May 12, 2022
CNS Pharameceuticals has received the go-ahead from regulators in Spain to conduct a trial for a new drug called Berubicin, which is designed to treat recurrent glioblastoma multiforme. The news follows similar regulatory approval in France and Switzerland.
The trials will see some patients given the drug while others receive the existing chemotherapy treatment Lomustine.
Commenting on the development, CNS Pharmaceuticals CEO John Climaco said: “We continue to build momentum in our potentially pivotal study of Berubicin, and importantly advance toward bringing a much needed treatment option to patients.” He added his thanks to the Spanish drug authority AEMPS and ethics committee CElm Provincial de Sevilla for approving the trial.
Should the study prove successful, it could bring nearer the day when the drug might be added to the existing list of treatments available for glioblastoma.
At present, gamma knife radiosurgery remains one of the most effective treatments for brain tumours, particularly due to its non-invasive nature and absence of recovery time.
Indeed, it is worth noting that even if Berubicin does prove to be effective, this form of radiosurgery will still be a very effective and important option.
Moreover, it is important to note that Berubicin will still need to go through not just the trials, but also peer review and then seek regulatory approval before it can be made available in Austria and elsewhere. This process may take some years. Besides all this, it is far from certain at this early stage whether the treatment will prove to make a significant difference.
The quest to find new treatments that might help fight glioblastoma and other tumours has also focused on possible treatments such as Paxalisib.
Kazia Therapeutics, which produces Paxalisib, recently announced it had completed the second phase of trials and will shortly be presenting the results.
Chief executive officer of the company Dr James Garner said: “This study has greatly expanded our understanding of paxalisib, and the insights it has provided have informed all our subsequent work with the drug.”
A key finding of the trial was that it appeared to be very effective in achieving longer survival times among patients whose genetic profile made them resistant to Temozolomide, the only drug currently approved in the US for glioblastoma.
It found that the average survival time for the intent-to-treat population was 15.7 months, compared with 12.7 months for Temozolomide, while median progression-free survival was also higher, at 8.4 months to 5.3 months.
Final data from this stage of the research is expected to emerge next year, which may inform further research ahead of the third stage of trials. Further research is planned in Europe and China.
While this may be good news and Berubicin may provide more, this will not diminish the potential value of gamma knife treatments. Indeed, it may be a combination of the drugs and this form of radiosurgery could turn out to bring the best results in the future.