Trial of NovoSorb hit with delays: Calzada

Calzada (ASX:CZD) has been forced to push back the planned completion date for a planned human clinical trial of its NovoSorb BTM burns treatment product until well into 2013.

In a market update, the company revealed that recruitment to the trial had been slower than initially projected, so the initial Q4 completion target will need to be extended.

NovoSorb BTM (Biodegradable Temporising Matrix) is a polymer material being developed for use in the repair of full-thickness wounds, and particularly in burns.

It is being developed by NovoSkin, a joint venture between Calzada subsidiary PolyNovo and associate professor John Greenwood, the director of the Adult Burn Unit at the Royal Adelaide Hospital. PolyNovo was initially spun out of the CSIRO.

The trial will involve using NovoSorb BTM in free flap donor site repair surgery, as a controlled model for the treatment of serious burns and other full-thickness wounds.

But recruitment of the 10 subjects needed for the trial has been held up by an unexpected slump in the number of patients requiring free flap elective surgery.

Some potentially suitable patients have had to be excluded due to their age and poorer state of health, Calzada said, noting that due to the small sample size the trial will need to involve patients in generally good health.

On the plus side, PolyNovo has now enrolled more than half of the required 20 patients for a separate trial of NovoSorb in vacuum assisted closure (VAC) surgery.

More patients are on a waiting list for entry into this trial, and will be treated when the Royal Adelaide Hospital has beds available.

Due to the rate of enrolment, PolyNovo has maintained its target of completing this trial by the end of the calendar year.

PolyNovo is also seeking to develop a new product using BTM technology as a scaffold, a composite cultured skin (CCS). This would be a synthetic skin that incorporates a patient's own skin cells.

The company has now teased positive results from animal trials demonstrating that a viable CCS can be produced and implanted onto animals.

Successfully developing a synthetic skin would potentially eliminate the requirement for skin grafts in burn treatment.

Calzada (ASX:CZD) shares were trading 2.22% lower at $0.044 as of 4pm on Friday.