Company Reports Strong Interim Data in Phase 2 Study Targeting Late-Stage Melanoma; Full Recruitment Expected by End of 2013
SYDNEY, Australia I July 29, 2013 I Viralytics Limited (ASX: VLA; OTC: VRACY), an oncolytic virotherapy company developing new drugs to treat a wide range of cancers, today announced that progress in its Phase 2 clinical trial of intratumourally administered CAVATAK™ for the treatment of late-stage melanoma (the CALM study) continues to accelerate with the recent reporting of strong interim results at the 8th World Congress of Melanoma, Hamburg, Germany.
The interim data from the first 35 patients in the CALM study demonstrated solid progress towards achieving the primary endpoint of the study – immune related Progression Free Survival (irPFS) at 6 months – and strengthens the evidence of the tolerability of CAVATAK™ in late stage melanoma patients. At present, 23 patients have met the protocol criteria for assessment of the primary endpoint of irPFS at 6 months. Eight of these 23 (35%) have achieved the endpoint. The trial target will be realized if 10 of 54 patients meet the primary endpoint.
Concurrently, the independent Data Monitoring Committee (DMC) of the trial met recently to review data from the first 35 patients in the study (Stage 1). It reported that CAVATAK™ has met the safety and tolerability criteria, and thus the study is progressing into Stage 2, full enrollment and its conclusion. On the basis of the current recruitment rates, Viralytics anticipates full enrollment of the study by the end of 2013.
“The outstanding progress of our Phase 2 ‘CALM’ clinical trial exemplifies the recent success that Viralytics has experienced,” remarked Dr. Malcolm McColl, Chief Executive Officer of Viralytics Ltd. “The recently reported interim data and affirmation from the DMC, combined with the expected initiation of our Phase 1/2 trial of CAVATAK™ administered intravenously – the STORM study – should further distinguish Viralytics as a leading developer of targeted cancer biologics.”
These advancements add to several accomplishments by Viralytics during the first half of 2013 that underscore the potential of CAVATAK™ and the company’s mission to develop oncolytic virotherapies for the treatment of a wide range of cancers.
Recent corporate and clinical achievements:
- July 19, 2013: Interim results from the first 35 melanoma patients in the Phase 2 CAVATAK™ CALM trial were presented by Dr. Robert Andtbacka of the Huntsman Cancer Institute and lead investigator in the CALM study at 8th World Congress of Melanoma
- June 4, 2013: Viralytics announced completion of Stage 1 recruitment in the Phase 2 CALM clinical trial. Viralytics anticipates full enrollment of the study by the end of 2013.
- June 3, 2013: The CALM trial was featured in a poster presentation at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO). Dr. Robert Andtbacka provided an overview of the trial design and an update on patient recruitment.
- April 9, 2013: Viralytics reported positive results from the Phase 1 study of CAVATAK™ administered intravenously to late stage melanoma, prostate, breast or colorectal patients. CAVATAK™ was well tolerated with evidence of disease stabilization despite most patients receiving only a single dose. Subject to regulatory approval, Viralytics anticipates commencing a Phase 1/2 intravenous study – STORM – at three prominent sites in the United Kingdom prior to the end of 2013.
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 (VLA.AX) while its ADRs also trade under VRACY on the US OTC market. For more information on the company, please visit http://www.viralytics.com.
SOURCE: Viralytics
Post Views: 270
Company Reports Strong Interim Data in Phase 2 Study Targeting Late-Stage Melanoma; Full Recruitment Expected by End of 2013
SYDNEY, Australia I July 29, 2013 I Viralytics Limited (ASX: VLA; OTC: VRACY), an oncolytic virotherapy company developing new drugs to treat a wide range of cancers, today announced that progress in its Phase 2 clinical trial of intratumourally administered CAVATAK™ for the treatment of late-stage melanoma (the CALM study) continues to accelerate with the recent reporting of strong interim results at the 8th World Congress of Melanoma, Hamburg, Germany.
The interim data from the first 35 patients in the CALM study demonstrated solid progress towards achieving the primary endpoint of the study – immune related Progression Free Survival (irPFS) at 6 months – and strengthens the evidence of the tolerability of CAVATAK™ in late stage melanoma patients. At present, 23 patients have met the protocol criteria for assessment of the primary endpoint of irPFS at 6 months. Eight of these 23 (35%) have achieved the endpoint. The trial target will be realized if 10 of 54 patients meet the primary endpoint.
Concurrently, the independent Data Monitoring Committee (DMC) of the trial met recently to review data from the first 35 patients in the study (Stage 1). It reported that CAVATAK™ has met the safety and tolerability criteria, and thus the study is progressing into Stage 2, full enrollment and its conclusion. On the basis of the current recruitment rates, Viralytics anticipates full enrollment of the study by the end of 2013.
“The outstanding progress of our Phase 2 ‘CALM’ clinical trial exemplifies the recent success that Viralytics has experienced,” remarked Dr. Malcolm McColl, Chief Executive Officer of Viralytics Ltd. “The recently reported interim data and affirmation from the DMC, combined with the expected initiation of our Phase 1/2 trial of CAVATAK™ administered intravenously – the STORM study – should further distinguish Viralytics as a leading developer of targeted cancer biologics.”
These advancements add to several accomplishments by Viralytics during the first half of 2013 that underscore the potential of CAVATAK™ and the company’s mission to develop oncolytic virotherapies for the treatment of a wide range of cancers.
Recent corporate and clinical achievements:
- July 19, 2013: Interim results from the first 35 melanoma patients in the Phase 2 CAVATAK™ CALM trial were presented by Dr. Robert Andtbacka of the Huntsman Cancer Institute and lead investigator in the CALM study at 8th World Congress of Melanoma
- June 4, 2013: Viralytics announced completion of Stage 1 recruitment in the Phase 2 CALM clinical trial. Viralytics anticipates full enrollment of the study by the end of 2013.
- June 3, 2013: The CALM trial was featured in a poster presentation at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO). Dr. Robert Andtbacka provided an overview of the trial design and an update on patient recruitment.
- April 9, 2013: Viralytics reported positive results from the Phase 1 study of CAVATAK™ administered intravenously to late stage melanoma, prostate, breast or colorectal patients. CAVATAK™ was well tolerated with evidence of disease stabilization despite most patients receiving only a single dose. Subject to regulatory approval, Viralytics anticipates commencing a Phase 1/2 intravenous study – STORM – at three prominent sites in the United Kingdom prior to the end of 2013.
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 (VLA.AX) while its ADRs also trade under VRACY on the US OTC market. For more information on the company, please visit http://www.viralytics.com.
SOURCE: Viralytics
Post Views: 270
