DURHAM, N.C., July 26, 2017 -- Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today announced immunogenicity data from a study of AGS-004 dendritic cell therapy in patients treated during acute HIV infection. These data were recently published in the Journal of AIDS Research and Human Retroviruses.

 

The immunogenicity data was generated in a single arm, open label study in six patients with acute HIV infection conducted at the University of North Carolina and Duke University. AGS-004, an autologous cell therapy manufactured using the Arcelis® precision immunotherapy technology platform, was produced on an individual basis for each patient. 

HOUSTON, TX--(Marketwired - July 25, 2017) - Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has agreed to provide support to help accelerate the start of a physician-sponsored Investigational New Drug (IND) application to study the Company's drug candidate WP1066 for the treatment of adult glioblastoma (brain tumors).

 

Dr. Robert Shepard, Moleculin's Chief Medical Officer added: "We have never seen a drug like WP1066 that appears capable in vitro of both stimulating a natural immune response and directly killing tumor cells to block tumor progression. There continues to be a serious unmet need for the treatment of glioblastomas, the most aggressive and lethal form of brain cancer, which is why we are working so hard and are excited to get WP1066 into the clinic."

-- Phase 2 Trials in ALS and CMT to Commence in the US This Quarter --

-- Prioritizing US Phase 2 COMMEND Trial; Exploratory Australian ALS Study to End Early --

 

BOSTON -- Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology company that is developing innovative and proprietary treatments for cramps and spasticity associated with serious neurological diseases including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Charcot-Marie-Tooth (CMT), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FLX-787, the Company’s co-activator of TRPA1 and TRPV1, to treat severe muscle cramps in patients with ALS. There are currently no drugs approved in the US for this condition.Fast Track designation is intended to accelerate the clinical development and review of drugs to treat serious conditions that address an unmet medical need.

TORONTO, ONTARIO--(July 24, 2017) -Spectral Medical Inc. (TSX:EDT), a Phase III company developing the first treatment for patients with septic shock, today announced that the United States Food and Drug Administration ( "FDA") has accepted its rolling PMA application for Toraymyxin™ ("PMX") for review.

 

The acceptance of the filing means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. The Company will continue to work closely with the FDA to facilitate a timely process.

 

"The acceptance of this PMA filing for review by the FDA represents another significant step forward in our regulatory pathway towards potential approval of our personalized treatment for patients with endotoxemic septic shock. The incidence of sepsis continues to rise in North America with no specific treatment yet available," said Dr. Paul Walker, President and CEO of Spectral.