Oncology-focused biotechnology company Novogen (ASX:NRT) is terminating further development of its preclinical program ATM-3507 (Anisina), with immediate effect.
The company said the decision follows a review by the internal scientific committee of its Board of Directors, which concluded the balance of available preclinical data did not support a transition into clinical trials, and that the future commercial potential of the asset was likely to be low.
"In particular, a level of toxicity was observed that raised significant concern around the ability to safely dose patients to a therapeutic level," it said. "In addition, the recent evolution of the treatment landscape for patients with the kinds of cancer in which Anisina might be tested suggested that there would likely be regulatory and commercial barriers to success."
According to CEO, Dr James Garner, “The work that has been done on the Anisina program has been first-class, and it is important to acknowledge the efforts of the many dedicated scientists that have been involved. However, our responsibility to patients and to shareholders lies in taking forward only those development programs which are likely to provide benefit in the treatment of cancer. Our view is that the data that has been collected for Anisina does not, in aggregate, make it an appropriate candidate for clinical development.”
He added, “While this has been a difficult decision, we believe it to be the most responsible course of action. The considerable quantum of funds that would have been devoted to a clinical trial of Anisina can now be reallocated to activities that are more likely to benefit patients and drive economic value for the company. We have a strong pipeline, and we are tightly focused on driving forward our clinical programs, GDC-0084 and Cantrixil. These are entirely independent of Anisina in scientific terms.”
Under the terms of a License Deed with Genscreen Pty Ltd, which was executed in 2013, it is anticipated the intellectual property associated with the program will revert to Genscreen. Novogen will work closely with the Genscreen team to execute any necessary handover.
Novogen said it anticipates significant future cost savings associated with the termination.
"A reduction in headcount will be implemented, and other employees will be reallocated to new responsibilities, focused on driving forward the clinical-stage programs and the ‘next-generation ATM’ program," it said.