Alchemia Completes Enrolment in Pivotal Phase III HA-Irinotecan Trial of Metastatic Colorectal Cancer
Published: Feb 28, 2013
BRISBANE, AUSTRALIA--(Marketwire - February 28, 2013) -
- 415 patients recruited; recruitment now closed
- Participation in sub-study outperformed expectations
- Results expected early 2014
Brisbane drug discovery and development company Alchemia Limited (ASX: ACL) has completed enrolment of patients in a pivotal Phase III clinical trial evaluating its lead product, HA-Irinotecan, for the treatment of metastatic colorectal cancer. Final trial enrolment totalled 415 patients, including 71 patients who are enrolled in a trial sub-study. Although the trial was originally planned for 390 patients, enthusiasm for the clinical trial shown by both investigators and patients resulted in an additional 25 patients being recruited in four weeks. Patients were recruited across 76 sites in Australia, Eastern, and Western Europe.
The optional pharmacokinetic and cardiotoxicity sub-study conducted along with this pivotal trial is intended to provide further confirmation of HA-Irinotecan's safety profile. The additional 25 patients enrolled served to boost the size of this sub-study, increasing patient numbers to around 90% of the sample size targeted by Alchemia. Supplementary patient enrolment also increases the statistical power of the whole trial, and improves the predictability of when the primary endpoint of progression free survival is likely to be met.
"The rapid recruitment of these additional 25 patients will allow Alchemia to determine the success of this pivotal trial in the first half of 2014," said Dr. Tracey Brown, Chief Scientific Officer of Alchemia. "We have been encouraged by the initial statistical review and modelling of the available blinded data, as it suggests that patients as a group are continuing on treatment for longer than anticipated before their disease progresses. Additionally, we anticipate these further recruitments will provide enhanced validation of the safety and efficacy of the HyACT platform technology."
HA-Irinotecan is a new formulation of irinotecan which targets the drug to the tumour. It enables the drug to be retained at the tumour site for longer, allowing substantially more drug to be internalised by the cancer cells. This occurs through a well established receptor-based mechanism. Increased uptake of the anti-cancer drug into tumour cells has resulted in a superior efficacy profile, as shown in a Phase II trial of HA-Irinotecan in metastatic colorectal cancer, where a statistically significant increase in Progression Free Survival (PFS) compared with irinotecan (5.2 months vs 2.4 months, p=0.017) with no increase in toxicity was observed. After consultation with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), both regulatory agencies indicated that the successful completion of this single pivotal Phase III trial may be sufficient for registration in both the U.S. and Europe.
This final stage double blind study is being conducted in second and third line colorectal cancer patients and administered as part of the FOLFIRI regimen where the Company's primary objective is to demonstrate that its technology enables superior outcomes for colorectal cancer patients, as indicated by an increase in Progression Free Survival time without increasing treatment toxicity.
About Alchemia Limited - www.alchemia.com.au
Alchemia is a drug development company with late stage oncology product pipeline (Phase II and III), and an FDA approved drug (fondaparinux) that is already in market.
Fondaparinux (a generic version of GlaxoSmithKline's Arixtra®) is an injectable anticoagulant approved in the US for the prevention and treatment of deep vein thrombosis (DVT) after knee or hip surgery. The ANDA for generic fondaparinux was approved by the US FDA in July 2011 and launched in the US by marketing partner Dr Reddy's Laboratories. Alchemia received its first profits from sales of fondaparinux in August 2011.
Alchemia's pipeline of oncology products is built on the proprietary platform technology: HyACT® (targeted cancer delivery), which is used to selectively target cancer drugs to tumours. The primary objective of the HyACT® technology is to develop a new generation of anti-cancer drugs which demonstrate better efficacy. The Company recently announced the final recruitment for its most advance cancer drug -- HA-Irinotecan which is in Phase III for the treatment of metastatic colorectal cancer.
In addition, Alchemia has a drug discovery platform known as VAST® which is based on the Company's chemistry expertise. VAST is run on a business model designed to limit use of cash expenditure through the use of partnerships and government grants. The company has projects running with academic institutions and evaluation underway with big pharma partners.
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