суббота, 14 мая 2011 г.

Derma Sciences Enrolls First Patient In DSC127 Phase II Study

Derma Sciences, Inc.
(OTC Bulletin Board: DSCI) announced the first study patient has been
entered into the company's Phase II study of its drug candidate, DSC127.
Enrollment of the 75-patient study, looking into the drug's ability to
accelerate healing in diabetic foot ulcers, is expected to be completed
within 12 months. Currently, 4 US facilities have signed on as clinical
study sites, with an additional 15 sites pending contract negotiations and
internal review board approvals. All sites are based in the United States
and include top-tier academic institutions and large, highly regarded wound
care clinics. Derma Sciences acquired the global rights to the product and
to the patent portfolio surrounding it - for wound care and scar prevention
applications - in November, 2007.



Extensive pre-clinical studies have shown that DSC127 - a biologically
active angiotensin analog - significantly increases wound healing rates,
notably in reliable and validated diabetic animal models. Diabetic
ulcerations represent a large and growing portion of the overall chronic
wound care market. More than simply a blister on a patient's foot,
non-healing diabetic foot ulcerations can lead to a cascade of events
including infection, amputation of the patient's limb, and even death. In
the United States alone, there are an estimated 2.4 million diabetic foot
ulcers and over 60,000 diabetes-related amputations each year. Depending on
the study, 5-year mortality rates following a diabetic ulcer related
amputation have been shown to range from 39% to 68%. Ulcers are present in
3% to 6% of all hospital stays in which diabetes is listed on the discharge
record. The average length of these hospital stays is 59% greater than
stays in which diabetes is listed on the discharge record but when an
ulceration is not present. In 2001, the financial costs to US healthcare
payers for the management of diabetic ulcers and associated amputations
were over $10 billion.



Not merely a problem in the United States, the World Health
Organization has recognized that there is a "global epidemic of obesity",
with a sharp rise in the incidence of diabetes around the world as part of
that epidemic. The International Diabetes Federation has stated that in
2006 there were 246 million people living with diabetes, and that this
number is expected to increase to 380 million within 20 years.



Speaking about the first patient entered into this Phase II study, CEO
Ed Quilty stated, "I am excited to say that, based on the exceptional
results of multiple pre-clinical studies, some of the top wound care
researchers in the US have signed on as investigators for this trial.
Diabetic foot ulcerations are a major problem in the US and worldwide, as
the incidence of diabetes continues to grow rapidly. A significant portion
of diabetic ulcerations leads to lower limb amputation, which itself is
associated with a high long-term mortality rate." Quilty continued, "Our
recent launch of MedEfficiency's EZ-Cast and the investment we are making
into DSC127 for diabetic ulcers speaks volumes to our commitment to help
reduce the number of these amputations. We are confident that taking a
leadership position in this area will help us reach our goal as a leader in
advanced wound care, which in turn will drive shareholder value. A drug
that is as effective in humans as DSC127 has been shown to be in validated
animal models could have blockbuster potential."
















DSC127, a topically applied pharmaceutical, has been shown to promote
healing in a variety of ways; by increasing keratinocyte proliferation,
extracellular matrix production, and vascularization.



Peer reviewed articles on the technology as applied to wound healing
and scar reduction have appeared in such journals as the Journal of Peptide
Research, Wound Repair and Regeneration, Experimental Dermatology, Plastic
and Reconstructive Surgery, the Annals of Plastic Surgery, and the Journal
of Burn Care and Rehabilitation.



Derma Sciences Chief Scientific Advisor, Laura Bolton, Ph.D, whose
involvement in wound care began in 1974 as a Johnson & Johnson Scientist
and continued in Wound Care R&D before retiring in 2006 as Global Director
of Scientific Affairs at ConvaTec, a Bristol-Myers Squibb company, said,
"This is the most rigorously researched, most promising active wound
healing agent I have seen. The clinical studies are well-designed to test
the promise of this unusually versatile and effective molecule in diabetic
foot ulcers. If results match the pre-clinical findings, surpassing
moisture-retentive dressing and growth factor effects, diabetic patients
will have a sterling option they can count on to help them heal their foot
ulcers..."



About DSC127



The skin represents one of the few human tissues with a high turnover
rate. Upon injury, the expression of receptors in injuried skin is
upregulated and down regulates as the skin heals. In human skin,
angiotensin II type 1 (AT1) and angiotensin II type 2 (AT2) receptors are
found in the epidermis and in dermal vessel walls. DSC127, a novel
angiotensin analog, has been shown to accelerate skin healing in a variety
of animal models including wound repair after full-thickness excision in
normal rats, in adriamycin or steroid-treated rats, in diabetic mice, after
partial thickness thermal injuries in guinea pigs, and after random flap
injuries in rats.



DSC127 upregulates a cassette of genes at the site of skin healing.
These genes are involved in energy metabolism (glycolysis and electron
transport), oxidative stress, and production of cytoskeletal proteins, all
of which could be involved in the growth of new skin during wound healing.
This finding suggests that DSC127 produces different actions at the wound
site during various stages of healing. DSC127 appears to stimulate
production of dermal progenitor cells following injury.



Acute and chronic administration of DSC127 in rodents and dogs failed
to demonstrate any meaningful toxicity to major organ systems. No mutagenic
effects of DSC127 were observed in standard test panels. Pre-clinical and
human Phase 1 studies of DSC127 have demonstrated safety in FDA monitored
studies.



About Derma Sciences



Derma Sciences is a global manufacturer and marketer of advanced
wound-care products. Its key product, MEDIHONEY(TM), is sold throughout the
world by Derma Sciences and Comvita New Zealand -- the licensor of the
patented honey- based technology -- and is the leading brand of honey-based
dressings for the management of wounds and burns. The product has been
shown to be effective in a variety of wounds and burns, and was recently
the focus of a large-scale randomized controlled trial on leg ulcers. Derma
has two products in development: the BIOGUARD(TM) line of barrier gauze
dressings, and DSC127, the company's novel angiotensin analog for
accelerated wound healing and scar reduction. The barrier technology was
licensed from Quick-Med in Q1 of 2007 and is pending its initial FDA
marketing clearance. DSC127 was licensed from the University of Southern
California in Q4 of 2007. For more information about Derma Sciences, Inc.,
visit its home page on the Internet at dermasciences.



Forward looking Statements



Statements contained in this release that are not statements of
historical fact may be deemed to be forward-looking statements. Without
limiting the generality of the foregoing, words such as "may," "will,"
"expect," "believe," "anticipate," "intend," "could," "estimate" or
"continue" are intended to identify forward-looking statements. Readers are
cautioned that certain important factors may affect the Company's actual
results and could cause such results to differ materially from any
forward-looking statements which may be made in this release or which are
otherwise made by or on behalf of the Company. Factors which may affect the
Company's results include, but are not limited to, product demand, market
acceptance, impact of competitive products and prices, product development,
completion of an acquisition, commercialization or technological
difficulties, the success or failure of negotiations and trade, legal,
social and economic risks. Additional factors that could cause or
contribute to differences between the Company's actual results and
forward-looking statements Include but are not limited to, those discussed
in the Company's filings with the Securities and Exchange Commission.


Derma Sciences, Inc.

dermasciences

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