The study will seek to determine the maximum tolerated dose and recommended Phase II dose of LOR-253, as well as the compound's safety profile, antitumor activity and pharmacokinetics
The study, dubbed PISCES (Pilot Investigation of Stem Cells in Stroke), launched last month and is designed primarily to test the safety profile of ReN001 at a range of cell doses, though a number of efficacy measures also will be evaluated. (See BioWorld Today, Nov. 17, 2010
Neovacs SA, of Paris, said final results of its Phase I/II trial of TNF-Kinoid demonstrated an excellent safety profile in all subjects, with an immune response to the drug as intended and a high clinical response rate, with clinical remission in almost half the patients
ChemoCentryx Inc., of Mountain View, Calif., reported Phase I results showing that CCX168, its oral, small-molecule antagonist designed to target complement 5a, exhibited an excellent safety profile while producing greater than 90 percent receptor blockade of inflammatory cells in the blood throughout the day
Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., reported positive results from a series of CPP-115 preclinical safety and efficacy evaluations, which showed that the drug had a significantly improved retinal safety profile compared to Sabril (vigabatrin, H. Lundbeck A/S...The primary objective is to determine the maximum tolerated dose, while secondary objectives will include describing the safety profile, pharmacokinetics and treatment response
PharmaMar SA, of Madrid, Spain, presented six abstracts on Yondelis (trabectedin) at the annual meeting of the European Society for Medical Oncology in Milan, Italy, with three analyses confirming that the product candidate is well characterized and has a manageable safety profile
Zanolimumab at a dose of 980 mg weekly demonstrated clinical activity and an acceptable safety profile in this poor-prognosis population, suggesting that the potential benefit of combining zanolimumab with standard chemotherapy in the treatment of PTCL should be investigated
The results also showed that V-101 has an adverse event profile similar to placebo, with the active ingredient not detectable in study participants' plasma, which indicated the overall tolerability and safety profile of the product
The company said it plans to soon start its first-in-man Phase I dose-escalation trial of LOR-253 in advanced or metastatic solid tumors to assess the safety profile, tolerability and antitumor activity of the drug candidate and its pharmacokinetic and pharmacodynamic properties
Results, however, demonstrated a good safety profile for all doses of injectable vaccine and adjuvant patches studied, and Intercell said it intends to conduct further clinical evaluation using VEP in combination with an injectable H5N1 vaccine to be supplied by London-based GlaxoSmithKline plc as part of the companies' 2009 agreement
The results also demonstrated a positive safety profile for NLX-P101, with no serious adverse events related to the gene therapy or surgical procedure reported...The purpose of the study was to determine if Visudyne (verteporfin) combined with Lucentis (ranibizumab, Genentech Inc.) reduced retreatment rates compared with Lucentis monotherapy, while maintaining similar vision outcomes and an acceptable safety profile
The safety profile of RG7128 (1,000 mg bid or 500 mg bid), when administered for eight or 12 weeks with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), the standard of care (SOC), was similar to the safety profile of SOC alone
Intravitreal injections of iCo-007 were well tolerated with a good safety profile, ultimately progressing to the highest dose of 1,000 mcg based on positive safety evaluation committee meetings two months post each dosing level
The study also showed that TB-402 and enoxaparin had a similar safety profile...Additionally, the analysis showed that Prochymal continued to demonstrate a benign safety profile with no significant differences in any of the pre-defined safety outcomes compared to placebo
Icagen Inc., of Research Triangle Park, N.C., said that based on the efficacy demonstrated in the firm's recent study of photosensitive epilepsy patients, coupled with a favorable clinical safety profile, consistent pharmacokinetics and the lack of a maximal tolerated dose in all clinical studies to date, the firm proposed, and the FDA has approved, a study of up to two additional cohorts of photosensitive epilepsy patients at higher doses of ICA-105665
The study will seek to determine the maximum tolerated dose and recommended Phase II dose of LOR-253, as well as the compound's safety profile, antitumor activity and pharmacokinetics