Trials stopped early for futility
Conference call begins at 8:30 a.m. Eastern time today
PRINCETON, N.J.--(BUSINESS WIRE)--Nov. 12, 2015--
Derma Sciences, Inc. (Nasdaq: DSCI), a tissue regeneration
company focused on advanced wound and burn care, announces the
termination of its Phase 3 clinical trials with aclerastide (DSC127) for
diabetic foot ulcer healing. This action is based on futility
determinations conducted by the Data Monitoring Committee (DMC) for the
planned, pre-specified interim analyses regarding the primary efficacy
endpoint of confirmed complete wound closure of the target ulcer within
12 weeks of the start of treatment. The decision to end the studies
followed the recommendation by the DMC to stop enrollment in the
studies. The DMC also reported that there were no safety concerns
attributed to aclerastide.
“We are very disappointed with the findings of the analyses of the DMC,
but are grateful for the support and commitment from the participating
patients and the study investigators,” said Edward J. Quilty, chairman
and chief executive officer of Derma Sciences. “We have stopped further
enrollment and initiated an orderly termination of the aclerastide
trials and program, which we believe will be substantially complete by
year end. We are also halting all development work with DSC127 in scar
reduction and radiation dermatitis.”
The development program termination eliminates a projected cash burn of
approximately $5 million per quarter in 2016. As of September 30, 2015
Derma Sciences had $49.4 million of cash and cash equivalents and $12.0
million of long-term investments. The Company’s primary focus is to
continue to grow its advanced wound care net sales and increase gross
margins. The Derma Sciences Board of Directors and senior management are
committed to a path of profitable growth and positive operating cash
flow in 2016, including assessing all aspects of the Company’s
operations and infrastructure that could enhance shareholder value.
Derma Sciences will host a conference call beginning at 8:30 a.m.
Eastern time today to discuss this announcement and answer questions. To
access the conference call, U.S.-based listeners should dial
866-820-1713 and international listeners should dial 706-634-7417. All
listeners should provide the following passcode: 78730079. Individuals
interested in listening to the live conference call via the Internet may
do so by logging on to the Company’s website at www.dermasciences.com.
Following the conclusion of the conference call, a replay will be
available through November 18, 2015 and can be accessed by dialing (855)
859-2056 from within the U.S. or (404) 537-3406 from outside the U.S.
All listeners should provide passcode 78730079. The webcast will be
available for 30 days.
About Derma Sciences, Inc.
Derma Sciences is a tissue regeneration company focused on advanced
wound and burn care. It offers a line of products with patented
technologies to help better manage chronic and hard-to-heal wounds, many
of which result from diabetes and poor vascular functioning. The Company
sells AMNIOEXCEL® amniotic allograft membrane and AMNIOMATRIX®
amniotic allograft suspension into the $500 million market for skin
substitute products. Derma Sciences’ MEDIHONEY® product line is the
leading brand of honey-based dressings for the management of wounds and
burns. The product has been shown in clinical studies to be effective in
a variety of indications. TCC-EZ® is a gold-standard total
contact casting system for diabetic foot ulcers. Other novel products
introduced into the $14 billion global wound care market include XTRASORB®
for better management of wound exudate, and BIOGUARD® for
barrier protection against microbes and other contaminants. The Company
also offers a full product line of traditional dressings.
For more information please visit www.dermasciences.com.
Statements contained in this news 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 that may be made in this news release or
that are otherwise made by or on behalf of the Company. Factors that may
affect the Company's results include, but are not limited to decisions
regarding aclerastide (DSC127), product demand, market acceptance,
impact of competitive products and prices, product development,
completion of an acquisition, 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 U.S. Securities and Exchange
View source version on businesswire.com: http://www.businesswire.com/news/home/20151112005228/en/
Source: Derma Sciences, Inc.
Derma Sciences, Inc.
Yetter, Chief Financial Officer, (609) 514-4744
Sutton Golodetz, (212) 838-3777
Voss, (310) 691-7100