First clinical study with oral formulation of Cara's lead compound, CR845
BOONTON, N.J., Nov. 30, 2011 /PRNewswire/ -- Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that Cara Therapeutics commenced the Phase 1 study of its oral proprietary peptide-based, investigational drug, CR845, a novel peripherally-acting kappa opioid agonist in healthy volunteers. CR845 oral capsules were formulated using Unigene's validated, proprietary peptide manufacturing technology under a Manufacturing and Clinical Supply Agreement established in May 2011.
Ashleigh Palmer, Unigene's President and CEO, commented, "The commencement of Cara's Phase 1 study of CR845 is the first clinical study initiated as a result of launching our new strategy a year ago and further validates our mission to deploy Peptelligence™ into as many oral peptide development programs as possible. With seven feasibility studies ongoing or completed, we believe we are well positioned to build a diverse portfolio of highly targeted project proposals from which we plan to generate near-term revenue from feasibility studies and service fees, while establishing a solid foundation for the potential of licensing agreements with high-value milestones and royalties."
"Initiation of this Phase 1 trial represents an important advancement in the clinical potential of CR845 and will provide the basis for developing the drug beyond the treatment of acute pain in a hospital setting," said Frederique Menzaghi, V.P. of R&D at Cara Therapeutics. "There remains a significant unmet need among chronic pain patients for an effective analgesic without the debilitating or dangerous side-effects of currently used narcotic analgesics and NSAIDs. We believe that an oral formulation of CR845 has the potential to provide an effective and safer option for the treatment of chronic pain."
CR845 is a highly selective, peptide-based, peripherally-restricted kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain. In a previous randomized, placebo-controlled Phase II study, CR845 demonstrated evidence of analgesic efficacy when administered as a single intravenous dose to women following laparoscopic hysterectomy. In addition to decreases in reported pain levels, patients receiving CR845 required substantially lower amounts of post-operative opioids (narcotics) and showed a significant reduction in the incidence of post-operative nausea and vomiting. A multicenter double-blind, randomized, placebo-controlled 200-patient Phase II trial is ongoing to evaluate the efficacy and safety of intravenous CR845 when administered both pre- and post-operatively in women undergoing laparoscopic hysterectomy. Analysis of this trial is expected in 1Q'12. To date, more than 150 human subjects have been exposed to CR845 with no cases of the dysphoria or hallucinations that have been reported with centrally-acting kappa opioids. For more information visit: www.caratherapeutics.com.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara's current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.
About Unigene Laboratories, Inc.
Unigene Laboratories, Inc. is a leader in the design, delivery, manufacture and development of peptide-based therapeutics. The Company is building a robust portfolio of proprietary partnerships in this expanding drug class based on its Peptelligence™ platform. Peptelligence encompasses extensive intellectual property covering delivery and manufacturing technologies, unsurpassed research and development expertise, and proprietary know-how representing a genuine distinctive competence. Core Peptelligence assets include proprietary oral and nasal peptide delivery technologies, and proprietary, high-yield, scalable and reproducible E. coli-based manufacturing technologies.
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SOURCE Unigene Laboratories, Inc.