Message #4 From:
Stock News Bot Date: January 3, 2006 08:13:00 AM
EIA News Ecopia Announces Filing of Clinical Trial Application for ECO-4601
MONTREAL--(BUSINESS WIRE)--Jan. 3, 2006--Ecopia BioSciences Inc. (TSX:EIA) announces it has filed at the end of the day on Friday, December 30, 2005 a Clinical Trial Application (CTA) for ECO-4601, a small molecule that has potential for the treatment of specific cancers such as primary brain tumors, breast cancer and prostate cancer. A CTA filing is the equivalent of an investigational new drug (IND) application in the United States and is a request to the regulatory authorities in Canada to seek approval to conduct a clinical study in humans.
Upon approval of the CTA by the Therapeutic Product Directorate of Health Canada, Ecopia is proposing to conduct a phase I clinical trial with up to 30 patients who will be recruited at the Clinical Research Unit of the Sir Mortimer B. Davis - Jewish General Hospital (JGH), a McGill University Teaching Hospital. Dr. Gerald Batist will chair the trial and Dr. Peter Kavan will be the Principal Investigator. Dr. Batist chairs the Department of Oncology of the Faculty of Medicine of McGill University and is the Scientific Director of the JGH-based Montreal Centre for Experimental Therapeutics in Cancer. Dr. Kavan is an Associate Professor of the Department, the Director of the Adolescent and Young Adult Oncology Program of the McGill University Department of Oncology, and an oncologist at the JGH.
The type of patient to be recruited is one who suffers from one of six types of cancers and is refractory to current chemotherapies. Such cancers are glioblastomas, breast, prostate, ovarian, lung and colon cancers. The purpose of the trial will be to test the compound's safety and tolerability of ECO-4601. The clinical trial involves a 21-day cycle where different patients will receive escalating dosages of the compound via continuous infusion using ambulatory pumps for 14 days, followed by a seven-day rest.
"This clinical trial is an important milestone for Ecopia because it is our first oncology compound originated from our discovery platform", commented Dr. Pierre Falardeau, President and Chief Executive Officer of the Company. He added, "The safety profile of ECO-4601 found in preclinical studies allows us to test increasing doses of ECO-4601 over a relatively long period. Long-term treatment and chronic usage of chemotherapies are features that form part of the new modality in fighting cancer. We look forward to obtaining sufficient safety data so we can design future phase II trials that will test this novel compound in treating specific cancers such as glioblastomas, an urgent unmet medical need".
About Ecopia
Ecopia is finding novel anticancer therapies from soil-dwelling microorganisms that are one of the most prolific sources of drugs. Our current focus is to move our flagship compound ECO-4601 through phase I clinical trials. ECO-4601 is a novel small molecule that crosses the blood brain barrier and is effective in significantly inhibiting primary brain tumor growth and other types of cancers. Just like well-known chemotherapies such as doxorubicin and mitomycin C, ECO-4601 comes from microorganisms that live in common soil. However, unlike these drugs that were discovered many decades ago, ECO-4601 represents a new chemical class that is the fruit of a very unique drug discovery platform called the Decipher(R) technology. The common shares of Ecopia are listed on the TSX (symbol: EIA).
Additional information about the Company can be obtained from Ecopia's website at www.ecopiabio.com.
About the JGH
Since 1934, the Sir Mortimer B. Davis - Jewish General Hospital, a McGill University teaching hospital, has provided "Care for All," serving patients from diverse religious, linguistic and cultural backgrounds in Montreal, throughout Quebec and beyond. As one of the province's largest acute-care hospitals, the JGH has achieved a reputation for excellence in key medical specialties by continually expanding and upgrading its facilities for clinical treatment and teaching, as well as research at the Lady Davis Institute for Medical Research. For more, please visit www.jgh.ca.
About Primary Brain Tumors
The incidence of malignant brain cancer in the seven major pharmaceutical markets is estimated at 45,120 cases in 2005. These markets consist of France, Germany, Italy, Japan, Spain, the UK and the US. After leukemia, brain cancer was the second leading cause of death in males aged between 20-29 in the US in 1997-99, 2001-02. In 2000, brain cancer was the leading cause of death in this age group. In young adult females aged between 20-34, the disease ranked fifth in terms of cause of death in 1997-2000 and 2002.
The most common brain tumors are gliomas, which account for 77% of all malignant brain tumors. The most virulent form of malignant brain tumors is glioblastoma that constitutes 52% of all gliomas. It is estimated that the incidence of glioma in the seven major markets is 34,742 in 2005, and will reach 35,548 by 2015. Opinion leaders believe that all patients with low-grade gliomas will eventually progress to develop high-grade glioblastoma. The incidence of glioblastomas is estimated at 17,719 in 2005 and 18,130 in 2015. De novo glioblastomas do occur and account for 60% of cases, while the remainder result from a lower-grade primary brain tumors. Source: Datamonitor, "Stakeholder Opinions: Primary Brain Cancer", June 2005.
Certain statements in this press release that do not relate exclusively to historical facts are forward-looking statements. When used in this press release, the expressions "has potential", "is proposing", "will", "to be", "believe" and similar expressions, as they relate to ECO-4601, Ecopia or Ecopia's management are intended to identify forward-looking statements. These statements represent the Company's current expectations regarding future events. These forward-looking statements, including the potential of ECO-4601 as a cancer therapeutic and the belief that ECO-4601 has potential in regards to specific cancers such a primary brain tumors, breast cancer and prostate cancer, are based on data from preclinical animal studies and may rely on a number of assumptions concerning future events and are therefore subject to a number of risks and uncertainties, many of which are outside Ecopia's control. Actual results may therefore vary materially from the expectations expressed by the Company and depend on a number of factors, including the efficacy of ECO-4601 in treating specific cancers in human patients, the success and timely completion of clinical trials, the availability of funds and resources to pursue development of ECO-4601 and the impact of general economic conditions. Investors are cautioned against placing undue reliance on forward-looking statements or forward-looking information. These forward-looking statements or forward-looking information should not be relied upon as representing the Company's views as of any date subsequent to the date the statements were originally made or information originally provided. A more complete discussion of the risks and uncertainties facing the Company appears in Ecopia's 2004 Annual Report under Management's Discussion and Analysis of Financial Position and Results of Operations for fiscal 2004 and the 2004 Annual Information Form available at www.sedar.com. Except as required by law, Ecopia does not undertake and disclaims any obligation to update or revise its forward looking statements or forward looking information whether as a result of new information, future events, or otherwise.
