|[June 23, 2014]
Chinese FDA Accepts Phase 2 IND for RGN-259 for Dry Eye
ROCKVILLE, Md. --(Business Wire)--
RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("RegeneRx") and
Lee's Pharmaceutical Holdings Ltd. ("Lee's") today jointly announced
that the Chinese FDA has accepted a Phase II IND for RGN-259 (thymosin
beta 4-based, preservative-free eye drops) to be tested in patients with
moderate to severe dry eye syndrome in China.
Lee's Pharmaceutical Holdings Ltd., headquartered in Hong Kong, is the
sponsor of the clinical trial. RGN-259 is one of several product
candidates licensed to Lee's by RegeneRx in China, Hong Kong, Macau and
Taiwan. On 17th June 2014, Lee's received the official CFDA
Acceptance Notice (No. CXHL1400799X) for its application to conduct the
Phase II trial, which aims to assess the safety and efficacy of RGN-259.
"Keratoconjunctivitis sicca," commonly known as dry eye syndrome,
affects a great number of people in China and can lead to severe
consequences such as cornea damage and ocular inflammation. There is
clearly an unmet medical need in this area. RegeneRx demonstrated in its
Phase II study that RGN-259 is a promising agent in alleviating dry eye
syndrome by addressing the underlying pathology with a unique mechanism
"We're pleased with the acceptance of review by the CFDA for this
important application," said Dr. Benjamin Li, CEO of Lee's. "The
successful submission of Tß4 highlights Lee's research & development
capability in developing its product pipeline focused on ophthalmic
therapeutic area. We are looking forward to moving the registration
process forward and expect to initiate the clinical trial in China in Q1
"We're very pleased that the Chinese FDA has accepted Lee's IND for a
Phase 2 dry eye study. Showing strong safety and efficacy results in
China will not only be important to future commercialization in that
country, but also validate our results in the U.S. and extend the
opportunities for this product throughout the world," stated J.J.
Finkelstein, RegeneRx's president & CEO.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the development of a novel therapeutic peptide,
Thymosinbeta 4, for tissue and organ protection, repair and
regeneration. RegeneRx currently has three drug candidates in clinical
development for ophthalmic, cardiac and dermal indications, three
strategic licensing agreements in China, Pan Asia (Korea, Japan, and
Australia, among others) and the EU, and has an extensive worldwide
patent portfolio covering its products. Recently, RGN-259, the Company's
ophthalmic drug candidate has been designated as an orphan drug for the
treatment of neurotrophic keratopathy, which is the primary focus of
RegeneRx's clinical development efforts in the U.S. For additional
information about RegeneRx please visit www.regenerx.com.
Any statements in this press release that are not historical facts
are forward-looking statements made under the provisions of the Private
Securities Litigation Reform Act of 1995. Any forward-looking
statements, such as the initiation by Lee's Pharm of its Phase II dry
eye clinical trial in China, may involve speculation and uncertainties
that may or may not prove to be accurate and may be materially different
from any results implied by such forward-looking statements. Please
view these and other risks described in the Company's filings with the
Securities and Exchange Commission ("SEC (News - Alert)"), including those identified
in the "Risk Factors" section of the annual report on Form 10-K for the
year ended December 31, 2013, and subsequent quarterly reports filed on
Form 10-Q, as well as other filings it makes with the SEC. Any
forward-looking statements in this press release represent the Company's
views only as of the date of this release and should not be relied upon
as representing its views as of any subsequent date. The Company
specifically disclaims any obligation to update this information, as a
result of future events or otherwise, except as required by applicable
About Lee's Pharmaceutical Holdings Ltd.
Lee's Pharmaceutical is a research-based Hong Kong biopharmaceutical
company with over 19 years operation in China's pharmaceutical industry.
It is fully integrated with strong infrastructures in drug development,
manufacturing, sales and marketing. It has established extensive
partnership with over 20 international companies and currently has 14
products in the market place. Lee's focuses on several key disease areas
such as cardiovascular, oncology, gynecology, dermatology and
ophthalmology. Lee's development program is lauded with 30 products
stemming from both internal R&D efforts and collaborations with US,
European and Japanese companies and aspiring to combat diseases such as
liver cancer and pulmonary hypertension. The mission of Lee's is to
become a successful biopharmaceutical group in Asia providing innovative
products to fight diseases and improve health and quality of life.
Additional information about Lee's, please visit www.leespharm.com.
Safe Harbor Statement
The performance and the results of operation of Lee's during the past
years are historical in nature and past performance can be no guarantee
of future results of the Lee's. This news release may contain
forward-looking statements and opinions that involve risks and
uncertainties. Actual results may differ materially from expectations
discussed in such forward-looking statements and opinions. Neither Lee's
nor the Directors, employees or agents of Lee's assume (a) any
obligation to correct or update the forward-looking statements or
opinions contained in this news release; and (b) any liability in the
event that any of the forward-looking statements or opinions does not
materialise or turns out to be incorrect.
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