BRISBANE, Australia, Dec. 20, 2016 (GLOBE NEWSWIRE) -- Factor Therapeutics Limited (ASX:FTT) is pleased to announce that it has enrolled the first patient for its US multi-centre Phase II trial of VF001 in Venous Leg Ulcers (clinicaltrials.gov : NCT02973893). The FPI milestone was achieved at Miami Dade Medical Research Institute under the supervision of Dr. Francisco Oliva.
CEO Nigel Johnson commented, “We are delighted to have now formally launched this Phase II trial. It has been clinically and operationally-designed to ensure the very best chance of achieving a successful outcome.”
The clinical trial (VF00102) is a 168-patient double blind, placebo controlled Phase II study of VF001-DP (drug product) in moderately-severe Venous Leg Ulcers (VLUs). The trial will randomize patients 1:1:1 into 3 arms: 28µg/ml VF001 (low dose) and 280µg/ml VF001 (high dose), and placebo. All three arms will be combined with compression bandaging and moisture-retentive dressings (standard care). The trial features strict inclusion/exclusion criteria intended to optimise patient response on the basis of the company’s prior clinical experience with the product. After a 2 week screening period to eliminate easy healers, randomised patients will be treated weekly for 12 weeks, with a 12 week follow-up period.
Enrolment will take place across up to 26 clinical sites across the US, with up to 32 sites qualified should additional patient recruitment sites be required. The company plans to provide an enrolment update in Q1 2017, and is targeting a top-line read-out of efficacy by Q4 2017. The trial also includes a quality of life survey to support the use of the study as a second confirmatory trial that will support the submission for a CE Mark in Europe, where VF001 is classified as a Class III, Rule 13 medical device.
Executive Director Dr Christian Behrenbruch commented, “We have assembled an outstanding clinical team that is able to execute a very sophisticated trial. The Miami investigator meeting was highly successful for the company and we have made a solid launch into the study. We are encouraged by the positive investigator response and engagement with this trial.”
About Venous Leg Ulcers
Chronic wounds, unlike normal wounds, remain in a prolonged inflammatory state which leads to damage of critical extracellular components. VLUs cost the US healthcare system in excess of $3Bn/year. Up to one third of all patients experience 4+ recurrent episodes of disease, and VLUs affect up to 1.7% of the US population with a prevalence of ~600,000 patients/year in the 65+ age group. The average per-ulcer cost is $9,600/year. Not only is there a major unmet need for new products to achieve a more robust wound-healing trajectory, but pain management (a secondary end-point in Factor’s trial) is also of major importance in this patient population. There are over 1,000 out-patient wound care centres in the United States, with a trend toward treating patients in the community setting.
About VF001
VF001 is a proprietary recombinant fusion protein consisting of an engineered vitronectin motif linked to insulin-like growth factor 1 (IGF-1). The product is designed to accelerate chronic wound repair by providing wound bed cell attachment sites and stimulating cellular proliferation. VF001 is a multi-action product that enables fibroblasts and keratinocytes to attach, migrate, and proliferate within the extracellular matrix, thereby reinstating a more normal wound healing process. VF001 is part of Factor Therapeutics’ strong intellectual portfolio around vitronectin-targeted growth factors. VF001 and related molecules in the Factor portfolio are also being evaluated for other advanced wound care applications, such as surgical and ocular wound care.
About Factor Therapeutics
Factor Therapeutics Limited (“Factor”) is a biomedical technology company that is developing treatments for acute and chronic wound healing applications. Factor is a clinical stage company with its lead program (VF001) in Phase II for the treatment of venous leg ulcers (VLUs). The company’s platform technology originates from the Institute of Health and Biomedical Innovation at the Queensland University of Technology, Australia. Factor’s shares are traded on the Australian Securities Exchange (ASX) under the ticker FTT. For more information, please visit www.factor-therapeutics.com.
Important Information
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available.