On September 29, 2015 Clovis Oncology, Inc. (NASDAQ: CLVS) reported two major regulatory milestones for rociletinib, its investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation (Press release, Clovis Oncology, SEP 29, 2015, View Source;p=RssLanding&cat=news&id=2091515 [SID:1234507613]). The U.S. Food and Drug Administration (FDA) has accepted Clovis’s New Drug Application (NDA) for rociletinib and has granted it priority review status with a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2016.

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Additionally, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for rociletinib. Europe’s Committee for Medicinal Products for Human Use (CHMP) granted Clovis an accelerated assessment for the drug, which reduces the time limit for CHMP to reach an opinion from 210 days to 150 days. Accelerated assessment is granted in recognition of the likelihood that a therapeutic will be of major public health interest in the EU, given the importance of therapeutic innovation in a patient population that exhibits a high unmet need.

Rociletinib is the company’s novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Data from both the pivotal, single-arm TIGER-X and TIGER-2 clinical trials served as the basis for the U.S. and EU regulatory submissions for the treatment of advanced mutant EGFR T790M-positive lung cancer. Rociletinib was given Breakthrough Therapy designation by the FDA in May 2014.

On September 29, 2015 Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle") reported that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 9,144,568, which pertains to the use of the bendamustine hydrochloride (HCl) formulation administered in a 50mL bag within ten minutes (the "rapid infusion" product) (Press release, Eagle Pharmaceuticals, SEP 29, 2015, View Source [SID:1234507608]). The patent issued today expires on March 15, 2033. This new patent, along with three previously issued Patents (Nos. 8,609,707, 9,000,021, and 9,034,908), further expands and protects Eagle’s bendamustine HCI intellectual property estate.

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"Today’s patent issuance further strengthens our intellectual property for the bendamustine rapid infusion product, for which a New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA)," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "We believe that approval of and subsequent launch by Teva of this important product, along with royalty payments earned on sales and the potential for additional milestone payments, will expedite Eagle’s ability to deliver long term, sustainable growth."

The Prescription Drug User Fee Act (PDUFA) goal date for a decision on the NDA by the FDA is December 2015. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The NDA for Eagle’s rapid infusion bendamustine product is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low- volume, 50 mL admixture.

The rapid infusion product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval.

In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.

On September 29, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it will present an abstract entitled, "Dianhydrogalactitol (VAL-083) Offers Potential Therapeutic Alternatives in the Treatment of Pediatric Brain Tumors," at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship conference being held November 9–12, 2015 in Fort Lauderdale, FL (Press release, DelMar Pharmaceuticals, SEP 29, 2015, View Source [SID:1234507607]).

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The Company will present on Tuesday, November 10th during Poster Session A scheduled to begin at 4:30 p.m. The poster presentation will summarize the potential of VAL-083 as a new treatment for malignant pediatric brain tumors in the context of historical clinical trials sponsored by the U.S. National Cancer Institute and DelMar’s recent research.

The Company recently presented an update from its ongoing multicenter Phase I/II clinical study for the treatment of adult refractory glioblastoma multiforme (GBM) at the GBM2015 Conference. VAL-083 demonstrated a favorable safety-profile and doses up to 40mg/m2 were well tolerated by patients receiving three daily doses in a 21 day cycle. A sub-group analysis of patients receiving up to 5 mg/m2 daily x 3 every 21 days (low dose) versus those patients receiving 30mg/m2 or 40mg/m2 (high dose) of VAL-083 demonstrated a dose-related survival benefit in adult GBM patients failing standard front-line therapy and bevacizumab.

About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory GBM in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA) at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes following front-line treatment with Temodar (temozolomide).

On September 29, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company"), reported that the Journal of Clinical and Cellular Immunology has published a paper titled, "The Potential of Intralesional Rose Bengal to Stimulate T-Cell Mediated Anti-Tumor Responses (Filing, 8-K, Provectus Pharmaceuticals, SEP 29, 2015, View Source [SID:1234507601])." The paper can be found online at View Source

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Authors Ajay V Maker, Bellur Prabhakar, and Krunal Pardiwala state that their "article serves to evaluate the potential of intralesional rose bengal [RB] to stimulate T-cell mediated anti-tumor responses in in-vitro, pre-clinical, and clinical studies." The review covers findings in both animal models and human clinical trials covering the use of intralesional RB in the treatment of: melanoma, breast cancer, ovarian cancer, gastric cancer and sarcoma.

They conclude, "Our current research is establishing the role of RB in generating anti-tumor immune responses in gastrointestinal cancer and liver metastases. Decrease in tumor burden and stimulation of an immune response with PV-10 has been demonstrated in animal models of metastasis, and correlations of these responses in clinical studies is consistent with such results. That PV-10 treatment can potentially increase circulating cytotoxic T-cells, even in patients who were previously treated with immune-activating checkpoint blockade, supports the possibility that RB induced cytotoxicity may activate T-cells that are responsible for the bystander effect on untreated lesions. As such, intralesional therapy with RB may be a promising new mode of therapy to stimulate T-cell mediated anti-tumor immune responses."

On September 29, 2015 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has received additional approval for the vascular embolization device DC Bead (specially controlled medical device, "DC Bead") to be used for the treatment of hypervascular tumors and arteriovenous malformations (AVM) in Japan (Press release, Eisai, SEP 29, 2015, View Source [SID:1234507598]). The product will be able to be reimbursed for this newly approved purpose once procedures are completed for insurance reimbursement listing as a specially controlled medical device (the original purpose for treatment of hepatocellular carcinoma is already eligible for reimbursement).

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DC Bead contains hydrophilic microspheres made from cross-linked polyvinyl alcohol polymer. Developed by Biocompatibles UK Limited (Biocompatibles), a BTG International group company, as an intravascular embolization device, it is injected via catheter into targeted blood vessels to achieve selective embolization. Eisai acquired the exclusive rights to develop and market DC Bead in Japan from Biocompatibles in July 2009 and received manufacturing and marketing approval for the device from Japan’s Ministry of Health, Labour and Welfare (MHLW) in April 2013 for use in transcatheter arterial embolization in hepatocellular carcinomas. Eisai subsequently launched DC Bead in Japan in February 2014.

A hypervascular tumor most commonly refers to hepatocellular carcinoma, certain metastatic liver cancers, renal cell carcinoma, soft tissue sarcoma, uterine fibroids and other tumors that are nourished via a sophisticated vascular network developed in tumor tissue. An AVM is a congenital vascular malformation that leads to various functional, organic and developmental disorders that are caused by an abnormal connection between the arteries and veins disrupting the normal circulation of blood. By selectively embolizing the sections of blood vessels that are supplying nutrients to tumor tissue and malformations, it is possible to necrose or reduce tumors, and improve associated symptoms.

It was recommended at the MHLW’s Study Council for the Early Introduction of Highly Needed Medical Devices that DC Bead be made available as soon as possible as a device indicated for the treatment of hypervascular tumors as well as AVM. Upon receiving this recommendation, Eisai conducted clinical studies aiming to confirm safety and efficacy of using DC Bead as an embolization material on hypervascular tumors and AVM (excluding central nervous system, heart and lung AVM) in Japan in order to secure an indication expansion. Results of these studies suggested safety and efficacy for DC Bead as replenishment material to promote embolization within the arteries of the central circulatory system, which led Eisai to submit an application for an additional purpose in September 2014.

Through the approval of this indication expansion for DC Bead, Eisai seeks to further contribute to addressing the diverse needs of, and increasing the benefits provided to, patients and their families as well as healthcare providers.