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Alchemia reports preliminary positive efficacy data from HyCAMP Phase II trial |
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27 Apr 2007 |
Alchemia Limited today announced preliminary results from its randomised Phase II clinical trial in patients with metastatic colorectal cancer, where Alchemia's drug HyCAMP(TM) was compared to irinotecan which is considered to be a cornerstone drug for the treatment of colorectal cancer.
SYDNEY, Australia | Apr 26, 2007 | Australian drug development company Alchemia Limited today announced preliminary results from its randomised Phase II clinical trial in patients with metastatic colorectal cancer, where Alchemia's drug HyCAMP(TM) was compared to irinotecan which is considered to be a cornerstone drug for the treatment of colorectal cancer. This announcement is being made at a preliminary stage of the analysis in accordance with the ASX disclosure requirements once the company became aware of the results reported below.
Primary safety endpoint - Comparison of the incidence of late grade 3 or 4 diarrhoea in patients receiving HyCAMP(TM) versus irinotecan alone:
not met due to lower than expected incidence of diarrhoea in the control arm
Secondary safety endpoints:
No major differences in overall adverse events between the two treatment arms
Secondary efficacy endpoints:
38 of 41 (93%) HyCAMP(TM) patients compared to 28 of 35 (80%) irinotecan patients completed 2 cycles (p=0.099)
14 of 41 (34%) HyCAMP(TM) patients compared to 5 of 35 (14%) irinotecan patients completed the full 8 cycles (p=0.064)
Patients on HyCAMP(TM) received a median of 6 cycles of therapy, compared to 2 for irinotecan alone (p=0.005)
Median progression free survival for HyCAMP(TM) patients was 5.2
months, compared to 2.4 months for the irinotecan arm (p=0.014).
The Phase II trial commenced in December 2004 and patient accrual closed on 30 June 2006. In the randomised trial, 80 patients with metastatic colorectal cancer who had previously failed treatment with the anti-cancer drug 5-fluoro uracil were eligible to receive up to eight cycles of chemotherapy in the form of irinotecan or HyCAMP(TM) intravenously. The primary endpoint of the trial was safety (incidence of Grade 3/4 diarrhoea) with secondary safety and efficacy endpoints such as disease control, progression free survival and overall survival.
The major findings from the preliminary analysis of trial data are as follows. The two arms of the study were very well balanced for known prognostic factors. Preliminary data regarding toxicity indicates no major differences between the two arms, with an overall impression that HyCAMP(TM) was associated with less cumulative toxicity because the HyCAMP(TM) arm received significantly more doses. The overall incidence of grade 3/4 diarrhoea was lower in this study (14%) than anticipated at the commencement of the trial, presumably reflecting improved medical management today of this side effect in patients, and thereby impeding any meaningful analysis of this endpoint. Patients on HyCAMP(TM) received a median of 6 cycles of therapy, compared to 2 for irinotecan alone (p=0.005). Median progression free survival for HyCAMP(TM) patients was 5.2 months, compared to 2.4 months for the irinotecan arm (p=0.014). Preliminary data indicates the proportion of patients exhibiting disease control (complete responses, partial responses or stable disease) in the HyCAMP(TM) arm was at least 40 % greater than that observed in the irinotecan arm.
Analysis of the trial data is ongoing and full results will be presented when available. This is expected by the end of May. However, from the data analysed to date, HyCAMP(TM) is able to deliver more cycles of therapy and this has translated into an improved disease control rate, and a statistically significant improvement in progression free survival. "The findings have far exceeded our expectations in that we did not expect to achieve a statistically significant improvement in efficacy from such a small number of patients" commented principal investigator Associate Professor Peter Gibbs. Alchemia CEO Dr Ramsdale said "we will be moving as quickly as possible to discuss our plans for future studies with the FDA. We are hopeful that these results will enable us to move forward to a pivotal phase III study earlier than originally anticipated."
These results are important not only for the development and approval path for HyCAMP(TM) itself but they provide validation of the technology platform. The HyACT(TM) platform is an extremely flexible formulation technology as it can be used with virtually any intravenously administered anti-cancer treatment. We have successfully completed Phase I clinical studies on HyACT(TM) formulations of two other chemotherapy drugs, doxorubicin and 5- flurouracil. Encouraging preclinical data has also been obtained on a number of other cytotoxics. More recently, we have demonstrated in preclinical studies that HyACT(TM) can also be used to significantly enhance the efficacy of newer targeted antibody therapies such as Avastin(TM) and Erbitux(TM) In the case of generic drugs or drugs close to patent expiry, the HyACT(TM) formulation may provide a means for companies to differentiate their products from other competitors in the market place, and thereby build product value.
HyCAMP(TM) and the proprietary formulation technology, HyACT(TM), were obtained following the successful acquisition of Melbourne based oncology company Meditech Research Limited in 2006. "The Phase II clinical results provide proof of concept for the HyACT(TM) platform. We expect this technology to build substantial value for shareholders, not only with HyCAMP(TM), but with other oncology drugs as well" Dr Ramsdale said.
Before HyCAMP(TM) can be marketed in the US, the drug needs to successfully complete a Phase III study, and receive marketing approval from the US FDA.
Alchemia wishes to acknowledge the commitment and thank the patients who volunteered to participate in this trial, and to acknowledge and thank the investigators, study research personnel and nursing staff at the 10 clinical sites across Australia who looked after the welfare of the patients and diligently collected the data for analysis in this trial.
SOURCE: Alchemia Limited |
