TLC Announces Approval Of The TLC178 Investigational New Drug Application By TFDA
11/16/2016 10:53:22 AM
TAIPEI, Taiwan – Nov. 15, 2016 – TLC (4152:TT) announced the approval of an investigational new drug (IND) application by the Taiwan Food and Drug Administration (TFDA) for its oncology product TLC178.
With this approval, TLC will begin its Phase 1/2 open-label, dose-escalation study investigating the safety, tolerability and pharmacokinetics of intravenous TLC178 administration. A conventional 3+3 dose escalation design in up to 54 patients with solid tumor will be used to determine the maximum tolerated dose (MTD) at this stage. After the MTD is established by a safety monitoring committee (SMC), an additional 15 efficacy evaluable lymphoma patients will be enrolled in an expansion cohort at the MTD level. If the safety profile of the patients enrolled at the MTD and expansion cohort is deemed satisfactory, then the MTD will be established as the recommended dose for the pivotal study.
With prior IND approval from the US FDA, this Phase 1/2 clinical trial will be conducted in both Taiwan and the US sites. Details of this trial is now available on clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT02925000?term=TLC178A1001&rank=1
TLC178 is a liposomal-encapsulated formulation of the chemotherapy drug vinorelbine that applies the NanoX™ nanotechnology platform to decrease the toxicity of the drug. Lower toxicity is likely to expand applications for TLC178 from the current vinorelbine indications of non-small cell lung cancer (NSCLC) to lymphomas and other advanced solid tumors.
There are two classes of lymphoma: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. TLC178 is designed to target non-Hodgkin’s lymphoma, a type of cancer originating from cells of the immune system. According to a recent report from GBI Research, the global market for the treatment of non-Hodgkin’s lymphoma is expected to reach $9.2 billion by 2020, reflecting a compound annual growth rate (CAGR) of 7.4% from a market of $5.6 billion in 2013.
TLC is developing nanomedicines for the treatment of oncologic and ophthalmologic diseases as well as for the management of acute and chronic pain. The company’s proprietary Lipid-Assembled Delivery (LipAD™) technology is highly scalable and versatile, enabling the design of sustained release and targeted therapies capable of reducing toxicities and improving effectiveness. TLC’s advanced programs include TLC388 (Lipotecan), a first-in-class chemo-radiosensitizer for oncologic indications such as hepatocellular carcinoma and rectal cancer; ProDex (TLC399), a durable treatment for macular edema secondary to retinal vein occlusion and TLC599, a sustained release treatment for pain management in osteoarthritis.
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