1stOncology™: Cancer Intelligence Service – Page 18143 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Oncolytics Biotech® Inc. Announces Filing for Orphan Designation with the EMA for Pancreatic and Ovarian Cancers

On December 22, 2014 Oncolytics Biotech reported that it has submitted applications for Orphan Designation to the European Medicines Agency ("EMA") for REOLYSIN for the treatment of pancreatic and ovarian cancers (Press release Oncolytics Biotech, DEC 22, 2014, View Source [SID:1234501238]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"This is the second jurisdiction in which we have elected to file for Orphan Designation," said Dr. Brad Thompson, President and CEO of Oncolytics. "The EMA serves all 28 member countries of the EU and securing Orphan Designation would help support the future development of REOLYSIN in the region."

The EMA grants Orphan Designation to medicines intended to treat, prevent or diagnose life threatening and debilitating disease, with a prevalence no greater than five in 10,000 in the EU, and where no satisfactory method of treatment, prevention or diagnosis exists, unless the proposed medicine offers a significant benefit to those with the condition. Following Orphan Designation, sponsors can access a number of incentives including protocol assistance, market exclusivity for a ten-year period following approval and potential fee reductions. The receipt of Orphan Designation does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit: View Source

REOLYSIN is Oncolytics’ proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70% of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.

Pharmacyclics Announces Update on IMBRUVICA® (ibrutinib) Waldenstrom’s macroglobulinemia (WM) Submission

On December 22, 2014 Pharmacyclics reported that the U.S Food and Drug Administration (FDA) has provided a Prescription Drug User Fee Act (PDUFA) target date of April 17, 2015 by which time the FDA is planning to finalize its review of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) as a treatment for patients with Waldenstrom’s macroglobulinemia (WM) (Press release Pharmacyclics, DEC 22, 2014, View Source [SID:1234501234]). IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

Kite Pharma Submits Investigational New Drug Application for Phase 1/2 Trial of KTE-C19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, for the Treatment of Refractory Aggressive Non-Hodgkin Lymphoma

On December 22, 2014 Kite Pharma reported that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 1/2 study of KTE-C19, the Company’s investigational anti-CD19 CAR T cell therapy, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL) (Press release Kite Pharma, DEC 22, 2014, View Source [SID:1234501230]).

Cancer Research UK, CRT and Amgen to trial leukaemia immunotherapy drug in other cancers

On December 22, 2014 Cancer Research UK, Cancer Research Technology (CRT) and Amgen Inc., reported that they have reached an agreement to take forward Amgen’s experimental immunotherapy treatment, AMG319, into its first trial involving patients with solid tumours, following a successful phase one trial of this drug in leukaemia and lymphoma patients (Press release, Cancer Research Technology, 22 22, 2014, View Source [SID1234523243]).

The collaboration forms part of Cancer Research UK’s Clinical Development Partnership (CDP) scheme, a joint initiative between Cancer Research UK’s Centre For Drug Development (CDD) and CRT, to develop promising anti-cancer agents for which pharmaceutical companies do not have the resource to progress through early phase clinical trials.

AMG319 targets an important protein called P13 kinase delta to disable the ‘cloaking device’ that tumours use to evade detection by the immune system.

Studies in mice with solid tumours, part-funded by Cancer Research UK, have shown the ability of this class of drug to mount a response against cancer cells by independently stimulating the immune system but this is the first time it has been trialled in patients with solid tumours.*

Cancer Research UK’s Centre for Drug Development will manage and sponsor the study through the Experimental Cancer Medicine Centre (ECMC) network, with the aim of evaluating the safety and biological effect of AMG319 in patients with head and neck cancer.

Dr Jeremy Haigh, Chief Operating Officer for Amgen’s European R&D Organisation, said: "We fully recognise the value of working with Cancer Research UK in this project. Its distinctive expertise and resources will make a big contribution to our deeper understanding of this area of cancer treatment and wider understanding of AMG319. Cancer Research UK brings more than a century of experience in the prevention, diagnosis and treatment of cancer. "

Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "We’re pleased that this collaboration will allow patients with a wider variety of cancers to access this promising new immunotherapy treatment, which was originally developed for blood cancer patients. Treatments that train the immune system to recognise and kill cancer cells are showing huge promise, so we look forward to seeing whether this drug could echo those results."

Cancer Research UK, CRT and Amgen to trial leukaemia immunotherapy drug in other cancers

On December 22, 2014 Cancer Research UK, Cancer Research Technology (CRT) and Amgen Inc. reported an agreement to take forward Amgen’s experimental immunotherapy treatment, AMG319, into its first trial involving patients with solid tumours, following a successful phase one trial of this drug in leukaemia and lymphoma patients (Press release, Cancer Research Technology, DEC 22, 2014, View Source [SID1234523214]).

AMG319 targets an important protein called P13 kinase delta to disable the ‘cloaking device’ that tumours use to evade detection by the immune system.