On September 23, 2019 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of unmet medical need in pain management, ophthalmology and oncology, reported that new in vivo data on the efficacy and enhanced tumor accumulation of TLC178 will be presented at the European Society for Medical Oncology Congress (ESMO 2019). ESMO (Free ESMO Whitepaper) 2019 takes place from September 27 to October 1, 2019 in Barcelona, Spain (Press release, Taiwan Liposome Company, SEP 23, 2019, View Source [SID1234539710]). TLC178 is a proprietary NanoX formulation of vinorelbine, an anticancer drug frequently used off-label to treat soft tissue sarcoma.
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Details of the poster presentation (#1722P) are as follows:
Title: In Vivo Efficacy and Enhanced Tumor Accumulation of Liposomal Vinorelbine (TLC178) in Human Sarcoma Xenograft Mouse Models
ID#: 1844
Location: Poster Area (Hall 4), Fira Gran Via
Speaker: Wan-ni Yu, PhD
Date/Time: 12:00pm to 1:00pm CEST, September 28, 2019
The objectives of the studies were 1) to compare the anti-tumor activity of TLC178 to the reference drug in human soft tissue sarcoma xenograft mouse models, and 2) to investigate the pharmacokinetic and the drug distribution of vinorelbine (VNB) from a single intravenous injection of TLC178 or VNB in a tumor-bearing mouse model.
Key findings are as follows:
TLC178 remarkably suppressed fibrosarcoma tumor growth compared with doxorubicin, an approved drug for treatment of sarcomas. TLC178 reached 14% complete regression (CR) and 86% partial regression (PR) while no tumor regression was observed with doxorubicin.
TLC178 showed a better inhibitory effect than both VNB alone and VNB + cyclophosphamide treatments in the rhabdomyosarcoma xenograft model.
TLC178 was well tolerated in all listed studies, as shown by no body weight loss and no lethality, compared to body weight loss and one lethality in doxorubicin-treated mice.
TLC178 showed an improved in vivo systemic pharmacokinetic profile and a five-fold accumulation at the tumor site compared to non-liposomal VNB, which resulted in superior anti-tumor activity.
TLC178 could potentially be used as a single or combination treatment for sarcomas with decreased dosing frequency, reduced toxicity, and enhanced efficacy.
"We are pleased that TLC178 data was selected for presentation at this prestigious conference," said George Yeh, President of TLC. "TLC has long been active in the oncology space, with two oncology products already approved and sold in Asia, and we remain committed to developing medicines with the potential to deliver a better quality of life for patients."
The poster presentation can be accessed under "Publications" in the Pressroom section of TLC’s website at www.tlcbio.com.
About TLC178
TLC178 is TLC’s proprietary NanoX liposomal formulation of vinorelbine, an anticancer drug frequently used off-label to treat soft tissue sarcoma. TLC178 is designed to increase the therapeutic index and reduce side-effects through prolonged circulation time and increased accumulation of vinorelbine in tumor tissues, with the potential to decrease toxicity, improve tolerability, and increase durable response rates. The US Food and Drug Administration (FDA) has granted TLC178 Rare Pediatric Disease Designation in rhabdomyosarcoma, which will qualify TLC178 in this indication for priority review. The FDA and the European Medicines Agency (EMA) have both granted TLC178 Orphan Drug Designation for the treatment of soft tissue sarcoma, which can provide seven and ten years of marketing exclusivity in the US and the EU, respectively.