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Derma Sciences To Enter Phase II Development Of Wound Healing Product That May Use Body's Own Naturally Occurring Stem Cells
Derma Sciences, Inc.
(OTC Bulletin Board: DSCI), a provider of advanced wound care products,
announced that it has signed a clinical services agreement with San
Luis Obispo-based, privately held U.S. Biotest, Inc. and will enter Phase
II clinical development of DSC127, a novel and rapid wound-healing and
scar-reduction product that has a unique mechanism of action potentially
linked to the body's own, naturally occurring stem cells. The product has
shown promising activity in pre-clinical animal models and has already been
tested for safety in a Phase I study in humans.
Through DSC127, Derma Sciences will be able to position itself as a key
player in the very large diabetic foot ulcer and scar reduction markets,
two rapidly growing and global segments of the wound care market. In the
U.S. there are an estimated 2.4 million diabetic foot ulcers and 60,000
diabetes-related amputations each year, which cost healthcare payers more
than $10 billion. The market for an FDA-approved scar reduction treatment
could reach as high as $4 billion annually in the U.S. alone.
The Phase II study for DSC127, which will be focused on diabetic foot
ulcers, is scheduled to begin enrollment in the third quarter of 2008.
"The development of DSC127 is an important milestone for Derma Sciences
because it represents an opportunity for us to enter two of the largest and
fastest-growing wound care markets in the world today," said Ed Quilty, CEO
of Derma Sciences. "Diabetes is a chronic medical issue around the globe
and scar reduction, due in large part to the very rapid growth of cosmetic
surgeries, is a significant new market for the wound care industry. These
are the markets wound care needs to be focused on in the coming months and
years and we believe DSC127, particularly due to its potential link to
healing through the activation of stem cells, is the kind of product the
medical industry is looking for."
Derma Sciences obtained the rights to DSC127 via license with the
University of Southern California, and has signed a clinical services
agreement with U.S. Biotest. The scope of the agreement covers pre-study
services, study management, clinical operations, data management and
medical writing.
Early testing of DSC127 demonstrated that its healing powers may work
by promoting the recruitment of mesenchymal stem cells to sites of tissue
injury. Mesenchymal stem cells are integral to the creation of several
tissue types including skin, beginning in the fetal stages of development.
DSC127 is a novel angiotensin analog that was shown in various animal
models to promote healing and reduce scar formation. As a person ages and
gets beyond the age of rapid growth, the number of his or her mesenchymal
stem cells greatly diminishes. However, administration of DSC127 at the
site of tissue injury may promote the recruitment of mesenchymal stem cells
in numbers that support the rapid healing of tissue. Application of DSC127
in various animal models has resulted in the increased pace of
angiogenesis, as well as increased keratinocyte and extracellular matrix
production, all key drivers for dermal repair.
U.S. Biotest, founded by Drs. Gere diZerega and Kathleen Rodgers,
maintains an expertise in the licensed compound and has extensive
capability in the development of devices and pharmaceutical agents. Drs.
diZerega and Rodgers have previously been involved in the development of 4
medical products that have received FDA approval and 7 medical products
that are marketed worldwide. Regarding DSC127, they have directed all
pre-clinical work, including compound development, manufacturing
validation, toxicology studies, successful National Institutes of Health
(NIH) grant submissions, acquisition of an Investigational New Drug (IND),
and completion of a Phase I clinical trial.
Regarding Derma Sciences' contract with U.S. Biotest, Quilty commented,
"Dr. diZerega and Dr. Rodgers have done a terrific job up to this point
with DSC127, and have a history of successful product development behind
them in the area of tissue repair. Additionally, not only will the clinical
development of the product continue to be managed by those who have
developed the product thus far, but it also allows us to work together with
the NIH grant already in place to accelerate Phase II studies."
Dr. Gere diZerega of U.S. Biotest said "We are excited to have the
opportunity to continue with the development of DSC127. We have a great
deal of experience with products that involve tissue repair, and believe
that DSC127 presents a truly unique mechanism of action that should have
significant activity in both areas of wound healing and scar reduction.
Derma Sciences is aggressively focused on developing evidence-based
pharmaceutical products to bring to the advanced wound care market, so we
are delighted to be working with them on this project."
About Derma Sciences:
Derma Sciences is a manufacturer and marketer of advanced wound-care
products, with operations based in the US and Canada, and sales worldwide.
The company recently launched its MEDIHONEY(TM) Wound & Burn dressings with
Active Leptospermum Honey. The Company has also obtained FDA clearance to
market and sell its MOBILITY-1(TM) boot and compressor device for the
treatment of venous ulcers, lymphedema, and other conditions that require
compression therapy. For more information about Derma Sciences, Inc., visit
its home page on the Internet at http://www.dermasciences.com.
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.
http://www.dermasciences.com
Derma Stiinte Pentru a intra în faza a II-a leziunii, de dezvoltare de produs care poate utiliza de organismul propriu natural celule embrionare - Derma Sciences To Enter Phase II Development Of Wound Healing Product That May Use Body's Own Naturally Occurring Stem Cells - articole medicale engleza - startsanatate