Amicus Therapeutics Inc., of Cranbury, N.J., disclosed more preliminary results from an open-label Phase II drug-drug interaction study (Study 013) to evaluate a single oral dose of migalastat HCl (150 mg or 450 mg) co-administered with enzyme replacement therapy (ERT) in males with Fabry disease

The trial was a randomized, active-controlled, open-label, crossover study evaluating DM-1992 dosed twice daily against a generic version of immediate-release carbidopa/levodopa dosed as needed (mean daily dosing frequency = 4.8

The open-label, multiple-dose, dose-escalation study is enrolling about 15 patients with relapsed or refractory multiple myeloma, DLBCL and MCL, who will receive SNS01-T, a drug designed to selectively trigger apoptosis in B-cell cancers, via intravenous infusion

The Phase II single-arm, open-label expansion study will enroll up to 15 patients with unresectable Stage III or IV melanoma and further evaluate the safety and efficacy of intratumoral injections of Ad-RTS IL-12 in combination with an oral activator ligand

Astex Pharmaceuticals Inc., of Dublin, Calif., said it started an open-label Phase II trial testing Hsp90 inhibitor AT13387 in anaplastic lymphoma kinase-positive non-small-cell lung cancer (NSCLC) patients or other potentially Xalkori- (crizotinib, Pfizer Inc.) sensitive NSCLC patients who have been receiving Xalkori...Multiple doses of PT003 were shown to provide superior bronchodilation compared to open-label tiotropium and monotherapy components

NPS Pharmaceuticals Inc., of Bedminster, N.J., reported data related to seven patients who achieved complete independence from parenteral nutrition and/or intravenous fluids (PN/I.V.) while on long-term Gattex (teduglutide) therapy in STEPS 2, a 24-month, open-label study in adult short bowel syndrome (SBS

The single-arm, open-label study will enroll up to 20 patients, with a primary endpoint of objective response rate and secondary endpoints of safety and tolerability, duration of response, complete remission rate and progression-free survival

Amgen Inc., of Thousand Oaks, Calif., presented data at the American Society for Bone and Mineral Research meeting in Minneapolis, including results from the open-label extension study of the pivotal Phase III trial of Prolia (denosumab), which showed continued increases in bone mineral density (BMD) and low fracture incidence over six years

Pfizer Inc., of New York, disclosed top-line Phase III data from an open-label long-term safety study of ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, noncancer pain

Canyon Pharmaceuticals Inc., of Parsippany, N.J., said results from its open-label, single-arm study, dubbed DESIR-ABLE, showed that desirudin (Revasc, Iprivask) demonstrated clinical utility and safety for the prevention of dangerous blood clots in a broad population of surgical and medically ill patients

Alexion Pharmaceuticals Inc., of Cheshire, Conn., said researchers presented data from an open-label Phase II study in 14 patients with severe, relapsing neuromyelitis optica (NMO), showing that Soliris (eculizumab) met its primary endpoint with high degrees of clinical and statistical significance...Oculus Innovative Sciences Inc., of Petaluma, Calif., said results of its open-label pilot study testing Microcyn Technology-based Atrapro Antipruritic Hydrogel in combination with Neosalus Cream in

In an open-label, single-ascending dose Phase I study, orally administered Ex-RAD was rapidly absorbed and well tolerated...The open-label, dose-escalation trial is expected to enroll a total of 16 patients to receive the HuCNS-SC cells, administered via a single injection into the space beneath the retina in the most affected eye

NewLink Genetics Corp., of Ames, Iowa, said it launched an open-label, adaptive design Phase IIb/III study to evaluate immunotherapy candidate tergenpumatucel-L (HyperAcute Lung) in patients with progressive or relapsed Stage IIIb/IV non-small-cell lung cancer

Dendreon Corp., of Seattle, started enrolling patients in an open-label European study with Provenge (sipuleucel-T

Oculus Innovative Sciences Inc., of Petaluma, Calif., said results of an open-label pilot study in which a Microcyn Technology-based antipruritic hydrogel was evaluated in the treatment of atopic dermatitis were published in the August 2012 issue of Cutis

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said researchers at Mount Sinai School of Medicine in New York initiated a an open-label safety and tolerability study of CPP-109 (vigabatrin) in young adults with treatment refractory Tourette's disorder (TD

The open-label trial will enroll about 40 patients chronically infected with HCV genotype-1a, and the primary endpoint will be sustained virologic response 12 weeks after the end of treatment

Navidea Biopharmaceuticals Inc., of Dublin, Ohio, began enrolling patients in its open-label Phase II safety and efficacy PET imaging study of

Pfizer also will report data from a pooled analysis of two long-term, open-label extension studies (NCT00413699, NCT00661661) demonstrating patients with moderate-to-severe RA who had participated in randomized Phase II or III studies of tofacitinib showed a consistent safety profile and sustained efficacy over 48 months