Lorus Announces Intention To Enter Phase II Clinical Trials For GTI-2040 With Strategic Supply Alliance.Business Editors TORONTO--(BUSINESS WIRE)--Oct. 17, 2000 Lorus (NASDAQ:LORFF)(TSE:LOR.) Promising Interim Clinical Results With Lead Anti-Cancer Drug Lorus Therapeutics Inc. ("Lorus") today announced that confidence in the promising interim results for a lead antisense anti-cancer drug, GTI GTI - Galway Technical Institute GTI - Gas Technology Institute GTI - General Telemarketing International Inc (Denton, Texas) GTI - Georgia Transportation Institute GTI - Gires Tournois Interferometer GTI - Global Taxonomy Initiative GTI - Global Threat Intelligence GTI - Global Title Indicator (SS7 SCCP) GTI - Global Trade Information Services, Inc GTI - Good Time Interval GTI - Gordon Training International-2040, has led to the Company's decision to move the drug into Phase II clinical trials. To prepare for this step, Lorus has formed a strategic supply alliance with Proligo, a premier nucleic acid chemicals supply enterprise. The arrangement with Proligo will allow Lorus to swiftly advance GTI-2040 into Phase II and realize significant cost savings due to production efficiencies. Proligo, a joint venture between SKW SKW - Schweizerischer Kosmetik- und Waschmittelverband (Swiss union of cosmetics and detergents) SKW - Strike Warfare Trostberg AG and Gilead Sciences, will invest in capital assets and other resources to increase the capacity of the production process for GTI-2040 to supply higher volumes of drug product required by Lorus for its multiple Phase II clinical trials. In addition, Proligo will accelerate the progress toward cGMP manufacturing, thereby proactively adhering to regulatory standards. The combination of a streamlined process and higher production volumes will result in economies of scale and an overall decrease in the cost of GTI-2040 and other Lorus oligonucleotide compounds. The interim results from the Phase I/II clinical trial for GTI-2040 conducted at the University of Chicago indicates that the drug is achieving the milestone clinical endpoints of safety and tolerability. Conducted in patients with advanced or metastatic solid tumors or lymphoma, interim study results for GTI-2040 did not identify any drug-related safety issues, demonstrated that the drug is very well tolerated up to the fourth dose level and showed early signs of disease stabilization. Lorus reported in an earlier announcement that GTI-2040 gave outstanding anti-tumor results when tested alone or in combination chemotherapy with a wide variety of human cancers in animal models. "The Phase I/II clinical trial with GTI-2040 is still underway and on schedule to be completed by fourth quarter 2000 and the final results to be announced early in the first quarter of 2001," said Dr. Jim Wright, president and chief scientific officer of Lorus. "We are very pleased with the results that we have attained to this stage, and that explains why Lorus has established a strategic alliance with Proligo, a well-known supplier of high quality chemicals and manufacturer of antisense drugs. This puts Lorus in a solid position to begin Phase II clinical trials of GTI-2040 as scheduled in second quarter 2001. We are looking forward to working with Proligo with the goal of moving GTI-2040 into the next stage of clinical development." "We are excited to contribute our innovative and highly back-integrated custom manufacturing service to the clinical studies of GTI-2040," said Dr. Wolfgang Pieken, president and chief executive officer of Proligo. "Our goal is to contribute to the ultimate commercial success of Genetic Medicines by providing scalable, cost-efficient manufacturing technology." The Phase I/II clinical trial for GTI-2040 was initiated in December 1999 and human dosing began in February 2000, at the University of Chicago Cancer Research Centre under the direction of Dr. Richard Schilsky. The Phase II clinical trials will also be conducted by Dr. Schilsky at the University of Chicago. About Proligo Proligo is a joint venture between SKW Trostberg AG (51% ownership) and Gilead Sciences (49% ownership). The SKW Group is the parent company of an extensive specialty chemicals corporation with almost 200 investments in subsidiaries and affiliated companies in more than 50 companies worldwide, active in its four core business sectors of Nature Products, Chemicals, Construction Chemicals and Performance Chemicals. Proligo is building the premier nucleic acid chemicals supply enterprise. The company is the leading supplier of key ingredients for oligonucleotide manufacturers, supplies innovative specialties for DNA/RNA synthesis applications to the Biopharma/Diagnostic market, supplies active ingredients with highest chemical/biological quality for Genetic Medicines applications, and supplies innovative nucleic acid chemistry technology to the Genomics industry. The company's sales force and distributor network provides global availability of Proligo's products and services. For more information about Proligo, please visit http://www.proligo.com or call toll free 1-888-80-OLIGO (65446). About Lorus Lorus is a biopharmaceutical company focused on the research and development of cancer therapies. Lorus' goal is to capitalize on its research, pre-clinical, clinical and regulatory expertise by developing new drug candidates that can be used, either alone, or in combination, to successfully manage cancer. Through its own discovery efforts and an active acquisition and in-licensing program, Lorus is building a portfolio of promising anti-cancer drugs. Late-stage clinical developments and marketing will be done in cooperation with strategic pharmaceutical partners. Founded in 1986, Lorus Therapeutics Inc. is a public company listed on the Toronto Stock Exchange under the symbol LOR, and on the NASDAQ OTCBB exchange under the symbol LORFF. Except for historical information, this press release contains forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties, which may cause actual results to differ materially from those statements. Those risks and uncertainties include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time-to-time in the Company's ongoing quarterly filings, annual reports and 40-F filings. Lorus Therapeutics Inc.'s press releases are available through the Company's Internet site: http://www.lorusthera.com. |
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