SIOPEL 6: "A Multicenter Open Label Randomized Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma" is being conducted by The International Childhood Liver Tumour Strategy Group, SIOPEL. As of this date, the study has enrolled 76 out of a planned 102 patients. SIOPEL 6 is being conducted in standard risk hepatoblastoma patients where the effectiveness of the platinum treatment is known to be very high. The first two interim safety analyses were conducted after 20 and 52 patients, and in each case, the Independent Data Monitoring Committee recommended continuation of the study. An interim efficacy analysis is planned with the possibility for early completion of the trial, if there is greater than expected difference in hearing loss between the two treatment arms.
STS Development Plan
Adherex presented to FDA's Pediatric Oncology Drug Advisory Committee (ODAC) on November 1, 2011. The Committee acknowledged the challenge of demonstrating that STS does not reduce the efficacy of cisplatin and agreed an adult study would not be appropriate. The presentation and minutes from the meeting are available to download from the FDA and Adherex websites. If convincing efficacy and safety results are received from COG ACCL0431, Adherex plans to propose to the FDA the filing of a New Drug Application (NDA) based on this single study.
As previously disclosed, on May 22, 2013, the FDA made a recommendation as to the clinical trial that would be required to support registration of eniluracil in Metastatic Breast Cancer. After review of the FDA's recommendation, the Company determined that the recommended trial would be larger than that originally envisioned and proposed by the Company. Adherex management believes it would be in the best interests of shareholders and the cancer community to focus on seeking a partnership for eniluracil, which may include the Company evaluating viable indications for eniluracil other than MBC. Data from the Phase 2 trial will be submitted for publication in a scientific journal.
"Adherex has taken proactive steps to eliminate most of its payables and reduce its cash burn to a minimum. The Company does not anticipate the need for immediate funding, until results from COG are reported later in the year," said Mr. Raykov.
The Company reported a net loss from operations of $0.9 million excluding the $7.5 million non-cash gain on derivatives for the second quarter ended June 30, 2013, compared to a net loss from operations of $1.2 million excluding the non-cash gain of $0.6 million in the same period in 2012. The decrease in the net loss from operations excluding the non-cash impact of derivatives is primarily due to a decrease in research and development expenses associated with the Company Phase II eniluracil trial.
Research and development expenses totaled $0.5 million for the second quarter ended June 30, 2013, as compared to $0.9 million in the same period in 2012. The decrease in research and development expenses relates to the conclusion of enrollment and ongoing clinical support of the Phase II eniluracil trial.
The Company reported a net loss from operations of $1.5 million excluding the $4.0 million non-cash gain on derivatives for the six month period ended June 30, 2013, compared to a net loss from operations of $1.9 million excluding the non-cash gain of $4.0 million in the same period in 2012. The decrease in the net loss from operations excluding the non-cash impact of derivatives is primarily due to a decrease in research and development expenses associated with the Company Phase II eniluracil trial offset by a slight increase in general and administrative expenses.
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