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[fickena] 15/2/2007 09:55

Thu 15 Feb 2007

Ardana shares surge 5% on positive results for drug trial
HAMISH RUTHERFORD ([e-mail])
ARDANA shares rose almost 5 per cent yesterday after it received favourable results from a study for its potentially lucrative drug Teverelix, which could become a major treatment of advanced prostate cancer.

The Edinburgh specialist pharmaceutical company said the eight-week trial was to determine whether Teverelix was effective suppressing testosterone levels in both normal weight and obese subjects, and showed it was effective for both.

While the treatment is unlikely to hit the market before 2009, further trials are pending, Teverelix is regarded by the City as Ardana's most promising drug, with potential sales estimated in the hundreds of millions.

Reducing levels of testosterone can help slow the growth of prostate cancer when the disease is advanced, with many patients facing castration.

Ardana said previous studies for the treatment confirmed it could suppress the male hormone at the same level as castration.

In December, Ardana said it was in advanced negotiations over a potential partnership to help pay for the remaining trials and commercialisation for Teverelix.

An additional Phase II study in patients with advanced prostate cancer is underway with results expected in the second quarter of 2007, and phase three studies could be underway this summer.

Chief executive Maureen Lindsay said the company was "very encouraged" by the progress in the development of its long-acting formulation of Teverelix.

"This programme of studies continues to support the development of Teverelix LA as a potential new treatment for prostate cancer, a disease where new therapies remain a major medical need in a multi-billion dollar market."

Shares rose 5.5p to 120.5p, yesterday, its highest close since October, valuing the company at around £78 million.

This article:

Last updated: 15-Feb-07 00:21 GMT

[gnomet2] 14/2/2007 16:37

Good to see some life in the share today. Hopefully a major uptrend underway, in anticipation of a deal or even takeover.

[vpatel25] 14/2/2007 13:36

Tipped in the Independent as a BUY today.....!!

[n_w_b] 14/2/2007 08:09

Another box ticked towards a Licesnsing deal which is already at an advanced stage.

[Abuse team] 12/2/2007 18:37

Post removed by ADVFN

[jonfa] 12/2/2007 18:27

I agree - bought in on friday. Looks to me like something is cooking!

[goodgrief] 12/2/2007 18:26

I rckon this has started to climb.

[qazwsx123] 07/2/2007 16:22

I rckon this has further to fall.

[n_w_b] 29/12/2006 09:25

The IC tip, posted last week, is in todays edition. There wasn't a printed edition last week.

[gnomet2] 24/12/2006 05:23

Thanks for your thoughts on that issue n_w_b. Have a good Xmas.

[n_w_b] 22/12/2006 21:35

Ok, I see what you mean now, no figures mentioned, but I and the press at the Analyst meeting take "The findings in this study confirm the effects of Teverelix LA on symptoms of BPH as previously reported." as what was reported before. Maybe was rushed out to statisfy investers, but they've been reported as a positive trial.

Trial ARD-0301-001 was to look at the safety and effects of two different single dosses of Teverelix in BPH patients for 3 months. There is a follow on trial ARD-0301-002, giving the patients the same dose they received in 001, after they have become non-responders.

Therefore it was a dose finding study which confirmed previous results "Teverelix LA, administered as a single subcutaneous injection, demonstrated symptomatic improvement from as early as week two and the duration of the effect appears to be in the order of 8 weeks based upon a preliminary analysis of the relevant clinical endpoint, the International Prostate Symptom Score (IPSS). "

Ok, they might not have had time to go through the data and report which dose was superior, but the effects were the same and this is what counts. Maybe once 002 is complete, they'll have a fuller picture.

Theres also another PII apoptosis study in the US in BPH patients. The aim of the study is to look at the effects of Teverelix on cell death in prostate biopsies from patients with BPH. This trial is mostly of acedemic value, however it opens the door into US clinics.

So these seperate PII trials are additional requirements the FDA requires and not "proof of concept" like the first PII trial.

[gnomet2] 22/12/2006 20:17

These the two trials for comparison btw

[gnomet2] 22/12/2006 20:10

Where did it say what? :) What I'm saying is what it didn't say, and couldn't say (at least at this point)- ie that these effects were of a degree that were statistically significant,which they were in the earlier trial.After all, that's what having placebo controls etc is all about - determining whether any positive effects could be down to chance.

This isn't a trivial issue because I think it's likely to influence the the size and cost of a phase 3 trial, the degree of effectiveness of the treatment(and hence its sales potential)and its perceived risk of failure at phase3 (very low,I think,but phase 3s typically require stats showing p = 0.01 or better, which was actually achieved in the earlier trial).

Maybe the data analysis takes a lot longer than I think, or they felt they had to rush out a preliminary statement with the results and the further analysis will be able to cite some good stats in line with those reported in the earlier trial.

[n_w_b] 22/12/2006 08:23

I'm lost, where did it say that?

This is what they said.

"The findings in this study confirm the effects of Teverelix LA on symptoms of BPH as previously reported. Further analysis of data is ongoing."

[gnomet2] 22/12/2006 07:41

No statistical significance figures cited this time - which were very strong
in the the first trial.Ok further analysis ongoing but I thought such figures very quickly established these days. I'd love to know whether this issue was queried in the analyst meeting. share price didn't fall on the day,though, so hopefully
my concerns are unjustified

[n_w_b] 21/12/2006 20:55

Why?,they were good with the same results as the previous trial.

"Teverelix LA, administered as a single subcutaneous injection, demonstrated symptomatic improvement from as early as week two and the duration of the effect appears to be in the order of 8 weeks based upon a preliminary analysis of the relevant clinical endpoint, the International Prostate Symptom Score (IPSS).

The study was a Phase II, randomised, double-blind, placebo-controlled study investigating the effects and safety of two different

[gnomet2] 21/12/2006 20:33

I'm actually a bit disappointed at the trial results- not as good as the previous ones and a fair old sample size for a phase2. Can anyone cheer me up on that front?

[n_w_b] 21/12/2006 19:23

Thanks, just us three here. :-(

[gnomet2] 21/12/2006 18:46

Thanks for that info both of you.