DNAPrint Genomics, Inc. (OTCBB: DNAG) today announced that its German business partner, Biofrontera AG (FRANKFURT: B8F), in which the Company owns an approximate 10% stake, has completed the enrollment of patients in the first part of its phase IIb/III clinical trial for its lead product, BF-200 ALA, a proposed treatment of actinic keratosis (precancerous and cancerous skin lesions).
Initially, clinical results for three different doses of the active ingredient 5-aminolevulinic acid (ALA) and placebo are compared. Following the treatment and 2-month observation of 80 patients enrolled in the first part of the study, independent experts will perform an interim analysis to select the optimal dose of the drug. All 80 patients have already completed the treatment and Biofrontera expects the results of the interim analysis in the first quarter 2007. Subsequently, efficacy and safety of BF-200 ALA will be verified with an additional 160 patients.
The randomized, placebo-controlled clinical phase IIb/III trial is conducted in 13 centers in Germany. In parallel to the ongoing trial, a second phase III trial is currently prepared with approximately 200 patients to compare BF-200 ALA with a standard therapy. Clinical efficacy of combinations of ALA with nanoemulsions has already been demonstrated for superficial basal cell carcinoma in two earlier phase II trials, where a single treatment eliminated more than 80% of the tumors.
BF-200 ALA
Biofrontera's lead product BF-200 ALA combines a nanoemulsion with 5-aminolevulinic acid (ALA). The product is developed for the photodynamic therapy of pre-cancerous skin lesions (actinic keratosis). The ALA nanoemulsion is applied to the skin lesions and, upon irradiation, a chemical reaction is triggered which destroys the affected skin without scar formation.
Actinic keratosis
Actinic keratosis or solar keratosis is a precancerous skin lesion. These lesions develop as single, small plaques on the face or bald scalp of a patient and then gradually progress in sun-exposed areas, such as the nose, the forehead, and the cheeks. About 10% of non-treated actinic keratosis progresses to invasive squamous cell carcinoma. Actinic keratosis is the 3rd most common reason for attending a dermatologist. The estimated incidence for actinic keratosis is 5 million new cases per year in Europe.
About Biofrontera AG
Biofrontera AG is specialized in the development of pharmaceutical products in the area of dermatology. The company is characterized by a broad, relatively close-to-the-market product portfolio and a solid liquidity. Biofrontera is listed in the regulated market of the Düsseldorf stock exchange and other German stock markets under the symbol B8F and the ISIN number DE0006046113. Visit the website at www.biofrontera.com.
About DNAPrint Genomics, Inc.
DNAPrint Genomics, Inc. is a developer of genomics-based products and services in two primary markets: biomedical and forensics. DNAPrint Pharmaceuticals, Inc., a wholly owned subsidiary, develops diagnostic tests and theranostic products (drug/test combinations) using the Company's proprietary ancestry-informed genetic marker studies combined with proprietary computational modeling technology. Computational Biology and Pharmacogenomics services are also offered externally to biopharmaceutical companies. The Company's first theranostic product is PT-401, a "Super EPO" (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (with end stage renal disease). Preclinical and clinical development of all the Company's drug candidates will benefit from simulated pre-trials to design actual trials better and are targeted to patients with genetic profiles indicating their propensity to have the best clinical responses. DNAPrint is proud of its continued dedication to developing and supplying new technological advances in law enforcement and consumer ancestry heritage interests. Please refer to www.dnaprint.com for information on law enforcement and consumer applications which include DNAWITNESS™, RETINOME™, ANCESTRYbyDNA™ and EURO-DNA™. DNAWitness-Y and DNAWitness-Mito are two tests offered by the Company. The results from these tests may be used as identification tools when a DNA sample is deteriorated or compromised or other DNA testing fails to yield acceptable results.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint's products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint Genomics, Inc. expressly disclaims any obligation or undertaking, except as may be required by applicable law or regulation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
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