TLC Announces Initiation of Phase III Pivotal Clinical Trial of TLC599 for the Treatment of Osteoarthritis Knee Pain
- Phase II results showed statistically significant pain relief through 24 weeks
- Phase III to evaluate efficacy of single and repeated doses up to 52 weeks
In the Phase II clinical trial, a single intraarticular injection of TLC599 resulted in statistically significant and clinically meaningful improvement in pain relief in both the
EXCELLENCE is a multi-center, randomized, double-blind, placebo- and active comparator-controlled pivotal study that will treat approximately 500 knee OA patients at 40-50 sites in the US and
“The initiation of EXCELLENCE, which was carefully designed in alignment with guidance from the
OA is the most prevalent joint disease and a leading source of chronic pain and disability in
EXCELLENCE, a Phase III, randomized, double-blinded, placebo- and active comparator-controlled pivotal study, will evaluate the safety and efficacy of single and repeat doses of TLC599 in patients with knee OA of Kellgren-Lawrence Grade 2 to 3 severity across 40-50 sites in
TLC (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 a combination of onset speed and benefit duration, improving 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 a 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.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the clinical development of TLC599, the clinical benefits of TLC599 for knee osteoarthritis, the timing, scope, progress and outcome of the clinical trials, and the anticipated timelines for the release of clinical data. Words such as “may,” “believe,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” 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 risks, assumptions, uncertainties and factors, including risks that the outcome of any clinical trial is inherently uncertain and TLC599 or any of our other product candidates may prove to be unsafe or ineffective, or may not achieve commercial approval. Other risks are described in the Risk Factors section of TLC’s annual report on Form 20-F for the year ended
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