The company projects to initiate its second Phase III trial
of tedizolid phosphate in ABSSSI, designated TR701-113, for its intravenous to oral transition therapy later this year.
Specifically, the FDA advised the Company to: 1) pursue pediatric studies in parallel with adult studies so that if pagoclone is effective and safe in both populations, the NDA could be approvable for the broadest possible stuttering population; 2) conduct the next adult and pediatric placebo-controlled trials as fixed dose-response studies to determine the minimally-effective dose; 3) pursue Phase III trials
under special protocol assessments (SPAs) to allow the FDA to formally sign off on trial designs.
When combining safety data from both Phase III trials
, which will be the basis of the proposed product labeling, the incidence of dry mouth observed in SANCTURA XR patients was 10.
Our plan for this Phase III trial
was to conclude the recruitment process by the end of June, and we have accomplished this milestone ahead of schedule.
Intracel's proposed Phase III trial
of the OncoVAX vaccine for Stage II colon cancer is based on an earlier published study that showed delays in the recurrence of tumors following surgery in those patients with Stage II disease.
The second of the two Phase III trials
is fully enrolled with over 560 patients and the Company anticipates reporting results in July of 2006.
Depending on dose, approximately 25 to 52 percent of subjects in the Phase III trial
had 100 percent reduction of hot flashes by the end of the study.
The Dutton report states, "Based on the assumptions that Nymox will announce a marketing collaborator over the near term and will be in Phase III clinical trials next year at this time, and comparing the current value of Nymox to an average of comparable biopharmaceutical companies in Phase III trials
, we arrive at our 12-month price target on the common shares of $6.
The status of the Company's Pivotal Phase III trial
One of the reasons cited was competition within medical centers between participation in phase II versus phase III trials
Data from two Phase III trials
in community-acquired pneumonia are expected in early 2007.