Oxford BioMedica plc, of Oxford, UK, and partner Sanofi SA, of Paris, disclosed a positive interim review of the ongoing UshStat Phase I/IIa study by the data safety monitoring board (DSMB), with no serious adverse events in the three patients treated at dose level one related to the product

Bio-Path reported that the drug's safety profile continued to be favorable, with no treatment-related serious adverse events reported, and data continue to suggest some possible anti-leukemia activity

primary safety measures include serious adverse events, adverse events and major bleeding events

Serious adverse events included six cases of pelvic inflammatory disease (PID, two with LNG-IUS12 and four with LNG-IUS16

OncoSec Medical Inc., of San Diego, reported preliminary results from a Phase II trial suggesting that ImmunoPulse, which locally delivers a DNA-based cytokine coded for the immune-stimulating agent interleukin-12 (IL-12) via electroporation, may elicit increased levels of IL-12 in the tumor microenvironment, which has the potential to result in a systemic immune response in treating aggressive cancers without serious adverse safety events

Methylgene Inc., of Montreal, presented Phase I data for MGCD290, an antifungal compound, showing that all doses and schedules of the drug were tolerated with no severe or serious adverse events, and that pharmacokinetics were dose dependent

No serious adverse events were reported in the primary analysis period, and no clinically meaningful differences in related adverse events were reported between the two treatment groups

No serious adverse events were reported, and there were no patient discontinuations

No patients discontinued the study due to adverse events, and the incidence of adverse events and serious adverse events was similar in both the treated and placebo groups

The compound was well tolerated at all doses evaluated, with no serious adverse events...Serious adverse events were lower in the enzalutamide group than in the placebo group

With nine patients treated to date in the RetinoStat trial and eight in the StarGen trial, no serious adverse events related to the compounds or their administration have occurred

Only one patient out of 25 evaluable patients had a serious adverse event, and thus the study was found to have met its prespecified safety criteria and may proceed as planned

Novavax Inc., of Rockville, Md., reported positive top-line results from a Phase II trial of its seasonal influenza virus-like particle (VLP) candidate showing that the product had immunogenicity against all four viral strains, and was well tolerated with no vaccine-related serious adverse events

Several prior clinical studies demonstrated that Bendavia appeared to be safe and well tolerated with no serious adverse events across a broad dose range with highly predictable pharmacokinetics. (See BioWorld Today, April 10, 2012

Immunovaccine Inc., of Halifax, Nova Scotia, said results from the first cohort of a dose-ranging Phase I study showed that DPX-Survivac, which consists of survivin-based peptide antigens formulated with the DepoVax adjuvanting platform, was well tolerated, with no serious adverse events reported and that the vaccine is immunogenic as a monotherapy

The decision was made by a safety review committee established by AstraZeneca after the trial met a predefined stopping criterion involving a serious adverse event

The selective 5-HT1A/1B partial agonist was well tolerated, with no serious adverse events

Secondary endpoints are the incidence of treatment-emergent Grade 3/4 adverse events and serious adverse events, the frequency of dose modifications, and patient quality of life. (See BioWorld Today, Jan. 4, 2012

Visonac was well tolerated, and no serious adverse events were reported