CeNeS signs two collaboration deals; starts phase II trials for pain drug
Cambridge-based biopharmaceutical CeNeS Pharmaceuticals (CEN.L) today announced the start of Phase II clinical trials and two deals to push its pain treatment drug labelled CNS 5161 further towards commercial exploitation.
Chairman Alan Goodman (pictured) told shareholders at today's Annual General Meeting that "CeNeS continues to make good progress in all of its drug development programmes".
Its lead programme M6G (morphine-6-glucuronide) is recruiting patients in six countries at 18 sites into its Phase III trial testing it against morphine as a new treatment for post-operative pain. Patient recruitment is expected to complete in the next few months and CeNeS is on track to announce results before the end of this year.
Mr Goodman said that success in M6G 's pivotal Phase III trial will mean a major breakthrough in the development of new pain drugs. M6G has the potential to be a significant new drug with a unique profile.
To make it to market, new drugs must successfully go through three main stages of clinical trials. Phase I trials test for safety in healthy people. Phase II trials establish the best dose and are an initial test of efficacy in a small patient population. Phase III trials are 'pivotal' (i.e. used to present data to a regulating authority), longer and on a patient population of at least 500. The further along the trials' path a drug is, the greater its prospects of making it to the market.
Ergomed collaboration
CeNeS said it is beginning two Phase II studies with its novel NMDA antagonist CNS 5161 in diabetic neuropathic pain and opioid refractory cancer pain respectively. The studies are planned to report results in 2007.
At the same time, CeNeS and Frankfurt-headquartered Ergomed, a specialist clinical development firm, announced they have signed a revenue sharing and co-development deal whereby they will collaborate on the development of CNS 5161. The two companies worked successfully together on the most recent Phase IIa clinical trial of the drug. Seven Phase II trials are planned, including the two announced today.
The two firms will assemble a Phase II data package with the goal of demonstrating that CNS 5161 can provide sustained pain relief in certain conditions. Both will invest their expert internal resources and contribute funding to external clinical trial costs.
Ergomed will get a share of revenues generated in a ratio of its investment compared to the total development costs.
The start of two Phase II studies under this agreement means that CeNeS now has three clinical studies underway in Europe.
Delivery by patches
It was altogether a busy day. CeNeS also announced it has acquired rights to patents and patent applications from Alza Corporation of California relating to transdermal delivery of CNS 5161. Alza will get paid on the basis of sales of future products covered by the acquired intellectual property.
CeNeS has already produced preliminary data showing the feasibility of a transdermal patch formulation of CNS 5161 for managing chronic neuropathic pain, which it now plans to complete using Alza's patch intellectual property.
Mr Goodman said the Alza deal "also demonstrates that CeNeS is well positioned to deliver the data package that will be required by larger pharmaceutical companies if a successful CNS 5161 partnering deal is to be achieved for the neuropathic pain market which is forecast to reach $5bn by 2010".
"CeNeS’ earlier pipeline continues to progress well", Mr Goodman said. Preclinical studies with the short acting sedative CNS 7056X and the lead optimisation work on its novel series of COMT inhibitors for Parkinson’s disease "confirms the firm's confidence that it has high quality programmes that are well positioned to deliver proof of concept data in the next 12 months.
"We are also encouraged by the commercial interest in both our early stage programmes from potential partners", he said.
"I am looking forward to the short term and longer term future of the company with confidence.”
Stock price becalmed
The share market remained unmoved, however, although it was on a day when there was much red ink about in tech stocks. CeNeS's share price was unchanged at 5.62p, though it has shed over a quarter of its value since the end of March in line with many small tech stocks. The company is currently valued at around £22.5m.
13th July 2006
