YM BioSciences Inc. (YMI) announced on Monday that preliminary results of a Phase II study evaluating the safety and efficacy of nimotuzumab in pediatric patients with recurrent diffuse intrinsic pontine glioma (DIPG) were reported at the 43rd Congress of the International Society of Paediatric Oncology conference being held in New Zealand. Nimotuzumab is designated an Orphan Drug for adult and pediatric glioma by the FDA as well as the EMEA for Europe.
"Nimotuzumab is an anti-EGFR antibody that has shown promising activity in a previous Phase II study in patients with recurrent/refractory DIPG, a particularly severe, inoperable form of cancer for which there are currently no lifesaving effective treatments," said Dr. Ute Bartels at the Hospital for Sick Children in Toronto, Canada. "In the study we conducted, nimotuzumab was found to be safe and well tolerated. In this very challenging disease, a small subset of patients showed prolonged survival and benefit from nimotuzumab."
The study was a Phase II, open-label, single-arm, multi-center study conducted at multiple sites in the US, Canada, and Israel. Treatment with nimotuzumab was well tolerated with most adverse events reported as mild or moderate in severity. The majority of Adverse Events (AEs) were associated with CNS disorders and not related to study drug. The most commonly reported events related to study drug were rash and lymphopenia occurring in 9.1% and 6.8% of patients respectively. Study drug discontinuation was reported in four patients overall due to AEs. Only one patient experienced serious Adverse Events (Grade 5 intracranial tumor hemorrhage and tumor necrosis), assessed as possibly related to nimotuzumab.
No Complete Responses (CR) were observed. At week 8, a PR was reported in two patients, SD in six patients and Progressive Disease (PD) in 11 patients who were evaluable for response, resulting in a Clinical Benefit Rate (CR+PR+SD) of 18.2%. At week 18, one patient continued to have a PR and three patients continued with SD, giving an Overall Response Rate of 2.3%. The Median Duration of Response, Time to Progression, and Overall Survival were 2.1 months, 1.7 months and 3.2 months respectively.
The BioMedReports FDA Calendar and Worldwide Catalyst Tracker shows additional upcoming catalysts for the stock including Full Phase I/II trial results for CYT387 as an indication for Myelofibrosis.
CYT387 is an orally-administered, potent, selective inhibitor of the JAK1 and JAK2 kinases, enzymes which have been implicated in a number of disorders including myeloproliferative neoplasms (MPNs), inflammatory diseases and certain cancers. The molecule possesses an excellent selectivity and safety profile with minimal off-target activity, a favorable pharmacokinetic and toxicological profile, and the prospect of limited drug/drug interactions. Given the number of targets and indications, during the past few years there has been quite a bit of enthusiasm for JAK Inhibitors from Big Pharma with various licensing and acquisition deals from Novartis (NYSE:NVS), Eli Lilly (NYSE:LLY) and others. CYT387 is currently unpartnered.
Previously, the Mayo Clinic announced positive interim data from the first 60 patients enrolled in the Phase I/II trial for CYT387. The results were reported in an oral presentation at the 52nd American Society of Hematology Annual Meeting. In our tracked 6K SEC filing, the Company stated that they were anticipating that a full data set would be reported by the end of calendar 2011. YM BioSciences is also working towards completing in calendar 2011 any preclinical and manufacturing activities required to enable CYT387 to commence a Phase III pivotal trial for CYT387 in myelofibrosis in calendar Q1 2012.
An additional catalyst for the firm involving a Japan Phase III trial initiation for Gastric Cancer is also expected early in 2012.
Shares of the company are currently trading -54.50 %% from their 52-Wk High of $ 3.78 and have been basing at these levels since August.
YM BioSciences' pipeline is oncology-focused and aims to develop products for patients suffering from cancer and cancer-related disorders. Nimotuzumab is licensed to YM's majority-owned, Canadian subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and was developed at the Center of Molecular Immunology. CYT387 and CYT997 are wholly-owned by YM BioSciences Inc.
YM BioSciences has collaborations with University of Toronto, TTY BioPharm, Sanofi-aventis (NYSE:SNY), University of Saskatchewan, LG Life Sciences Ltd and others.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.