PRINCETON, NJ, USA I June 12, 2013 I Derma Sciences, Inc. (DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces that all data from the pharmacokinetic (PK) study with 0.03% DSC127 gel has been collected and analyzed. The open-label, single center, Phase 1 PK study enrolled 21 diabetic subjects with at least one chronic non-healing Wagner Grade 1 or 2 plantar neuropathic foot ulcer(s) on the mid and fore foot that was at least 3.0 cm2. Eighteen subjects completed the trial. Three subjects were withdrawn due to adverse events that were deemed unrelated to the investigational drug. Subjects topically applied 0.03% DSC127 to the wound once each day for 28 days. The mean ulcer area at baseline was 9.5 cm2 (Standard Deviation 11.9 cm2).
DSC127 was not detected in any subject’s serum samples at any time point, using an assay with a lower limit of quantitation of 0.200ng/mL. Accordingly, no PK parameters could be calculated. All samples were also considered to be non-reactive in an assay for anti-drug antibodies. Study subjects showed no clinically significant changes in clinical chemistry, hematology, and electrocardiograms. The 0.03% DSC127 gel was well tolerated and there were no adverse events or serious adverse events considered related to the study drug, as determined by the Principal Investigator. None of the wounds treated with DSC127 gel deteriorated.
“This PK study was required by the U.S. Food and Drug Administration as part of our development program, and its findings are important as we continue to enroll subjects into the Phase 3 studies,” said Barry J. Wolfenson, Group President of advanced wound care and pharmaceutical development. “We continue to be very encouraged by the results with this investigational drug, and are optimistic about being able to demonstrate that DSC127 is safe and effective for treating diabetic foot ulcers.”
“The results of this PK study suggest that there is a low risk of an adverse systemic effect because DSC127 could not be detected in the study subjects’ blood samples. This is important for diabetics with foot ulcers who typically have multiple medical problems,” said Alan Dunton, M.D., a medical advisor to Derma Sciences and founder of Danerius, LLC, a drug development consulting firm.
About DSC127 and the Phase 3 Clinical Trials
DSC127 is an angiotensin analog formulated as a topical gel discovered by researchers at the University of Southern California and licensed to Derma Sciences for all dermal-related indications. Recent laboratory studies indicate that DSC127 may increase proliferation of local stem cells (epithelial stem cells in the hair follicle) in partial thickness wounds where such stem cells are available. In the Phase 2 study intent to treat population, 54% of wounds treated with DSC127 0.03% were healed at 12 weeks, compared with 33% in the vehicle control group (p=0.148). The difference between the two groups continued to expand out to 24 weeks, the last time wounds were assessed, with 73.1% in the arm treated with DSC127 0.03% healed compared with 45.8% in the vehicle control group of the intent to treat population (p=0.053). There were no serious safety concerns observed in any of the preclinical, and human Phase 1 and Phase 2 studies of DSC127. DSC127 is covered by a number of issued U.S. patents, with expiration dates through 2032.
Derma Sciences expects to enroll 211 subjects into each of the five arms of the Phase 3 program (for 1,055 subjects total across two studies), which ultimately will include more than 90 sites in the U.S. and Canada. The first trial will evaluate DSC127 0.03% against a topical vehicle, similar to the design of the completed Phase 2 trial. The second trial will evaluate DSC127 0.03% against a topical vehicle and against a standard of care hydrogel dressing. In both trials, subjects will receive standard of care, including debridement, cleansing, maintenance of a moist wound environment and an off-loading device throughout the course of the study. After a 14-day run-in period, subjects with wounds that have not healed by more than 30% will be randomized into one of five arms in a blinded trial design.
Subjects will receive the study drug or vehicle in the two-arm study; and study drug, vehicle, or placebo hydrogel in the three-arm study once daily for four weeks. Subjects will then receive standard of care only for up to six additional weeks to determine confirmed complete wound closure. Confirmed complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at a study visit two weeks after initially observed. Following a determination of confirmed complete wound closure, subjects will continue to receive standard of care and will be observed to determine the durability of the healing for up to twelve weeks. The primary endpoint of the Phase 3 trials is the proportion of ulcers completely closed by 10 weeks and remaining completely closed two weeks later. Secondary endpoints include rate of healing and safety.
In addition, a chronic use safety study of up to 200 subjects will be conducted, and will include subjects from the pivotal trials, as well as new subjects. This study will assess the safety of DSC127 dosed for a longer duration than in the pivotal studies, up to 12 weeks. Additionally, safety after repeat applications will be assessed on those subjects whose ulcers either recur or who develop additional diabetic foot ulcers after their initial treatment has concluded.
Further information may be found at www.clinicaltrials.gov.
About Derma Sciences, Inc.
Derma Sciences is a medical technology company focused on three segments of the wound care marketplace: pharmaceutical wound care products; advanced wound care dressings to address chronic wounds including diabetic ulcers; and traditional dressings. The Company has begun its Phase 3 clinical trial on diabetic foot ulcer healing with DSC127, based on Phase 2 data. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product maintains a moist wound environment conducive to wound healing for a variety of wounds. TCC-EZ® is its gold-standard total contact casting system for diabetic foot ulcers. Other products introduced into the $14 billion global wound care market include XTRASORB® for management of wound exudate, and BIOGUARD® for infection prevention. For more information please visit www.dermasciences.com.
