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AMRI Initiates Phase I Study of Proprietary Oncology Drug Candidate
Business Wire, August 18, 2008
ALBANY, N.Y. -- AMRI (NASDAQ: AMRI) today announced the initiation of its Phase I study of ALB109564(a), a novel tubulin inhibitor, which is designed to kill cancer cells by preventing cell mitosis.
The study will be conducted at four clinical trial sites for a period of nine to twelve months and include up to 40 subjects. The drug will be administered intravenously to cancer patients with advanced solid tumors in an ascending dose study to evaluate the compound's safety, tolerability and pharmacokinetic profile.
Today's announcement marks the second compound from AMRI's internally funded R&D portfolio to advance into Phase I clinical testing, following on the recent announcement of the submission of a Canadian Clinical Trial Application (CTA) by Bristol-Myers Squibb (BMS) for a compound licensed by BMS from AMRI's central nervous system research program.
"We are pleased to begin the process of enrolling patients and commencing Phase I clinical trials of our compound and are hopeful that this first clinical step will ultimately lead to a new weapon in the fight against cancer," said AMRI Chairman, President and CEO Thomas E. D'Ambra. "The initiation of this study demonstrates the company's ability to leverage its full spectrum of scientific capabilities to generate new products with commercial potential and to execute on the R&D portion of our strategic plan to provide value to stakeholders."
About ALB 109564(a)
ALB109564(a) is a novel analog from an established and marketed class of tubulin inhibitors, which is designed to kill cancer cells by preventing cell mitosis. In preclinical testing, the compound has been shown to demonstrate improved and potentially superior efficacy over existing members of its class which are currently marketed and used extensively in anticancer chemotherapy. Significant tumor growth delay was seen against human colon, lung and prostate solid tumors (as xenografts in mice) and against leukemia in mice. When administered intravenously to mice bearing prostate xenografts, ALB 109564(a) showed efficacy comparable to that of the important clinical agent paclitaxel.
ALB 109564(a) is a cytotoxic agent and a semi-synthetic derivative of a natural product originally extracted from the Madagascar periwinkle flower. Cytotoxic agents, used alone or most commonly in combination, continue to be an important part of the arsenal of anticancer agents.
This research program leveraged AMRI's unique biocatalysis technology platform, natural products chemistry expertise, and high potency development capabilities. AMRI has filed several patent applications to protect the intellectual property associated with this compound, and plans to ultimately seek a licensee to commercialize this technology.
About AMRI
Founded in 1991, Albany Molecular Research, Inc. (AMRI) provides scientific services, products and technologies focused on improving the quality of life. AMRI works on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world's leading healthcare companies. As an additional value added service to its customers, the company is also investing in R&D in order to expand it contract services and to identify novel early stage drug candidates with the goal to outlicense to a strategic partner. With locations in the U.S., Europe, and Asia, AMRI provides customers with a wide range of services, technologies and cost models.
Forward-Looking Statement
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These statements may be identified by forward-looking words such as "may," "could," "should," "would," "will," "intend," "expect," "anticipate," "believe" and "continue" or similar words and include, without limitation, statements regarding the company's clinical development plans for its proprietary compounds, the company's research programs and the license arrangement with BMS concerning the company's biogenic amines program. Readers should not place undue reliance on our forward-looking statements. The company's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the company may not be able to predict and may not be within the company's control. Factors that could cause such differences include, but are not limited to delay or denial of approvals from the FDA, potential changes in the cost, scope and duration of clinical trials as compared to the company's current expectations, the company's ability to attract and retain experienced scientists, trends in pharmaceutical and biotechnology companies outsourcing of chemical research and development, the company's ability to enforce its intellectual property and technology rights, the risks posed by international operations to the company, and the company's ability to effectively manage its growth as well as those factors discussed in the company's Annual Report on Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission on March 17, 2008 and the company's other SEC filings. The company does not undertake any duty to and does not intend to update any forward-looking statements contained in this press release after the date of this press release.
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