EXCALIARD ANNOUNCES POSITIVE DATA FROM PHASE 2 CLINICAL TRIAL OF ITS ANTI‐SCARRING DRUG, EXC 001
CARLSBAD, CA, August 3, 2010– Excaliard Pharmaceuticals, Inc., today announced positive results from its Phase 2 clinical trial of EXC 001, a new chemical entity for reducing fibrosis. Results showed that EXC 001 treatment significantly reduced scar severity in subjects undergoing an elective abdominoplasty compared to placebo.
In the randomized, double‐blind multicenter study conducted in the U.S., EXC 001 or placebo was administered intradermally adjacent to the surgical incision in patients who were undergoing elective abdominoplasty surgery. In this study multiple measurements of scarring were performed with analysis conducted at 12 weeks post‐surgery. Data reported today showed statistically significant improvements in scarring for EXC 001 compared to placebo in both physician and patient reported outcomes (p values ranged from 0.017 to 0.002). In addition, EXC 001 was well tolerated with no clinically important adverse events. The final analysis for this study will be conducted 24 weeks after surgery and these data will be available in the second half of 2010.
“The prevention and treatment of unsatisfactory skin scarring remains an important unmet medical need,” said Lincoln Krochmal, MD, CEO & President of Excaliard Pharmaceuticals. “Unsatisfactory skin scarring can be associated with various dermatologic conditions such as hypertrophic scars and keloids, elective and reconstructive surgery, traumatic wounds and Caesarian sections. We are delighted with these results from our Phase 2 study indicating a strong efficacy signal from EXC 001 delivered locally with multiple parameters of skin scarring significantly improved by treatment with EXC 001. In addition, we are pleased that there were no clinically relevant safety findings reported in this trial. We look forward to receiving additional results from our ongoing Phase 2 program and further evaluating our novel therapeutic in future studies for conditions in which the amelioration of scarring postoperatively would be highly desirable to the patient.”
“EXC 001 is a second generation antisense medicine that may inhibit the process of fibrosis by inhibiting a growth factor. In a variety of animal models of scarring, EXC 001 has demonstrated significant and reproducible reductions in scar formation, including in skin,” said Nicholas Dean, PhD., Founder and Chief Scientific Officer. “EXC 001 is an exciting and novel approach that may prevent excessive skin scarring, and represents the first time an antisense medicine has been used for this significant, unmet medical need.”
EXCALIARD INITIATES PHASE 2 TRIALS IN U.S. FOR ITS SKIN SCARRING DRUG, EXC 001
CARLSBAD, Calif, January 5, 2010 - Excaliard Pharmaceuticals, Inc. announced today theinitiation of three proof of concept Phase 2 trials of EXC 001, an antisense medicine thatreduces fibrosis, for the amelioration of skin scarring and other fibrotic disorders. The U.S.multicenter trials will test the efficacy, safety, and tolerability of EXC 001 in two different modelsto evaluate the improvement of the appearance of scars in subjects undergoing electiveabdominoplasty surgery and revision of scars associated with prior breast surgery.
“The prevention and treatment of unsatisfactory skin scarring remains an important unmetmedical need” said Lincoln Krochmal, MD, CEO & President of Excaliard Pharmaceuticals.“Unsatisfactory skin scarring can be associated with various dermatologic conditions such ashypertrophic scars and keloids, elective and reconstructive surgery, traumatic wounds,Caesarian sections and burns. We are delighted with our Phase 1 study results indicating EXC001 delivered locally has a very impressive safety profile. We look forward to further evaluatingthe safety and efficacy of our novel therapeutic in Phase 2 trials for conditions in which theamelioration of scarring post-operatively would be highly desirable by the patient.”
“EXC 001 is a second generation antisense medicine that inhibits fibrosis. In a variety ofanimal models of scar formation, EXC 001 has demonstrated significant and reproduciblereductions in skin scar formation,” said Nicholas Dean, PhD., Founder and Chief ScientificOfficer. “EXC 001 is an exciting and novel approach to reducing skin scarring, and representsthe first time an antisense medicine has been used for this significant, unmet medical need.”
EXCALIARD PHARMACEUTICALS APPOINTS LINCOLN KROCHMAL, MD, PRESIDENT & CHIEF EXECUTIVE OFFICER AND JEFFREY JENSEN, HEAD OF CLINICAL OPERATIONS.
