00:00 , Aug 11, 2018 |  BioCentury  |  Product Development

Exacerbation management

Based on work spearheaded by the Cystic Fibrosis Foundation, Corbus Pharmaceuticals Holdings Inc. will be the first company to attempt to gain approval in CF based on pulmonary exacerbations instead of FEV1. The company is...
23:39 , Mar 9, 2018 |  BC Extra  |  Clinical News

Phase I/II of Roche PNH candidate temporarily halted

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said enrollment was temporarily stopped in the Phase I/II COMPOSER trial evaluating RG6107 (SKY59) in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) after two patients who received RG6107...
20:34 , Feb 23, 2018 |  BC Week In Review  |  Clinical News

Akari's Coversin meets in Phase II for PNH

Akari Therapeutics plc (NASDAQ:AKTX) said subcutaneous Coversin met the primary endpoint of reducing lactic dehydrogenase (LDH) to ≤1.8 times the upper limit of normal (ULN) at day 28 in the open-label Phase II COBALT trial...
04:55 , Jan 19, 2018 |  BC Week In Review  |  Clinical News

Eiger discontinues ubenimex for PAH

Eiger BioPharmaceuticals Inc. (NASDAQ:EIGR) discontinued development of ubenimex to treat pulmonary arterial hypertension (PAH). The company made the decision after the product missed the primary endpoint in the Phase II LIBERTY trial in the indication....
19:31 , Jan 17, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Sepsis; fungal infection Mouse studies suggest inhibiting BLT1 could help treat fungal sepsis. In a mouse model of Candida albicans -induced fungal sepsis, systemic knockout of BLT1 decreased hemorrhage and capillaritis in the lung...
19:51 , Jan 16, 2018 |  BC Extra  |  Clinical News

Phase II PAH readout sinks Eiger shares

Eiger BioPharmaceuticals Inc. (NASDAQ:EIGR) lost $7.90 (49%) to $8.10 Tuesday after discontinuing development of ubenimex to treat pulmonary arterial hypertension. The company made the decision after the product missed the primary endpoint in the Phase...
23:53 , Sep 21, 2017 |  BC Extra  |  Clinical News

Akari gains on Phase III PNH plans for C5 inhibitor

Akari Therapeutics plc (NASDAQ:AKTX) gained $3.15 (56%) to $8.74 on Thursday after the company announced plans to start Phase III testing in 1Q18 of lead candidate Coversin to treat paroxysmal nocturnal hemoglobinuria. The announcement appears...
19:10 , May 19, 2017 |  BC Week In Review  |  Clinical News

Eiger completes enrollment in Phase II to treat PAH

Eiger BioPharmaceuticals Inc. (NASDAQ:EIGR) completed enrollment of 61 patients with pulmonary arterial hypertension (PAH) in the North American Phase II LIBERTY trial evaluating Bestatin ubenimex plus standard of care (SOC). Patients in the double-blind, placebo-controlled...
20:22 , Feb 16, 2017 |  BC Week In Review  |  Clinical News

Kevetrin: Ph IIa started

Cellceutix began an open-label, U.S. Phase IIa trial to evaluate 250 and 350 mg/m 2 IV Kevetrin thrice weekly for 3 weeks in about 10 patients. Cellceutix Corp. (OTCQB:CTIX), Beverly, Mass.  Product: Kevetrin thioureidobutyronitrile  Business:...
21:44 , Feb 1, 2017 |  BC Week In Review  |  Clinical News

Bestatin: LIBERTY2 extension study started

Eiger began the open-label LIBERTY2 extension study of oral Bestatin for ≥24 weeks in about 45 patients who completed the double-blind, placebo-controlled, North American Phase II LIBERTY trial, which is evaluating thrice-daily 150 mg Bestatin...