BRISBANE, Australia, May 29, 2007 /PRNewswire/ -- Phase II results exceed expectations - Alchemia prepares for FDA talks on HyCAMP(TM)
Australian drug development company Alchemia Limited will commence discussions with the US Food and Drug Administration (FDA) following the successful conclusion of the Phase II clinical trial of its metastatic colorectal cancer treatment, HyCAMP(TM).
The final data from the randomized Phase II clinical trial in 80 patients with metastatic colorectal cancer treated with HyCAMP(TM) versus Camptosar(R) shows:
- HyCAMP(TM) exerted superior anti-cancer activity with a significantly greater number of patients with observed tumour responses - A statistically significant increase in 'time to treatment failure' demonstrating that HyCAMP(TM) patients were able to stay on treatment longer due to reduced toxicity and increased efficacy - A significantly longer period (+116%) of 'progression-free survival' for patients receiving HyCAMP(TM)* - Patients on HyCAMP(TM) were able to receive therapy for a median of three times longer than those receiving Camptosar(R)* - A clinically significant trend towards longer overall survival for patients receiving HyCAMP(TM) - HyCAMP(TM) patients received less doses of anti-diarrheal medication than Camptosar(R) patients - This data was announced to the ASX on April 26 2007
Alchemia Chief Executive Officer, Dr Peter Smith said, "The fact that we are seeing statistically significant improvements in efficacy end-points from such a small study is a reflection of the substantial increase in anti-tumour activity seen with HyCAMP(TM). Generally, much larger studies would be required to show such effects. This data is an exceptional validation of our HyACT(TM) drug delivery technology platform and its application to the treatment of cancer patients.
The Company's priority is now to identify the most expeditious path to make HyCAMP(TM) available to patients and, to that end, we will be liaising closely with the FDA and the EMEA (European Medicines Agency). Improvement in progression-free survival has been an acceptable end-point for the approval of several important cancer drugs and we believe that this study will substantially reduce the time to get HyCAMP(TM) to market."
The principal investigator of the Phase II clinical trial, Associate Professor Peter Gibbs said, "The differences in both time to treatment failure and progression-free survival are clinically meaningful and are differences that would lead to a change in clinical practice if these figures can be reproduced in a further study. The improved tumour control rates (76% in the HyCAMP(TM) arm versus 46% in the Camptosar(R) arm) are very consistent with the differences in the observed survival outcomes."
Associate Professor Tracey Brown, Alchemia's Head of Preclinical Research and inventor of the technology, added "Our preclinical data showed that HyCAMP(TM) was able to deliver a higher concentration of irinotecan (Camptosar(R)) to tumours with reduced side-effects. The targeting of drug to the tumour, coupled with the ability of HyCAMP(TM) to deliver more doses due to lower toxicity, has been successfully translated into man with a greater therapeutic benefit to patients in this Phase II trial compared with Camptosar(R)."
Dr Smith noted, "Commercially this result is very important for Alchemia. We have shown in preclinical studies that a broad range of anti-cancer drugs and antibodies can be targeted to different cancers with comparable therapeutic improvement to that seen with HyCAMP(TM). This means that the HyACT(TM) technology is capable of generating multiple product and partnering opportunities."
To view the Clinical Appendix for Alchemia Limited please go to www.asianet.news.net
ENQUIRIES: Dr Pete Smith Alchemia Limited Chief Executive Officer Tel: +61-7-3340-0200 RELEASED BY: Mr Geoff Breusch Phillips Group Tel: +61-7-3230-5000
HyACT(TM) is a proprietary technology which utilises hyaluronic acid (HA), to deliver and enhance the retention of anti-cancer drugs and biologics within tumours. The drug becomes entrained within the HA matrix and the HA binds to receptors located on the tumour cell resulting in more of the drug being delivered to the tumour. Preclinically, the HyACT(TM) technology has demonstrated improved delivery of drug to the tumour resulting in significantly reduced toxicity as well as increased efficacy and survival.
About Camptosar(R) (irinotecan)
Camptosar(R) is widely used in the treatment of metastatic colorectal cancer, and is being evaluated in many other tumour types. Like most cytotoxic drugs the use of Camptosar(R) is restricted by its side-effects, the most significant of which are diarrhea and neutropenia. Sales of Pfizer's Camptosar(R) were US$903 million in 2006. Patent exclusivity for the drug expires in 2008 in the US and 2009 in the EU.
Camptosar(R) is a registered trade mark of Pfizer Inc.
HyCAMP(TM) is a proprietary formulation of the anti-cancer drug Camptosar(R) with HA. Preclinical studies with HyCAMP(TM) demonstrated improved delivery of the drug to the tumour, resulting in increased efficacy and reduced toxicity. The phase II clinical trial was initiated to evaluate HyCAMP(TM) in patients with metastatic colorectal cancer.
HyACT(TM) and HyCAMP(TM) were obtained through Alchemia's acquisition of Melbourne-based oncology company Meditech Research Ltd in 2006.
This clinical study was financially supported in part by NovoZymes Biopolymer A/S.
CONTACT: Dr Pete Smith, Chief Executive Officer of Alchemia Limited,+61 -7-3340-0200
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