HEIDELBERG PHARMA AG starts second clinical phase II study with
FOSALVUDINE
Ladenburg - Heidelberg Pharma AG, a company specialized on the
development of state-of-the-art treatment of cancer and AIDS, has
recently started a second clinical phase II study with its HIV
therapy drug Fosalvudine. On November 6th the first patient was
accepted in the study.
Thirty-six patients in six test centres in Russia and Argentina will
participate. It is a randomised, double-blind phase ll study on HIV-1
infected patients who, during a previous antiviral therapy, developed
resistance against multiple NRTI (Nucleoside Reverse Transcriptase
Inhibitors). Patients will either receive 10, 20, 40 mg oral daily
doses of Fosalvudine in combination with at least two additional
antiretroviral compounds, or their previous medication over a period
of 14 days. Reduction of viral load, tolerability and pharmacokinetic
properties of Fosalvudine are to be evaluated. Patient recruitment
should be completed still in 2007 so that results can be expected in
the first quarter of 2008.
Dr. Erwin Boehm, responsible for Heidelberg Pharma AG's medical
progress commented, "In the initial phase ll study, completed in the
first half of 2007, Fosalvudine proved its effectiveness against
HIV-1 and good tolerability in HIV-1 treatment-naive patients. The
present study aims at efficacy and tolerability in patients who have
received antiviral treatment over a long period and now, due to
resistance reaction, no longer sufficiently respond to conventional
therapies. This study presents an important milestone in
Fosalvudine's development. "
Fosalvudine
Fosalvudine is a nucleotide reverse transcriptase inhibitor (NRTI)
for the treatment of HIV-1 infections. In focus of Fosalvudine's
development, are HIV-1 strains, which have developed resistance
against therapies with conventional NRTI and therefore are difficult
to treat. Fosalvudine is an "Enhanced Pro-Drug" derived from
Alovudine. Although the basic property Alovudine is effective against
NRTI resistant HIV-1 strains, it cannot be clinically developed due
to its side effects. Fosalvudine has the potential of offering
considerably better tolerability with simultaneous comparable
effectiveness in therapy-resistant HIV patients.
Heidelberg Pharma AG
Heidelberg Pharma, located in Heidelberg, is an enterprise
specializing in the development of state-of-the-art medication in the
fight against cancer and AIDS. Heidelberg Pharma has a valuable
product portfolio, rich in prospects. At present, the active agents
Fosfluridine and Fosalvudine are being tested in advanced clinical
development programmes.
Contact Public and Investor Relations:
Heidelberg Pharma AG
Dr. Marcel Linssen
Senior VP Corporate Development & Marketing
Certified Investor Relations Officer
Phone: +49 6203 1009 40
m.linssen@heidelberg-pharma.com
MC Services AG
Raimund Gabriel
Phone: +49 89 210 2280
raimund.gabriel@mc-services.eu
The press release can be downloaded from the following link:
