From Biotech Daily in 2013.
'Tissue Therapies says that the US Food and Drug Administration has approved a 250
patient clinical trial of Vitrogro extra-cellular matrix (ECM) for venous ulcers.
Tissue Therapies chief executive officer Dr Steven Mercer told Biotech Daily that the trial
would be a prospective, randomized, double-blinded, controlled study and Vitrogro ECM
had been classified by the FDA as a combination product of a biologics and a medical
device.
Dr Mercer said that the primary endpoint was time to wound closure.
Dr Mercer said the company would need to raise funds for the trial.
Tissue Therapies has had its European marketing application delayed with regulatory
bodies changing Vitrogro ECM’s classification (BD: Oct 30, 2012; Jul 29, 2013).
Today, Tissue Therapies said that the only request from the FDA for final approval to be
granted was a plan acceptable to the FDA for an additional quality control test for
manufacturing and stability test of Vitrogro ECM.
The company said that the scientific and clinical results demonstrated that Vitrogro ECM
was stable and effective.
Tissue Therapies said that the additional test requested by the FDA was to detect a
theoretically possible change in stability that the company has not observed with extensive
testing to date.
The company said that it was not a requirement for this new testing to be complete to
obtain approval for the venous ulcer clinical trial to proceed.
Tissue Therapies said that a contractor was actioning the plan for submission to the FDA.
The company said that the FDA had no other issues for approval of the Vitrogro ECM trial.
Tissue Therapies said that its immediate focus was the start of sales in the UK and
Europe but it was “valuable to know that the US venous ulcer clinical trial will be able to
proceed as soon as funding is available”.
The company said that the final Conformité Européenne (CE) mark review required by the
European Medicines Authority was progressing as expected and should allow the start of
sales of Vitrogro ECM in the UK and Europe by July 2014.
Tissue Therapies was up one cent or 4.55 percent to 23 cents.'
Why not go for the FDA trial?
TIS Price at posting:
5.0¢ Sentiment: Hold Disclosure: Held
