Cellular Biomedicine Group (CBMG) Announces the Addition of a Second Clinical Site in the Expansion of its Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for Its CARD-1 Trial in Patients with Non-Hodgkin Lymphoma (NHL)

SHANGHAI, China and CUPERTINO, Calif., May 15, 2017 -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, today announced the addition of a new independent Phase I clinical trial of the Company’s ongoing CARD-1 study in patients with chemorefractory and aggressive DLBCL. The Company and Shanghai Tongji Hospital (Tongji) are conducting a single arm, non-randomized study to evaluate the safety and efficacy of C-CAR011 (Anti-CD19 single-chain variable fragment (scFv) (41BB-CD3ζ)) therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The trial will enroll 15 patients comprised of DLBCL, Primary Mediastinal Large B-Cell Lymphoma (PMBCL) and Follicular Lymphoma (FL).

Published: 15 May 2017

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SYN-004 (Ribaxamase) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Prevention of Clostridium difficile Infection

-- FDA Action Marks First Breakthrough Therapy Designation for Clinical Program Designed to Prevent Primary Clostridium difficile Infection --

-- Type-B Meeting Anticipated to Discuss Potential for Expedited Drug Development Strategy --

ROCKVILLE, Md., May 11, 2017 -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection. SYN-004 (ribaxamase) is the Company's first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics.

Published: 11 May 2017

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Delcath Announces First Quarter 2017 Financial Results

NEW YORK, May 09, 2017 -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, announces financial results for the three months ended March 31, 2017.

Highlights for the first quarter of 2017 and recent weeks include:

First quarter 2017 revenue of $0.74 million, an increase of 100% compared with revenue of $0.37 million in prior year quarter;

CHEMOSAT treatment milestone set by SPIRE Southampton Hospital in the U.K. with more than 100 CHEMOSAT treatments performed, including eight treatments on a single patient;

Announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of a pivotal trial of Melphalan/HDS to treat patients with intrahepatic cholangiocarcinoma (ICC);

Published: 09 May 2017

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Oncolytics Biotech® Inc. Announces FDA Fast Track Designation for REOLYSIN® in Metastatic Breast Cancer

CALGARY, May 8, 2017 - Oncolytics Biotech® Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for REOLYSIN®, the Company's proprietary immuno-oncology viral agent, for the treatment of metastatic breast cancer.

"Fast Track designation represents an important step for our clinical development plan, which is squarely focused on a registration pathway in metastatic breast cancer and advancing REOLYSIN to regulatory review as quickly as possible," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Our goal is to conduct an End-of-Phase 2 meeting with the FDA as soon as is practical and obtain scientific guidance. We are eager to leverage this designation and use the opportunity for more frequent dialogue with the FDA, as well as the potential for an expedited review process, to support the future development of REOLYSIN."

Published: 08 May 2017

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Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 for Alzheimer ’s Disease Agitation

NEW YORK, May 08, 2017 -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for AXS-05 for the treatment of agitation in patients with Alzheimer’s disease (AD). There are currently no approved treatments for this condition. Axsome previously received Investigational New Drug Application (IND) clearance from the FDA to proceed with a Phase 2/3 trial of AXS-05 in this indication.

“Agitation is reported in nearly half of individuals living with Alzheimer’s disease, results in distress to patients and caregivers, and has significant consequences including early nursing home placement and increased mortality,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “The receipt of Fast Track designation from the FDA highlights the serious nature of this condition, the lack of FDA-approved treatments, and the potential of AXS-05 to address this high unmet medical need.”

Published: 08 May 2017

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