Thursday 15 July 2010

Renovo well funded while drug portfolio investments continue

In a trading update for the first three quarters, Renovo Group (LON:RNVO)said it  continues to invest cash into the development of its product portfolio, and it remains appropriately funded while several key products are progressing well through the trial process.

The company is advancing five key products, of which three are currently in trails – with Juvista’s EU Phase 3 trial and Prevascar trials due to report data in H1 2011, and the Adaprev’s first clinical trial likely to be reported in H2 2011.

As at 30 June, Renovo’s cash and cash equivalents - term deposits maturing within one year - was £56.1m, compared to the £58m reported for the end of March, in May’s H1 results statement. Over the 9-month period the company has received R&D tax credits worth £3m, and once the first Juvista EU Phase 3 trial is reported, in H1 2011, the company expects to have at least £25-£30m in cash.
The first ‘pivotal’ Juvista EU Phase 3 trial, in scar revision surgery, has recruited over 350 patients from approximately 50 centres internationally - with patients in the UK, France, Hungary, Germany, Italy, Poland, Spain, Denmark, Latvia and the USA. The company said that the trial is on track to report data in H1 2011.

This trial evaluates two doses of Juvista (200ng and 500ng per 100µl per linear cm of wound margin) given twice - following wound closure and 24 hours later.

Also a pilot safety trial, not powered for efficacy, in earlobe keloid removal and a trial investigating the efficacy of a new single dose paediatric formulation are both on track to report in H2 2010.

The company is carrying out a proof-of-concept clinical trial in skin incisions and excisions for its Prevascar treatment - for improving the appearance of scars. Renovo highlighted that the trial follows ‘statistically significant’ Phase 2 efficacy data, and the trial is on track to report interim data in H1 2011.

The company’s third treatment in trials, Adaprev, is being developed for the prevention of  scar tissue (adhesions) between a tendon and tendon sheath, as well as the improvement of tendon function in patients undergoing hand surgical. 

The treatment's first clinical trial - in tendon repair - began in November 2009 in the UK, with a Class III medical device designation. The company believes it is likely that the trial data will be reported in H2 2011, once it has opened additional clinical trial sites in Germany and sought device designation with the FDA for the USA.

In reference to its other products, Renovo told investors that it intends to partner Juvidex - a topical formulation to improve skin appearance - as a cosmetic ingredient and is actively seeking a suitable partner to ensure its rapid development and commercialisation.

Whilst a previous proof-of-concept clinical trial into Juvidex failed to achieve its primary endpoint, the company highlights that there were significant improvements in pre-specified secondary endpoints - skin appearance and acceleration of healing.

Renovo also highlighted that the pre-clinical development of RN1005 was recently awarded a further grant, from the Government's Knowledge Transfer Partnership Scheme. The company describes RN1005, as a “promising new drug candidate”, discovered by Renovo, which targets a novel pathway and has demonstrated promising anti-scarring activity in pre-clinical models.

Renovo is a specialist biopharmaceutical company, focused on the discovery and development of drugs to reduce scarring, improve wound healing and enhance tissue regeneration. The company has a portfolio of products which exploit different novel mechanisms to reduce scarring at multiple body sites and improve healing.

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