On November 13, 2015 GenSpera, Inc. (OTC/QB: GNSZ), a biotech company developing a novel prodrug therapeutics for the treatment of cancer, reported it is providing an update on its clinical development programs and corporate developments (Filing, 8-K, GenSpera, NOV 13, 2015, View Source [SID:1234508236]).

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The Company also announced that a poster entitled "Phase II study of mipsagargin (G-202), a PSMA-activated prodrug targeting the tumor endothelium, in adult patients with recurrent or progressive glioblastoma" will be presented at the 20th Annual Society for Neuro-Oncology Annual Scientific Meeting and Education Day on Friday, November 20, by Principal Investigator David Piccioni, MD, PhD, of the University of California, San Diego.

Mipsagargin Clinical Development

Glioblastoma (brain cancer)

· The Phase II data observed in the first 12 glioblastoma patients exceeded criteria required to expand enrollment and commence the second stage of the Phase II trial. Encouraging interim Phase II data demonstrated clinical benefit in a subset of patients with high levels of prostate-specific membrane antigen (PSMA) expression in the primary tumor. Three of 11 evaluable patients experienced stable disease for at least two months and a reduction in tumor volume. Additionally, an immediate reduction in edema was observed in one patient who remains on study 10 months after initiation of treatment.

· The U.S. Food and Drug Administration (FDA) granted $1.6 million for the study of PSMA and other biomarkers to better identify the subset of patients that will receive the most therapeutic benefit with mipsagargin treatment. Santosh Kesari, MD, PhD, of the John Wayne Cancer Institute will lead this initiative.

· A total of 18 patients have been treated by early November. Additional interim results of the Phase II trial are expected in first quarter of 2016 and final data, evaluating six-month progression-free survival, is expected in the fourth quarter of 2016.

Hepatocellular Carcinoma (liver cancer)

· Discussions and preparations for a Phase IIa dose-escalation trial evaluating safety, tolerability and efficacy focused in East Asian patients are ongoing. Previously presented data showed 63% of patients experienced disease stabilization at two months. Mipsagargin was considered safe with minimal and manageable side-effects and demonstrated decreased blood flow in liver tumors as measured by DCE-MRI.

"We believe that the positive clinical activity we observe is due to mipsagargin’s ability to attack the PSMA-expressing cells within solid tumors, which is a highly differentiated approach from conventional chemotherapy," said Craig Dionne, PhD, CEO of GenSpera. "Mipsagargin does not need to cross the blood-brain barrier to be effective, which further distinguishes the drug from other agents in development for glioblastoma. The company will strategically focus efforts on the glioblastoma trial while continuing to be opportunistic to additional collaborations and partnerships for further research and development advances through 2016."

Third Quarter and Recent Corporate Highlights

· In October, Dr. Santosh Kesari a recognized leader in neurology and neuro-oncology, joined our Scientific Advisory Board. Dr. Kesari is Chair of the Department of Translational Neuro-Oncology and Neurotherapeutics at the John Wayne Cancer Institute and Director of Neuro-Oncology at Providence Saint John’s Health Center.

· Phyton Biotech announced that its international patent application WO 2015/0892978 A1 "PRODUCTION OF THAPSIGARGINS BY THAPSIA CELL SUSPENSION CULTURE" was published by the World Intellectual Property Organization (WIPO). The invention described in the patent application provides, for the first time, a suspension cell culture suitable for mass production of thapsigargin and offers a potential alternative route to commercial-scale production of this starting material for synthesis of mipsagargin.

· In October Dr. Dionne acquired 262,500 shares of GenSpera by electing to convert $105,000 of notes due to him by the Company at $0.40 per share and waiving outstanding accrued interest.

On November 13, 2015 Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) reported that it has put a temporary hold on patient enrollment in its ongoing Phase 2 portion of the trial, "A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer," pending the institution of a protocol amendment following receipt of recommendations from its independent Data Safety Monitoring Board (DSMB) (Press release, Momenta Pharmaceuticals, NOV 13, 2015, View Source [SID:1234508230]).

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The DSMB met to discuss a limited number of specific toxicities, including thrombocytopenia, risk of bleeding, and thromboembolic events. After thorough review, the DSMB found no safety signals to suggest the need to unblind results, close the study, or discontinue dosing in patients already enrolled in the trial. The DSMB did recommend that the company amend its protocol to standardize the approach to diagnosing and managing thrombocytopenia and consider holding new patient accrual until the amendment is instituted. The DSMB also noted that the causes of thrombocytopenia and subsequent bleeding in these patients can be multifactorial. The Company is assessing whether its protocol amendment and enrollment pause will delay release of top-line data beyond the first half of 2017.

"We support the DSMB’s recommendations regarding the most appropriate path forward for the Phase 2 portion of the trial. As always, patient safety is our primary concern, and we will work diligently to institute their recommendations and resume enrollment in this study," stated Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals.

About Necuparanib

Necuparanib (M402) is a novel oncology drug candidate engineered to have a broad range of effects on tumor cells. The use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity; however, the dose of these products has been limited by their anticoagulant activity. Leveraging its experience in deciphering the structure-function relationships of complex therapeutics, Momenta engineered necuparanib from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins. A Phase 2 randomized, double-blind, controlled study to evaluate the antitumor activity of necuparanib in combination with nab-paclitaxel (Abraxane) plus gemcitabine, versus nab-paclitaxel plus gemcitabine alone in pancreatic cancer is currently underway. Necuparanib has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.