Patient enrollment of EXCELLENCE pivotal trial reaches 98%
SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. 18, 2020 (GLOBE NEWSWIRE) -- TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, held a virtual investor conference earlier today under the invitation of KGI Securities, and provided an update on the company’s pipeline as well as corporate strategy for the year ahead. George Yeh, President of TLC, commenced the conference and welcomed the company’s new Chief Business Officer, Mr. Tom Bliss. With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Mr. Yeh then proceeded to provide a company and pipeline update, details of which are as follows:
- Patient enrollment of EXCELLENCE, the Phase III pivotal study of TLC599 for symptomatic knee osteoarthritis, is at 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months. EXCELLENCE will evaluate the efficacy and safety of both a single and a repeated dose of TLC599; topline data of TLC’s leading program is expected in the second half of 2021.
- Preparations for pivotal studies of TLC590 for postsurgical pain management are currently underway. TLC590 demonstrated more pain relief than the active comparator in both a soft tissue setting (Phase I/II clinical trial in hernia repair surgery) as well as a bony tissue setting (Phase II clinical trial in bunionectomy), and TLC is arranging discussions with the United States Food and Drug Administration (FDA) regarding the design of the pivotal clinical trials. In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches.
- TLC’s Ampholipad™ (amphotericin B liposome for injection) for the treatment of systemic fungal infections, is the only complex generic drug which has shown bioequivalence to Gilead’s AmBisome® in all three forms, proving its sameness as the originator. Ampholipad received scale-up production approval in June 2020, allowing a production capacity of over a million vials a year. Ampholipad recently achieved an important milestone in its global commercialization efforts, having signed the first term sheet in Latin America, with options in other markets. More details regarding the collaboration will be disclosed following the execution of a formal agreement. The Marketing Authorization Application for Ampholipad in China is currently under review; in addition, numerous business collaboration discussions for North America, Latin America, the European Union, and the Middle East are underway, led by Mr. Bliss.
- The newly established subsidiary, InspirMed, will focus on inhalable liposomal treatments in both acute and chronic lung diseases. Its pipeline will include TLC19 and other chronic lung disease programs with potential indications including childhood interstitial lung disease (ILD), rheumatoid arthritis associated ILD, and idiopathic pulmonary fibrosis.
- Following peer review and confirmation that the literature proficiently answers fundamental questions asked by Clinical and Translational Science Journal and verifying that a novel inhalable liposomal hydroxychloroquine formulation could serve as a promising targeted delivery strategy to treat COVID-19 disease by providing antiviral effect at a significantly lower and safer dose, the first manuscript of TLC19 (inhalable liposomal hydroxychloroquine) has officially been published in the publication of American Society of Clinical Pharmacology and Therapeutics (ASCPT). The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.
- Development pace for ophthalmology program TLC399 will relax to focus on the development of pain management programs, as the pain management market is more expansive than ophthalmology. Business partnership negotiations for TLC399 are underway to augment revenue and enhance the company’s overall interests and long-term value.
- The maximum tolerated dose of the oncology program TLC178 has been found to be 31mg/m2 from its Phase I/II, open-label, dose escalation study, which treated 33 patients. 50% of patients with soft tissue sarcoma had durable stable disease (SD) (24 to 31 mg/m2 dose) for at least 4 months. Disease control rate (DCR) in all types of tumor was found to be 41%, of which 1 patient with apocrine adenocarcinoma (28 mg/m2 dose level) completed study and showed partial response (PR) up to the 10th month follow-up, 2 patients (31 mg/m2 dose level) with NSCLC and pancreas cancer, respectively, had durable SD for at least 8 months, and 1 patient with metastatic ovarian cancer (31 mg/m2 dose level) had durable SD for at least 4 months. Business partnership negotiations for TLC178 are underway to augment revenue and enhance the company’s overall interests and long-term value.
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™), including BioSeizer® sustained release technology and NanoX™ active drug loading technology, which are versatile in the choice of active pharmaceutical ingredients and scalable in manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics targeting areas of unmet medical need in pain management, ophthalmology, oncology and infectious diseases. TLC is consistently ranked top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.
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 TLC’s product candidates, including TLC599, TLC590, TLC19, TLC399 and TLC178, the clinical benefits of TLC’s product candidates, the timing, scope, progress and outcome of TLC’s clinical trials, how sufficient cash and equivalents will be to fund operations, the anticipated timelines for the release of clinical data and progress of TLC’s manufacturing capabilities. 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 product candidates may prove to be unsafe or ineffective, or may not achieve commercial approval, and delays or disruptions on our business or clinical trials due to the COVID-19 pandemic. Other risks are described in the Risk Factors section of TLC's annual report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission (the “SEC”) as well as subsequent filings with the SEC. 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.