ARDANA BEGINS PHASE IIa CLINICAL TRIALS WITH
THE GnRH-ANTAGONIST TEVERELIX LA IN PATIENTS WITH PROSTATE CANCER
Ardana Bioscience, the emerging pharmaceutical company dedicated
to better reproductive health, has initiated a Phase IIa trial
with its sustained release Gonadotrophin Releasing Hormone (GnRH)-antagonist,
Teverelix LA, in patients with prostate cancer and will begin
a second Phase IIa trial in patients with benign prostate hyperplasia
(BPH) later this week.
Simon Best, Ardana Chief Executive Officer commented: Teverelix
is an important product for Ardana because it is relevant to several
sizeable markets and we believe that it offers potential, significant
advantages compared with existing therapies. In addition to prostate
cancer and BPH, Teverelix could be used to treat female indications
such as endometriosis and fibroids. A Phase I trial of the drug
in healthy female volunteers is already underway.
The prostate cancer trial will involve two sets of fourteen patients
with advanced prostate cancer with each set receiving a different
dose regimen. In the BPH trial, half of the seventy patients will
receive Teverelix and half will receive placebo.
Ardana recently acquired full global rights to Teverelix from
the biopharmaceutical company Zentaris, a wholly owned subsidiary
of Aeterna Laboratories Inc (NASDAQ:AELA;TSX:AEL).
The move to Phase IIa trials follows the successful completion
of Phase I trials in healthy male volunteers, which enabled clinicians
to establish the dosing regimes necessary to achieve different
levels of testosterone suppression.
Mr Best announced the start of the Teverelix trials in his presentation
to the Bio Equity Meeting, held in the Sheraton Hotel in Edinburgh,
UK. The news comes a matter of weeks after Ardana received UK
regulatory approval for its testosterone replacement therapy Striant™
SR, indicated for men with primary or secondary hypogonadism.
As at September 2003, the global GnRH agonist market, for use
in Prostate Cancer, was worth $2.6 billion, and grew 6% in the
previous year, while the global BPH market was worth almost $3
billion, and grew 21% in the previous year.
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