Perth-based burns treatment developer Clinical Cell Culture Ltd, or C3, has deferred the date it expects to win approval from the US Food and Drug Administration to the fourth calendar quarter of 2007, or even to early next year.
Perth-based burns treatment developer Clinical Cell Culture Ltd, or C3, has deferred the date it expects to win approval from the US Food and Drug Administration to the fourth calendar quarter of 2007, or even to early next year.
An announcement from the company said the delay had been caused by a slower than expected rate of patient recruitment for trials of its ReCell cell harvesting device.
The FDA had requested additional clinical data for the product to show that it had a similar use and characteristics to an already legally marketed product without the introduction of new safety or efficacy concerns.
C3 chief executive Bob Atwill said in an announcement the rate of patient recruitment was beyond the company's control, despite it working closely with the trial centres.
"To date, five sites are fully trained with eight patients being screened. Due to the variable rates of burn wound healing these patients did not meet the criteria for inclusion in the clinical trial process. We are therefore actively recruiting a further site to increase the rate of patient recruitment," he said.
A company announcement in November indicated a total of 71 patients were required to be treated under the trial design.
Shares in the company closed down 10.7 per cent at 12.5c.
The full text of a company announcement is pasted below
Clinical Cell Culture Ltd (C3, ASX: CCE) today released its quarterly report, Appendix 4C, for the quarter ending 31 December 2006.
The key activities for the period included:
- Successful completion of the Share Purchase Plan (SPP) and placement raising$13.7m in new capital
- Regulatory approval for sale of ReCell® in Brazil and Turkey
- Regulatory approval for sale of CellSpray® in Greece
- Selection of US FDA trial centres, initial site visits and training concluded .
C3 Chief Executive Officer Bob Atwill said a number of important milestones had been achieved during the quarter including the successful capital raising, product approvals in key target markets and increased sales penetration in existing markets.
"Following our review last year, considerable progress has been made in key areas," he said.
"Sales traction of ReCell® is improving and sales for the half year to December for all three of our products are ahead of last year. While this is encouraging there is still a lot to do and our focus is on achieving our set of identified milestones."
"The successful capital raising, completed in December, was a particularly important achievement and will ensure C3 has sufficient funding to implement our commercial strategy.
Mr Atwill said sales of CellSpray® and CellSpray® XP in Europe during the period had been lower than expected and these markets would need to be reinvigorated.
"We will be working closely with our European sales and marketing team to ensure sales of CellSpray® and CellSpray® XP improve," he said.
"Sales traction in the current quarter will be key to achieving the current year sales targets.
"We have also experienced delays in regulatory approvals in Russia, Mexico and China and this may impact on the timing of reorders in these key markets."
The key milestones to be achieved in the remainder of the 2007 financial year include:
- Reorders in key approved markets such as Australia, Brazil, Canada, Italy, UK, Germany, France and Saudi Arabia
- Increased usage of CellSpray® in key European markets
- Regulatory approval and orders for ReCell® in China, Mexico and Russia
- Recruitment of patients at the US FDA trial centres
Mr Atwill said the FDA trial was progressing with most centres ready for patient recruitment .
"While the speed of patient recruitment is a key variable beyond the Company's control, C3 is working closely with the trial centres to maximise the recruitment process," he said.
"To date, 5 sites are fully trained with 8 patients being screened. Due to the variable rates of burn wound healing these patients did not meet the criteria for inclusion in the clinical trial process. We are therefore actively recruiting a further site to increase the rate ofpatient recruitment."
"Following the slower than expected initial patient recruitment there is a risk, as previously identified, that the speed of patient recruitment will impact on approval timelines. As a result the completed trial documentation is expected to be submitted during Q3 2007 and, subject to the final FDA review period, we anticipate approval to be achieved by Q4 CY2007 or Q1 CY2008."
Net cash inflows for the quarter amounted to $10.1 million following the SPP and placement which was completed in December. The cash balance at 31 December 2006 is $16.1 million.
