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TLC Presents New Pharmacokinetic and Toxicokinetic Data on TLC599 Following Intra-articular Injections in Dogs at EULAR 2019

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2019-06-12

TLC599 showed locally sustained release profile up to 120 days, dose proportionality, minimal systemic exposure and potential for repeat dosing

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 osteoarthritis, pain management, ophthalmology and oncology, today announced that new pharmacokinetic and toxicokinetic data are presented on TLC599 following intra-articular injections in dogs at the Annual European Congress of Rheumatology (EULAR 2019) on Thursday, June 13th in Madrid, Spain. Results from the study showed that TLC599, a proprietary BioSeizer® sustained release formulation of dexamethasone sodium phosphate, has the potential to be a long-lasting chronic treatment for osteoarthritis pain.

The new data are presented in a poster presentation titled:

“Pharmacokinetic and Toxicokinetic Studies of a Sustained Release Liposomal Formulation of Dexamethasone Sodium Phosphate (TLC599) following Intra-articular Injection in Dogs” (program number THU0465)

Key findings from the study are as follows:

  • TLC599 showed a long-lasting release profile in dog joints after a single intra-articular injection; drug levels were locally maintained for up to 120 days.
  • No accumulation of dexamethasone phosphate was observed in dog plasma following multiple-doses of TLC599 with administration every 3 months, supporting the possibility of repeat dosing in humans.
  • Systemic exposure following intra-articular injections of TLC599 is minimal and generally dose proportional.

“TLC is honored to be presenting this exciting information at EULAR, an influential event in rheumatology which represents a unique opportunity for the exchange of scientific, clinical and patient-focused information,” commented TLC President George Yeh. “We are happy to see TLC599’s sustained release ability in dogs, lasting up to 120 days after a single injection. The lack of drug accumulation in dog plasma even after multiple injections gives us the confidence that TLC599 could be an effective and safe treatment that can be administered repeatedly as needed.”

The poster presentation can be accessed under “Publications” in the Pressroom section of TLC’s website at www.tlcbio.com.

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. An in vivo toxicity study by staining of the cartilage showed TLC599 to be cartilage sparing compared to current treatments. In its Phase II clinical trial, TLC599 was well-tolerated, fast-acting, and demonstrated statistically significant and clinically meaningful improvement in pain relief compared to placebo from Day 3 through Weeks 12, 16, 20 and 24; over half of the patients in the TLC599 group had a durable response, maintaining ≥30% in WOMAC Pain score reductions at all visits through 24 weeks.

About TLC

Taiwan Liposome Company (Nasdaq: TLC, TWO: 4152) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of 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, and improve active drug concentrations while decreasing unwanted systemic exposures. TLC’s BioSeizer® technology is designed to enable local sustained release of therapeutic agents at the site of disease or injury; its NanoX™ active drug loading technology is designed to alter the systemic exposure of the drug, potentially reducing dosing frequency and enhancing 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. 

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