Halloran Consulting Group, a national consultancy serving biotech, pharma, & medical device companies with clinical, quality and regulatory compliance projects, announced their role as U.S. regulatory consultants for Curtana Pharmaceuticals.
The FDA granted orphan drug designation to CT-179, Curtana Pharmaceuticals’ lead Olig2 inhibitor for the treatment of gliomas, including glioblastoma (GBM) in adults and pediatric high-grade glioma in children.
Curtana Pharmaceuticals received orphan drug designation for CT-179 from the FDA after a review period of only 19 days. In June, FDA Commissioner Dr. Scott Gottlieb announced a strategic plan to eliminate the backlog of orphan designation requests and establish a response to all new requests within 90 days of receipt. Before this announcement, FDA had informed sponsors, including Halloran clients, to expect review of requests for orphan drug designation to take 180 days. Halloran applauds the FDA’s recent commitment to expedite approval of orphan drug designations and notes that their efforts have contributed to the rapid approval of Curtana’s designation.
“As part of Curtana’s development team, it was thrilling to receive FDA approval of Curtana’s orphan drug designation so soon after the initial application. Dr. Gottlieb recently committed to clearing the backlog of reviews at FDA and reducing the time for review of new applications,” said Halloran Consulting Group CEO and president, Laurie Halloran.
“My team and I view the Agency’s speedy issuance of the orphan designation as concrete evidence that Dr. Gottlieb and his team at the FDA are making quick progress in this area, which is a positive step in the Agency’s quest to speed life-saving treatments to patients quickly and productively,” Halloran continued.
Curtana’s highly potent small molecule Olig2 inhibitor, CT-179, was created to treat glioblastoma, the most common and deadliest of the malignant primary brain tumors in adults. According to the National Institutes of Health, the number of new glioblastoma diagnoses made annually is about 3.2 per 100,000 people in the United States and Europe, and median survival for adults is about 15 months with a five-year survival rate less than 10 percent. Glioblastoma is especially difficult to treat effectively because conventional therapy debulks the tumor, but the Olig2-expressing cancer stem cells are resistant to chemotherapy and radiation therapy ultimately causing the cells to survive and give rise to tumor reoccurrence.
According to Curtana Pharmaceuticals, their solution to treat this devastating disease is to add an Olig2 inhibitor to conventional therapy at the time of diagnosis. In addition to debulking the tumor, this treatment strategy may also eliminate the cancer stem cells, thereby markedly delaying or, ideally, preventing reoccurrence of the cancer.
Halloran acts as Curtana’s development and regulatory team for CT-179, providing strategic guidance and tactical regulatory, clinical, quality and non-clinical expertise. In 2016 alone, Halloran submitted a total of 13 IND and 14 pre-IND applications and has recently completed 17 successful orphan designation applications for FDA review, including several for products designed to treat brain cancers. Halloran provides exceptional value through its team of highly experienced professionals who work closely with pharmaceutical organizations of all sizes to prepare and submit FDA dossiers.
“We engaged Halloran as a strategic partner in early 2016 due to their breadth of clinical knowledge and dedication to thinking outside the box to create unique and inspired solutions,” said Curtana CEO Gregory Stein, M.D., M.B.A. “Their guidance on the orphan application for CT-179 was highly valued, and the results speak for themselves. We are one step closer to bringing our innovative Olig2 inhibitor to bear in treating patients with glioblastoma. This is an outstanding milestone for Curtana, and we look forward to continuing to work closely with our Halloran team on the IND application submission which is planned for early next year.”
CT-179 is an orally available, daily treatment which readily crosses the blood-brain barrier, achieves very high concentrations in the brain, and significantly prolongs survival in animal models of brain cancer. At doses that are hypothesized to be therapeutic, CT-179 has been found to be well tolerated in animals.