Phase111 granted approval!!!!!!!!!News release out on the company website dated yesterday. Entering phase 111 of STS. Exciting times ahead.
Regards, DH
Adherex and The International Childhood Liver Tumour Strategy Group (SIOPEL) Announce The Launch Of A Phase III Trial Of STS
Research Triangle Park, NC, October 30, 2007 - Adherex Technologies Inc. (AMEX:ADH, TSX:AHX), a biopharmaceutical company with a broad portfolio of oncology products under development, today announced with its collaborative partner, the International Childhood Liver Tumour Strategy Group (known as SIOPEL), a multi-disciplinary group of specialists under the umbrella of the International Society of Pediatric Oncology (SIOP), that the planned Phase III trial of sodium thiosulfate (STS) in children with hepatoblastoma (liver cancer) has opened for patient enrollment in the United Kingdom, with SIOPEL centers in up to 33 further countries also expected to participate following the international launch of the trial at a SIOPEL meeting in Mumbai, India today.
“Hearing loss remains a very significant yet potentially preventable side effect of contemporary cancer treatment,” said Penelope R. Brock, MD, PhD, FRCPCH, Consultant in Paediatric Oncology, Great Ormond Street Hospital for Children in the United Kingdom, and International Chairman for the SIOPEL STS study. “Cisplatin, for instance, continues to be an important treatment option in childhood cancers but can cause permanent hearing loss; such hearing loss can lead to significant long term social and behavioral issues for these children. Drugs such as STS that protect against this hearing loss, without interfering with the effectiveness of the chemotherapy, could greatly improve the quality of these children’s lives.”
“We are truly thrilled to open a new study on standard-risk hepatoblastoma (SR-HB) in children. Since the cure rate in SR-HB currently approaches 90%, we have decided to focus more on toxicity issues, which only recently have been appreciated enough,” said Dr. Piotr Czauderna, Chairman of SIOPEL. “We hope, if the study proves to be successful, that we shall be able to cure more patients with less lifelong sequelae. In such a case, our approach may delineate a new direction in pediatric oncology.”
The multi-center, prospective randomized Phase III clinical trial is expected to enroll approximately 100 evaluable children with hepatoblastoma, an orphan disease, being treated with cisplatin. Patients will be randomized to receive either cisplatin alone, a platinum-based drug associated with frequent hearing loss used to treat hepatoblastoma, or cisplatin plus STS. The study, which will be coordinated through the Children’s Cancer and Leukaemia Group (CCLG) in the United Kingdom, will compare the level of hearing loss (ototoxicity) associated with cisplatin alone versus the combination of cisplatin plus STS, as well as the safety, tolerability and anti-tumor activity in both arms of the study.
Adherex has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the use of STS for the prevention of platinum-induced ototoxicity in pediatric patients.
“The launch of this Phase III trial with SIOPEL is another important step forward in Adherex’s development of STS as a protectant against ototoxicity,” said William P. Peters, MD, PhD, Chairman and CEO of Adherex. “We hope to change the fact that there are currently no approved drugs to protect against this type of hearing loss. With the launch of this trial, we begin another critical evaluation of this drug, which we hope will bring to children an important improvement in their quality of life, and spare their families the risk of significant hearing loss that so frequently accompanies the treatment of their cancer. We are very pleased to be working with SIOPEL which has the world-wide reach to accomplish this important trial as quickly as possible.”
Adherex has exclusively licensed intellectual property rights from Oregon Health & Science University (OHSU) directed to the use of STS as a chemoprotectant. Investigators at OHSU have previously conducted Phase I and Phase II studies with STS, which have shown STS can reduce the hearing loss associated with platinum-based chemotherapy. In one study, the need for hearing aids to overcome high frequency hearing loss was reduced from about 50% to less than 5%. Adherex continues to work with the Children’s Oncology Group to initiate a randomized trial of STS in pediatric patients in the United States. STS is currently FDA approved for use in humans as part of a treatment for cyanide poisoning.