On December 15, 2015 Takeda Pharmaceutical Company Limited ("Takeda") reported that "Leuplin PRO for Injection Kit 22.5 mg" (hereafter 24-week depot formulation), the 24-week depot formulation of "Leuplin" (generic name: leuprorelin acetate; hereafter "Leuplin"), is now available in Japan for the treatment of prostate cancer and premenopausal breast cancer (Press release, Takeda, DEC 14, 2015, View Source [SID:1234508575]).

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Leuplin is an LH-RH agonist that consistently stimulates the pituitary gland, resulting in suppressed production of male/female hormone. Leuplin is used as a treatment for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, and it is currently available in the United States, Europe, and Asia. The 24-week depot formulation becomes available for the first time in the world for the treatment of premenopausal breast cancer.

The 24-week depot formulation can maintain stable blood concentration by sustained release using Takeda’s unique microcapsule formulation technology through 24 weeks with a single injection. The new formulation providing sustained efficacy over a 24-week period will be a valuable addition to the available dosing options and provides the added benefit of less frequent dosing thus helping reduce the burden of treatment for patients with prostate cancer and premenopausal breast cancer.

"Given the high unmet needs that remain among patients with prostate cancer and premenopausal breast cancer, we have continued the Research and Development with our drug delivery for Leuplin even after its launch in Japan in 1992," said Masato Iwasaki, Ph.D., Director and President, Japan Pharma Business Unit of Takeda. "We are confident that the new 24-week depot formulation will help ease the various burden of treatment for patients with prostate cancer and premenopausal breast cancer".

On December 14, 2015 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that it has received a notice of allowance for a new patent from the Chinese Patent Office which covers MN-029 (denibulin) di-hydrochloride (Press release, Avigen, DEC 14, 2015, View Source;p=RssLanding&cat=news&id=2122476 [SID:1234508573]).

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Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than July 2032. The allowed claims cover the compound, pharmaceutical compositions and a method of treating certain cell proliferative diseases, including cancer, using denibulin di-hydrochloride. MediciNova intends to use denibulin di-hydrochloride in future development.

"We are very pleased that the Chinese Patent Office will grant our compound patent for MN-029 especially considering that a compound patent is typically very highly valued in China. We will now consider developing a program for MN-029, perhaps through our Chinese joint venture," commented Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.

About MN-029

MN-029 is a novel, small molecule vascular disrupting agent (VDA) being developed for the treatment of solid tumor cancers. MediciNova licensed MN-029 from Angiogene Pharmaceuticals, Ltd. Several preclinical pharmacology studies conducted by Angiogene Pharmaceuticals and MediciNova have assessed the mechanism of action and anti-tumor activity of MN-029 in vivo in rodent models of breast, adrenocarcinoma, colon carcinoma, lung carcinoma and KHT sarcoma. In these studies, MN-029 damaged poorly formed tumor blood vessels by weakening tumor blood vessel walls and causing leakage, clotting and eventual vascular shutdown within the tumor. These studies suggest that MN-029 acts quickly and is rapidly cleared from the body, which may reduce the potential for some adverse effects commonly associated with chemotherapy. Shutdown of tumor blood flow in tumor models was confirmed through the use of dynamic contrast-enhanced MRI. In two Phase 1 clinical studies conducted by MediciNova, MN-029 was well-tolerated at doses that reduced tumor blood flow.

On December 14, 2015 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported that the Company will host a Key Opinion Leader breakfast focused on the treatment landscape for myelodysplastic syndromes (MDS), including the Company’s late-stage drug candidate, rigosertib, a small molecule Ras mimetic that inhibits cellular signaling (Press release, Onconova, DEC 14, 2015, View Source [SID:1234508570]). The event and live webcast will take place on Wednesday, December 16, from 8:00-9:30 AM Eastern Time in New York City.

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The meeting will feature presentations by Guillermo Garcia-Manero, M.D., Chief of the Section of Myelodysplastic Syndromes, Deputy Chair of Translational Research, Co-Director of the DNA Methylation Core, and Professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center, and Lewis R. Silverman, M.D., Associate Professor of Medicine in Hematology and Medical Oncology and Assistant Professor of Oncological Sciences at the Icahn School of Medicine at Mount Sinai. The Onconova management team will also provide an overview of the Phase 2 data from the combination trial of oral rigosertib and azacitidine in higher-risk MDS and AML that was recently presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, which took place December 5-8, 2015. A Q&A session with the featured experts and management will follow the presentations.

