DFB Acquires EpiSource from IsoTis OrthoBiologics
DFB Pharmaceuticals Inc. (Fort Worth, Tex) announces the acquisition of the wound management activities of EpiSource SA (Upland, Calif) from IsoTis OrthoBiologics (Irvine, Calif).
DFB provides technology-driven products, outsourcing services, and licensing opportunities to the healthcare industry worldwide through its affiliate companies, contract partners, and branded marketing organizations. EpiSource SA, with facilities in Lausanne, Switzerland, focuses on research, development, and manufacturing of cell-based therapies.
In August 2003, IsoTis OrthoBiologics and HEALTHPOINT Ltd., a DFB affiliate, entered into an exclusive licensing agreement for Allox™, a cell-based product used to treat chronic skin wounds. In 2003, IsoTis announced the establishment of EpiSource SA to create an independent vehicle and a potential spin-off company for its wound management portfolio. Allox is the lead product of that portfolio, which also includes EpiDex™ and AcuDress™ technologies.
The initial focus following the acquisition will be on Allox. Allox is a spray delivery platform that utilizes live human cells. Allox is currently entering late stage development and is anticipated to receive marketing approval in the United States within 4 years.
Visit http://www.dfb.com/ for more information.
Premier Awards Medline New National Agreement on Advanced Wound Care Dressings
Medline Industries (Mundelein, Ill), a privately held manufacturer and distributor of healthcare supplies, recently won a new 3-year national agreement to offer silver wound care dressings to members of Premier Purchasing Partners, one of the nation’s largest healthcare group purchasing organizations.
The agreement will provide silver wound care products at significant savings to Premier’s group purchasing membership of nearly 1,500 hospitals.
The agreement, which became effective January 1, 2005, covers numerous silver products used in the treatment of chronic wounds, including Medline’s controlled-release silver products SilvaSorb® and Arglaes®.
Visit http://www.medline.com for more information.
National Healing Corporation and the Ohio State University Announce Million-Dollar Partnership
National Healing Corporation (NHC, Boca Raton, Fla) has signed a contract forming an official partnership with the Wound Healing Research Program at Ohio State University (OSU) in Columbus. The goal of the new partnership is to improve ways of delivering cost-effective wound care to millions of Americans as rates of vascular diseases and diabetes continue to rise among the nation’s aging population.
The agreement includes:
• Clinical studies conducted at NHC Wound Healing Centers around the country
• Continued management of the NHC Wound Healing Center at OSU Hospital East and the establishment of a second NHC Wound Healing Center on the OSU campus opening in 2005
• Establishment and underwriting for the positions of a full-time research nurse and a part-time research coordinator at OSU and a full-time research coordinator at NHC
• Sponsorship of national and international wound healing conferences to be held every other year at OSU
• Direct support in the amount of $150,000.
The partnership is the latest in an ongoing relationship between the Florida-based firm and OSU. Ten to 12 times a year, NHC presents the National Healing Institute on the OSU campus where physicians, nurses, and technicians at NHC centers from around the country complete 60 hours of specialized training. The wound healing center staff members learn the company’s proprietary clinical pathway, which guides treatment protocols and incorporates the most current diagnostic tests, technologies, and treatments available today.
Visit http://www.nationalhealing.com for more information.
Helix BioMedix Announces Anti-Infective Collaboration with Smith & Nephew
Helix BioMedix (Bothell, Wash) announces that it has signed a memorandum of understanding with Smith & Nephew (Largo, Fla) that gives Smith & Nephew a right of first offer to license certain rights to a number of wound-related indications for HB50, a Helix BioMedix proprietary peptide. In return, Smith & Nephew agrees to provide input on the preclinical and clinical development of HB50 as a topical anti-infective for use in wound care. Under the terms of the agreement, Smith & Nephew will be providing wound management expertise to the Helix BioMedix development team throughout the development process.
HB50 is the company’s lead topical anti-infective peptide. Its attributes include broad-spectrum activity, lack of resistance induction, cost-effective synthesis, stability, and activity against multiple-antibiotic-resistant pathogens. In preclinical testing, HB50 in a gel formulation has been shown to significantly reduce the numbers of Staphylococcus aureus in an abraded skin infection model and in the majority of cases to eradicate the organism. Due to potent activity against multiple-resistant S. aureus, HB50 holds great potential for the prevention of wound infections. In addition, with activity against other gram-positive bacteria and gram-negative bacteria, such as Pseudomonas aeruginosa, the peptide also has application in the areas of burn wounds and dermatology.
