Navigation Links
Primary Endpoint Achieved in CAVATAK Phase 2 Melanoma Trial
Date:9/18/2013

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:

http://www.asx.com.au/asx/statistics/displayAnnouncement.do?display=pdf&idsId=01444703

Full details of the clinical trial design can be found at the following website:

http://clinicaltrials.gov/show/NCT01227551

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.comFor Viralytics Ltd:

US Investor Contacts:Dr. Malcolm McColl

Joshua Drumm, Ph.D. / Jason Rando+61 2 9988 4000

Tiberend Strategic Advisors, Inc.212.827.0020jdrumm@tiberend.com jrando@tiberend.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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Elcelyx Therapeutics NewMet for Type 2 Diabetes Meets Primary Endpoint in Phase 2b Study
2. Takeda EXAMINE Cardiovascular Safety Outcomes Trial of Alogliptin Met Primary Endpoint of Non-Inferiority Compared to Placebo in Addition to Standard of Care Showing No Increase in Cardiovascular Risk in Type 2 Diabetes Patients at High-Risk for Car
3. Rigels R343 Did Not Meet Primary Endpoint in Asthma Study
4. ARRY-502 Meets Primary And Key Secondary Endpoints In Asthma Study
5. TREATMENT OF PRIMARY LIVER CANCER: SARAH STUDY NOW AVAILABLE FOR ALL ELIGIBLE PATIENTS THROUGHOUT FRANCE
6. OxThera Strengthens Patent Portfolio for Orphan Disease - Primary Hyperoxaluria
7. Primary Efficacy and Safety Findings from Phase 3 Study of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
8. Top-line Data Demonstrate Primary Endpoint Achieved in Final Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Management of Post-Operative Pain
9. Lilly Announces Enzastaurin Phase III Study Did Not Meet Primary Endpoint in Diffuse Large B-Cell Lymphoma
10. Carena Launches 24/7 Virtual Care Delivery Service for Hospital Systems and Primary Care Clinics
11. Top-line Data Show AcelRx Pharmaceuticals ARX-04 Achieves Primary Endpoint in Dose-Finding Phase 2 Clinical Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
(Date:6/23/2016)... June 23, 2016 Bracket , a leading ... next generation clinical outcomes platform, Bracket eCOA (SM) 6.0, ... June 26 – 30, 2016 in Philadelphia ... Clinical Outcome Assessment product of its kind to fully integrate ... Bracket eCOA 6.0 is a flexible platform for electronic ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their ... Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... Pro X users can now reveal the media of their split screens with ...
(Date:6/26/2016)... ... 27, 2016 , ... Quality metrics are proliferating in cancer care, and are ... the eye of the beholder, according to experts who offered insights and commentary in ... Managed Care. For the full issue, click here . , For the American ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room ... Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. ... of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
Breaking Medicine News(10 mins):