Viralytics Full Year Financial Results

SYDNEY, Sept. 3, 2013 /PRNewswire/ -- Viralytics Limited (ASX:VLA, OTCQX:VRACY) has released its financial results for the year ended 30 June 2013. 

Operational Highlights

CAVATAK™ Phase II CALM Melanoma Clinical Trial (USA)

Highlights include:

• CAVATAK™ presented at the American Society of Clinical Oncologists conference in June 2013 and the World Melanoma Congress in July 2013 to a global oncology audience.
• Key milestone achieved with enrolment of the 35th patient. Independent Data Monitoring Committee reported that CAVATAK™ had met safety and tolerability criteria.
• Patient enrolment now at 10 prestigious US cancer clinics, with acceleration since early 2013. Aiming for full recruitment by the end of the calendar year.
• 23 patients have reached assessment point against the trial's primary endpoint of immune related Progression Free Survival (irPFS) at 6 months. Interim results very promising with 8 of 23 patients having achieved the primary endpoint. Trial target is 10 of 54 evaluable patients achieving primary endpoint.
• 2 complete and 6 partial tumour responses from 30 assessable patients. Anti-cancer activity demonstrated in non-injected (metastatic or secondary) as well as the injected tumours.

CAVATAK™ Phase I studies completed (Australia)

• Intravenously administered CAVATAK™ well tolerated in late stage cancer patients.
• Some evidence of tumour stabilization in intravenous study after only a single dose.
• Sound basis for a multi-dose intravenous Phase 1 / 2 trial (our STORM study).

CAVATAK™ Preclinical studies completed (Australia and the UK)

• Broad anti-cancer activity of CAVATAK™ demonstrated in preclinical setting.
• Synergistic effect from the combination of CAVATAK™ and Docetaxel.  Potential combination therapy.
• Combination with either radiation or chemotherapy resulted in more potent anticancer activity in bladder cancer cell lines than radiation or chemotherapy alone.
• Potent anti-cancer activity in chronic lymphocytic leukaemia (CLL) cell lines.

"The 2013 financial year has been one of outstanding progress at Viralytics, which leaves us well positioned to further develop the business in the coming year," said Dr. Malcolm McColl, Chief Executive Officer of Viralytics. "We have achieved key milestones in our Phase 2 CALM study, with interim results demonstrating promising anti-cancer activity. We also had a number of excellent outcomes in our Phase 1 and preclinical programs, demonstrating the broad anti-cancer activity of CAVATAK™.  Our focus is to maintain momentum in clinical development and translate this progress into valuable commercial outcomes."

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 CAVATAK™ 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 also plans to commence a Phase 1/2 study of CAVATAK™ delivered intravenously in patients with melanoma, prostate, lung or metastatic bladder cancers prior to the end of 2013 (the STORM study).

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 market.  For more information on the company, please visit http://www.viralytics.com. 

SOURCE Viralytics Ltd.