Visit http://www.helixbiomedix.com/ for more information.
US BioDefense Files Stem Cell Technology Proposal with Chemical Biological Defense Agency
US BioDefense (City of Industry, Calif) announces that the company filed its Small Business Innovation Research (SBIR) Grant proposal with the Department of Defense Chemical Biological Defense Agency. The proposal is titled, “Stem Cell Technology and Autologous Bioengineered Skin for the Treatment of Cutaneous Vesicant Injury.”
CEO David Chin stated, “The company’s technical objective is to grow large, bioengineered skin grafts from embryonic stem cells. The successful result will enable restoration of epidermal and dermal compartments and preservation of epidermal stem cells for complete healing and long-time restoration of skin wounds—particularly wounds resulting from vesicant agent-induced cutaneous burns.”
US BioDefense hopes to develop a product that will enable medical personnel to react quickly and efficiently in the face of biological warfare in the midst of the battlefield, abroad, and within national borders. To achieve this, the company proposes a collaboration of resources from doctors, universities, hospitals, Fortune 500 companies, and government agencies to create a bioengineered skin based on embryonic stem cell technology.
E-mail info@usbiodefense.com or call 626-961-0562 for more information.
RegeneRx’s Venous Ulcer Trial Initiated in Europe
RegeneRx Biopharmaceuticals Inc. (Bethesda, Md) announces the beginning of a phase II clinical trial to test its drug Thymosin beta 4 (TB4) for the treatment of venous stasis ulcers.
The phase II trial will be a randomized, double-blind, placebo-controlled trial designed to test several dosages of TB4 in patients with venous stasis ulcers in Italy and at least 1 other European country. The drug will be topically administered to each patient over a period of several weeks. The study is scheduled for the second quarter of 2005 and should be completed and analyzed within approximately 1 year from enrollment of the first patient.
This trial is the second in a portfolio of complementary clinical trials planned by RegeneRx and designed to evaluate TB4’s effect on wound healing for specific types of dermal and ocular wounds.
Published data showing that TB4 promotes angiogenesis, stimulates cell migration, and increases collagen deposition in treated wounds in laboratory animals provides the rationale for testing the drug in the venous stasis ulcer patient population. It is estimated that nearly 2.5 million people in the US and a smaller number in Europe have venous stasis ulcers.
Visit http://www.regenerx.com/home.htm for more information.
Bancroft Joins HEALTHPOINT as Tissue Management Marketing VP
Michael E. Steadman, President of HEALTHPOINT, Ltd., Tissue Management, an affiliate of Fort Worth, Texas-based DFB Pharmaceuticals, Inc., announces that Robert E. Bancroft has joined the Tissue Management division of HEALTHPOINT as Vice President, Marketing.
Mr. Bancroft was formerly senior marketing director for Global BOTOX® at Allergan, Inc. BOTOX has been one of the most successful therapeutics worldwide, a franchise that exceeds $500 million annually.
HEALTHPOINT, founded in 1992, is a specialty pharmaceutical company focusing on the research, development, and marketing of branded pharmaceuticals, over-the-counter drugs, and medical devices worldwide. Its Tissue Management business includes marketing prescription drugs and innovative prescription technologies and devices for skin and soft tissue, including the treatment of acute and chronic tissue compromises and full- and partial-thickness wounds, and for the management of intact skin.
Current marketing focus at HEALTHPOINT is on incontinence-related skin problems; chronic wounds, such as pressure, venous, and diabetic ulcers, and associated skin conditions like periwound dermatitis and maceration; and unique therapies for burns.
While at Allergan, Mr. Bancroft contributed to the significant success of the BOTOX business by overhauling the therapeutic business plan, defining the global competitive strategy, and leading a cross-functional team in developing the life cycle management roadmap for the franchise.
Mr. Bancroft began his career in sales of topical ophthalmics for Allergan’s US Eye Care business in the late 1980s before rising to senior director of global marketing.
A 1987 graduate of Indiana University in Bloomington with a Bachelor of Science degree in biology, Mr. Bancroft completed his Master of Business Administration degree in marketing and finance in 1996 at the University of Southern California, Los Angeles.
Visit http://www.healthpoint.com.
Kinetic Concepts, Inc. Announces Election of New Chairman
Kinetic Concepts, Inc. (San Antonio, Tex) announces that the board of directors has elected Ronald W. Dollens to serve as Chairman of the Board. Mr. Dollens has served as a director of KCI since 2000.
