Key Developments For Icagen, Inc.
Icagen, Inc. (ICGN.O) (Consolidated Issue listed on NASDAQ Global Market)
Icagen, Inc. Announces Top-line Results of Phase IIa Study of Senicapoc in Exercise-Induced Asthma
Icagen, Inc. announced that in a proof-of-concept, Phase IIa exercise-induced asthma study, senicapoc failed to demonstrate improvement in the primary study endpoints, including maximum decrease in FEV1, time to recovery of FEV1 after exercise and area under the FEV1 curve for sixty minutes. In this double blind placebo-controlled study, 69 patients were randomized to receive either senicapoc at a maintenance dose of 40 mg/day or placebo. All subjects were tested for pulmonary function following a standardized treadmill exercise regimen at baseline, two and four weeks after treatment. The results of the pulmonary function tests were compared between the treatment groups, adjusting for differences in baseline values. Although the Company will continue to evaluate the data from this trial, it does not anticipate continuing clinical development of senicapoc at this time.
Icagen, Inc. Describes Progress in Collaboration With Pfizer to Identify Selective Sodium Channel Inhibitors
Icagen, Inc. announced that data related to its collaboration with Pfizer focused on certain sodium channels for the treatment of pain and related conditions were presented in two poster presentations at the Neuroscience 2009 Annual Meeting sponsored by the Society for Neuroscience (SFN) in Chicago, Illinois. Icagen and Pfizer jointly presented data demonstrating progress in identifying subtype-selective modulators of the sodium channel Nav1.8. This channel is one of three sodium channel pain targets that form the basis of the collaboration. There are extensive preclinical data demonstrating a role for Nav1.8 in modulating pain. However, to date only limited examples of subtype-selective small molecule modulators of Nav1.8 have been described. In collaboration with Pfizer, Icagen presented pharmacokinetic and efficacy data for two modulators of this target. These orally bioavailable, use-dependent compounds have excellent in vitro profiles, impact nerve firing, are efficacious in models of inflammatory and neuropathic pain and have acceptable pharmacokinetic and drug-like properties. Overall these data provide further evidence for the feasibility of identifying selective Nav1.8 compounds as potential therapeutic agents for the treatment of pain.
Icagen, Inc. Announces Initiation of Proof-of-Mechanism Study of ICA-105665 in Pain
Icagen, Inc. announced the initiation of a proof-of-mechanism study of ICA-105665 for the treatment of pain. ICA-105665 is an orally available opener of subtypes of KCNQ channels, which have been validated by both genetic and physiologic evidence as playing an important role in certain conditions characterized by abnormal neuroexcitability, such as seizures, and potentially also chronic pain disorders. This randomized, double-blind, placebo-controlled study will employ a cross-over design in order to assess the ability of ICA-105665 to decrease the sensation of pain in response to the injection of a small amount of capsaicin under the skin and to a simulated sunburn. Approximately twenty-four healthy volunteers are expected to be enrolled in the study, which will be conducted at a single clinical research site in the United Kingdom. Initial results are expected during the first half of 2010.
Icagen, Inc. Announces Initiation of Proof of Concept Study of ICA-105665 In Photosensitive Epilepsy
Icagen, Inc. announced the initiation of a proof of concept study of ICA-105665 in patients with photosensitive epilepsy. ICA-105665 is an orally available opener of subtypes of KCNQ channels, which have been validated by both genetic and physiologic evidence as playing an important role in certain conditions characterized by abnormal neuroexcitability, such as seizures, and potentially also chronic pain disorders. The photosensitive epilepsy study was designed with international experts including members of the Epilepsy Study Consortium and will be conducted at up to four clinical research centers in the United States with specialized expertise in the conduct of this study. Eligible subjects are those patients with demonstrated epileptiform activity by electroencephalogram (EEG) in response to photic stimulation (also called a photoparoxysmal response to light) and represent a small subset of all patients with epilepsy. Successive cohorts consisting of four patients each will be studied at each dose level, beginning at 100mg. In accordance with a standardized protocol, patients receive single doses of placebo or ICA-105665 on successive days followed by photic stimulation with EEG monitoring. The study measures the ability of ICA-105665 to reduce the photic induced epileptiform EEG responses, with the response observed in each cohort used to determine the subsequent dose for the next cohort. The study is expected to be completed by mid 2010.
Icagen, Inc. Announces Extension of Pfizer Collaboration
Icagen, Inc. announced a one year extension to a prior worldwide collaboration and licensing agreement with Pfizer aimed at discovering, developing and commercializing compounds that modify three specific sodium ion channels as new potential treatments for pain and related disorders. For the past two years, Icagen and Pfizer have partnered to identify compounds that target three ion channels in a global research and development collaboration. The companies have also formed a joint research committee (JRC) to monitor and oversee the collaboration. During the extension period, Pfizer will continue to fund all aspects of the collaboration including research efforts at both companies. Pfizer also will continue to have exclusive worldwide rights to commercialize products resulting from the collaboration. Under the terms of the extended agreement, Pfizer will provide approximately $5.0 million in committed funding to Icagen over the next year of the collaboration through September 30, 2010. Additionally, Icagen remains eligible to receive approximately $359 million in research, development, regulatory and commercialization milestones for each product. Icagen is also eligible to receive tiered royalties, against which the commercialization milestones are creditable, based upon product sales.
