IntelGenx Technologies Corp. (OTCQX: IGXT) develops pharmaceutical treatments that specialize in oral immediate-release and controlled-release pharmaceuticals. Shares of the drug delivery company are rallying 6.11% during trading on Friday, August 26, 2016. Over the past three months, IntelGenx Technologies Corp. (OTCQX: IGXT) has seen average daily volume of 215,284 shares. However, nearly 218,500 shares or dollar volume of $172,615, has already exchanged hands Friday.
Shares of IntelGenx Technologies Corp. (OTCQX: IGXT) are rallying after management announced the company had successfully completed a round of pilot clinical trials for the firm’s Montelukast VersaFilm treatment. The Montelukast VersaFilm is designed to combat brain degenerative diseases, such as Alzheimer’s disease. Here is the press release detailing of the successful pilot clinical trials:
IntelGenx Technologies Corp. Press Release:
SAINT-LAURENT, CANADA–(Marketwired – Aug 22, 2016) – IntelGenx Corp., (TSX VENTURE:IGX)(IGXT), today announced the successful completion of a pilot clinical study for Montelukast VersaFilm™ that demonstrated a significantly improved pharmacokinetic profile against the reference product. Montelukast is a unique drug repurposing opportunity for the treatment of degenerative diseases of the brain, such as mild cognitive impairment and Alzheimer’s disease, the most prominent form of dementia.
The study data confirmed that buccal absorption of the drug from the Montelukast film product resulted in a significally improved bioavailability of the drug compared to the commercial tablet. The study was designed as a single-dose, randomized, two-way cross-over pilot study in 8 healthy subjects. AUC0-inf was 3863 ± 1343 ng/ml*h-1 for the IntelGenx product vs. 2697 ± 1003 ng/ml*h-1 for the reference product Singulair® tablets, representing a 52% increase in bioavailability of the drug after administration of the IntelGenx film product. In addition, the study data confirmed that Montelukast crosses the blood/brain barrier when administered using IntelGenx’ Versafilm™ delivery technology.
The Company has begun preparation for a phase II-a proof-of-concept (POC) study. Patient enrolment for this study is expected to commence in Q1/2017. The Company expects the results from the study to be available in Q4/2017. Based on the outcome of this first efficacy trial in humans, IntelGenx will be actively seeking a partnership or alliance opportunity to further advance developmental work and commercialization of this product.
“We are very pleased by the results of the study which confirmed that our Montelukast VersaFilm™ significantly improves the bioavailability of the drug when given as an oral film product. The study demonstrates that the VersaFilm™ technology is an effective delivery system for CNS applications,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “Montelukast is an important drug repurposing opportunity that the company has in its product pipeline which could potentially become a multi-billion-dollar product in the large and underserved market for degenerative diseases of the brain.”
IntelGenx is collaborating with Dr. Ludwig Aigner, a neuroscientist who is a member of IntelGenx Scientific Advisory Board and head of the Institute of Molecular Regenerative Medicine at the Paracelsus Medical University in Salzburg, Austria. Dr. Aigner has made major contributions in the field of brain and spinal cord regeneration over the last 25 years. He was the first to develop tools to visualize neurogenesis in living animals and identified signaling mechanisms that are crucially involved in limiting brain regeneration. One of these mechanisms, leukotriene signaling, is related to asthma. In consequence, Dr. Aigner and his team recently demonstrated that the anti-asthmatic drug montelukast structurally and functionally rejuvenates the aged brain. His main aim is to develop molecular and cellular therapies for patients with neurodegenerative diseases and for the aged population. A video interview with Dr. Aigner discussing montelukast is available at: http://www.intelgenx.com/product/Montelukast/default.aspx
Montelukast (trade name Singulair) is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. Montelukast is a CysLT1 antagonist; it blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene and results in less inflammation. The “Mont” in Montelukast stands for Montreal, the place where Merck developed the drug.
IntelGenx is a leading oral drug delivery company focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform. Established in 2003, the Montreal-based company is listed on the TSX-V and OTC-QX.
IntelGenx highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx state-of-the art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to our clients. More information is available about the company at: www.intelgenx.com.