Innocoll, Inc, a privately-held specialty pharmaceutical company, would start the first of three phase II clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd. The company has commenced dosing for the trial, which will investigate Innocoll's diabetic foot ulcer drug CollaRx Gentamicin Topical.
CollaRx Gentamicin Topical is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx. Upon application to a wound, the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic (having a concentration-dependent mechanism of action), for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.
CollaRx Gentamicin Topical represents the clinical development of Innocoll's Gentamicin-Collagen Sponge as a therapy for the treatment and prevention of infected chronic wounds. The product is already approved and marketed in Europe and other non-US territories as a surgical implant for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues. The development of the topical indication is based upon a series of published clinical case studies and anecdotal reports from clinicians where the marketed implant product was applied topically to chronic wounds of various etiologies. These data support its effectiveness for such clinical applications, particularly in the treatment of infected diabetic foot ulcers.
Chronic ulcerations are often colonized or contaminated with bacterial pathogens that can prevent ulcers from healing. A high proportion of such wounds will become clinically infected and require treatment with antibiotics. Orally and parenterally administered antibiotics are often associated with systemic side effects and widespread use can lead to development of bacterial resistance. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow (ischemia), which may render systemically acting antibiotics less effective. Infection can also spread to the bone (osteomyelitis), which is less well vascularised than soft tissue. Currently, there are no topically applied antibiotics marketed in the US that are specifically indicated for the treatment of infected diabetic foot ulcers and recent market research independently performed by L.E.K. Consulting forecast peak annual revenues for CollaRx Gentamicin Topical approaching US $270 million, when limiting the sales projections to diabetic foot indications only.
Innocoll plans to study CollaRx Gentamicin Topical for the treatment of diabetic foot infections of varying severity in a series of phase II trials and has appointed the full-service Clinical Research Organization, Premier Research Group, to co-ordinate the trials and provide US regulatory support. The first of these trials is for the treatment of mildly infected diabetic ulcers, as defined according to Infectious Disease Society of America (IDSA) guidelines, where the safety and efficacy of CollaRx Gentamicin Topical will be compared to an orally administered antibiotic (the current standard of care). This is a multi-centred trial performed at ten sites, nine in the US and one in the UK. In two subsequent controlled, multi-centred phase II trials due to commence in early 2008, Innocoll will investigate the product as an adjunct to systemic therapy for treating moderately infected ulcers and also as a therapy to prevent ulcers from becoming clinically infected.
Dr. Michael Myers, president and CEO, Innocoll said, "Diabetes has reached epidemic proportions and is continuing to grow at an alarming rate across the globe. Diabetic foot is one of the major complications of this disease, which is a huge problem for sufferers and an overwhelming burden on healthcare systems worldwide. We understand from talking to physicians that our product can and has saved limbs when applied topically to infected ulcers. Since there are no other topical antibiotics on the market for infected diabetic foot ulcers, we view this trial as a significant step forward in treating and potentially preventing the condition. Being the first of two phase II and two phase III studies on three different products that we anticipate starting this month, the dosing of this patient represents the start of Innocoll's first clinical trial to be performed in the US and so marks an important milestone for the company."
According to the Centres for Disease Control and Prevention (CDC), the estimated incidence of diabetes in the US exceeds 1.5 million new cases annually, with an overall prevalence of 20.8 million people, or 7 per cent of the US population. By 2030, the International Diabetes Federation predicts that the Global prevalence of diabetes will almost double from 193 million people (estimated in 2003) to 366 million.
An estimated 15 per cent of patients with diabetes will develop a lower extremity ulcer during the course of their disease. According to a large prospective study, approximately 7 per cent of diabetic patients with foot ulcers will require an amputation. Diabetic foot is the most common cause of nontraumatic lower extremity amputations in the US and Europe, with an average of 82,000 amputations per year in the US costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000, for the 2 years post diagnosis. The total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.
Innocoll is a privately held, specialty pharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. It develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx and Liquicoll.