SOURCE: Derma Sciences
Post Views: 195
PRINCETON, NJ, USA I June 12, 2013 I Derma Sciences, Inc. (DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces that all data from the pharmacokinetic (PK) study with 0.03% DSC127 gel has been collected and analyzed. The open-label, single center, Phase 1 PK study enrolled 21 diabetic subjects with at least one chronic non-healing Wagner Grade 1 or 2 plantar neuropathic foot ulcer(s) on the mid and fore foot that was at least 3.0 cm2. Eighteen subjects completed the trial. Three subjects were withdrawn due to adverse events that were deemed unrelated to the investigational drug. Subjects topically applied 0.03% DSC127 to the wound once each day for 28 days. The mean ulcer area at baseline was 9.5 cm2 (Standard Deviation 11.9 cm2).
DSC127 was not detected in any subject’s serum samples at any time point, using an assay with a lower limit of quantitation of 0.200ng/mL. Accordingly, no PK parameters could be calculated. All samples were also considered to be non-reactive in an assay for anti-drug antibodies. Study subjects showed no clinically significant changes in clinical chemistry, hematology, and electrocardiograms. The 0.03% DSC127 gel was well tolerated and there were no adverse events or serious adverse events considered related to the study drug, as determined by the Principal Investigator. None of the wounds treated with DSC127 gel deteriorated.
“This PK study was required by the U.S. Food and Drug Administration as part of our development program, and its findings are important as we continue to enroll subjects into the Phase 3 studies,” said Barry J. Wolfenson, Group President of advanced wound care and pharmaceutical development. “We continue to be very encouraged by the results with this investigational drug, and are optimistic about being able to demonstrate that DSC127 is safe and effective for treating diabetic foot ulcers.”
“The results of this PK study suggest that there is a low risk of an adverse systemic effect because DSC127 could not be detected in the study subjects’ blood samples. This is important for diabetics with foot ulcers who typically have multiple medical problems,” said Alan Dunton, M.D., a medical advisor to Derma Sciences and founder of Danerius, LLC, a drug development consulting firm.
About DSC127 and the Phase 3 Clinical Trials
DSC127 is an angiotensin analog formulated as a topical gel discovered by researchers at the University of Southern California and licensed to Derma Sciences for all dermal-related indications. Recent laboratory studies indicate that DSC127 may increase proliferation of local stem cells (epithelial stem cells in the hair follicle) in partial thickness wounds where such stem cells are available. In the Phase 2 study intent to treat population, 54% of wounds treated with DSC127 0.03% were healed at 12 weeks, compared with 33% in the vehicle control group (p=0.148). The difference between the two groups continued to expand out to 24 weeks, the last time wounds were assessed, with 73.1% in the arm treated with DSC127 0.03% healed compared with 45.8% in the vehicle control group of the intent to treat population (p=0.053). There were no serious safety concerns observed in any of the preclinical, and human Phase 1 and Phase 2 studies of DSC127. DSC127 is covered by a number of issued U.S. patents, with expiration dates through 2032.
Derma Sciences expects to enroll 211 subjects into each of the five arms of the Phase 3 program (for 1,055 subjects total across two studies), which ultimately will include more than 90 sites in the U.S. and Canada. The first trial will evaluate DSC127 0.03% against a topical vehicle, similar to the design of the completed Phase 2 trial. The second trial will evaluate DSC127 0.03% against a topical vehicle and against a standard of care hydrogel dressing. In both trials, subjects will receive standard of care, including debridement, cleansing, maintenance of a moist wound environment and an off-loading device throughout the course of the study. After a 14-day run-in period, subjects with wounds that have not healed by more than 30% will be randomized into one of five arms in a blinded trial design.
Subjects will receive the study drug or vehicle in the two-arm study; and study drug, vehicle, or placebo hydrogel in the three-arm study once daily for four weeks. Subjects will then receive standard of care only for up to six additional weeks to determine confirmed complete wound closure. Confirmed complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at a study visit two weeks after initially observed. Following a determination of confirmed complete wound closure, subjects will continue to receive standard of care and will be observed to determine the durability of the healing for up to twelve weeks. The primary endpoint of the Phase 3 trials is the proportion of ulcers completely closed by 10 weeks and remaining completely closed two weeks later. Secondary endpoints include rate of healing and safety.
In addition, a chronic use safety study of up to 200 subjects will be conducted, and will include subjects from the pivotal trials, as well as new subjects. This study will assess the safety of DSC127 dosed for a longer duration than in the pivotal studies, up to 12 weeks. Additionally, safety after repeat applications will be assessed on those subjects whose ulcers either recur or who develop additional diabetic foot ulcers after their initial treatment has concluded.
Further information may be found at www.clinicaltrials.gov.
About Derma Sciences, Inc.
Derma Sciences is a medical technology company focused on three segments of the wound care marketplace: pharmaceutical wound care products; advanced wound care dressings to address chronic wounds including diabetic ulcers; and traditional dressings. The Company has begun its Phase 3 clinical trial on diabetic foot ulcer healing with DSC127, based on Phase 2 data. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product maintains a moist wound environment conducive to wound healing for a variety of wounds. TCC-EZ® is its gold-standard total contact casting system for diabetic foot ulcers. Other products introduced into the $14 billion global wound care market include XTRASORB® for management of wound exudate, and BIOGUARD® for infection prevention. For more information please visit www.dermasciences.com.
SOURCE: Derma Sciences
Post Views: 195
