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Innocan Pharma Corp
Symbol INNO
Shares Issued 275,954,735
Close 2024-09-03 C$ 0.24
Market Cap C$ 66,229,136
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Innocan receives FDA OK for preinvestigational new drug

2024-09-03 18:57 ET - News Release

Ms. Iris Bincovich reports

INNOCAN PHARMA ADVANCES LIPOSOMAL CBD WITH POSITIVE RESPONSE FROM FDA FOLLOWING SUCCESSFUL PRE-IND MEETING

Innocan Pharma Corp. has received a positive response from the U.S. Food and Drug Administration following Innocan's successful preinvestigational new drug Type B meeting with the FDA, held in July, for its lead drug product liposomal technology CBD (LPT-CBD).

The FDA has agreed for LPT-CBD's submission under the 505(b)(2) new drug application by establishing a scientific bridge to the reference listed drug. The 505(b)(2) abbreviated pathway, as it is often described, typically enables a faster route to patent utilization and commercial approval. This pathway is a significant milestone for Innocan as it may pave the way for a streamlined and accelerated FDA approval process for LPT-CBD while allowing Innocan to advance its patent protected innovation.

In addition, Innocan has reached an alignment with the FDA on both its non-clinical development plan and the clinical study design for LPT-CBD's proposed investigational new drug filing for a phase 1 clinical study.

Prof. Chezy Barenholz, Innocan's chief scientific officer, said: "We are very pleased with the conclusion of our meeting and interactions with the FDA. We now have a clear and straight forward pathway toward generating the data needed for the initiation of our clinical study with LPT-CBD to treat chronic pain."

"Innocan is fully committed to bringing new opportunities for chronic pain management," added Dr. Eyal Kalo, research and development director of Innocan. "Chronic pain is a serious condition that affects around 20 per cent of the population (one of five U.S. adults) with significant unmet needs. The positive FDA feedback is a crucial milestone for us, enabling the advance of LPT-CBD to market and bring much needed relief to millions suffering from chronic pain."

"Given the current standard of care for chronic pain, we believe clinicians' ability to address existing gaps will be significantly enhanced by LPT-CBD," emphasized Dr. Joseph Pergolizzi, chief operating officer at Nema Research Inc., key opinion leader in chronic pain and a member of Innocan's advisory board.

Iris Bincovich, chief executive officer of Innocan, highlighted that LPT-CBD has demonstrated long-lasting cannabidiol release in non-clinical studies, and added, "Our work is a crucial element in the fight against chronic pain, bringing a novel technological approach to the forefront."

About Innocan Pharma Corp.

Innocan is a pharmaceutical technology company that operates under two main segments: pharmaceuticals and consumer wellness. In the pharmaceutical segment, Innocan focuses on developing innovative drug delivery platform technologies composed of cannabinoid science to treat various conditions to improve patients' quality of life. This segment involves innovative drug delivery technology: an LPT cannabidiol-loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the bloodstream. The LPT delivery platform research is in the preclinical trial phase for chronic pain management. In the consumer wellness segment, Innocan develops and markets a wide portfolio of innovative and high performance self-care products to promote a healthier lifestyle. Under this segment, Innocan has established a joint venture by the name of BI Sky Global Ltd. that focuses on developing advanced targeted on-line sales.

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