This event is intended for institutional investors and sell-side analysts. To reserve a place, please contact Mac MacDonald at 212-915-2567 or via e-mail at [email protected]. A live webcast and subsequent replay of the event will be available at View Source

Guillermo Garcia-Manero, MD, serves as Chief of the Section of Myelodysplastic Syndromes (MDS), Deputy Chair of Translational Research, Co-Director of the DNA Methylation Care, and Professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center (MDACC). He is also on the faculty of The University of Texas Graduate School of Biomedical Sciences at Houston. He has previously served as Co-Chair of the MDS Clinical Research Consortium. The focus of his academic and clinical efforts has been to improve outcomes for patients with MDS.

Lewis R. Silverman, MD, is Associate Professor of Medicine in Hematology and Medical Oncology and Assistant Professor of Oncological Sciences at the Icahn School of Medicine at Mount Sinai (ISMMS). He leads the Myelodysplastic Syndrome and Myeloproliferative Disease Program at ISMMS, where he served as the Principal Investigator for several national clinical trials exploring treatments for patients with MDS. He played an important role in the completion of the AZA-001 trial, which led to the approval of the first drug for the treatment of MDS, azacitidine (VIDAZA).

On December 14, 2015 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported the establishment of an agreement with a major Canadian cancer cooperative group, The Canadian Brain Tumour Consortium (CBTC), for the phase 3 registrational trial of its cancer immunotherapy ICT-107 in patients with newly diagnosed glioblastoma (Press release, ImmunoCellular Therapeutics, DEC 14, 2015, View Source [SID:1234508569]). Established in 1998, and including a national investigator network of over 100 brain tumor specialists and researchers, the CBTC partners with industry to evaluate and execute clinical trials of promising new agents in a timely and cost-effective manner. The CBTC’s major goals are furthering brain tumor research and development and supporting patients and their families who are affected by glioblastoma.

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "Partnering with the highly respected CBTC is a critical component of our clinical trial infrastructure, and further strengthens the multi-national clinical trial network for our ICT-107 phase 3 trial. With complementary collaborations in place with cooperative groups in the US and, Europe, the CBTC collaboration can enable us to execute this international clinical program in a high quality and efficient manner. As the lead asset in our cancer immunotherapy pipeline, we believe that ICT-107 represents a valuable opportunity for ImmunoCellular. As the phase 3 program progresses, we also intend to continue to build our cancer immunotherapy platform, including our Stem-to-T-cell program, with the goal of expanding our anti-cancer technological and therapeutic approaches."

The ICT-107 phase 3 registrational trial is open for enrollment in the US with additional sites anticipated to open in Canada and Europe in the coming weeks and months.

On December 14, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported that its San Diego diagnostic laboratory has been accredited by the College of American Pathologists (CAP) based on results of a recent on-site inspection (Press release, Ignyta, DEC 14, 2015, View Source [SID:1234508568]). This accreditation is awarded to facilities that meet the highest standards of quality in clinical laboratory services. With this recognition, Ignyta’s diagnostic laboratory joins the ranks of some of the most prominent clinical laboratories in the world.

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"We are extremely proud that our in-house diagnostic laboratory has achieved CAP accreditation, further validating our commitment to provide the highest quality laboratory services as part of our focus on helping healthcare providers take better care of patients suffering from cancer," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "This milestone is consistent with our vision of becoming the world’s leading precision medicine company, with an integrated approach to ‘Rx/Dx’ in oncology. Furthermore, we believe our diagnostic laboratory provides us with a competitive advantage. For example, in our potentially-registration-enabling Phase 2 clinical trial of entrectinib, STARTRK-2, we are using our lab as the FDA-required central lab to confirm the results of local genetic patient screening for enrollment, as well as to perform central testing for clinical sites without the means for local genetic screening to identify patients with molecular alterations eligible for this clinical trial that would otherwise not have been identified."

The U.S. Centers for Medicare & Medicaid Services (CMS) has approved CAP as an accreditation organization for clinical laboratories under CLIA (Clinical Laboratory Improvement Amendments). Ignyta had previously announced CLIA registration of its diagnostic laboratory, and CAP accreditation results in full CLIA certification for Ignyta’s diagnostic laboratory.