Shares in Avita Medical were unchanged today despite receiving approval from the US Food and Drug Administration (FDA) to begin clinical trials of its ReCell Spray-On Skin device early next year, after the company suspended initial trials in 2008.
Shares in Avita Medical were unchanged today despite receiving approval from the US Food and Drug Administration (FDA) to begin clinical trials of its ReCell Spray-On Skin device early next year, after the company suspended initial trials in 2008.
While trading as Clinical Cell Culture in 2006, Avita commenced trials of ReCell, developed by Australian of the Year, Dr Fiona Wood, under a conditional approval but challenging criteria stifled patient recruitment and FDA concerns over study endpoints, patient follow-up and data analysis led to the initial trial suspension.
Decreasing patient sample size, reducing patient follow-up periods from a year to 16 weeks and amending study endpoints, as well as specifics relating to wound sizes and where they are located on the body, led to the FDA (working closely with Avita) approving the trials.
Avita appointed 10 clinical sites to participate in the trials and the company is confident of being on track to receive its US regulatory approval process for ReCell.
Avita Medical chief executive, Dr William Dolphin said with the FDA protocol approval in place, the next steps are to obtain IRB approval at each site and train investigators in the use of ReCell prior to enrolment of initial subjects.
"We now have a pragmatic and clinically feasible trial protocol in place and we are confident of successfully achieving the trial endpoints," he said.
ReCell is currently cleared for sale in Australia, Europe, Canada and China.
Shares in the local bio-tech firm remained unchanged in trading today, closing at 16 cents per share.
Full announcement below:
FDA APPROVES RECELL US CLINICAL TRIAL
- FDA approves streamlined ReCell clinical trial protocol
- Addresses shortcomings of previous study
- Significant reduction in required number of subjects, study duration
- Anticipates enrolment to commence Q1 2010
8 December 2009: Avita Medical Ltd (ASX: AVH) has received approval from the United States Food and Drug Administration (FDA) to begin its US clinical trial for ReCell® Spray-On Skin, the first stand-alone regenerative point-of-care device enabling surgeons to treat burns, wounds and chronic skin defects using the patient's own cells.
The Company (as Clinical Cell Culture) had previously commenced US trials in 2006 under a conditional approval; due to excessively restrictive inclusion criteria patient recruitment was very low. Additionally, the company had failed to adequately address concerns of the FDA regarding study endpoints, patient follow-up and statistical analysis of collected data. The trial was suspended by Avita in July 2008. Working closely with the FDA, the company's regulatory advisory group and key clinicians, the company recently submitted a modified study protocol.
The changes to the newly approved protocol are substantial and include:
- Inclusion criteria allowing for an expanded wound size and body region;
- Decrease in number of patients required to 106;
- Decrease in patient follow-up period from 52 to 16 weeks;
- Change in study endpoint from 'time to 100% epithelialization' to a binomial
- assessment of 'healed vs non-healed' at 4 week follow-up;
- Inclusion of superiority as well as non-inferiority outcomes, significantly expanding post-study marketing claims.
The study will yield a randomised, controlled, clinical comparison with the current standard of care in treating burn wounds.
The Company has appointed 10 clinical sites to participate in the trials; patient enrolment is anticipated to commence in early 2010.
"Avita is now on track for its US regulatory approval process for ReCell," said Dr William Dolphin, Chief Executive Officer of Avita Medical. "Our regulatory advisors, MedDRA, based in the US, have done an exceptional job interfacing with the FDA review team.
"With the FDA protocol approval in place, our next steps are to obtain IRB approval at each site and train investigators in the use of ReCell prior to enrolment of initial subjects.
"We now have a pragmatic and clinically feasible trial protocol in place and we are confident of successfully achieving the trial endpoints."
Part of the funding for the clinical trial comes from a US$1.45 million grant from the US Army to help develop regenerative medicine through the recently initiated Armed Forces Institute for Regenerative Medicine (AFIRM).
"ReCell is a transformational technology that will fundamentally change the way we treat burns and other wounds" said Dr James Holmes of the Wake Forest Institute for Regenerative Medicine, Principle Investigator for the trial. "When ReCell is approved for use in the United States there is no doubt that it will save the lives of burn victims."
"What's available today is the same technology that was available 30 years ago," said Dr Holmes. "In a burn one is always working against time. ReCell will allow us to turn back the clock on all kinds of burns. We are very anxious to complete administrative details and commence enrolment for this important study."
ReCell is currently cleared for sale in Australia, Europe, Canada and China.
