Primary Endpoint Achieved in CAVATAK Phase 2 Melanoma Trial
- Primary endpoint achieved while still recruiting
- Measure is immune related Progression Free Survival (irPFS) at six months after first CAVATAK™ dose
- 10 of first 30 evaluable patients reach six month irPFS target
- Continuing to full enrollment to build safety and efficacy data
- Data Monitoring Committee previously reported that CAVATAK™ met required safety, tolerability and response criteria
- 44 patients now enrolled, full recruitment forecast by end 2013
- Randomised melanoma study next step towards registration
SYDNEY, Sept. 18, 2013 /PRNewswire/ -- Viralytics Limited (ASX: VLA, OTCQX: VRACY) has achieved the primary endpoint in its Phase 2 clinical trial of CAVATAKTM in the treatment of late stage melanoma patients (the CALM study).
The Phase 2 trial is a single arm study being conducted at 10 US sites and is designed to investigate the safety and efficacy of intratumoral CAVATAKTM (Coxsackievirus A21) in 54 evaluable1 patients with late stage (IIIc and IV) malignant melanoma.
The primary endpoint measured is immune related Progression Free Survival (irPFS) at six months after first dose of CAVATAK™. Progression Free Survival is the length of time, during and after treatment, that the patient lives with the cancer without it worsening. It includes patients that achieve a complete tumour response2, partial tumour response3 or stable disease4.
The primary endpoint of the study was to have 10 patients from a total of 54 evaluable patients reporting irPFS at six months after the first dose of CAVATAK™. This was achieved after only 30 evaluable patients, representing an irPFS rate so far of 33%.
"Achieving the primary endpoint of the CALM study before patient recruitment has been completed is very encouraging. In addition to the positive irPFS data we have observed responses in both injected and non-injected lesions," said Dr Robert Andtbacka, Lead Study Investigator from the Huntsman Cancer Institute in the US.
Dr Malcolm McColl, Chief Executive Officer of Viralytics said: "We are delighted to achieve this major milestone in the development of CAVATAK™. Given the excellent progress achieved to date and the encouraging feedback from key opinion leaders in the melanoma field we also believe it is now timely to consider the design of a randomised study in melanoma patients."
There are now 44 patients enrolled in the study with full enrollment forecast by the end of 2013.
Additional details about the Phase 2 CALM clinical trial can be found in the full ASX release issued by Viralytics:
Full details of the clinical trial design can be found at the following website:
About Viralytics Ltd:
Viralytics is developing oncolytic virotherapy treatments for a range of cancers. Viralytics' lead product, CAVATAK™, is a proprietary formulation of the common cold Coxsackievirus Type A21 (CVA21). CVA21 binds to specific "receptor" proteins highly expressed on multiple cancer types including, but not limited to melanoma, prostate, lung, breast and bladder cancers; and multiple myeloma. Intratumourally administered CAVATAKTM is currently being studied in a Phase 2 clinical trial in the treatment of Late stage Melanoma (the CALM study) at multiple cancer clinics in the US.
Viralytics plans to commence a Phase I/II trial of CAVATAK™ being delivered systemically (intravenously). This trial referred to as the STORM (Systemic Treatment Of Resistant Malignancies) study will be undertaken in patients with melanoma, prostate, lung or metastatic bladder cancers. Viralytics has received regulatory approval from the UK Medicines and Healthcare products Regulatory Agency and will commence the STORM trial at three prominent UK sites later in 2013.
Based in Sydney Australia, Viralytics is listed on the Australian Securities Exchange (ASX: VLA) while its ADRs also trade under VRACY on the US OTCQX International market. For more information on the company, please visit http://www.viralytics.com.
1 Evaluable patients are those being on study for the six month tumour assessment visit or patients that have earlier withdrawn from the study due to progressive disease or for other reasons.
2 A complete tumour response (irRECIST 1.1) is the disappearance of the tumour burden.
3 A partial tumour response (irRECIST 1.1) is a reduction in the total tumour burden by greater that 30%.
4 Stable disease (irRECIST 1.1) is cancer that is neither decreasing nor increasing in extent or severity.
SOURCE Viralytics Ltd.