The safety profile of alitretinoin observed in this study was consistent with previous trials, and the new data will be integrated into regulatory submissions planned for later this year
The drug was well tolerated, with a safety profile consistent with the clinical experience of patients on dialysis using its Renagel (sevelamer hydrochloride) product
The trial is designed to determine the safety profile of Azixa and the extent of its ability to improve the overall survival of patients with melanoma skin cancer with brain metastases
Primary objectives include determining the product's safety profile, identifying dose-limiting toxicity, finding the maximum tolerated dose and studying the pharmacokinetics, while secondary objectives will assess preliminary evidence of antitumor activity
Genelabs Technologies Inc., of Redwood City, Calif., said results of a clinical trial of its investigational hepatitis E virus vaccine show that it was found to be 95.5 percent effective in preventing disease caused by infection with HEV and had a safety profile similar to placebo, except for injection site pain
Results from the trial showed that the drug was well tolerated and demonstrated an improved safety profile, which included reducing the extrapyramidal symptoms associated with available therapies
Data from a low dose trial indicate a good safety profile and positive immune responses in human volunteers receiving a one-tenth dose of the vaccine...Results of a second larger full-dose trial also indicate a good safety profile
Ambrilia Biopharma Inc., of Montreal, said the Phase I repeat-dose study with PPL-100, the company's lead protease inhibitor to treat HIV and AIDS, demonstrated a good safety profile, and only mild adverse events were observed in the treatment groups...Ostarine continued to demonstrate a favorable safety profile, with no serious adverse events reported
The key objective will be to determine the drug's efficacy in those patient populations, and secondary objectives include determining the safety profile and assessing biomarkers and predictive markers for the drug
Data showed that the compound has a good safety profile and established the maximum tolerated dose at 267 mg/m(2), which will be used in a Phase II trial
At 12 months, Orencia showed a durable response as measured by DAS28 (mean change at six months: -2.53; mean change at 12 months: -2.88), as well as a more favorable safety profile than Remicade
Inspire Pharmaceuticals Inc., of Durham, N.C., reported results of a 28-day Phase II study of denufosol inhalation solution in cystic fibrosis patients, ages 5 to 7, showing that both the 20-mg and 60-mg doses of the drug given three times daily were well tolerated, with a safety profile similar to placebo
LAB CGRP showed statistically significant broncho-protective effects compared to placebo and a similar safety profile to placebo except for transient and mild headaches and flushing in some of the patients
Acologix Inc., of Hayward, Calif., said results from a 40-patient Phase II feasibility study of AC-100 in periodontal defects demonstrated a favorable safety profile but the drug did not significantly regenerate more periodontal bone vs
Peplin Ltd., of Brisbane, Australia, said results from a Phase IIa trial of PEP005 topical demonstrated a favorable safety profile and showed dose-dependent tumor clearance rates in patients with nodular forms of basal-cell carcinoma
The primary objective of the Phase Ib trial is to determine the maximum tolerated dose, dose-limiting toxicity and safety profile of Reolysin when administered intratumorally to patients receiving radiation
The safety profile of alitretinoin observed in this study was consistent with previous trials, and the new data will be integrated into regulatory submissions planned for later this year