piii clinical trial

Last night I sent a follow-up email to Sharoni requesting an update. Here is the reply received this am.

"Burns are not planned for and therefore one cannot recruit patients in advance for the study. The study also has very strict inclusion criteria, some of which requires that the patient have a total burn surface area (TBSA) not larger than 20% of the body, the burn injured area can be divided into two treatment areas (control and treatment), each of a particular size (100-320 cm2) and that the subject is willing to complete all follow-up evaluations as required by the protocol. In many burn patients, there seems to be a tendency to get treatment and then not return for the required follow-ups required by the study. There are many other inclusion/exclusion criteria that have made enrollment extremely challenging. This has been very frustrating to all.

We have been working closely with Dr. James Holmes, the Principal Investigator of the study, to increase the enrollment numbers and have been in contact with each of the sites to see what can be done to expedite enrollment. The Armed Forces Institute of Regenerative Medicine (AFIRM) is also working with Avita to see how enrollment can be improved. Management is actively evaluating additional burn centers to add to the study (there are currently 8 sites in the trial).

. At the same time, we are also very enthusiastic about our other clinical programs (pigmentation and chronic wounds). These are markets that are vastly larger than burns and, pending good data from the current trials (Vitiligo trial at the Netherlands Institute for Pigment Disorders (SNIP) and RESTORE trial for chronic wounds), we plan to initiate pivotal clinical programs in the US in these indications as well"