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Associated Press
18-02-2025
- Health
- Associated Press
Devonian Announces Positive in Vivo Results of Thykamine™ on Gene Expression Associated With Fibrosis
QUEBEC CITY--(BUSINESS WIRE)--Feb 18, 2025-- Devonian Health Group Inc. (' Devonian ' or the ' Company ') ( TSXV: GSD; OTCQB: DVHGF), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, today announced positive results from a gene analysis conducted as part of in vivo study in STAM™ mouse model. Thykamine™ was administered orally, at doses of 0.5 mg/kg, 5.0 mg/kg and 50.0 mg/kg once a day for a period of three (3) weeks. Thykamine™ treatment was associated down regulation of key genes associated with the progression of inflammatory diseases toward fibrosis. These include inhibitory (%) effects on inflammatory-related genes and fibrosis-related genes namely: Act2: up to 57%, TGFβ : up to 49.3 % (p<0.05), Ctgf: up to 44.2%, Ccl2: up to 77.28% (p<0.005), MMP9: up to 58.2% (p<0.005), Timp1: up to 73.5% (p<0.0005), Ccr2: up to 70.8% (p<0.0005), Socs3: up to 46.7%, SerpinF: up to 62.1% (p<0.05), IFNγ: up to 73.1% (p<0.05. Results will be published in a peer-reviewed scientific publication in 2025. Fibrosis is the common and final pathological outcome of chronic inflammatory diseases. Several genes are associated with different fibrotic diseases such as eye fibrosis, heart fibrosis, hepatic fibrosis, intestinal fibrosis, lung fibrosis, pancreas fibrosis, renal fibrosis and skin fibrosis 1. Most genes involved in the overlapping fibrosis diseases 1,2,3,4,5 were downregulated following Thykamine™ treatment expanding its potential anti-fibrotic effect to several organs. 'The changes in gene expression observed following treatment with Thykamine™ provide further evidence of its potential benefit not only as anti-inflammatory medication and related diseases but may expand its potential use as antifibrotic medication for many chronic diseases in multiple organs,' said Dr. Andre P. Boulet, PhD, Chief Scientific Officer of the Company. About Fibrosis 1,2,3,4,5 A complex physiological process, fibrosis encompasses both acute and chronic inflammatory disorders. It is characterized by an excessive buildup of fibrous connective tissue in and around damaged or inflamed tissues, which results in the production of permanent scars. In several organs, including the skin, heart, lungs, gut, liver, and kidneys, fibrosis is the final stage of chronic illness. Fibrotic tissue pathologic buildup leads to a loss of structural integrity and function, which raises morbidity and mortality. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian's focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability 'from the seed to the pill'. Devonian is traded publicly on the TSX Venture Exchange (the 'Exchange') (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF). References Gu Chang, Shi X, Dang X, et al. Identification of Common Genes and Pathways in Eight Fibrosis Diseases, Frontiers in genetics, Jan 15 (11), art 627396, 2021. Guo S, Zhang Q, Guo Y, et al. The role and therapeutic targeting of the CCL2/CCR2 signaling axis in inflammatory and fibrotic diseases. Frontiers in Immunology, Jan 09, 2025. Kitagawa K, Wada T, Furuichi K, et al . Bloackade of CCR2 ameliorates progressive fibrosis in kidney. AJP, 165 (1), 237-246, 2004. Ihn H. Pathogenesis of fibrosis: role of TGF-β and CTGF. Curr Opin Rheumatol ,14(6):681-5, 2002. Steen EH, Wang X, Balaji S, et al. The role of the anti-inflammatory Cytokine Interleukin-10 in Tissue Fibrosis. Advances In Wound Care, 9 (4); 184-198, 2019. Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including but, not limited to those relating to the economic impact of clinical study, the efficiency of the highly anti-inflammatory potency proven and the position of the Thykamine™ as a possible first-line treatment of choice for several autoimmune conditions in the early stages of the disease and the reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long-term negative consequences, and, generally, the above 'About Devonian' and 'About Altius' paragraphs, which essentially describes the Corporation's outlook, constitute 'forward-looking information' or 'forward-looking statements' within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release. CONTACT: Devonian Health Group Inc. Mr. Luc Gregoire President & CEO Dr. Andre P. Boulet, PhD Chairman, Chief Scientific Officer Telephone: 1 (450) 979-2916 E-mail: [email protected] Financial Communications Inc. Mr. Ben Ozerkevich Telephone: (416) 644-2020 or (212) 812-7680 E-mail: [email protected] SOURCE: Devonian Health Group Inc. Copyright Business Wire 2025. PUB: 02/18/2025 08:45 AM/DISC: 02/18/2025 08:47 AM
Yahoo
06-02-2025
- Business
- Yahoo
CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories
VANCOUVER, Washington, Feb. 06, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today positive results from its preclinical studies with SMC Laboratories ('SMC'). The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01). The first two studies, completed in late 2024, evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis in mice who received a single dose of Streptozocin at birth and were then fed a high fat diet from weeks four to twelve. The third study, concluded in January 2025, evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent, from birth to sacrifice at day 35. 'The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab's ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,' said Melissa Palmer, MD FAASLD, the Company's Lead Consultant in Hepatology. Dr. Jacob Lalezari, CEO of CytoDyn, added, 'We are very encouraged by these initial findings, which add to the growing body of evidence that leronlimab's core mechanism of action, binding to CCR5 receptors on cells, could translate into a variety of meaningful clinical benefits for patients across a number of medical conditions. As the Company continues to prioritize its oncology objectives for 2025, we look forward to establishing the right partnership to further the clinical development pathway for leronlimab in the treatment of fibrosis of the liver and potentially other organs, such as the lungs and heart.' CytoDyn is currently in discussions with several third parties regarding next steps in an effort to expand on these promising findings. The Company intends to explore a number of potential synergies and partnership opportunities in the coming months as it furthers its clinical development pipeline, including opportunities that might explore the potential widespread applications for leronlimab as a treatment path for fibrosis in other organs. About CytoDyn CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including infectious disease, oncology, and autoimmune conditions. About SMC Laboratories SMC Laboratories, Inc. is a CRO, with a focus on conducting the non-clinical research necessary for the drug development process. As a global consulting company that designs studies according to customer requests, it supports cutting-edge non-clinical pharmacological studies. The company owns a variety of mouse models for inflammation and fibrosis in various organs, centered on the innovative STAM™ mouse animal model of liver cancer derived from MASLD (metabolic dysfunction-associated steatotic liver disease). This patented mouse model was developed by SMC Laboratories as a worldwide-first model based on MASLD. We offer non-clinical pharmacological studies using the model mouse. Please check the company's website for further details. Note Regarding Forward-Looking Statements This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned 'Forward-Looking Statements' and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments. Media Contacts CytoDyn Inc. Riyaz Lalani Gagnier Communications CytoDyn@ in to access your portfolio
