TLC Reports Last Patient Last Visit (LPLV) in TLC599 Phase II Trial and FDA Clearance to Commence New Clinical Trials

Published: Jul 09, 2018 By

  • LPLV marks the final steps toward completion of TLC599 trial for osteoarthritis (OA) pain
  • Phase II topline results on-track for 2018 release
  • Set to initiate enrollment of US Phase II pharmacokinetic (PK) trial for TLC599
  • Clearance received from the U.S. Food and Drug Administration (FDA) for the TLC590 and TLC178 Investigational New Drug (IND) applications, allowing Phase I/II trials to proceed in the US

Taiwan Liposome Company, Ltd. (4152.TWO) (“TLC”), 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, today announced that LPLV has occurred in the Phase II clinical trial in knee OA pain for its lead product candidate TLC599. TLC599 is TLC’s proprietary BioSeizer™ formulation of dexamethasone sodium phosphate (DSP) intended for the treatment of OA pain, designed to deliver both rapid onset pain relief plus sustained pain relief for more than three months. The trial is currently conducting a cleaning of the database, which is scheduled to last approximately one month. TLC expects to announce topline results from this trial in August 2018.

LPLV occurred on July 4, 2018 in the double-blind, placebo-controlled Phase II safety and efficacy clinical trial, which randomized 75 patients into three groups that received a single dose of placebo or TLC599 at 12mg or 18mg DSP, and then evaluated them over a 24-week period. The primary endpoint of the trial is the change from baseline by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale at week 12, and secondary endpoints include change from baseline in WOMAC and visual analog scale (VAS) pain subscales at weeks 16, 20 and 24. WOMAC and VAS are well-accepted measures of pain in patients with knee OA. The results of this trial will help determine the sample size and efficacy period for pivotal trials.

“TLC remains highly motivated and committed to developing TLC599 for patients suffering from OA, which is estimated to affect 30.8 million Americans and 10% of the world’s population over the age of 60,” stated TLC President George Yeh. “We are planning an End-of-Phase II meeting with the FDA, following which we expect to have identified the key elements to design and initiate a pivotal trial.”

TLC also received clearance from the FDA on July 9, 2018 to proceed with a Phase II, open-label, PK trial for TLC599 in the United States. The primary objective of this trial is to characterize the PK profiles of TLC599 and immediate release DSP in the knee joint synovial fluid and blood plasma of subjects with mild to moderate knee OA. Safety and tolerability will also be evaluated. TLC expects to commence enrollment of this PK trial in the fourth quarter of 2018.

Additionally, the FDA has recently cleared the IND applications for TLC’s product candidates TLC590 and TLC178. TLC590 is a BioSeizer sustained release formulation of ropivacaine. Preparations for enrollment have begun for a Phase I/II clinical trial in the US to assess the safety, tolerability, and PK profile of TLC590 for postsurgical pain in escalating dose cohorts compared to free, non-liposomal ropivacaine. TLC178 is a NanoX™ liposomal formulation of the anticancer drug vinorelbine. The clearance allows TLC to proceed with a Phase I/II dose-escalation clinical trial in pediatric rhabdomyosarcoma patients in the US. The TLC178 clinical trial is expected to span across dozens of sites across America, Asia, and Europe.

TLC has managed to apply and receive clearance for three new clinical trials in the US within a span of three months, marking a significant milestone in TLC’s history.

About TLC599
TLC599 is a BioSeizer sustained release formulation of dexamethasone sodium phosphate (DSP) intended for the treatment of osteoarthritis (OA) pain. OA is a joint disorder involving the degeneration of the articular cartilage that leads to inflammation of the soft tissue and bony structures of the joint. Current intraarticular sustained release anti-inflammatory treatments for OA have potentially toxic side effects and may lead to the destruction of cartilage filler proteins called proteoglycans, resulting in chondrotoxicity. An in vivo toxicity study by proteoglycan staining of the cartilage showed TLC599 to be cartilage sparing compared to the current treatment. Data from its Phase I/II clinical trial demonstrated that a single dose of TLC599 at 6mg or 12 mg DSP led to rapid improvements in visual analog scale (VAS) pain scores and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Decreases in VAS and WOMAC were observed at one week post-injection and persisted without the notable loss of effect through the end of the trial at 12 weeks; the extent of decrease in WOMAC score exceeded the minimally clinically important different cutoff according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International, indicating the improvement in symptoms was clinically meaningful. Phase II clinical trial introduced an 18mg DSP dose group to provide a more durable response and higher three-month responder rate, with an extended 24-week evaluation period to confirm preliminary data. 

About TLC
TLC (4152.TWO) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of best-in-class novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD™). TLC believes that its deep experience with liposome science allows TLC to combine onset speed and benefit duration, while establishing drug levels at target tissues without incurring large systemic exposures. TLC’s BioSeizer technology enables local sustained release of therapeutic agents at the site of disease or injury; its NanoX targeted delivery technology enables prolonged pharmacokinetic profiles and enhanced distribution of liposome-encapsulated active agents to the desired site. These technologies are versatile in the choice of active pharmaceutical ingredients and scalable with respect to manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics that target areas of unmet medical need in pain management, ophthalmology, and oncology. TLC is consistently ranked in the top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations. 

Cautionary Note on Forward-Looking Statements
This press release may contain forward-looking statements. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the clinical development of TLC178 for the treatment of rhabdomyosarcoma, the potential clinical benefits of TLC178, the expected enrollment in and the timing of clinical trials. Words such as “may,” “believe,” “will,” “plan,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance and involve a number of unknown risks, assumptions, uncertainties and factors that are beyond TLC’s control. All forward-looking statements are based on TLC’s expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Except as required by law, TLC expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise. 

Contacts:
Taiwan Liposome Company (TLC)
Dawn Chi
Corporate Communications
+886 2 2655 7377 ext. 136
dawn@tlcbio.com

Solebury Trout
Julia Balanova
Vice President
+1 646 378 2936
jbalanova@trougroup.com

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