HERZLIYA, ISRAEL AND CALGARY, AB, Sept. 3, 2024 /PRNewswire/ — Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) (“Innocan” or the “Company”) is a pharmaceutical and The biotech industry is hopeful of a positive response from the U.S. Food and Drug Administration (FDA) following Innocan's successful completion of the pre-IND Type B meeting with the FDA in July. I'm happy to share what I've learned. Evaluation of main drug liposome technology-CBD (LPT-CBD).
The FDA agreed to submit LPT-CBD under a 505(b)(2) new drug application (NDA) by establishing a scientific bridge to the reference list drug. The 505(b)(2) abbreviated pathway, as well described, typically allows for a faster route to patent exploitation and commercial approval. This pathway is an important milestone for Innocan as it may pave the way for streamlining and accelerating the FDA approval process for LPT-CBD while advancing patent-protected innovations.
In addition, Innocan has reached an agreement with the FDA on both its non-clinical development plan and clinical study design for LPT-CBD's proposed Phase I clinical study of its Investigational New Drug (IND) application.
Professor Chezy Barenholz, Chief Scientific Officer at Innocan, said: “We are very pleased with the outcome of our meetings and interactions with the FDA. We now have a clear and straight path.” -CBD treats chronic pain. ”
“Innocan is committed to bringing new opportunities to chronic pain management,” added Dr. Eyal Kalo, Director of Research and Development at Innocan. “Chronic pain is a serious condition that affects approximately 20% of the population (1 in 5 U.S. adults).
They have important unmet needs. Positive feedback from the FDA is an important milestone for us and allows us to bring LPT-CBD to market, bringing much-needed relief to millions of people suffering from chronic pain. can. ”
“Given the current standard of care for chronic pain, we believe that LPT-CBD will significantly improve clinicians' ability to address existing gaps,” said COO of NEMA Research Inc., a key opinion in the field of chronic pain. Leader Dr. Joseph Pergolizzi emphasized. Member of Innocan's Advisory Board.
Iris Vinković, CEO of Innocan, emphasized that LPT-CBD has demonstrated long-term sustained release of CBD in non-clinical studies, stating, “Our research is important in the fight against chronic pain.'' “We are bringing new technological approaches to the forefront.” . ”
https://www.cdc.gov/nchs/products/databriefs/db390.htm?utm_source=STAT+Newsletters&utm_campaign=94ea767867-MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-94ea767867-149614717#fig1
About Innocan:
Innocan is a pharmaceutical technology company that operates in two main segments: Pharmaceuticals and Consumer Wellness. In the pharmaceutical sector, Innocan focuses on developing innovative drug delivery platform technologies, including cannabinoid science, to treat a variety of conditions and improve patients' quality of life. This segment includes innovative drug delivery technologies. LPT CBD-loaded liposome platform facilitates precise dosing and sustained and controlled release of CBD into the bloodstream. Research on LPT delivery platforms is in preclinical testing for chronic pain management. In the Consumer Wellness segment, Innocan develops and markets a broad portfolio of innovative, high-performance self-care products to promote healthier lifestyles. Under this division, Innocan established a joint venture named BI Sky Global Ltd to focus on developing highly targeted online sales. https://innocanpharma.com/
contact address:
For Innocan Pharma Corporation:
Iris Vinkovic, CEO
+1 5162104025
+972-54-3012842
+442037699377
(email protected)
Neither the Canadian Securities Exchange nor its regulatory services provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Caution regarding forward-looking information
Certain information contained in this news release, including without limitation the human testing plans for the Company's LPT-CBD platform, is forward-looking information within the meaning of applicable securities laws. By their nature, forward-looking information involves a number of risks and uncertainties, some of which are beyond Innocan's control. The forward-looking information contained in this news release reflects certain assumptions made by Innocan, including expectations and assumptions regarding the expected benefits of the product, the satisfaction of regulatory requirements in various jurisdictions, and the satisfactory completion of production and sales arrangements. based on key expectations and assumptions.
Forward-looking information is subject to various risks and uncertainties that could cause actual results or experience to differ materially from the anticipated results or expectations expressed in this news release. Principal risks and uncertainties include, but are not limited to: Governmental and Regulatory Requirements and Actions by Governmental Authorities. Relationships with suppliers, manufacturers, customers, business partners and competitors may be disrupted. There are also risks inherent to the nature of product distribution, such as import and export issues and the inability to obtain (or timely obtain) necessary regulatory or other approvals. Our anticipated schedule for market entry is subject to change for a variety of reasons, including the inability to secure necessary regulatory requirements and the need for additional time to enter into and/or satisfy manufacturing and distribution arrangements. . For the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release. A comprehensive discussion of other risks affecting Innocan is contained in Innocan's public reports and filings, which are available from Innocan's profile at www.sedarplus.ca.
Readers are cautioned not to place undue reliance on forward-looking information, as actual results may differ materially from such forward-looking information. Innocan does not undertake to update, amend or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law.
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SOURCE Innocan Pharma Corporation
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