TLC Provides Corporate Update at Investor Conference
18 Dezembro 2020 - 6:00AM
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.
TLC Contact:
Dawn Chi
Corporate Communications
dawn@tlcbio.com
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