Mr. Dollens is President, Chief Executive Officer, and a director of Guidant Corporation, a corporation that pioneers lifesaving technology for millions of cardiac and vascular patients worldwide. He has served in that capacity since 1994. Mr. Dollens also held the position of President and Chief Executive Officer of Guidant’s subsidiary, Advanced Cardiovascular Systems, Inc. Previously, he served as President of Eli Lilly and Company’s Medical Devices and Diagnostics Division from 1991 until 1994. Mr. Dollens currently serves on the boards of Beckman Coulter, Inc., the Advanced Medical Technology Association, the Eiteljorg Museum, the Indiana Health Industry Forum, Alliance for Aging Research, and Butler University. Mr. Dollens became a director of KCI in 2000, and he currently serves as chairman of the KCI compensation committee. His current term expires at the KCI annual shareholder meeting to be held in 2007.
KCI also announced that 2 of its current board members, Robert Jaunich, II, and James T. Farrell, resigned from the Board. Mr. Jaunich and Mr. Farrell are both managing partners of Fremont Partners, which, together with its affiliates, has been a major shareholder in KCI since the company went private in 1997. Over the last 18 months, Fremont’s ownership in the company has decreased from approximately 40% of outstanding shares to approximately 6% as of February 7, 2005.
Alba Therapeutics Corporation Reports the Successful Treatment of Type I Diabetes in the BB/wor Rat Model of Diabetes with Zonulin Antagonist AT-1001
A team of scientists at Alba Therapeutics Corporation and the University of Maryland School of Medicine report a direct link between zonulin-mediated increased intestinal permeability and type 1 diabetes (T1D) in the BB/wor Rat Model of Diabetes. Even more remarkable, the investigators were able to successfully prevent the onset of the autoimmune destruction of pancreatic beta cells and the onset of T1D in these animals by using the specific zonulin blocker AT-1001. Daily, oral administration of the drug beginning before the onset of autoimmunity in the diabetic prone rats cut the incidence of the disease by 2/3, and completely blocked the development of autoimmune antibodies in the treatment responders.
Published in the latest issue of the Proceedings of the National Academy of Science (PNAS), these results constitute the first successful result in preventing the autoimmune process characteristic of T1D by blocking the zonulin-mediated abnormal intestinal permeability. “These results go well beyond the development of a prevention strategy for T1D,” says Dr. Alessio Fasano, lead author of the article and Professor of Pediatrics, Medicine, and Physiology at The University of Maryland School of Medicine. “They open a new field of investigation in which the interplay between host and environment at the mucosal level may help us [understand] the molecular basis of many diseases.”
“These results reinforce our conviction that the zonulin pathway provides a roadmap for the discovery and development of innovative products to treat many important diseases, including diabetes, in ways previously thought to be inconceivable,” stated Dr. Blake M. Paterson. “These preclinical proof-of-concept results with AT-1001 support the salvaging of beta cell function in pre-diabetics or in new-onset diabetes, giving us the impetus to rapidly move through the development process, bringing this dream to a reality for treatment in the diabetes community.”
T1D is an autoimmune disease that results in the destruction of the insulin-producing cells of the pancreas, the islet beta cells. Current treatment of T1D is limited to the administration of insulin and other medications to treat the consequence of diabetes, elevated blood sugar, and the complications thereof. The inability to treat the cause of T1D—a process known as autoimmunity, in which the body’s immune system attacks the beta cells of the pancreas—has been the key obstacle to freeing patients from the yoke of this disease.
Autoimmune diseases are thought to occur in individuals with the genetic predisposition to attack and destroy various organ tissues by the body’s own immune system. This immune misrecognition is thought to be triggered by the presence of an environmental stimulus; in the case of T1D, the trigger is unknown. While the majority of research efforts have focused on identifying the trigger of T1D and modifying immune pathways, little is known about how such a trigger might enter the body and about how such an entryway might serve as a target for the treatment of the disease. The discovery of zonulin—a “gatekeeper” of intestinal barrier function—and its involvement in celiac disease led to the hypothesis that its malfunction could be involved in a series of other autoimmune diseases characterized by a “leaky gut,” including T1D. Previous work by Dr. Alessio Fasano has shown a close association of celiac disease in children at risk of developing T1D and led to the novel discovery research in support of AT-1001.
Alba Therapeutics is a Baltimore, Maryland-based biopharmaceutical company dedicated to commercializing disease-modifying therapeutics and drug delivery adjuvants based on the zonulin pathway. Alba’s lead molecule, AT-1001, is targeted toward the treatment of celiac disease and type 1 diabetes and is in the final stages of prehuman testing.
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