AVEO Announces TIVO-3 Passes The First Safety Monitoring Committee Safety Review

CAMBRIDGE, Mass. --  AVEO Oncology (NASDAQ:AVEO) today announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC), has successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment.
 
As recently announced, the TIVO-3 trial is enrolling substantially ahead of schedule, and with the SMC recommendation to replace early dropouts the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support regulatory approval of tivozanib in the U.S. as first and third line treatment for RCC.
Read more: AVEO Oncology ( AVEO )

Tetra Bio-Pharma Announces the Initiation of its Phase I Trial of PPP001 (dried Cannabis)

OTTAWA, ONTARIO--( Feb. 23, 2017) - PhytoPain Pharma (PPP), a subsidiary of Tetra BioPharma Inc. ("Tetra" or the "Company") (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce the launch of its Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers. 
 
The Phase I clinical research is a classical pharmaceutical study in the development of a new drug. The trial activities will occur over a 3 to 4-month period and involve site initiation, subject recruitment and enrolment, a single daily ascending dose phase and a 7-day multiple daily ascending dose phase, followed by study termination. Algorithme Pharma has already begun recruiting subjects for the Phase I trial.
Read more: Tetra BioPharma Inc ( TBP )

MabVax Therapeutics Announces FDA Authorization to Proceed with MVT-1075 in a Phase I Clinical Trial for the Treatment of Pancreatic Cancer

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.
Read more: MabVax Therapeutics Holdings ( MBVX )

VBI Vaccines Receives Positive Response from Health Canada's Initial Evaluation of the Proposed Sci-B-Vac Phase III Clinical Program

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.
Read more: VBI Vaccines Inc ( VBV / VBIV )

Analysis From Two Institutions Shows Strong Tumor Response, Overall Survival Potential of Delcath Investigational PHP Therapy

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.
Read more: Delcath Systems Inc ( DCTH )

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