It is more than two years since Icagen Inc. (ICGN) joined forces with pharma giant Pfizer Inc. (PFE) to find potential pain alleviating drugs. Good news is that there appears to be some progress in the collaborative work between the two companies.
The deal, worth more than $1 billion, inked in August 2007 aims to discover, develop and commercialize drugs that modulate three specific sodium ion channels that mediate the nervous system's pain signals. Apart from the initial upfront license fee of $12.0 million and up to $15.0 million through an equity commitment, Pfizer is obligated to fork out $359 million in milestone payments per product for Icagen as per the terms of the agreement.
As recently as September 21, Pfizer extended its collaboration and licensing agreement with Icagen for one more year. 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.
At the Neuroscience 2009 Annual Meeting sponsored by the Society for Neuroscience in Chicago, Illinois, Icagen and Pfizer on Monday, jointly presented data demonstrating progress in identifying subtype-selective modulators of the sodium channel Nav1.8, one of the three ion channel targets. Icagen presented pharmacokinetic and efficacy data for two novel modulators of Nav1.8.
According to Icagen, while sodium channel blockers have been used to treat pain for many years, currently available agents are not subtype-selective and therefore are limited by serious side effects. By blocking only one subtype of these channels it should be possible to identify compounds which demonstrate efficacy in pain with an improved side effect profile as compared with existing therapies.
Icagen's most advanced investigational drug candidate is Senicapoc, which is under mid-stage testing for asthma. Senicapoc is being evaluated under two phase II trials.
- the first trial focused on patients with allergic asthma, is designed to assess the safety and efficacy of Senicapoc on pulmonary function following exposure to an allergen. The top line results of the first phase II trial, which were released last month, showed that Senicapoc met the primary end point of reducing the intensity of late asthmatic response caused by inhaled allergens.
- the second trial is focused on patients with exercise-induced asthma and is designed to assess the safety and efficacy of Senicapoc on pulmonary function following exercise. The results of the second phase II trial are expected this quarter. (Q4).
In August 2006, the company halted enrollment of certain patients in a late-stage trial dubbed ASSERT, which was evaluating Senicapoc for sickle cell anemia, following the recommendation of the data monitoring committee. Sickle-cell disease is a genetic blood disorder. Following the news, Icagen shares plummeted nearly 80% to an intraday low of $0.86 on August 4, 2006 before closing at $1.12.
The company pulled the plug on the ASSERT study in April of 2007 because the trial was unlikely to achieve its primary end point of a reduction in crisis rate and subsequently terminated its deal with McNeil Consumer & Specialty Pharmaceuticals for the development of Senicapoc for sickle cell anemia in June of the same year.
Icagen's yet another investigational drug is ICA-105665, a compound for the treatment of epilepsy and neuropathic pain. ICA-105665 has completed its phase I program which consisted of two studies, a single ascending dose study conducted in healthy volunteers and a multiple ascending dose study conducted in both healthy volunteers and epilepsy patients.
Late last month, Icagen initiated a proof-of-concept study of ICA-105665 in patients with photosensitive epilepsy and a proof-of-concept pain study. (A Proof of Concept study is a trial to demonstrate clinical efficacy with a small number of strictly selected patients).
The proof-of-concept study of ICA-105665 in patients with photosensitive epilepsy is expected to be completed by mid-2010, while initial results of the proof-of-concept pain study are expected during the first half of 2010.
ICGN, which has thus far hit a 52-week low of $0.31 and 52-week high of $1.59, closed Monday's trade at $0.82. In after-hours trading, the stock gained over 12% and was at $0.92.
A potential near-term catalyst for Icagen stock is the upcoming trial results of Senicapoc slated for release this quarter. Stay tuned...
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