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PRESS RELEASE
CTA for TLC Novel Anticancer Drug Lipotecan Approved to commence Phase II
trial in China
Taipei, Taiwan – September 15, 2014 – Taiwan Liposome Co., Ltd. (TLC) (Ticket number: 4152)
announced today their multi-mechanistic anticancer NCE (New Chemical Entity) Lipotecan® has been
approved for CTA (Clinical Trial Application) to start Phase II trial by the Chinese State Food and Drug
Administration (CFDA). TLC has already been recruiting and executing Phase II trial in Taiwan, this
approval is expected to significantly boost the speed of recruitment.
Lipotecan® is a novel anti-cancer NCE (New Chemical Entity) developed by TLC with unique formulation
to enable a more effective and less toxic therapy for cancer treatment.
conducted in both the US and Taiwan.
Phase I clinical trial of the NCE was
Results indicated significant therapeutic potential for different types
of cancer, including hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), pancreatic cancer, and
thymoma.
HCC is not prominent within the Caucasian race.
Little has been done in the development of
NCEs targeting HCC, creating a niche, untapped market opportunity for Asian biotech companies.
Surgical resection is the most widely used course of treatment for early stage HCC.
For late stage HCC
patients who are inoperable, targeted therapy Nexavar® is the only approved treatment. Phase II clinical
trial of Lipotecan® will be targeted to recruit Nexavar® failure patients.
Compared to the currently
approved medication for HCC target therapy affecting tumor angiogenesis process, Lipotecan® employs
multiple mechanisms to inhibit tumor growth. It is a potent TOP-1 (topoisomerase I) inhibitor that prevents
DNA replication and leads to the death of the actively dividing cancer cells. In addition, Lipotecan® disrupts
both Sonic Hedgehog and HIF1-α pathways to overcome cancer drug resistance and inhibits angiogenesis
induced by tumor hypoxia.
In vivo studies in animal tumor models also demonstrated how Lipotecan®
enhances radiotherapy and act as a chemoradiosensitizer.
HCC is the 6th leading cause of cancer globally, with the 2nd highest mortality rate. There are over 780,000
new cases every year, half of which are from China. In 2012, there were 746,000 patients died from HCC,
out of which 383,000 were Chinese.
In clinical studies Nexavar® prolonged the overall survival to 10.7
months compared to 7.9 months for patients on placebo. After Nexavar® failure, survival is typically
limited to less than 3 months. TLC will use DCR (Disease Control Rate) as the end point in evaluating the
efficacy of the drug.
Clinical proof-of-concept will be reached if Lipotecan® can extend the overall
survival of Nexavar® failure patients beyond 3 months.
Given the favorable results demonstrated by Lipotecan® on different types of cancer in Phase I clinical study,
TLC is also in the process of planning Phase II trials on indications other than HCC, including RCC and
pancreatic cancer, to maximize the asset value as well as de-risk the product development.
About Lipotecan ®
Lipotecan® 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 is a biopharmaceutical company engaging in research, development and
commercialization of proprietary drug delivery system for improving the treatment of cancer, ophthalmic
conditions, and infectious diseases. TLC founded and led by renowned scientist, Dr. Keelung Hong, who has
over 30 years of research and development experience in liposomes with over 100 publications. TLC also
has a team of researchers, management, production experts, and advisors who are building the company into
an organization recognized for its excellence in targeted delivery and rapid advancement of products. TLC
currently operates from Headquarter in Taipei (Taiwan), and subsidiary offices in South San Francisco (US)
and Leiden (The Netherlands).
For more information, please visit www.tlcbio.com
Contact for Taiwan Liposome Company:
Paggy Liou
Tel: +886 (2) 2655 7377 ext. 105
Email: [email protected]