(Company Web Page, AllaChem, AUG 16, 2013, View Source [SID:1234502046])

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(Filing, 10-Q, Prothena, AUG 13, 2013, View Source [SID:1234505969])

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On August 12, 2013 Vical reported top-line results from a Phase 3 trial of Allovectin (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, in patients with metastatic melanoma (Press release Vical, AUG 12, 2013, View Source [SID:1234501043]). The 390-subject trial failed to demonstrate a statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization or the secondary endpoint of overall survival. Trial data will be further analyzed and detailed results will be submitted for publication.

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"We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," said Vijay B. Samant, President and Chief Executive Officer of Vical. "Based on this outcome, we are terminating the Allovectin program and focusing our resources on our infectious disease vaccine programs." Mr. Samant added, "We would like to recognize all of the patients and their families, trial investigators and employees who participated in the conduct of this trial and thank them for their efforts."

On August 8, 2013 Teva reported that the European Commission has granted marketing authorization for Lonquex (lipegfilgrastim) (Press release Teva, AUG 8, 2013, View Source;p=irol-newsArticle&ID=1846232 [SID:1234500815]). This approval provides the regulatory framework for the commercialization of Lonquex in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein.

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Lonquex is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) with the active ingredient lipegfilgrastim – a novel glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex (lipegfilgrastim) is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). Lonquex is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

"This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer" said Dr. Rob Koremans, President and CEO of Teva Specialty Medicines. "Lonquex is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy. The European approval comes earlier than expected, just 8 weeks after the positive CHMP opinion. We look forward to providing this oncology supportive care treatment option in all European Union member states."

Lonquex has undergone a full clinical development program, including pre-clinical to clinical in vivo studies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.

Dr. Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer, commented: "Effective prevention and treatment of febrile neutropenia is an important consideration for clinicians managing cancer patients who are undergoing cytotoxic chemotherapy. As well as targeting cancer cells, chemotherapy affects rapidly-dividing bone marrow cells, thereby dramatically reducing a patient’s ability to fight off infection, with potentially serious consequences. This approval is testament to Teva’s commitment to bringing new and alternative treatments to market to support clinicians in caring for patients."

On August 6, 2013 Benitec Biopharma reported that it has entered into a licensing agreement with San Diego (US) based Regen BioPharma. Benitec’s exclusive licence allows Regen to develop cancer vaccines using Benitec’s ddRNAi gene silencing technology (Press release Benitec, AUG 6, 2013, View Source [SID:1234500858]).

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Benitec’s licence to Regen covers the application of ddRNAi to silence indoleamine 2,3-doxygenase (IDO) in Dendritic Cells. IDO is associated with immune-suppression and is over-expressed in cancer. Regen has produced pre–‐clinical evidence that modification of these cells using ddRNAi targeting the silencing of IDO should significantly enhance their efficacy as anti- cancer vaccine agents. A peer – reviewed publication describing this work was published in the February 2013 volume of the International Journal of Cancer (Zheng et al. Silencing IDO in dendritic cells: a novel approach to enhance cancer immunotherapy in a murine breast cancer model. Int J Cancer. 2013 Feb 15;132(4):967 – 77). Whilst the terms are commercial, in confidence, they are within the expected guidelines for small biotech companies in the early stage of therapeutic development, with fees based on the achievement of agreed milestones.

Chief Executive Officer of Benitec Biopharma Ltd, Dr Peter French, commented, "Benitec is very pleased to have executed this licensing deal with Regen BioPharma. Using ddRNAi to manipulate Dendritic Cells to stimulate the immune system to kill cancer cells is an innovative concept for the treatment of cancer in a non–‐toxic manner. Regen joins a growing list of biotechnology companies that have recognised the advantage of licensing Benitec’s transformational gene silencing technology, ddRNAi, to develop novel therapies for human disease. For Benitec this provides the opportunity to generate additional evidence that validates and reinforces the potential of our platform technology."

Chairman & Chief Executive Officer of Regen BioPharma, Dr. David Koos, commented, "Benitec is the leader in clinical development of ddRNAi, which allows for "gene–‐specific surgery". By combining our existing data with the issued patents and experience of Benitec, we look forward to developing an immune–‐based, non–‐toxic, cancer treatment initially targeting breast cancer."