StemCell Therapy

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Oct. 21, 2019 (GLOBE NEWSWIRE) -- TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, recently presented data at the American Society of Anesthesiologists (ASA) ANESTHESIOLOGY annual meeting from a Phase I/II clinical trial which showed TLC590 to yield more immediate and long-lasting pain reduction than ropivacaine. In addition, in vivo findings in which TLC590 showed no dose-related toxicity and other preclinical data were recently published in the International Journal of Nanomedicine. TLC590 is a non-opioid, BioSeizer formulation of ropivacaine with the aim to manage postsurgical pain for four to seven days with a single dose, potentially deterring the use of opioids following surgery.

At ANESTHESIOLOGY 2019, which took place October 19-23 at the Orange County Convention Center in Orlando, FL, principal investigator Todd Bertoch, MD, Chief Medical Officer at JBR Clinical Research, a CenExel Clinical Research Center of Excellence, presented findings from a Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study of TLC590 following inguinal hernia repair.

Highlights from the e-poster presentation are as follows:

I am delighted to have had the opportunity to present these fantastic results, said Dr. Todd Bertoch. As a clinical researcher specializing in pain, it is so rewarding to be able to share findings that provide hope for a real, substantive weapon in the war against opioids. Clinicians have been waiting patiently for safe, easily administered, very long acting local anesthetics with a rapid onset. These data suggest that we may have found one.

Results of studies evaluating the release profile of TLC590 in vitro and its pharmacokinetics and anesthetic effect in vivo were recently published in the International Journal of Nanomedicine.

Highlights from the publication article are as follows:

The poster presentation and full text article can be accessed under Publications in the Pressroom section of TLCs website at http://www.tlcbio.com.

About TLC590

TLC590 is a non-opioid, BioSeizer sustained release formulation of ropivacaine designed to prolong the retention time of ropivacaine around the injection site as a drug depot, simultaneously extending its therapeutic period and reducing unwanted systemic exposure. A Phase II, randomized, double-blind, comparator- and placebo-controlled clinical trial to evaluate the safety, pharmacokinetics and efficacy of TLC590 following bunionectomy is ongoing.

About TLC

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. TLCs 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 TLCs expectations regarding the clinical development of TLC590, the clinical benefits of TLC590 for postsurgical pain management, 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 TLC590 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 TLCs annual report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on TLCs 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.

Read more:
TLC Presents Clinical and Preclinical Data of TLC590 at ANESTHESIOLOGY Annual Meeting and in International Journal of Nanomedicine TLC590 showed...

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