According to the company, TULIP 2 was the second phase III trial
designed to assess the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE.
A phase III trial
has indicated that Lynparza maintenance therapy decreased risk of disease progression or death by 70% in patients with newly-diagnosed, advanced BRCA-mutated (BRACm) ovarian cancer, it was reported on Monday.
The Phase III trial
was designed to support full approval of ASP0113 for the prevention of CMV reactivation in CMV seropositive HCT recipients.
Bristol Myers Squibb, a global biopharmaceutical company, has reported positive results from a Phase III trial
(CheckMate -066) comparing an investigational PD-1 immune checkpoint inhibitor, Opdivo, to the chemotherapy, dacarbazine, in patients with treatment naive BRAF wild-type advanced melanoma, it was reported yesterday.
As a result of lessons learned in the randomized phase II study, the phase III trial
will be restricted to patients with lymph node-positive tumors who are clinically disease-free after completing standard therapy Only patients with low levels of HER2 expression, meaning immunohisrochemistry 1+ or 2+, will be eligible.
In addition, AstraZeneca said that TC-5214 failed to meet the primary endpoint in a second of four Phase III trials
under the so-called RENAISSANCE development programme.
Four other phase III trials
of dimebon (proposed generic name latrepirdfne) are currently enrolling patients.
Osiris recently completed enrollment in a Phase III trial
evaluating Prochymal for the treatment of steroid-refractory acute graft versus host disease (GvHD).
This monoclonal antibody will possibly be the next available therapeutic monoclonal antibody if an acceptable safety profile is confirmed in the two Phase III trials
in progress (CAMMS 323, 324).
The FDA indicated that Advancis' recently concluded Phase III clinical trial in adults and adolescents, along with the company's Phase I pharmacokinetic studies, results from the Company's prior adult and adolescent Amoxicillin PULSYS Phase III trial
, and existing academic literature would be sufficient to support an NDA filing.
A phase III trial
with oral cladribine has been started.
In the phase III trial
, which included 476 women from 13 sites, 461 patients had worn the device for 1 year, 403 for 2 years, and 38 for 3 years.