Tetraphase Pharmaceuticals Inc., of Watertown, Mass., reported Phase II data at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco, showing that eravacycline (TP-434) was highly active against drug-resistant bacterial pathogens, demonstrating infection cure rates similar to that of comparator ertapenem for the treatment of complicated intra-abdominal infections and a strong safety profile, with low rates of gastrointestinal side effects
The overall safety profile was consistent with those of the PALACE-1 study and Phase II program, with tolerability improved over the Phase II program...Moberg Derma AB, of Stockholm, Sweden, said it completed recruitment of 97 patients with actinic keratosis on the head or face for the ongoing Phase II study of Limtop, a formulation of imiquimod designed for shorter treatment duration, improved safety profile and similar or better efficacy compared to competing preparations
StemCells Inc., of Newark, Calif., said interim six-month data from the first patient cohort in its Phase I/II trial of HuCNS-SC (purified human neural stem cells) for chronic spinal cord injury continued to demonstrate a favorable safety profile and showed considerable gains in sensory function in two of the three patients, compared to pre-transplant baselines
Symphogen A/S, of Copenhagen, Denmark, said final Phase II data published in Blood showed rozrolimupab's favorable safety profile and its induction of a rapid increase in platelet counts in patients with primary immune thrombocytopenia purpura
Secondary endpoints include survival from time of first etirinotecan pegol infusion, overall survival from date of pathologic diagnosis or confirmation of high-grade glioma and the safety profile of etirinotecan pegol
The paper described the maintenance of effectiveness and the safety profile of Cinryze as continuing prophylactic therapy in a large cohort of subjects with HAE
In addition, the company said all the important secondary endpoints evaluated to date, including safety and tolerability, indicated that APG101 is a new treatment option for glioblastoma, with an excellent safety profile
Boehringer Ingelheim GmbH, of Ingelheim, Germany, said findings from an analysis of four Phase III trials, comparing Pradaxa (dabigitran etexilate) to enoxaparin recently published in Thrombosis Research, supported the positive safety profile of Pradaxa for the prevention of venous thromboembolism (VTE) in patients undergoing total knee or hip arthroplasty
The data showed KP511 exhibited pharmacological and physicochemical characteristics that may suggest an improved safety profile compared to currently marketed hydromorphone products, including potential reduction or elimination of opioid-induced constipation
Histogenics Corp., of Waltham, Mass., said Phase II data published in the Journal of Bone and Joint Surgery showed its NeoCart Autologous Cartilage Tissue Implant had a comparable safety profile to microfracture surgery and significantly improved pain and function within six months of treatment in patients with Grade III chondral injury to the femur
The article reviews the safety profile and clinical activity of the PI3K/Akt pathway inhibitor when combined with Revlimid (lenalidomide, Celgene Corp.) and dexamethasone in relapsed and relapsed/refractory multiple myeloma
Genta Inc., of Berkeley Heights, N.J., said it completed a Phase II evaluation of tesetaxel as second-line treatment for advanced gastric cancer, confirming that its activity against the cancer is at least equivalent to docetaxel (Taxotere, Sanofi Inc.) but with an improved safety profile
The product also demonstrated good tolerability and had a favorable safety profile, with no Grade 4 adverse events considered attributable to the immunotherapy
The dal-OUTCOMES trial evaluated the efficacy and safety profile of dalcetrapib when added to existing standard of care in patients with stable coronary heart disease following an acute coronary syndrome
Tetraphase Pharmaceuticals Inc., of Watertown, Mass., reported Phase II data at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco, showing that eravacycline (TP-434) was highly active against drug-resistant bacterial pathogens, demonstrating infection cure rates similar to that of comparator ertapenem for the treatment of complicated intra-abdominal infections and a strong safety profile, with low rates of gastrointestinal side effects