CARLSBAD, Calif., Oct. 10, 2008- Excaliard Pharmaceuticals, a late stagge preclinicalcompany developing targeted therapeutics for the treatment of dermatological disorders andfibrotic diseases, is pleased to announce the appointment of Lincoln Krochmal, MD, asPresident & Chief Executive Officer and Jeff Jensen as Head of Clinical Operations.
Dr. Lincoln Krochmal is a board certified Dermatologist with over 25 years experience in thepharmaceutical and consumer goods industries. Prior to joining Excaliard in September of2008, Dr. Krochmal served as Executive Vice President, Research and Product Developmentfor Connetics Corporation, a specialty dermatology company headquartered in Palo Alto, CA,until the company’s acquisition by Stiefel Laboratories, Inc. Dr. Krochmal began his industrialcareer with Westwood Pharmaceuticals (the dermatology subsidiary of Bristol-Myers Squibb)becoming VP, Dermatology Research & Development and VP, Worldwide MedicalDevelopment. He then joined Unilever PLC, where he spent the next decade in variousexecutive management positions including SVP, Home and Personal Care Research &Development directing the worldwide development of numerous consumer products includinghelping to build the Dove® brand to a $ 2 billion dollar global business.
During his career, Dr. Krochmal has played a pivotal role in the approval of 15 NDAs/ANDAsfor new topical dermatologicals including LacHydrin®, Ultravate®, Dovonex®, Evoclin®,Verdeso®, Olux-E® and Extina® and numerous OTC and consumer goods in the US andinternationally.
Dr. Krochmal received his Doctor of Medicine from the Medical College of Wisconsin, and isboard certified in dermatology. Dr. Krochmal serves on the board of directors for theInternational Academy of Cosmetic Dermatology and Quinnova Pharmaceuticals, Inc. Heis a fellow of the American Academy of Dermatology, a Diplomat of the American Board ofDermatology, a member of the International Society of Dermatology and the DermatologyFoundation.
Isis and Excaliard Collaborate to Develop Antisense Drugs for Local Treatment of Fibrotic Diseases
CARLSBAD, Calif., Nov. 27. 2007-- Isis Pharmaceuticals, Inc. (Nasdaq: IISIS) and Excaliard Pharmaceuticals,Inc. announced today a new collaboration to discover and develop antisensedrugs for the local treatment of fibrotic diseases, including scarring.Isis has granted Excaliard an exclusive worldwide license for thedevelopment and commercialization of certain antisense drugs. Excaliardmade an upfront payment to Isis in the form of equity and paid Isis $1million cash for the licensing of a particular gene target. In addition,Isis is eligible to receive development milestones and royalties onantisense drugs developed by Excaliard.
"Isis has made superb progress in the development of second-generationantisense drugs over the last few years, as evidenced by its clinicalpipeline and current collaborations with companies such as Bristol-MyersSquibb, Eli Lilly and Ortho-McNeil among others. Having access to Isis'antisense technology and expertise provides a great opportunity forExcaliard," said J. Gordon Foulkes, Ph.D., acting CEO for Excaliard andManaging Director of RiverVest Venture Partners, who co-founded Excaliardand provided the initial seed funding for the company.
Excaliard closed a $15.5 million Series A financing, co-led by AltaPartners, ProQuest Investments, and RiverVest Venture Partners, with FarahChampsi, Alain Schreiber and Gordon Foulkes respectively joining the Boardof Directors. "It is a pleasure to once again be working with Isis, theleader in the discovery and development of RNA-based therapeutics," statedNicholas Dean, Ph.D., co-founder and CSO of Excaliard. Dr. Dean wasformerly Vice President of Oncology and Functional Genomics at Isis."Fibrosis represents a significant and expanding area of unmet medicalneed, and we believe that antisense offers unique advantages in this areafor developing a completely new class of anti-fibrotic agents. Excaliardplans to exploit this exciting opportunity by rapidly moving multipleantisense drugs into clinical development."
"The broad applicability of our antisense technology enables us tobuild a substantial and diverse pipeline of antisense drugs. In order tomaximize the value of this technology, a key component of our businessstrategy is to enter into promising partnerships that provide tremendousgrowth opportunities for antisense drugs in diseases that are outside ofour main therapeutic areas, cardiovascular and metabolic diseases," said B.Lynne Parshall, Executive Vice President and CFO of Isis. "Excaliard willbenefit from access to our technology and intellectual property and join agrowing list of partners who have focused teams dedicated to advancingantisense drugs and who enable us to continue to expand the breadth of ourantisense drug pipeline."
