Press Release
TLC receives IND approval for Arthritis Drug TLC599
Taipei, Taiwan – April 28, 2015 –Taiwan Liposome Company Limited (TLC) (4152:TT)
announced that its Investigational New Drug (IND) application has been approved by TFDA.
today
The
Company is now ready to initiate the planned Phase I/II clinical trial with its arthritis drug TLC599.
TLC599 is a New Formulation drug, entrapping corticosteroid with its proprietary sustained release platform
“BioSeizer” as a local injection treatment for arthritis.
The lipid formulation of TLC599 enables
administration with smaller-sized 30 gauge needles as opposed to the thicker 21 gauge needles used for
current crystallized formulation treatments, this will help ease the discomfort felt by patients during injection,
as well as broadening the usage into areas that are too delicate for 21 gauge needles to reach. The
multi-lamellar structure of BioSeizer platform also allows for fast onset with sustained release. Thus,
patients can be relieved from of inflammatory pain promptly, while the sustained release of the corticosteroid
will help to suppress inflammation over a prolonged period, reducing the administration frequency and
discomfort between treatments.
Since TLC599 is encapsulating corticosteroid, an existing API (Active Pharmaceutical Ingredient), the
amount of safety tests required by the regulatory agency is far less than that of NCEs (New Chemical
Entities). A Phase I/II trial totaling 40 subjects will be executed.
GBI Research shows a global arthritis market totaling 20.6 billion in 2010, and is expected to grow at a
CAGR of 7.2% over 2010 to 2018 to reach a market size of 38 billion by 2018.
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About TLC599
Arthritis is the most commonly seen chronic disease, affecting the musculoskeletal system, specifically the
joints.
The currently available corticosteroid arthritis treatments aim to prolong the efficacy, so are
generally in crystallized formulation, but these crystallized formulations will in turn induce synovitis,
causing more severe inflammation, and result in patient discomfort. Furthermore, since the crystallized
formulation is greater in size, they need to be administered with 21 gauge needles; besides the pain caused
during injection, it has a higher likelihood of causing infections.
The lipid formulation of TLC599 has a
much smaller particle size, enabling administrations to be done with 30 gauge needles, not only can it help to
eliminate the abovementioned side effects, the applicable areas can also be broadened to smaller joints such
as fingers.
Arthritis patients suffer from a considerable amount of pain when inflammation occurs.
Current treatments
are mostly crystallized formulations that could take a days before they can take effect. In view of the
discomfort patients have to suffer, TLC chose to encapsulate a water soluble corticosteroid dexamethasone
sodium phosphate. This particular corticosteroid was mostly used to treat acute inflammation because of its
fast onset nature. However since dexamethasone sodium phosphate lacks sustainability, it hasn’t been an
ideal candidate for arthritis treatment. With the proprietary sustained release BioSeizer platform developed
by TLC, TLC599 is capable of achieving both fast onset and sustained release.
In addition, the current corticosteroid arthritis treatment will induce chondrotoxicity, death of cartilage
making cells.
Crystallized formulation of current treatments means terminal sterilization may not be
enough and preservatives are needed in order to prolong its shelf life. Preservatives induce the death of
chodocyte, which means both the API and the excipient of current treatments will exacerbate damage to the
cartilage by treating them.
TLC599 is a lipid formulation which can go through terminal sterilization and
avoid the use of preservatives. Non-clinical data demonstrated no chondrotoxicity 3 months after the
administration, meaning that with proper control and care, TLC599 can potentially delay or avoid the need
for joint replacement.
About TLC
Taiwan Liposome Company is a biopharmaceutical company engaging in research, development and
commercialization of proprietary drug delivery system for improving the treatment of cancer, ophthalmic
conditions, and infectious diseases. TLC founded and led by renowned scientist, Dr. Keelung Hong, who has
over 30 years of research and development experience in liposomes with over 100 publications. TLC also
has a team of researchers, management, production experts, and advisors who are building the company into
an organization recognized for its excellence in targeted delivery and rapid advancement of products. TLC
currently operates from Headquarter in Taipei (Taiwan), and subsidiary offices in the US, the Netherlands,
China. Hong Kong, and Australia.
For more information, please visit www.tlcbio.com
Contact for Taiwan Liposome Company:
Paggy Liou
Tel: +886 (2) 2655 7377 ext. 105
Email: paggy@tlcbio.com