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Aptuit Consulting Inc. And Taiwan Liposome Company (TLC) Collaborate to Complete All IND Enabling Work and IND Submission for Novel Anti-Cancer Treatment in 12 Months

Posted on: Wednesday, 25 June 2008, 09:03 CDT

Taiwan Liposome Company (TLC) and Aptuit Consulting Inc., a subsidiary of Aptuit Inc., today announced that TLC's Lipotecan(R) cleared review by the U.S. Food and Drug Administration (FDA) following the filing of an Investigational New Drug (IND) application, the first anti-cancer drug from Taiwan to achieve this milestone. TLC will initiate a Phase 1 trial in patients with solid tumors in 3Q08. Lipotecan(R) is a chemically modified camptothecin designed to improve stability and potency and to minimize toxicity. Unlike other camptothecin-derived drugs that are used solely for chemotherapy, Lipotecan(R) has demonstrated effects as a chemotherapeutic and radio-sensitizer in preclinical animal studies. Aptuit Consulting, Aptuit's global pharmaceutical drug development consultancy, managed the IND-enabling studies from manufacturing through IND submission and is engaged in the Phase 1 program.

"Over the past 10 years we have successfully developed a solid drug pipeline ranging from commercialized drug products to novel compounds. The new generation of dual-function drugs under development at TLC has the potential for higher anti-tumor potency and lower toxicity," stated Dr. Keelung Hong, CEO and Chairman of TLC. "The success of Lipotecan(R) entering Phase 1 clinical trials is a critical milestone for TLC, demonstrating our ability to develop new small molecule drug candidates for cancer treatments. We are expecting more drug candidates to be developed through our proprietary drug discovery program in the near future. The expertise provided by Aptuit Consulting was invaluable to us as we navigated the U.S. regulatory environment."

"Our consultants have deep expertise in all facets of drug development and the collaboration with TLC in filing the first anti-cancer IND for a Taiwanese company is representative of the collaborative work we do in supporting many emerging companies, globally," noted Dr. William Kerns, Managing Director, Aptuit Consulting. "We have a deep understanding of regulatory processes worldwide and are able to help clients navigate the different country requirements quickly to successfully reach critical milestones."

About Lipotecan(R) and the Study

Lipotecan(R) is structurally related to topotecan and other camptothecins, but has been chemically modified to improve stability and potency and to minimize toxicity. This drug class inhibits DNA topoisomerase I (Topo I), an important enzyme involved in cell replication. Lipotecan(R), a potent Topo I inhibitor, has demonstrated cytotoxic activity against a variety of human tumor cell lines. The reduced toxicity of Lipotecan(R) may facilitate the use of higher doses of the drug in patients in order to maximize anti-tumor activity. Lipotecan(R) has shown both chemotherapeutic and radio-sensitizing effects in preclinical animal studies. TLC will start the Phase 1 study of Lipotecan(R) as a chemotherapeutic drug in U.S. and is planning to launch a Phase 1 study in Asia in 4Q08.

Lipotecan(R) will eventually be evaluated for use as monotherapy and/or in combination with approved chemotherapeutic agents. The Phase 1 study will be a typical open-label, dose-escalation safety, tolerability and pharmacokinetic study in patients with solid tumors.

Lipotecan(R) was developed utilizing TLC's proprietary Synergistic Dual-Function Drug Discovery (SDFDD) Program. The SDFDD Program is targeted at selective modification of chemotherapeutics for synergistic efficacy. The technology combines the properties of radiotherapy and chemotherapy and enables drugs to overcome the problem of radio-and-chemo resistance that is frequently encountered in clinical therapies.

About TLC

Taiwan Liposome Company (TLC) is a private-owned biopharmaceutical company engaged in research, development and commercialization of proprietary drug delivery system for improving the treatment of cancer, ophthalmic conditions, and infectious diseases. TLC has a team of researchers, management, production experts, and advisors who are building TLC into an organization recognized for its excellence in drug delivery systems and rapid buildup of product pipeline through the drug development process in South San Francisco and Taipei. For more information, please visit www.tlcbio.com

About Aptuit Consulting

Aptuit Consulting is a unique global pharmaceutical, medical device and intellectual property consultancy supporting pharmaceutical companies and investment firms in all major markets. Our seasoned drug development experts have broad drug development, medical device and product defense skills covering all therapeutic areas. Practice areas include: intellectual property defense, product tampering, manufacturing, formulation, metabolism, pharmacokinetics, safety pharmacology, toxicology, regulatory and Phase 1 through Phase 2 clinical program management. Aptuit Consulting is a wholly-owned subsidiary of Aptuit Inc. For more information, please visit www.aptuitconsulting.com

About Aptuit

Aptuit, Inc. is a global company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators. The company was founded by a group of industry experts with extensive market experience who have a track record of building a similar, highly successful company through acquisitions and investment. Aptuit provides a comprehensive suite of product development services and competencies to more than 800 biotechnology and large, fully integrated pharmaceutical innovators worldwide. Aptuit's mission is to engineer a better drug development process, and is partnered with Welsh, Carson, Anderson & Stowe, one of the world's largest private equity investors. For more information about Aptuit, please visit www.aptuit.com.

Safe Harbor Statements

Statements contained in this press release, which are not historical facts, are forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All such forward-looking statements including the statements contained herein regarding anticipated trends in the Company's business are based largely on management's expectations and are subject to and qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, the Company's ability to continue to attract and retain qualified personnel, the nature of contracts or the loss of large contracts, and other market factors.

Source: Business Wire

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