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.

On December 14, 2015 Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating activity at the glucocorticoid receptor (GR), reported initial efficacy data from its Phase 1/2 trial of mifepristone in combination with the chemotherapy drug eribulin to treat patients with GR-positive, metastatic, triple-negative breast cancer (TNBC) (Press release, Corcept Therapeutics, DEC 14, 2015, http://www.corcept.com/news_events/view/pr_1450104306 [SID:1234508565]). The data were presented at the 2015 San Antonio Breast Cancer Symposium (SABCS) on Saturday, December 12th, 2015.

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Trial Design and Objective

Corcept is investigating whether the addition of mifepristone, the active ingredient in Corcept’s approved medication, Korlym, will enhance the effect of eribulin in patients whose TNBC tumors express GR, one of the receptors to which Korlym binds.

The trial is being conducted in two parts. In the first phase, researchers determined the maximum tolerated combined dose of mifepristone and eribulin. This dose — 300 mg of mifepristone daily with 1.1 mg/m2 of eribulin taken on days one and eight of a three week cycle — is now being administered to patients in the trial’s second, efficacy phase, which will enroll 20 patients with GR-positive, metastatic TNBC. This phase of the trial is ongoing.

Initial Efficacy Results

At SABCS, the trial’s investigators presented efficacy data from the 15 patients enrolled to-date with GR-positive TNBC who have been treated with the recommended dose (two patients from the trial’s first phase and 13 from its second). As determined using the Response Evaluation Criteria in Solid Tumors (RECIST), initial efficacy results in this group were as follows: one patient exhibited a partial response (defined as a 30 percent or greater reduction in tumor size), seven had stable disease and five had progressive disease. Two patients were too early in their treatment to be assessed.

The combination of mifepristone and eribulin has been well-tolerated. Most adverse events have been disease-related and of mild or moderate severity, with the most common being neutropenia, fatigue, hypokalemia, nausea, hair loss and neuropathy. Neutropenia has been manageable with the administration of growth factor. No patient has suffered a serious adverse event. Pharmacokinetic data show no interaction between eribulin and mifepristone.

"We are pleased that the combination of mifepristone and eribulin appears to be active in these very ill patients," said Robert S. Fishman, MD, Corcept’s Chief Medical Officer. "Our oncology program is based on the hypothesis that GR modulators such as mifepristone can enhance the efficacy of a variety of chemotherapeutic agents in GR-positive disease. We very much look forward to completing the trial. If the final results are sufficiently positive, we plan to initiate a Phase 3 trial of this treatment regimen next year."

Corcept’s trial builds on pre-clinical and clinical research performed by investigators at Corcept and at the University of Chicago showing that modulation of activity at GR enhances the effect of chemotherapy in the treatment of TNBC. At the 2013 SABC, University of Chicago researchers presented positive results of a trial in which six patients with metastatic, GR-positive TNBC received a combination of nab-paclitaxel and mifepristone

About Triple-Negative Breast Cancer

TNBC is a form of breast cancer in which the three receptors that fuel most breast cancer growth — estrogen, progesterone and HER-2 — are not present. Because the tumor cells lack these receptors, treatments that target estrogen, progesterone and HER-2 are ineffective. Approximately 40,000 women are diagnosed with triple-negative breast cancer each year. It is estimated that more than 75 percent of these women’s tumor cells express GR. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed triple-negative breast cancer patients exists.

Corcept has licensed patents from the University of Chicago covering the use of GR antagonists in combination with chemotherapy to treat TNBC and castration-resistant prostate cancer.

About Korlym (mifepristone)

Korlym modulates the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has marketed Korlym as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness, and the FDA has designated Korlym as an Orphan Drug for that indication.