On October 10, 2014 Ipsen reported positive results from the phase III study of triptorelin pamoate 11.25 mg (Decapeptyl 3 months) administered subcutaneously in patients with locally advanced or metastatic prostate cancer at the European Association of Urology (EAU) 14th Central European Meeting in Cracow, Poland (10-12 October 2014) (Press release Ipsen, OCT 10, 2014, View Source [SID:1234500820]).

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The primary objective of the study was to assess the efficacy and safety profile of the sustained-release triptorelin pamoate 11.25 mg (Decapeptyl 3 months) formulation when administered by the subcutaneous route in men with locally advanced or metastatic prostate cancer. This objective was met with castration levels of testosterone achieved in 97.6% [95% CI: 93.2-99.5] of men at week 4 and castration maintained in 96.6% of these men [95% CI: 91.6-99.1] at week 26.

Mean testosterone levels decreased to 18.4 ng/dl and 10.2 ng/dl at week 4 and week 8,
respectively, and remained within this range until the end of the study. Median time to achieve
castration was 22 days. For more than 90% of the patients, the level of testosterone was
maintained below 20 ng/dl from week 8 up to the end of the trial.

Median Prostate Specific Antigen (PSA) levels were reduced by 64.2% and 96.0% at week 4
and week 26, respectively. PSA levels remained within the normal range (0–4 ng/ml) from week 8 until the end of the study.

On October 9, 2014 GenSpera reported that patient enrollment has been completed in the company’s Phase II clinical trial in patients with liver cancer (hepatocellular carcinoma) (Filing 8-K , GenSpera, OCT 10, 2014, View Source [SID:1234500819]). Formal results of the study are expected to be available during the first quarter of 2015.

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"We are grateful to the trial investigators for their efforts, as well as the patients and their loved ones who are supporting this important trial," said Craig Dionne, PhD, GenSpera’s CEO. "The completion of the enrollment period for this trial marks another company milestone. The data we have collected to date establish proof of concept for mipsagargin’s destruction of blood vessels within tumors and encouraging signs of potential anti-tumor activity. We anticipate similar results in our ongoing Phase II trials in patients with glioblastoma as well as our planned Phase II trial in patients with prostate cancer."

Interim data from the ongoing Phase II clinical trial in liver cancer patients were recently presented at the Asia Pacific Primary Liver Cancer Expert Meeting in Taipei in July 2014 (APPLE2014) and at the International Liver Cancer Association (ILCA) meeting in Kyoto in September 2014. Impressively, 80% of liver cancer patients in the Phase Ib and Phase II studies experienced disease stabilization at two months and a significant percentage of patients had stable disease for at least nine months after beginning treatment with mipsagargin.

The US Food and Drug Administration (FDA) granted Orphan Drug designation in 2013 for the evaluation of mipsagargin in patients with hepatocellular carcinoma.

On October 10, 2014 ARIAD Pharmaceuticals reported that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded its review of Iclusig (ponatinib) under the Article 20 referral procedure and has recommended that Iclusig continue to be used in Europe in accordance with its already approved indications (Press release Ariad, OCT 10, 2014, View Source;p=RssLanding&cat=news&id=1976197 [SID:1234500818]).

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"We are grateful for the rigorous and in-depth review provided by the PRAC and the Scientific Advisory Group for Oncology," stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "The PRAC recommendation provides insightful guidance to healthcare professionals and patients regarding the use of Iclusig in patients with Ph+ leukemias and importantly, leaves the original Iclusig indication statement unchanged. We look forward to consideration and adoption of these recommendations by the CHMP later this month and authorization by the European Commission by the end of the year."

The authorized indications of Iclusig in Europe, as approved in July 2013, are as follows:

The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or
The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Other recommendations made by the PRAC related to the Iclusig Summary of Medicinal Product Characteristics (SmPC) include, (1) patient monitoring for response according to standard clinical guidelines, (2) consideration of Iclusig dose-reduction following achievement of major cytogenetic response with subsequent monitoring of response and, (3) consideration of Iclusig discontinuation if a complete haematologic response has not been achieved by three months. Further information is provided indicating that the risk of vascular occlusive events is likely dose-related. An update of the Warning and Precautions and Undesirable Effects sections is also provided for inclusion in the Iclusig SmPC.

"The recommendation from the PRAC confirms a positive benefit-risk assessment for Iclusig after thorough consideration of updated safety information," said Stephen G. O’Brien, M.D., Ph.D., Professor of Haematology at the Northern Institute for Cancer Research at Newcastle University, United Kingdom. "This is a good outcome for patients and healthcare professionals in Europe as it continues to offer a treatment option to CML patients who have become resistant to, or intolerant of, certain other TKIs."

The PRAC is the committee at the EMA that is responsible for assessing and monitoring safety issues for human medicines. The PRAC’s recommendations are considered by the CHMP when it adopts opinions for centrally authorized medicines and referral procedures.

On October 9, 2014 Vernalis plc reported that it has licensed worldwide rights in vipadenant (V2006), a small molecule A2A receptor antagonist, to RedoxTherapies Inc (Redox) (Press release, Vernalis, OCT 9, 2014, View Source [SID:1234513891]). Vipadenant has the potential to disrupt an immunosuppressive mechanism of tumor protection, generating improved efficacy for immunotherapies of certain cancers when used in combination.

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Redox is a private, Boston-based start-up company that is the exclusive licensee of National Institute of Health (USA) intellectual property in the field of using extracellular adenosine receptor inhibitors in combination with immuno-oncology therapies.

The detailed financial terms of the Licence Agreement with Redox are not disclosed, but Vernalis can earn milestones and royalties on successful clinical, regulatory and commercial advancement.

Commenting on the new relationship, Ian Garland, CEO of Vernalis said "We look forward to having Redox as a partner and to the progress of vipadenant into clinical studies in this exciting new setting for the potential benefit of cancer patients worldwide".

(Press release, Intensity Therapeutics, OCT 9, 2014, View Source [SID:1234503398])

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