MVT-1075 Combines the Company's HuMab-5B1 Antibody with the Radiopharmaceutical (177)Lutetium to Treat Pancreatic Cancer. Patient Enrollment in Trial Expected to Begin in First Half of 2017

 

SAN DIEGO, Feb. 23, 2017  -- MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company, announces that it has received notice from the U.S. Food and Drug Administration (FDA) authorizing the initiation a Phase I clinical trial with MVT-1075 as a therapeutic treatment for pancreatic cancer. MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1) is the Company's novel fully human antibody radioimmunotherapy (RIT). MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies the first half in 2017.  This is the third IND authorized by FDA in the last fourteen months by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company's proprietary cancer vaccines.

CAMBRIDGE, MASSACHUSETTS--(Feb. 22, 2017) - VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) ("VBI") announced today that the Biologics and Genetic Therapies Directorate (BGTD) of Health Canada expressed its general support and acceptance of the company's development path for its Sci-B-Vac™ vaccine, a prophylactic vaccine against hepatitis B, in a pre-Clinical Trial Application ("CTA") meeting. A complete CTA must be filed with and approved by BGTD, and all conditions of BGTD must be met, prior to the initiation of a clinical program in Canada.

 

Given the extensive manufacturing data, licensed clinical efficacy and safety experience of Sci-B-Vac™, BGTD agreed in principle with the overall development strategy of VBI. In addition, BGTD agreed that the proposed Phase III program would satisfy the regulatory requirements for marketing authorization in Canada, supporting the indication for active immunization against hepatitis B in adults. Sci-B-Vac™ fills a significant gap in an unmet medical need to protect against hepatitis B, especially in older individuals who may not be protected with currently licensed hepatitis B vaccines.

NEW YORK, Feb. 21, 2017  -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced that a retrospective, multicenter study demonstrated that 45.7 percent of patients with ocular melanoma that metastasized to the liver who underwent percutaneous hepatic perfusion (PHP) using investigational Melphalan/HDS experienced a complete or partial response. The study further showed that among those who responded to treatment, overall survival was projected to be more than three years.

ApoGraft TM, Cellect’s flagship technology, validated as safe, robust and reproducible process for clinical use after a 104 donor test base

Cellect CEO: “In plain words, these positive results bring us one step closer to making stem cell therapies safe, effective and available”

 

TEL AVIV, Israel, Feb. 21, 2017  -- Cellect Biotechnology Ltd. (Nasdaq:APOP) (TASE:APOP), a developer of stem cell selection technology, announced today positive final results from its clinical trial of ApoGraft™ in healthy donors. The study’s primary objective was to validate the Company's propriety method of stem cell selection by going through the process of production and characterization with ApoGraft™, and was conducted on samples obtained in collaboration with two leading medical centers in Israel, The Schneider Children's Medical Center and the Rambam Medical Center.