Chronogen Inc. Receives Approval To Proceed With A Phase I/II Clinical Trial
Published: Apr 26, 2006
MONTREAL, April 26 /PRNewswire/ - Chronogen Inc. (Montreal, Canada), a drug discovery company developing novel therapeutics to treat oxidative stress disorders in age-related diseases, announced today that it has received approval of their Clinical Trial Application (CTA) from Health Canada to begin human clinical trials of one of their novel class of drugs called Cellular Oxidative Stress Modulators. This Phase I/II study will assess the ability of a topical formulation of CHGN111 to prevent cutaneous phototoxicity induced by photodynamic therapy (PDT). The CTA approval was based on extensive preclinical data and a complete manufacturing dossier. This first-in-man proof of concept clinical study is planned to be completed by the summer 2006.
"We are extremely hopeful that CHGN111 will be the first drug to target what is believed to be the root cause of most oxidative stress-related diseases" said Dr Max Fehlmann, Chief Executive Officer of Chronogen. "This is a significant and exciting milestone for the growth of Chronogen and its clinical development program."
CHGN111 is an inhibitor of the mitochondrial enzyme CLK-1 which is a demethoxyubiquinone hydroxylase. Numerous parameters of mitochondrial function are altered when the activity of CLK-1 is reduced, which results in a decrease of ROS at critical cellular sites, as well as in a decrease of systemic oxidative stress. Chronogen expects to have another promising CLK-1 inhibitor in the clinic, CHGN104, by early 2007. Compared to free radical scavengers or other detoxifying agents they directly modulate reactive oxygen species production and detoxification at an early stage to prevent damage and stop disease initiation as well as progression. Such drugs with a new mechanism of action allows Chronogen to target different pathological situations from acute and severe conditions like reperfusion-injury to more chronic situations in cardiovascular and central nervous system diseases.
PDT is a therapeutic modality combining the administration of a photosensitizer followed by its activation by light of the appropriate wavelengths in order to treat a disease. One of the main problems associated with the use of photosensitizer for photoaging, acne and extensive actinic keratosis is profound skin sensitivity to visible light that lasts for days after topical application of the photosensitizer. If the patient is exposed to sunlight or bright artificial light after large surface application a severe phototoxic reaction can occur. This phototoxic reaction is characterized by severe erythema, edema, pruritus and pain followed by desquamation and sometimes hyperpigmentation. The mechanism by which phototoxic effects occur during PDT is well understood and is due to the generation of Reactive Oxygen Species (ROS) affecting cells and tissues in and around the treated area.
Having a remarkable know-how in the genetics of aging, Chronogen has initially developed a series of unique, rapid and reliable screening assays aimed at the identification of small molecule modulators mimicking the genetic effects obtained in C. elegans and mouse mutants. Identified longevity target genes have been used to screen drug candidates that could modulate oxidative stress and lipid metabolism in major cardiovascular and neurodegenerative disorders. Drugs that are cellular oxidative stress modulators with a new mechanism of action are currently in preclinical and clinical development. Targeted indications are age-related diseases in which oxidative stress plays a key role, such as in ischemia-reperfusion injury and chronic diseases such as Parkinson's disease, Alzheimer's disease or Atherosclerosis. More information on Chronogen can be found on: http://www.chronogen.com.CHRONOGEN INC.
CONTACT: Pascal Puchois, Ph.D., VP Corporate & Business Development, (514)521-9595 ext. 201, Fax: (514) 521-9087, firstname.lastname@example.org