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Cenes Pharmaceuticals - exciting stock for Christmas?????? (CEN)     

rkausar - 12 Aug 2004 10:43

Shares mag. recommending this stock this week. Is this going to be our killer this christmas!!!! any comments anyone?????

queen1 - 24 Jan 2007 12:15 - 193 of 297

Bless them!

queen1 - 26 Jan 2007 08:38 - 194 of 297

CEN said it could receive up to 5 mln usd in milestone payments over the next few years if trials of its experimental smoking cessation drug, being carried out by a licensee, prove successful.

The group out licensed the selective dopamine D1 receptor antagonist, called ADX10061, to Addex Pharmaceuticals in 2002. The group has now started a phase IIa study in the US, and positive results will trigger the payments to CEN.

The company would also receive annual royalties on sales, should ADX10061 reach the market.

'Whilst we are not guaranteed success from any of our carried interests the chance of realising a financial return from Addex is much increased as a result of them commencing this phase II trial,' CEN chief executive Neil Clark said in a statement.

myway - 05 Feb 2007 12:00 - 195 of 297

Hi queen1 Your post is indeed good news for the company and the investors

The big news should be out soon.. CeNeS M6G022 Phase III study on treatment with either M6G or Morphine. Effective analgesic could result in lower levels of nausea in patients receiving M6G compared to those receiving morphine. Keep your eyes on this company.

queen1 - 05 Feb 2007 19:16 - 196 of 297

Indeed myway - They've steadied over 8p which they haven't done for a couple of years now so my eyes are firmly fixed on next moves!

johnny the fox - 06 Feb 2007 12:30 - 197 of 297

This is from the CeNeS site. The results could be announced anytime

Phase III trials of M6G

CeNeS is also pleased to announce that it has successfully completed patient recruitment in its pivotal Phase III trial with M6G in Europe (Study M6G022) for the treatment of post operative pain. The study enrolled over 500 patients at 24 centres in six countries. Results from the study are expected in early 2007.

J

myway - 12 Feb 2007 11:16 - 198 of 297

CeNeS 5 February 2007 The Goldman Sachs Group, Inc. ("GS Inc."), had an interest in 38,960,863 ordinary shares of 1p each in the capital of the Company. This interest arose from a beneficial interest held by Goldman Sachs International Limited, a wholly-owned indirect subsidiary of GS Inc. This shareholding represents 8.1 per cent. of the issued share capital of the Company.

They only buy for profit..

Ludlow Castle - 14 Feb 2007 14:16 - 199 of 297

If on 4/12/2007 CEN reported the PIII M6G EU trial complete, they should have received the results by now and be on the verge of publicising.

If the results are good, these could be worth more than 40p.

Ludlow Castle - 14 Feb 2007 22:33 - 200 of 297

I telephoned CEN today and was told Neil Clark is on holiday until Friday (this is currently school half-term) so I do not expect any news regarding the Phase 3 M6G results this week.

Maybe next week ?

andysmith - 20 Feb 2007 07:55 - 201 of 297

The good news is out today. M6G successful in phase III European trials.

Confidant - 20 Feb 2007 07:55 - 202 of 297

:-)

Confidant - 20 Feb 2007 08:06 - 203 of 297

12p today maybe. I think end results hit all targets --- 25% improvement over morphine was needed --- got 28% ---- phew! Close but enough for c150m-200m sales -- my guess. That's enough for c12p alone for CEn let alone other pipeline which looks nice too

Jobibear - 20 Feb 2007 08:19 - 204 of 297

Get in - come on baby!

johnny the fox - 20 Feb 2007 09:35 - 205 of 297

Chart.aspx?Provider=EODIntra&Code=CEN&Si

Looking very good.

johnny the fox - 20 Feb 2007 09:38 - 206 of 297

It feels good when the patience starts to pay off. Good luck too all.

J

Ludlow Castle - 20 Feb 2007 10:15 - 207 of 297

Superb results today for CEN's M6G in the pivotal European Phase 3 trial, meeting all endpoints.

This almost guarantees the financial security of the Company imo.

The share price is obviously undervalued and should now be quickly rerated as the good news becomes more widely known.

I am holding for a massive upturn during 2007.

Well done CEN, you have actually done it!

Also a massive boost for the credibility of the management and the rest of the pipeline.

Excellent.

capetown - 20 Feb 2007 11:21 - 208 of 297

Have to say after holding for so long i am shocked at the SP after such stunning news,the saying buy on rumour and sell on news comes to mind,but i missed the boat thinking it would go to at leat 12p,guess i will have to hold for the long term and hope the market wakes up to the MASSIVE potential of CEN.
Good luck to all.

Confidant - 20 Feb 2007 12:11 - 209 of 297

A little surprised too Capetown but let's wait for the shares mags next week

I have no knowledge whether the endpoints were strong enough to ensure that a major player will be interested but seems that the co thinks so.

But likely institutional holder will be using volumes to sell down stake. Goldmans have been selling according to recent news and they still had over 37m shares at last count

Their continued selling would only be good news IMHO

queen1 - 20 Feb 2007 12:12 - 210 of 297

Yes, it's a strange feeling - such fantastic news and yet so little sp activity. They say the market's never wrong but surely in this case.....?!

capetown - 20 Feb 2007 12:30 - 211 of 297

Lets hope so Queen,if this is anything to go by i am tempted to sell my small stake in IQE,should that sp fall on expected good news.

johnny the fox - 20 Feb 2007 12:31 - 212 of 297

Here is this mornings email from cenes in full-


CeNeS Pharmaceuticals plc

Successful Phase III results announced on Lead Product M6G
Phase III trial in Europe demonstrates M6Gs benefit compared to morphine in the treatment of post-operative pain


Cambridge, UK, 20th February 2007 - CeNeS Pharmaceuticals plc (AIM: CEN), the Cambridge based biopharmaceutical company, today announces preliminary results of the pivotal Phase III trial (M6G022) of M6G (morphine-6-glucuronide) in over 500 patients with post-operative pain. This study is the largest carried out to date with M6G and has delivered very strong results with M6G showing benefits over morphine in the management of post operative patients. M6G022 demonstrates the unique product profile of M6G with equal analgesia to morphine but with reduced nausea and vomiting.

