Nash Pharmaceuticals Announces 84% Reduction of Fibrosis by Additional Lead Compound In Second Pre-Clinical Study For Non-Alcoholic Fatty Liver Disease

Nash Pharmaceuticals Announces 84% Reduction of Fibrosis by Additional Lead Compound In Second Pre-Clinical Study For Non-Alcoholic Fatty Liver Disease

VANCOUVER, British Columbia, Jan. 21, 2019 (GLOBE NEWSWIRE) — Nash Pharmaceuticals Inc., a wholly owned subsidiary of Breathtec Biomedical Inc. (CSE: BTH) (CNSX: BTH) (FRANKFURT: BTI) (OTCQB: BTHCF) (the “Company” or “Nash Pharma”) is pleased to announce that its lead compound for non-alcoholic steatohepatitis (“NASH”) NP-160 showed repeated positive results in a recently completed study investigating its therapeutic effects in the widely used STAM™ mouse model from SMC Laboratories. In addition, a second compound, NP-135 was identified as an additional lead. Both NP-135 and NP-160 are one of a number of already approved compounds that Nash has been screening for new therapeutic uses as part of its drug repurposing strategy.

Data from this study demonstrated statistically significant improvements in several key measures relevant to the development and progression of NASH including:

  • Cenicriviroc (40 mg/kg, QID) both a positive control and comparator arm in the study showed a 1.5 point drop in the NAFLD/NAS score vs controls (p<0.01) and 54.1% (p<0.0001) reduction in fibrosis area compared to controls as measured by Sirius Red staining
  • NP-160 (40 mg/kg, QID) showed a 1.25 point drop in the NAFLD/NAS score vs controls (p<0.05) and a 59.9% reduction (p<0.0001) in fibrosis area.
  • NP-135 (200 mg/kg, QID) showed a 1.1 point drop in the NAFLD/NAS score vs controls (p>0.05) and a 84.4% reduction (p<0.0001) in fibrosis area.
  • As previously reported, both NP-160 and NP-135 at the same doses recently showed significant anti-fibrotic activity in a unilateral urinary obstruction (UUO) model of chronic kidney disease (CKD), reducing fibrosis by 57.6% (p <0.000001) and 52.1% (p<0.000001) respectively. Cenicriviroc reduced fibrosis in the same study by only 31.9% (p=0.00032).

“We have now had several studies from multiple independent laboratories, confirming that these two compounds are remarkably active in pre-clinical models of NASH and in CKD, both of which involve fibrosis. We were also very pleased to see the performance of our compounds against the comparator data of Cenicriviroc, a known anti-fibrotic compound in the same two studies,” said Christopher J. Moreau, CEO of NASH Pharmaceuticals. “It is also important to note that Cenicriviroc, itself a re-positioned HIV drug from Takeda, was acquired by Allergan from Tobira in 2016 for a total potential consideration of up to $1.695 billion We are looking forward to advancing these compounds into Phase II clinical trials as quickly as possible to establish human efficacy.”

About NASH/NFLD

According to a new report published by Allied Market Research, “Global Opportunity Analysis and Industry Forecast, 2021-2025,” the global NASH market was valued at $1.17 Billion in 2017, and is expected to reach $21.4 Billion by 2025, growing at a CAGR of 58.4% from 2021 to 2025. Currently, there are no US FDA approved treatments for NAFLD or NASH.

About Nash Pharmaceuticals Inc. 

Nash Pharmaceuticals Inc. is a wholly owned subsidiary of Breathtec Biomedical Inc.  Nash is a clinical stage pharmaceutical development company focused on drug repurposing in the areas of non–alcoholic steatohepatitis (NASH), chronic kidney disease (CKD) and inflammatory bowel disease (IBD). Drug repurposing is the process of discovering new therapeutic uses for existing drugs.

For more information, visit www.nashpharmaceuticals.com

CONTACT INFORMATION

Christopher J. Moreau
CEO
Nash Pharmaceuticals Inc.
604.398.4175 ext 701
info@breathtechbiomedical.com
investors@breathtecbiomedical.com
www.breathtecbiomedical.com

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. The Canadian Securities Exchange has not in any way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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LSBAD, Calif., Jan. 15, 2019 (GLOBE NEWSWIRE) — International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based, clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that the United States Patent and Trademark Office (USPTO) has granted the Company US Patent No. 10,172,890 on the topical use of lysate from human parthenogenetic (non-embryonic) stem cells to visibly improve signs of skin aging. The patented stem cell lysate is encapsulated and delivered from protective liposomes, and is combined with antioxidants, vitamins and peptides to provide skin benefits including reducing the depth/number of facial fine lines and wrinkles, increasing skin elasticity/firmness, and improving skin hydration. This proven to be effective technology used in the products was developed by key ISCO scientists, who brought neural stem cells to the clinical trial for the treatment of Parkinson’s disease.

“It is important that ISCO’s intellectual property portfolio continues to expand and we are excited to receive this US patent covering a technology used in Lifeline’s stem cell-based product line, which won various prestigious awards and has been receiving positive feedback both from consumers and well-known doctors since 2010 when we launched the product line” – commented Russell Kern, PhD, Co-Founder and CEO of Lifeline Skin Care, Inc.

ISCO’s wholly-owned subsidiary Lifeline Skin Care®, Inc. is a cosmeceutical business which develops, manufactures and markets anti-aging topical products using a proprietary extract derived from human parthenogenetic (non-embryonic) stem cells (hpSC) that has been shown to have a beneficial effect on skin cells. Currently Lifeline has developed and markets nineteen products. The products have been clinically tested by third party to ensure safety and efficacy.

Lifeline Skin Care’s products are sold nationally and internationally through a branded website www.lifelineskincare.com , various e-tailers such as Amazon, as well as through dermatology and cosmetic surgery offices, medical, day and resort spas. The goal of Lifeline is to help individuals improve the look and feel of their skin by combining the latest discoveries in the fields of stem cell biology, nanotechnology and skin cream formulation technology to create the highest quality, scientifically tested and most effective skin care products.

About International Stem Cell Corporation

International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

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Contacts:
International Stem Cell Corporation
Russell A. Kern, PhD
Phone: 760-940-6383
Email: ir@intlstemcell.com

Or

Edison Advisors
Tirth Patel
Vice President, Investor Relations
(646) 653-7035
tpatel@edisongroup.com

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