One of the reasons cited was competition within medical centers between participation in phase II versus phase III trials
The Phase III trial
will be conducted at the Sahlgrenska Hospital in Gothenburg, Sweden and will compare the effectiveness and safety of Hyal's HA-Diclofenac formulation with a commercially available Diclofenac.
The SPA for MCRC follows an August 2005 SPA for a Phase III trial
of Litx in hepatocellular carcinoma (HCC).
Biovitrum's assignment is to develop the existing process for the biotechnical manufacturing of RES 08 to a standard that meets the high demands of a clinical phase III trial
, and furthermore to manufacture sufficient amounts of the substance for the trial.
While there is some risk, dosing improvements over previous failed trials give cethromycin a good chance of yielding positive results in ongoing Phase III trials
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.
Efficacy of Nebulized Arformoterol, a Long-Acting Beta2-Adrenergic Bronchodilator, in Patients with COPD: Results from Two Pooled Phase III Trials
With respect to ALTU-135, the Company's orally administered enzyme replacement therapy, Altus now expects to perform additional manufacturing development work in advance of initiating its Phase III trial
in patients with pancreatic insufficiency.
The results of this trial confirm the results from the first Phase III trial
of SANCTURA XR which were announced on June 15, 2006.
Dziewanowska, Vice President, Clinical Research at Ligand Pharmaceuticals conducted a retrospective pooled analysis of 1,213 patients in SPIRIT I and II phase III trials
to evaluate the presence of biomarker correlates of prolonged survival.
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.
The first of two Phase III trials
is fully enrolled with approximately 600 patients.