Phase I Clinical Trial of Oncolytic Delta-24-RGD (DNX-2401) with Biological Endpoints: Implications for Viro-Immunotherapy
A presentation at the 2015 American Association of Neurological Surgeons Annual Scientific Meeting
Article ID: 633564
Released: 3-May-2015 2:40 PM EDT
Source Newsroom: American Association of Neurological Surgeons (AANS)
Newswise — WASHINGTON, D.C. (May 4, 2015) — Winner of the Journal on Neuro-Oncology Award, Frederick F. Lang Jr., MD, FAANS, recently presented his research into Delta-24-RGD at the 2015 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting.
Delta-24-RGD is a new oncolytic virus with a favorable toxicity-profile that is capable of replicating in and killing human glioma cells, and that can produce durable complete-responses in subsets of patients. Based on promising preclinical studies, the authors undertook a first-in-human Phase I clinical trial with biological endpoints in order to assess the capacity of Delta-24-RGD to replicate in human gliomas, and to also determine safety and initial efficacy.
Patients with recurrent high-grade gliomas were enrolled in one of two arms. Group A, the clinical assessment group, received a single intratumoral injection of Delta-24-RGD into biopsy-proven recurrent glioma. Group B, the biological endpoint group, received an initial intratumoral injection through an implanted catheter, which was followed 14 days later by en bloc tumor/catheter resection. The resection was done to obtain post-treatment specimens; during subsequent injection of Delta-24-RGD into the post-resection cavity, the dose was escalated in eight cohorts. Outcome analyses show an overall median survival of 11 months. Remarkably, complete responses were seen in three patients (12 percent) all of whom are alive (3.5, 2.5 and 2 years after treatment). Serial MRIs revealed increased enhancement before tumor regression, consistent with inflammatory mediated responses.
Histological analysis of post-treatment en bloc surgical specimens proved for the first time that Delta-24-RGD is capable of infecting, replicating in and killing glioma tumor cells. Viral-induced anti-tumor-immunity plays a role in the anti-glioma effect.
Author Block: Charles Conrad, MD; Candelaria Gomez-Manzano, MD; Frank Tufaro, PhD; Raymond Sawaya, MD, FAANS; Jeffrey Weinberg, MD, FAANS; Sujit Prabhu, MD, FAANS; Gregory Fuller, MD, PhD; Kenneth Aldape, MD; Juan Fueyo, MD
Disclosure: Lang reported the following disclosure prior to the 83rd AANS Annual Scientific Meeting: DNAtrix, Inc.
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Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 9,000 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. Fellows of the AANS are board-certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons of Canada, or the Mexican Council of Neurological Surgery, A.C. Neurosurgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the spinal column, spinal cord, brain, nervous system and peripheral nerves.
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