Phase III trial results

1. M6G matches morphine for analgesic effect

Importantly for a novel pain product, the trial results unequivocally show that M6G is as good as morphine in terms of analgesia achieved in patients up to 48 hours post-operatively. Successful achievement of this first primary endpoint supports data from previous clinical trials of M6G and is an essential component in the product profile of M6G.

2. M6G shows significant reduction in post-operative nausea and vomiting compared to morphine

The trial results confirm the excellent potential of M6G as an analgesic with a clinically significant improved side effect profile compared to morphine. The study results show that patients receiving M6G experienced a 28% reduction in the severity of post-operative nausea and vomiting (PONV) in the key 6 24 hours after treatment (statistically significant, p=0.018).

In addition, the incidence of dry retching/vomiting in the M6G arm compared to the morphine arm in the 24 hour period after treatment was reduced by 32% (statistically significant, p= 0.044). The incidence and severity of post-operative nausea in the M6G arm was 27% less than that observed in the morphine arm in the period 6 24 hours after treatment. This was the second primary endpoint and approached statistical significance (p=0.052).

Morphine formulations are the gold standard treatment for the relief of moderate to severe post-operative pain. A limitation of morphine treatment is often the unpleasant side effects experienced, of which nausea and vomiting are the most common. PONV is rated among patients as one of the most distressing after-effects of surgery and reduces their quality of life.

M6Gs lower propensity to cause nausea and vomiting in the post-operative period strongly supports CeNeS belief in the potential of M6G as a novel product for the treatment of post-operative pain with clear advantages over morphine.


The global market was valued at $1 billion in 2000 and growing at a rate of 6-7%.

3. Safety profile/adverse events

The trial confirmed that M6Gs safety profile is similar to morphine. Aside from nausea and vomiting, the adverse events reported were at levels similar to those experienced by patients receiving morphine in a post-operative setting.

Dr Alexander Binning M.B. Ch.B. FRCA, Consultant Anaesthetist at Western Infirmary, Glasgow and Principal Investigator on M6G022, commented: These data demonstrate that M6G is equivalent to morphine in its analgesic properties. It also shows a clear improvement in managing post-operative nausea and vomiting and has significantly advanced the development of M6G as a potential new drug.

Neil Clark, Chief Executive of CeNeS, commented: These results strongly confirm our belief in the excellent potential of M6G as a novel product for post operative pain. The quality and breadth of the data contained in this large study support M6Gs anticipated product profile. With the completion of this large European study CeNeS is confident that it has a substantial data package that differentiates M6G from morphine which will be attractive to a larger pharma partner to licence. CeNeS intends to file an IND (Investigational New Drug application) for M6G with the FDA in the next few weeks. The data from this trial will also be submitted for publication in a scientific journal in due course.


The successful completion of this large, pan-European study demonstrates the excellence of our clinical development team and the quality of the clinical trial protocol. Following this success we now look forward to working with partners to register M6G as a product in major markets.


M6G022 Study Design
The study involved 24 centres in six European countries and recruited 517 patients. The study was designed primarily to provide key information on a comparison of effective intravenous pain management regimens of M6G or morphine treatment for a minimum of 24 hours (and up to 48 hours) following major abdominal surgery. Morphine is generally accepted as the gold standard drug for use in these circumstances. Initial pain management was achieved by administration of a loading dose and titration of either M6G or morphine to achieve acceptably low levels of pain for the patient to go onto the ward. In the ward, pain management treatment was achieved by patient controlled analgesia (PCA), whereby the patient was allowed to self administer a dose of M6G or morphine as required to control their pain. The study was randomised and double blind so that neither patient nor carer was aware of which treatment was being administered. The main purpose of the study was to demonstrate statistically that:

- treatment with either M6G or morphine, particularly during PCA, results in similar levels of pain management; and

- effective analgesic treatment during PCA results in lower levels of nausea and vomiting in patients receiving M6G compared to those receiving morphine.

In addition, other important side effect, efficacy and safety features were determined throughout the study.


M6G Commercial Strategy
CeNeS has commissioned a number of qualitative market research studies on M6G, which have been carried out by independent market research agencies with extensive experience of the pain market. The outcomes of these studies, involving interviews with clinicians and payers in major markets, support CeNeS view that potential global peak sales of M6G in post-operative pain could reach $400 million. This is underpinned by a clear need for an improvement on existing drugs for moderate to severe pain which do not offer the attractive M6G profile of morphine-like pain relief with reduced side effects.

CeNeS believes that the positive results announced today from M6G022 will enable the Company to secure valuable licensing agreements for Europe and North America with partners able to offer strong specialist marketing, sales and distribution capabilities within the hospital sector. CeNeS intends to explore all opportunities to capture value from any such licensing agreement including the possibility of retaining promotion or co-promotion rights within certain territories.

CeNeS is in discussion with a number of potential partners and is confident that the positive results from M6G022, together with the extensive package of clinical, non-clinical and manufacturing data provides an attractive package for out-licensing.

--ENDS--


There will be a teleconference briefing for analysts and investors today at 9.00am. For details please contact Mo Noonan on +44 (0) 207 831 3113 or mo.noonan@fd.
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