Author: [email protected]

(Report, JHL Biotech, MAR 10, 2014, View Source,%20a%20leading%20online%20provider%20of%20biopharmaceutical%20information(1).pdf [SID:1234503386])

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Successful completion of the Phase I trial of GSK1070916

On March 7, 2014 Cancer Research UK reported that Dr Nigel Blackburn, director of Cancer Research UK’s Drug Development Office, said: "It is fantastic news that this study has been successfully completed in partnership with GlaxoSmithKline. This is the first trial to conclude under Cancer Research UK’s Clinical Development Partnerships (CDP) initiative. This achievement clearly shows the CDP scheme is succeeding in providing an alternative route for companies to advance new anti-cancer drugs that would not otherwise be developed(Press release, Cancer Research Technology, MAR 7, 2014, View Source [SID1234523229])."

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Background Information

The Phase I trial was led by Professor Christopher Twelves at the Leeds and NIHR Experimental Cancer Medicine Centre (ECMC) and the Clinical Research Facility at St James’s Institute of Oncology and by Professor Iain Mcneish at the ECMC at Barts Cancer Institute in London. Cancer Research UK and GSK have agreed that pre-determined success criteria have been met, which in turn means that Cancer Research UK will receive a success payment from GSK. This was the third drug to enter Cancer Research UK’s CDP pipeline and is the first project to be completed.

The clinical trial involved GSK1070916, an inhibitor of Aurora B/C kinases that play a key role in multiple steps of cell division and are over-expressed in a range of cancers. The trial involved 36 adult patients with solid tumours and assessed the drug’s safety profile, dosing and tumour response. The drug was well tolerated and measurement of a surrogate marker of inhibition indicated on-target activity at the established maximum tolerated dose.

8-K – Current report

On March 2014 NewLink Genetics reported the continuation of the Phase 3 IMPRESS clinical study (NCT01544179) of algenpantucel-L for patients with surgically resected pancreatic cancer following the first of two planned interim data analyses (Filing 8K, NewLink Genetics, MAR 7, 2014, View Source [SID:1234500254]).
As part of the planned interim analysis, scheduled to occur following 222 patient events, the independent data safety monitoring committee (DSMC) met to review available patient data. Following their review, the DSMC recommended that the study should proceed as planned, without modification. A second interim analysis is planned upon reaching 333 patient events and, if needed, a final analysis is planned at 444 patient events.

Redx Pharma and Pierre Fabre collaborate in the promising field of Onco-Dermatology

On March 6, 2014 Redx Pharma and Pierre Fabre Laboratories entered into a collaboration and option agreement in cancer research (Press release Redx Pharma, MAR 6, 2014, View Source [SID:1234500250]).
The exclusive deal will see Redx and Pierre Fabre Research Institute (IRPF) work together on the evaluation and development of a small molecule program for an undisclosed oncology target. Following the first stage of the collaboration, IRPF will have the option to enter into exclusive negotiations to license global rights for the program in selected cancer indications.
The financial terms of the agreement have not been disclosed.

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Novartis announces positive Phase III study for Jakavi� in patients with rare blood cancer polycythemia vera

On March 7, 2014 Novartis reported that a pivotal Phase III trial of Jakavi (ruxolitinib) compared to best available therapy has met its primary endpoint of maintaining hematocrit control without the need for phlebotomy and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea (Press release Novartis, MAR 6, 2014, View Source [SID:1234500248]). The safety profile of ruxolitinib was generally consistent with previous studies based on initial review of the data.
Data from the study (RESPONSE) will be presented at an upcoming medical congress and submitted to worldwide regulatory authorities this year.
Novartis plans to submit these data to worldwide regulatory agencies this year, as they seek to bring ruxolitinib to patients with polycythemia vera who are no longer responding to or are intolerant of prior therapy.
RESPONSE is a global, randomized, open-label study conducted at 109 sites. The trial randomized 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea. Patients were randomized 1:1 to receive either ruxolitinib (10 mg twice-daily) or best available therapy, which was defined as investigator selected monotherapy or observation only. The dose was adjusted as needed throughout the study.
The primary endpoint of the study is the proportion of patients whose hematocrit is controlled without phlebotomy and whose spleen volume is reduced by 35% or more from baseline as assessed by imaging at 32 weeks. In addition to safety, key secondary endpoints include durable response and complete hematological remission.
Ruxolitinibis currently approved in more than 55 countries for patients with myelofibrosis, a debilitating and life-threatening blood cancer.