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Zalicus Inc. (NASDAQ: ZLCS) today reported financial results for the first quarter ended March 31, 2012.
“We made tremendous progress advancing our pipeline this quarter and will continue this momentum with further advancement of our product candidates during the remainder of 2012,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “Synavive enrollment is complete and we are on-track to report top-line data results in the third quarter of 2012. Also in the third quarter, Z160, our first in class treatment for neuropathic pain, is poised to enter Phase 2a clinical trials.”
First Quarter 2012 and Recent Accomplishments:
Completed enrollment in the Synavive® Phase 2b SYNERGY trial, with 292 patients enrolled. The SYNERGY clinical trial is designed to evaluate the safety and efficacy of Synavive, a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA). Top-line results of the clinical trial are expected to be available in the third quarter of 2012.
Advancing Z160, a novel, oral, N-type calcium channel blocker into multiple Phase 2a clinical trials for neuropathic pain indications. Zalicus has selected the most promising formulation for clinical use and is planning to initiate two Phase 2a clinical trials with Z160 for the treatment of neuropathic pain; the first of which is expected to begin enrolling patients in the third quarter of 2012.
Continuing to progress Z944 through Phase I clinical development in a study being conducted in the United Kingdom. Z944 is a novel oral T-type calcium channel blocker which has demonstrated efficacy in a number of preclinical inflammatory pain models and other disease models. T-type calcium channels have been recognized as key targets in the therapeutic inhibition of a broad range of cell functions and have been implicated in the frequency and intensity of pain signals. Safety and pharmacokinetic data for single and multiple ascending doses of Z944 are expected by the third quarter of 2012. If Z944 is safe and well tolerated, Zalicus is planning to advance it into Phase 2 clinical development.
Collaborations and Partnered Programs:
Extended our alliance with Novartis for an additional contract year, through April 2013, based on the success of the cHTS discovery collaboration up to this point. This is Novartis’ second extension, further validating the value of the cHTS discovery technology to the advancement of novel treatments for cancer.
Sanofi continues to project the potential launch of Prednisporin (FOV1101) in 2015 as one of 18 potential new product launches between 2012 and 2015.
Entered into collaboration with Hydra Biosciences to advance development of Zalicus’ preclinical Ion channel modulator product candidates into clinical development for the treatment of pain. This collaboration brings together Zalicus’ portfolio of novel, preclinical Ion channel product candidates with Hydra’s leadership in Ion channel discovery and preclinical drug development. Zalicus’ clinical-stage Ion channel modulators, including Z160 and Z944, are not included in this collaboration.
Published preclinical data in the journal Science Translational Medicine, describing the activity of Z944 to potently suppress seizures. This data reinforces the potential biologic activity of Z944, as it is generally understood that conditions of neuronal hyper-excitability, such as epilepsy and pain, are mechanistically linked.
Published preclinical data in the journal Molecular Cancer Therapeutics, in which Zalicus researchers, in collaboration with the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, have discovered that adenosine A2A and beta-2 adrenergic receptor agonists are highly synergistic and selective novel agents that enhance glucocorticoid activity in B-cell malignancies such as multiple myeloma and, importantly, can synergize in combination with current multiple myeloma treatment regimens such as melphalan, lenalidomide, bortezomib and doxorubicin.
Contributed to the book Drug Repositioning - Bringing New Life to Shelved Assets and Existing Drugs (Wiley Publications, ISBN: 978-0-470-87827-9, Available May 2012) in which Margaret S. Lee, PhD, Zalicus’ Vice President of Research, authored a chapter on the application of technology platforms to uncover new indications for existing drugs using systematic phenotypic screening for novel synergistic combinations.
Published an editorial in a special Targeted Oncology issue of the journal Future Medicinal Chemistry in which Dr. Lee discusses the promise and progress to date of the biopharmaceutical industry to adopt a systematic, high-throughput approach to identify selective and synergistic cancer combination therapies to provide meaningful clinical benefit to cancer patients.
Presented on the systematic discovery of novel cancer combination targets and therapeutics at the 3rd annual Cancer Targets and Therapeutics conference in Las Vegas, February 27-28, 2012.
First Quarter 2012 Financial Results (Unaudited):
As of March 31, 2012, we had cash, cash equivalents, restricted cash and short-term investments of approximately $52.5 million compared to $49.7 million on December 31, 2011.