Recruitment completed for phase IIa trial with fosfluridine tidoxil
in actinic keratosis
Heidelberg/Germany, February 5, 2007. Heidelberg Pharma, the private
German pure play drug-development company announced today that they
have completed the recruitment of patients for a randomized
placebo-controlled phase IIa trial in actinic keratosis with orally
administered fosfluridine tidoxil. The objective of the trial is to
investigate both efficacy and safety of Fosfluridine in this
indication.
In the first part of the study 47 patients were treated with either
placebo, 50 mg or 100 mg of Fosfluridine. The doses were given in 3
cycles, each consisting of one week treatment followed by a
treatment-free week. Post-study analysis was carried out up to 4
months after end of study. The results demonstrated that patients
treated with Fosfluridine showed dose-related response rates up to
75% in terms of clearance or almost complete clearance of skin
lesions. There were no responders in the placebo group. No
significant side effects were seen at either treatment dose,
confirming the safety profile of oral Fosfluridine.
Based on this initial data the protocol was modified: in the second
part of the study a total of 41 patients are treated with either
placebo or 150 mg of Fosfluridine and the post-treatment observation
period is extended from 1 to 4 months. The recruitment of patients
for this part of the study has now been completed. Final results are
expected by May 2007.
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Please contact:
Heidelberg Pharma AG MC Services
Dr. Marcel Linsse Raimund Gabriel
Senior VP Corporate Development &
Marketing Certified Investor Relations
Officer
Tel. +49 6203 1009 40 Tel. +49 89 210 2280
m.linssen@heidelberg-pharma.com raimund.gabriel@mc-services.eu
Heidelberg Pharma
Heidelberg Pharma is a pure-play drug-development company committed
to the development of new drugs for cancer or HIV. The company's
infrastructure includes clinical development, regulatory affairs,
chemistry, cell biology and biochemistry, in vivo pharmacology and
bioanalytics. As a business model Heidelberg Pharma intends to
develop its drug candidates through phase II before seeking a
development partner. As a mid-term perspective, Heidelberg Pharma
aims at performing phase IIb / III investigations in selected cancer
indications at its own responsibility.
Actinic keratosis
Actinic keratoses (AK) are an early stage of squamous cell carcinoma
of the skin. Current treatment of actinic keratosis involves a
variety of mechanical methods including cryotherapy, surgical
excision, curettage and laser, or treatments such as photodynamic
therapy and various topical drug applications (e.g., 5-fluorouracil,
imiquimod, diclofenac). These treatments are not suitable for
treating larger areas and mechanical removal can often leave
unsightly scars. Up to 50 % of patients do not respond
satisfactorily to existing topical treatments.
Fosfluridine
Fosfluridine is the Enhanced Pro-Drug of the 5-flurouracil metabolite
5-Fluorouridine. In clinical phase I studies, once daily oral
administration of Fosfluridine showed an excellent safety profile and
adequate pharmacokinetics. Following oral administration,
Fosfluridine is distributed to the skin, potentially allowing
treatment of actinic keratoses in deeper skin layers where topical
treatment may not penetrate. Oral Fosfluridine may also be
beneficial for the treatment of actinic keratoses which cover large
skin areas.
The press release can be downloaded from the following link:
