• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

DNAPrint Genomics Congratulates Biofrontera AG on Successful Clinical Trial Stages for Two Drugs

Posted on: Thursday, 5 October 2006, 09:00 CDT

DNAPrint Genomics, Inc. (OTCBB: DNAG) today announced that two products being developed by Biofrontera AG, a company in Germany in which DNAPrint Genomics owns an 18.3% stake, have been approved for the next stages of their respective clinical trial processes. The products are Biofrontera's BF-200 ALA treatment for actinic keratosis (precancerous and cancerous skin lesions), its lead product, and BF-derm1, a treatment for chronic urticaria (hives).

"We congratulate Biofrontera on its latest achievements in moving these drugs through their respective preliminary clinical trial stages in a timely fashion," stated DNAPrint Genomics' President and CEO, Richard Gabriel. "We have every confidence that these treatments for debilitating and painful skin conditions will find their way into common medical use in Europe and around the world, and as a result, DNAPrint's stake in Biofrontera will grow in value."

BF-200 ALA

BF-200 ALA was approved for a phase IIb/III clinical trial by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut fuer Arzneimittel und Medizinprodukte / BfArM). Participating dermatologists are now enrolling patients to analyze the optimal dose and efficacy of the drug, which combines a nanoemulsion with the active substance 5-aminolevulinic acid (ALA), a drug which is applied in photodynamic therapy of precancerous and cancerous skin lesions.

The approved clinical trial starts with a dose finding, followed by a phase III part to verify the efficacy and safety of the drug. In the first part of the study, the best dose for BF-200 ALA will be determined by treating 80 patients with three different doses or placebo. In the second part of the study, the optimal dose of BF-200 ALA is tested on 160 patients, 40 of whom will be treated with placebo. The clinical trial is randomized, placebo-controlled and takes place in 13 centers in Germany. Earlier clinical trials have demonstrated the clinical efficacy and safety of combinations of ALA and nanoemulsions.

"The approval of the phase III clinical study is an important milestone in the development of our company," commented Prof. Hermann Luebbert, CEO of Biofrontera AG. "We anticipate that the development plan, which has already been discussed with the BfArM, will lead to the approval of BF-200 ALA in the first European countries by the end of 2008, bringing Biofrontera closer to its goal of own marketing and sales of pharmaceuticals in Europe."

BF-derm1

Biofrontera's product candidate BF-derm1 is tested in an adaptive, double-blind, multi-center, placebo-controlled Phase II clinical trial. The adaptive study design allows interim analyses after previously defined parts of the trial. These evaluations are performed by an independent commission consisting of Prof. Hunzelmann, University of Cologne, Prof. Kramer, Focus Immunology Heidelberg, and Prof. Lehmacher, University of Cologne.

The first interim report had already indicated a positive trend for the efficacy of BF-derm1 with respect to the improvement of urticaria symptoms. The second report, which is now available, confirmed this tendency. Positive trends were observed with several clinical read-outs, including the reduction of urticaria symptoms, the visual activity score, and the reduction of sedating antihistamine intake. The visual activity score evaluates the general condition of the patients.

At all doses tested, the commission did not observe relevant side effects that could pose safety problems in the continuation of the study. For the final part of the trial it was recommended that Biofrontera increase the patient number in order to reach statistical significance.

BF-derm1 inhibits the enzyme histidine decarboxylase, which is responsible for the synthesis of histamine. Histamine is a major trigger for allergic symptoms such as itching, wheals or flushing of the skin. Biofrontera develops BF-derm1 for the treatment of chronic, severe antihistamine-refractory urticaria. The symptoms of this disease include intense itching, skin rash, red wheals and frequently angioedemas. Patients selected for the study cannot satisfactorily be treated by antihistamines. Such a severe form of antihistamine-refractory urticaria is a rare condition, affecting about 0.03% of the population worldwide. A large number of these patients are treated in specialized urticaria centers.

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 product portfolio, which is relatively close to the market. In August 2005, the company placed a EUR 20 million convertible bond, which since then is traded on the Frankfurt stock market. For more information, please visit http://www.biofrontera.com/.

About DNAPrint Genomics, Inc.

DNAPrint Genomics, Inc. (www.dnaprint.com) 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(TM), RETINOME(TM), ANCESTRYbyDNA(TM) and EURO-DNA(TM). 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.

 Company Contact:  Richard Gabriel CEO and President 941-366-3400      -or-  Ron Stabiner The Wall Street Group, Inc. 212-888-4848  

SOURCE: DNAPrint Genomics, Inc.

Source: MARKET WIRE

More News in this Category