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Summit Corporation Announces First Patient Dosed In A Phase 1b Clinical Trial Of Smt C1100 For Treatment Of Duchenne Muscular Dystrophy


12/9/2013 11:07:48 AM

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Oxford, UK, 9 December 2013 – Summit (AIM: SUMM), a drug discovery and development company advancing therapies for Duchenne Muscular Dystrophy (‘DMD’) and C. difficile infection, announces that the first DMD patient has been enrolled and dosed in a Phase 1b clinical trial of the oral, small molecule utrophin modulator SMT C1100.

“SMT C1100 is a promising treatment that has the potential to improve the life of all patients with DMD, irrespective of the underlying dystrophin fault,” commented Dr David Roblin, Summit’s Chief Medical Officer. “There is an urgent need to develop effective medicines for DMD patients and this study forms an important step in our clinical plans towards establishing SMT C1100 and utrophin modulation as a viable treatment that could slow or even stop the progression of this devastating condition.”

About the Phase 1b Clinical Trial

The Phase 1b trial is a dose-escalating, open-label study that is being conducted in paediatric patients with DMD. The primary endpoint of the trial is the evaluation of the safety and tolerability of SMT C1100. The study will also measure blood plasma concentration levels of SMT C1100 to determine the dose to be used in a subsequent Phase 2 proof of concept efficacy trial.

The trial is enrolling 12 patients aged between 5 and 11 years, divided equally into three dose cohorts. Each cohort will receive daily oral doses of SMT C1100 for a total of ten days with a review taking place after each cohort has completed dosing. The trial is being conducted at up to four NHS hospitals in the UK with the Chief Investigator being Professor Francesco Muntoni at Great Ormond Street Hospital, London.

About DMD, Utrophin Modulation and SMT C1100

DMD is a progressive muscle wasting disease that affects around 50,000 boys in the developed world. It is caused by different faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscle. There is currently no cure for DMD and life expectancy is around mid-twenties. Utrophin protein performs essentially the same functional role as dystrophin in developing muscle fibres and studies have shown that maintaining utrophin expression has the potential to slow down or even stop the progression of DMD, regardless of the underlying dystrophin mutation. It is also expected to be complementary to other therapeutic approaches in clinical trials. SMT C1100, an orally administered small molecule, is Summit’s most advanced utrophin modulator. Non-clinical studies showed SMT C1100 increases utrophin protein levels in skeletal and cardiac muscle resulting in a significant reduction in the dystrophic muscle pathology. SMT C1100 has successfully completed a Phase 1 trial in healthy volunteers with the drug shown to be safe and achieved expected therapeutic blood levels.

About Summit

Summit is an Oxford, UK based drug discovery and development Company targeting high-value areas of unmet medical need including Duchenne Muscular Dystrophy and C. difficile infection. Summit is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol SUMM. Further information is available at www.summitplc.com and follow Summit on Twitter (@summitplc).

For more information, please contact:

Summit

Glyn Edwards / Richard Pye Tel: +44 (0)1235 443 951

+44 (0)7825 313 476

Cairn Financial Advisers

(Nominated Adviser)

Tony Rawlinson / Liam Murray

Tel: +44 (0)20 7148 7900

Hybridan LLP

(Broker)

Claire Louise Noyce / William Lynne

Tel: +44 (0)207 947 4350 / 4361

Peckwater PR

(Financial public relations, UK)

Tarquin Edwards Tel: +44 (0)7879 458 364

tarquin.edwards@peckwaterpr.co.uk

MacDougall Biomedical Communications

(US media contact)

Michelle Avery Tel: +1 781-235-3060

Forward Looking Statements

This announcement contains "forward-looking statements", including, but not limited to, statements about the discovery, development and commercialisation of programme assets. These forward-looking statements are statements based on the Company’s current intentions, beliefs and expectations, which include, among other things, the Company’s results of operations, financial condition, prospects, growth, strategies and the industry in which the Company operates. No forward-looking statement is a guarantee of future performance and actual results could differ materially from those expressed or implied in the forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements or information. Forward-looking statements and information by their nature involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements or information. These include but are not limited to: adverse results in clinical or preclinical development studies; delays in obtaining regulatory approval; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; being unable to secure partnership agreements to develop and commercialise programme assets; being unable to secure the necessary funding to conduct any proposed research and development studies; and the ability to retain and recruit key personnel. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this announcement to reflect any changes in expectations with regard thereto or any changes in events, conditions or circumstances on which any such statement is based, except as required by applicable law.

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