma as well as breast, lung and colon cancers.
About the primary brain cancer market
Current prognosis for patients diagnosed with primary brain cancer is poor, with a two-year survival rate of 35%, dropping as low as 8% for some more aggressive forms. Each year 8.2 out of every 100,000 individuals are diagnosed with primary brain cancer, representing an estimated 58,000 new cases per year in developed countries. Presently, the standard of care involves surgery to remove the tumour when accessible, followed by radiation to shrink the tumour and chemotherapy to kill the cancer cells. The current chemotherapeutic standard of care for brain cancer costs an estimated US$25,000 per year, resulting in a potential market worth well over US$1 billion.
About Ecopia
Using its DECIPHER(R) technology, Ecopia continues to build a pipeline that includes several anticancer, antibacterial and antifungal agents. The Company is advancing its most promising compound ECO-4601, a potential new drug to treat brain cancer, through preclinical trials and expects to file an IND in 2005. With its innovative DECIPHER(R) technology, Ecopia uses a radically different approach to discover new drugs from bacteria called actinomycetes. The most promising discoveries are added to the Company's rapidly growing pipeline for further development. Ecopia's shares are listed on the Toronto Stock Exchange (ticker symbol: EIA).
Additional information about the Company can be obtained from Ecopia's website at www.ecopiabio.com.
This press release may contain forward-looking statements that reflect the Company's current expectations regarding future events. The forward-looking statements, including expectations as to the pharmaceutical potential of ECO-4601 and the timeframe for its development involve risk and uncertainties. Actual events could differ materially from those projected here and depend on a number of factors, including the results of continuing pre-clinical profiling of ECO-4601, uncertainties related to the regulatory process for drug development, the success and timely completion of clinical studies, and trials, and the impact of general economic conditions. Investors are cautioned against placing undue reliance on forward-looking statements. A more complete discussion of the risks and uncertainties facing the Company appears in Ecopia's 2003 Annual Report.
DECIPHER(R) is a trademark of Ecopia BioSciences Inc.
Ecopia BioSciences Inc. (TSX:EIA)
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