Prevascar Phase II Results

Renovo announces positive phase II efficacy trial results for PREVASCAR.

MANCHESTER, UK | Apr 17, 2007 |
Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing drugs for the prevention and reduction of scarring at multiple body sites, today announces positive Phase II safety and efficacy clinical trial results for Prevascar(TM). This was the first study in man to investigate Prevascar’s efficacy in the prevention and reduction of scarring in the skin.

Prevascar is a therapeutic drug formulation of human recombinant Interleukin 10 (IL-10) and is an important modulator of the inflammatory response resulting in an improvement in the subsequent scar appearance after wounding and surgery.

Phase II Clinical Trial Highlights

First in man dose ranging efficacy trial in 175 subjects met its primary endpoint with statistical significance (p=0.04)
Statistical significance also reported in multiple secondary endpoints illustrating that Prevascar-treated wounds resulted in scars that were scored improved by subjects and clinicians
Safe and well tolerated
Mechanism of action scientifically distinct compared to Renovo’s lead anti-scarring drug, Juvista(TM)
Further evidence of the strength and depth of Renovo’s drug pipeline

Trial Design and Results

This trial was a fully randomised, double-blind, placebo and standard care controlled dose ranging Phase II study to investigate the impact of eight varying doses of Prevascar administered by injection to subjects twice, at the time of surgery and the next day.

The primary endpoint of the study was the assessment of scars by an exernal lay panel using Visual Analogue Scale (VAS) scores. This demonstrated that two doses of Prevascar given twice (5ng/100uL/linear cm and 25ng/100uL/linear cm) showed an improved scar appearance compared to placebo and standard care at month twelve. Both doses reported the same statistically significant p-values (p=0.04).

In addition to meeting the primary endpoint, statistical significance was reported in multiple secondary endpoints including the assessment of scars by the subject. The findings of this study demonstrate, for the first time, the efficacy of Prevascar in the skin.

Potential Application to the Nerve Repair Market

Renovo’s product pipeline is founded on a substantial body of scientific research, which to date has been highly predictive of clinical efficacy. Based on such data, Renovo believes that Prevascar may be well suited to the nerve repair market. Severing of peripheral nerves usually leads to scar tissue formation, which presents a physical barrier to neuronal reconnection which in turn results in a loss of sensory or motor function. Though relatively small in patient volume the peripheral nerve repair market is high in terms of medical need and is likely to support a premium priced product for the prevention and reduction of scarring.

In addition to refining further Prevascar’s optimal dose in the skin, the Company plans to initiate a clinical trial to investigate Prevascar’s efficacy in the reduction of scarring following the severing of peripheral nerves. With excellent clinical data already reported for Juvista in the skin, developing Prevascar for the severed nerve indication provides the potential for the Company to broaden the indications of its scar prevention and reduction product portfolio.

Professor Mark Ferguson, Chief Executive Officer of Renovo, commented:

“The success of Prevascar in this first in man Phase II efficacy study demonstrates further the strength of Renovo’s scientific base and its unique pipeline of first-in-class drug candidates.

“As well as refining Prevascar’s optimal dose in the skin, we intend to diversify our scar prevention product portfolio further by investigating the efficacy of Prevascar in the prevention of scarring following peripheral nerve injury. Importantly, this market represents a high unmet medical need and we believe is likely to support a premium priced product.”

“With regard to partnering our lead drug, Juvista, discussions continue to progress and we will update the markets in due course.”


Further Information on the Trial

This trial (Study RN1003-0027) was a fully randomised, double-blind, placebo and standard care controlled Phase II dose ranging study designed to investigate the impact of varying doses of Prevascar in 175 subjects aged 18-85 in the reduction of scarring due to incisional wounds.

Four 1 cm cuts all the way through the skin were made by a plastic surgeon at the same time in similar anatomical locations on the right and left arms of each subject. Incisions were treated with Prevascar, placebo or standard care so that each subject acted as his/her own control.

Prevascar was administered by intradermal injection of 100uL/linear cm of wound margin twice, immediately prior to incision and 24 hours later, and at doses between 5ng/100uL/linear cm wound margin and 2000ng/100uL/linear cm wound margin.

The primary endpoint was a blinded assessment of the standardised scar photographs at month twelve by a panel of independent lay people (to simulate customers) using a Visual Analogue Scale. The secondary trial endpoints included assessment of the scars by plastic surgeons and subjects and objective measures of scar colour. In addition to meeting the primary endpoint statistical significance was reported in multiple secondary endpoints for the 5ng/100uL/linear cm and 25ng/100uL/linear cm doses.

About Renovo

Renovo is a biopharmaceutical product company and is the world leader in scar prevention and reduction research and the development of drugs to prevent and reduce scarring. The Company has a highly skilled management team with over 30 years of research experience in the field of scarring and significant pharmaceutical industry expertise.

Scarring can result from acute injury in, or surgery to, the skin, blood vessels, eyes, nerves, internal organs, tendons and ligaments. These are high value markets of significant unmet medical need.

Renovo has a portfolio of drugs which exploit different novel mechanisms of action to prevent and reduce scarring at multiple body sites and to accelerate healing. Juvista, Renovo’s lead drug for the prevention and reduction of scarring in the skin has been safely administered to over 1,500 human subjects and has reported statistical and clinical significance in four Phase 2 efficacy trials. Zesteem(TM), Renovo’s lead drug for the acceleration of wound healing in the skin, commenced Phase 3 clinical trials in December 2006. Juvidex(TM) and Prevascar, Renovo’s other two drugs in Phase 2 clinical development for the prevention and reduction of scarring, are also planned for additional indications in the prevention and reduction of scarring following injury or surgery to the cornea and nerves, respectively.

Renovo aims to be first to the market with a pharmaceutical drug in the US and Europe to prevent and reduce scarring and current demand is inadequately met.

According to external research, the potential commercial market for prevention and reduction of scarring in the skin is worth, in the order of, $4 billion per annum in the US alone.


SOURCE:  Renovo Group

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