Overview

CVBT's 2011 Wound Healing Program: Accelerate to a Phase III Pivotal Trial

Summary: CVBT initiated its diabetic wound healing program in 2004 and completed pre-clinical efficacy and toxicity studies with human fibroblast growth factor (FGF-1) to support human studies in 2005. An FDA-authorized Phase I study in diabetic patients was completed in 2008 where it was shown that topically-applied FGF-1 was well tolerated and showed no adverse effects when applied to diabetic wounds. To accelerate CVBT's wound healing program, the company has in-licensed Phase I and Phase II clinical trial data for its FGF-1 diabetic wound healing compound. This data coupled with CVBT's own internal data indicates FGF-1 delivers a treatment breakthrough for diabetes patients suffering from dermal wounds.

Phase II Clinical Trial Data

Data from placebo-controlled, double-blinded Phase IIa and Phase IIb clinical trials support the safety and efficacy of FGF-1 in treating ischemic diabetic ulcers. A summary of the data is as follows:

• In the Phase IIa trial, diabetic ulcers treated with FGF-1 healed at an average rate of 4.5 times faster than wounds treated with placebo/standard of care (which included debridement).
• In the Phase IIa trial, a distinct class of wounds termed venous stasis ulcers, healed at twice the rate when treated with FGF-1 versus placebo.
• In the Phase IIb trial, 100% of the diabetic wounds treated with FGF-1 achieved total closure within 5 months or less, whereas a full one-third of the placebo-treated wounds remained open at the end of the 5 month treatment period. Additionally, 57% of patients treated with FGF-1 had complete closure of their diabetic wounds at 8 weeks, versus 0% for the placebo group.
• Both Phase II trials demonstrated statistical significance to placebo (p<0.05).
• In all trials (Phase I and Phase II), there have been no significant safety or adverse events attributable to the drug.

With this data CVBT now believes that the time to complete the clinical trials necessary for regulatory approval in the U.S. will be decreased. If these results are confirmed in a larger pivotal Phase III trial then topical treatment with FGF-1 could provide a significant advance in medical therapy for patients who suffer from dermal ulcers, which has the potential to impact how this patient population is treated.

Market Figures for Wound Healing Drug

Advanced wound management technologies - those used in the clinical management of wounds (not OTC) - have continued to evolve beyond simple dressings and bandages to be able to accelerate wound healing, improve clinical outcomes and, in particular, attempt to reduce the cost of managing wound types including diabetic ulcers.

• According to a recent report (MedMarket Diligence, LLC; Report #S247), there are 13.5 million diabetic ulcers globally, and the incidence is growing at nearly 10% annually.
• In the United States alone there are 25 million diabetics and it is estimated that up to 10% of these patients have ulcers.
• According to Drexel University (NIR Device for Predicting Diabetic Wound Healing 2009) the annual management cost of skin ulcers (pressure, venous, and diabetic) is greater than $20 billion in the U.S. alone.
• According to a recent report in WebMed Professional, chronic wounds are prevalent, costly, and have a significant negative impact on quality of life. Therefore, effective treatment strategies for chronic wounds could provide tremendous benefits to both patients and society as a whole. Unfortunately, complete healing rates for diabetic ulcers, venous ulcers, or pressure ulcers remain at approximately 25% to 50% following up to 20 weeks of treatment when standard wound care therapies and traditional synthetic dressings are used. These low rates suggest that standard of care is inadequate for many patients while highlighting the need for more aggressive management strategies in this population. Significant cost savings, decreased morbidity, and substantial increases in quality of life can be achieved with more rapid and complete ulcer healing.

CVBT believes the macroeconomics of the wound healing market are very attractive. Wound healing is a large and growing market both in numbers of patients and revenue potential. Even with the huge spending on management costs there is a continuing and growing unmet medical need.

Clinical Trial Information

Once the protocol is developed and approved by the FDA, we will place the details of the study here, including criteria for entrance into the trial and its overall design. Please check back for updates.

Enrollment and Trial Locations

Locations for our trial have not been determined, and we are not yet enrolling patients for this study. Please check back for updates. If you would like to receive an email alert when enrollment opens for our Wound Healing trial, please complete our Clinical Trial Inquiry Form.

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