AMRI Presents Preclinical Data for Tubulin Inhibitor, ALB109564(a), at EORTC-NCI-AACR Symposium
ALBANY, N.Y.--(BUSINESS WIRE)--Oct. 30, 2008 - AMRI (NASDAQ: AMRI) reported data resulting from preclinical studies of ALB109564(a) at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, held October 21-24 in Geneva, Switzerland. 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 was shown to demonstrate improved and potentially superior efficacy over existing members of its class which are currently marketed and used extensively in anticancer chemotherapy.
The data, presented in a poster session (Abstract #449), included results from two separate studies in which human tumor cells were implanted into mice (xenograft models). In the first experiment ALB109564(a) was examined in a panel of xenografts including lung, colon and prostate tumors. In this experiment both ALB 109564(a) and the established anticancer drug, vinorelbine, used as a control were dosed intraperitoneally at equivalent therapeutic doses based on their MTDs. ALB109564(a) gave statistically significant tumor growth delays in all of these tumor types, whereas by comparison vinorelbine had no significant effect against any of these tumors.
In a second experiment, ALB109564(a) was administered in a range of dosing schedules, by the clinically relevant intravenous route. In this case only a prostate xenograft was examined and the important clinical agent, paclitaxel, was chosen as comparator. In this model, vehicle-treated animals reached end-point tumor growth in a median 36 days, animals treated with ALB109564(a) showed highly significant tumor growth delays, reaching end-point in a median 86 days, showing efficacy at least equivalent to that of paclitaxel (end-point 82 days). Even more importantly, the ALB109564(a) treated group showed 7 partial regressions and 1 complete regression (compared with the paclitaxel group which gave just 3 partial regressions); in one animal tumor growth was reversed and the animal was tumor-free at the end of the study.
The data presented indicates that ALB109564(a) has a broad-spectrum effect in animal models, with efficacy superior to vinorelbine and at least equivalent to that of paclitaxel. Based on these results, and others, AMRI filed an IND application in July and subsequently commenced Phase I clinical studies at four clinical trial sites to be conducted 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. The first human subject was dosed in September 2008; the study has expanded to include a total of three subjects who have recently completed the first cycle of testing.
"AMRI is pleased to have the opportunity to share this exciting preclinical data during this important cancer meeting. The data is indicative of differentiation of our tubulin inhibitor from other agents in this class and gives us confidence as we move forward with our Phase I study. We remain positive about ALB 109564(a)'s potential as a treatment for solid tumor cancers" said Dr. Bruce Sargent, vice president of discovery research and development.
About ALB 109564(a)
ALB109564 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 showed efficacy comparable to that of the important clinical agent paclitaxel.
ALB 109564 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.
Founded in 1991, 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.
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. 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.
Andrea Schulz, 518-512-2226
AMRI Corporate Communications
Peter Jerome, 518-512-2220
AMRI Director of Investor Relations
Posted: October 2008