ARDM Out Of Orbit, CLSN To Report Data In Q1, MRK Seeks New Use For Old Drug
WHITEHOUSE STATION (dpa-AFX) - Shares of Aradigm Corp.
(ARDM) plunged over 56% on Thursday after two phase III studies evaluating Pulmaquin for the chronic treatment of Non-Cystic Fibrosis Bronchiectasis patients with lung infections with Pseudomonas aeruginosa delivered a mixed bag of results.
The two studies - ORBIT-3 and ORBIT-4 - were identical in design, with an increase in the median time to first mild, moderate or severe pulmonary exacerbation ("PE") set as primary endpoint, and the frequency of PE's over the 48-week double-blind treatment period as the key secondary efficacy endpoint.
While the ORBIT-4 trial achieved the primary and secondary endpoints, the ORBIT-3 trial failed to meet both the goals.
But when the combined data from the two studies were considered for analysis, there was a statistically significant reduction in the number of PE's over the 48-week double-blind period, the company noted.
The company will review the next steps towards an application for approval of Pulmaquin in the U.S. at an upcoming meeting scheduled with FDA.
ARDM closed Thursday trading at $2.29, down 56.30%.
Celsion Corp.'s (CLSN) Phase 1b OVATION Study will continue as planned based on the recommendation of the independent Data Safety Monitoring Board.
The OVATION Study is a dose-escalating clinical trial combining GEN-1, the company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.
The company expects to report final data from the OVATION study in the first quarter of 2017.
CLSN closed Thursday's trading at $0.68, up 4.29%.
Inovio Pharmaceuticals Inc. (INO) has been awarded a $6.1 million sub-grant through The Wistar Institute to develop a DNA-based monoclonal antibody designed to provide a fast-acting treatment against Zika infection and its debilitating effects.
The company already has two trials for its DNA-based Zika vaccine in human testing. It expects to have preliminary results by year end for its U.S./Canada study.
INO closed Thursday's trading at $6.82, down 3.67%.
Merck's (MRK) supplemental Biologics License Application for KEYTRUDA for the treatment of patients with refractory classical Hodgkin lymphoma has been accepted for priority review by the FDA, with a decision date set for March 15, 2017. KEYTRUDA is already approved for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma. The drug brought home sales of $566 million in 2015 and $919 million in the first nine months of 2016.
MRK closed Thursday's trading at $60.76, down 0.70%.
Pfizer Inc (PFE) on Thursday announced phase III study results of LYRICA Capsules CV and Oral Solution CV as adjunctive therapy for pediatric epilepsy patients four to 16 years of age with partial onset seizures.
According to the trial results, treatment with LYRICA 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo. However, treatment with LYRICA 2.5 mg/kg/day although resulted in a numerical reduction in seizure frequency, it was not statistically significant.
LYRICA is already approved by the FDA for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia and spinal cord injury; as an adjunctive therapy for partial onset seizures and for the treatment of fibromyalgia.
LYRICA, whose patent is set to expire in 2018, recorded sales of $4.8 billion in 2015, according to database company Statista.
PFE closed Thursday's trading at $31.46, down 2.12%.
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