zalicus inc (ZLCS) Key Developments
Jason Cole to Resign as Executive Vice President, Corporate Development and General Counsel of Zalicus Inc., Effective as of March 5, 2014
Feb 7 14
On February 3, 2014, Mr. Jason Cole, Executive Vice President, Corporate Development and General Counsel, provided notice to Zalicus Inc. of his intention to resign from the Company effective as of March 5, 2014 to pursue a new career opportunity.
Zalicus Inc. Announces Results from Two Phase 2 Clinical Studies of Z160 in Chronic Pain Indications
Nov 11 13
Zalicus Inc. announced top-line results from two Phase 2 clinical studies of Z160 in chronic pain indications. Z160 did not meet the primary endpoint in either of the Phase 2 clinical studies in patients with lumbosacral radiculopathy (LSR) and post-herpetic neuralgia (PHN). Z160 was shown to be generally safe and well-tolerated with no drug-related serious adverse events. Based on these results, Zalicus is discontinuing the Z160 program and plans to focus efforts on Z944, its novel oral T-type calcium channel modulator in development for the treatment of pain.
Zalicus Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2013
Nov 4 13
Zalicus Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2013. For the quarter, total revenue was $3.400 million against $3.518 million a year ago. Loss from operations was $10.200 million against $11.690 million a year ago. Net loss before provision for income taxes was $10.529 million against $12.174 million a year ago. Net loss was $10.529 million or $0.46 per basic and diluted share against $12.174 million or $0.59 per basic and diluted share a year ago.
For the nine months, total revenue was $10.965 million against $8.762 million a year ago. Loss from operations was $28.021 million against $34.935 million a year ago. Net loss before provision for income taxes was $29.138 million against $36.481 million a year ago. Net loss was $29.138 million or $1.33 per basic and diluted share against $36.481 million or $1.90 per basic and diluted share a year ago.
Zalicus Inc. Announces Positive Results of Z944 Phase 1b Clinical Study in Pain
Nov 1 13
Zalicus Inc. announced positive results of a Phase 1b clinical study with Z944, a novel oral T-type calcium channel modulator in development for the treatment of pain. The Phase 1b study is an experimental clinical model utilizing Laser-Evoked-Potentials (LEP) to provide both objective and subjective assessments of the activity of Z944 in induced pain states. Based on these results, Zalicus is planning to advance a modified-release formulation of Z944 into Phase 2 clinical development in an appropriate pain indication in 2014. In addition, a second United States patent for Z944 (U.S. Patent number 8,569,344) covering methods of treating pain was issued on October 29, 2013, providing additional patent protection for Z944 in the United States until at least 2029. This exploratory, double-blind placebo-controlled, randomized cross-over, Phase 1b clinical study enrolled 16 healthy volunteers and was conducted in a single center in Germany. The primary objective of the study was to compare the analgesic/anti-hyperalgesic properties of three different single doses of Z944 in a model of inflammatory pain and in a model of chronic neuropathic pain as compared with placebo. Highlights of the results of the Z944 Phase 1b LEP study results include: Statistically significant and meaningful reductions at each of the three doses compared to placebo of overall peak-to-peak (PtP) amplitude of LEPs in models of both inflammatory (p<=0.0002) and neuropathic (p<0.05) pain. Consistent trends in reduction of subjective pain scores compared to placebo using a visual analog scale in both pain models. Meaningful trends in effects based on dose and concentration, providing important insights into the potential therapeutic window and effective plasma concentrations of Z944. Z944 was generally well tolerated with dose dependent CNS side effects and no serious adverse events. In this study, hypersensitivity to laser thermal stimulation was induced by UV light exposure as a model of inflammatory pain and by topical capsaicin as a model of neuropathic pain. Electrical voltage fluctuations evoked by laser thermal stimulation were quantified with vertex-Electroencephalography (EEG) in addition to a subject-reported pain score. Many currently approved and emerging pain drugs have been evaluated using the LEP model, providing the ability to benchmark the efficacy of Z944 against other therapies.
Zalicus Regains Compliance With Nasdaq Listing Requirements
Oct 15 13
Zalicus Inc. announced that it has received notice from the Listing Qualifications Staff of The Nasdaq Stock Market LLC that the Company has regained compliance with Nasdaq Marketplace Rule 5550(a)(2) relating to the maintenance of a minimum $1.00 bid price. The matter is now closed.