Ardana PLC
12 May 2005
ARDANA ANNOUNCES SUCCESSFUL RESULTS IN SECOND PHASE II STUDY OF TEVERELIX LA IN
PROSTATE CANCER
Edinburgh, UK, 12 May 2005; Ardana plc (LSE:ARA) the emerging pharmaceutical
company focused on improving human reproductive health, today announces
successful results of a second Phase II study of the Gonadotrophin Releasing
Antagonist (GnRH), Teverelix LA (Long Acting), in patients with advanced
prostate cancer.
The progression of prostate cancer is usually driven by male sex hormones
(androgens) such as testosterone. It is widely accepted that reducing levels of
these hormones in advanced disease can help slow the growth of the cancer and
prolong survival. The production of testosterone can be reduced either
surgically, with the removal of the testicles, or through drugs that affect
production of testosterone. This study confirmed that Teverelix LA can attain
and maintain suppression of testosterone to castration levels in patients with
advanced prostate cancer.
In previous clinical studies Teverelix has been shown to reduce testosterone
levels rapidly to castration levels. In this trial Teverelix LA was tested at a
lower dose and administered via a different route (intramuscularly) compared to
the first Phase II study reported on 17 February 2005.
In this second Phase II trial, 14 patients with advanced prostate cancer each
received two 90 mg doses of Teverelix LA. Each dose was administered as a
single intramuscular injection on Day 1 and Day 8 of the study. After the first
injection, suppression of testosterone to castration levels (<0.5 ng/ml) was
achieved as early as Day 3 in 11 out of the 14 patients. Two days after the
second injection, suppression of testosterone to castration levels was achieved
in all patients and this was maintained in all but one patient for between 4 and
8 weeks. In one patient, testosterone levels were only suppressed up to Day 23.
Teverelix LA was also shown to rapidly reduce and normalise PSA (Prostate
Specific Antigen) levels, a biological marker that is elevated in most patients
with prostate cancer. This clinical trial, like the previous Phase II study,
confirmed that Teverelix LA was generally well tolerated with no signs of
allergic reactions.
Dr. Maureen Lindsay, Chief Executive of Ardana, said:
'This study gives Ardana further insight into how Teverelix LA should be used to
achieve the optimal clinical effect. We believe that this compound has
considerable potential in the treatment of advanced prostate cancer and in the
management of several other diseases.'
After skin cancer, prostate cancer is the most common type of cancer diagnosed
in men in the US and is the fourth most common cause of cancer related deaths in
men in northern Europe. It is estimated that the prostate cancer market was
worth $3,716 million in 2004, and is expected to rise to $3,934 million in 2008.
In addition, Teverelix LA is currently in clinical development for other
indications such as Benign Prostatic Hyperplasia (BPH) and Endometriosis. Data
from an on-going Phase II study in patients with BPH is expected by mid 2005. .
It is one of a number of important products in the portfolio which position
Ardana to become a future leader in reproductive health.
For more information contact:
Ardana Financial Dynamics
Maureen Lindsay (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550 Julia Phillips/Davina Langdale
Tel: +44 (0)20 7831 3113
NB Public Relations
(trade/technical media relations)
Nicki Brimicombe
Tel: + 44 (0)1883 732353
About Ardana
Ardana plc is a pharmaceutical company focused on the discovery, development and
marketing of innovative products to improve human reproductive health, a $23.8
billion market.
Since its foundation, Ardana has maintained a broad and balanced portfolio to
manage risk and actively pursues product and technology in-licensing and
outlicensing to maintain a robust pipeline.
Ardana's four lead products are summarised below:
• StriantTM SR, a testosterone replacement therapy that has already been
launched by Ardana through its own sales force in the UK as a treatment for
men with hypogonadism and for which Ardana has marketing rights in Europe;
• Teverelix LA, in development for three initial indications (prostate
cancer, BPH and endometriosis);
• Testo Bi-gel, a trans dermal testosterone delivery system in development
for the treatment of male hypogonadism, shortly to enter Phase II trials;
• Invicorp, an injectable combination drug treatment for erectile
dysfunction, for which Ardana has marketing and manufacturing rights in
Europe.
In addition, Ardana has a strong portfolio of follow-on products in development.
Ardana completed its IPO on the London Stock Exchange in March 2005 raising £21
million.
For further information please see www.ardana.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange FLFFEEBZBBX
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.