BioWorld International Correspondent
LONDON - Ardana plc announced positive results in a Phase IIa study of its gonadatrophin-releasing hormone antagonist, Teverelix LA, in treating enlargement of the prostate gland, two weeks after reporting positive results in a Phase II trial in prostate cancer.
The combined results show that Teverelix can work both as an on-off mechanism, suppressing testosterone to castration levels in patients with advanced prostate cancer, or as a "dimmer switch," reducing testosterone levels to the low end of the normal range in treating benign prostatic hyperplasia (BPH).
The randomized, double-blind, placebo-controlled study treated 81 patients with BPH. As early as two weeks after dosing there was a statistically significant decrease in symptoms in the treated group. That increased over time and was most pronounced at the end of the study's 16 weeks.
Of the patients receiving Teverelix, 76 percent were classed as responders (defined as a 25 percent reduction in symptom score from baseline). There were no allergic reactions to the drug, a side effect that occurs with similar products.
Maureen Lindsay, CEO said, "These findings suggest that Teverelix LA, administered by subcutaneous injection two to three times per year, could be used not only for the improvement of BPH symptoms, but also to delay progression of BPH."
In the prostate cancer trial, Teverelix reduced testosterone to castration levels in all 14 patients, and in all but one it was maintained for between four and eight weeks. There was an associated fall in prostate-specific antigen levels.
Teverelix binds to a receptor in the pituitary gland, controlling the release of sex hormones. It is in a Phase I trial assessing dose-dependent reductions in the production of oestradiol, and Edinburgh, UK-based Ardana intends to develop the product for treating fibroids and endometriosis, also.
Sam Fazeli, biotechnology analyst at the investment bank Nomura International plc in London, said that, based on the data, it "is now more likely" that Ardana will see positive effects in endometriosis.
The company intends to market Teverelix itself in Europe and is building a specialist sales force in the five biggest markets. Ardana raised £21 million (US$38.3 million) in an initial public offering in March. The shares rose 7 pence to £1.21 when the BPH data were announced, still lagging behind the £1.28 pence flotation price.