VICTORIA, BC, May 18, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced that it has appointed Mark Kowalski, MD, PhD, as the Company's Chief Medical Officer ("CMO"), effective May 18, 2023.
Dr. James Helliwell, CEO of Eupraxia said, "Mark is an accomplished clinical leader with more than two decades of experience in global clinical development and regulatory strategy. As we approach our Phase 2 readout with EP-104IAR in osteoarthritis, expected in the second quarter of this year, together with the broadening of our pipeline with additional drug candidates, the need for an experienced CMO has become compelling. We are pleased to attract a candidate of Dr. Kowalski's calibre to this critical role and welcome Mark to the team."
"I am excited about the prospects of Eupraxia's lead candidate EP-104IAR in osteoarthritis and the broader utility of the underlying technology platform," said Dr. Kowalski. "This is an exciting time to be joining the Company and I look forward to working with the team as we advance this technology in the clinic and potentially through to commercialization."
Dr. Kowalski has more than 20 years of experience in the pharmaceutical and biotech industry. He is a clinical leader, developing regulatory strategy and global clinical development plans for a variety of product types including small molecules, biologics (monoclonals, immunoconjugates, siRNAs) and vaccines, while working in a range of indications, including oncology, infectious diseases, urology, analgesia, allergy, rheumatology and metabolic disorders.
He brings to Eupraxia experience with clinical study design, database design and authoring protocols for Phase 1 through 3 clinical trials, as well as medical monitoring and pharmacovigilance services for Phase 1 through 4 clinical trials, plus data analysis and writing of clinical study reports.
Dr. Kowalski held multiple senior roles, including Chief Medical Officer, at Sierra Oncology, a public company acquired by GSK plc in 2022 for US$1.9 billion.
Prior to that, he was the Chief Medical Officer and Senior Vice President at Arbutus Biopharma, a biotechnology company devoted to discovering and developing a cure for chronic Hepatitis B.
Before that, he held the same position at Tekmira, a biopharmaceutical company focused on developing therapeutics based on RNA interference utilizing lipid nanoparticle delivery technology in oncology, infectious disease, metabolic and other clinical indications.
Prior to Tekmira, Dr. Kowalski worked in the oncology and inflammation therapeutic area at Gilead Sciences, Inc. following Gilead's US$510-million acquisition of YM BioSciences Inc., at which Dr. Kowalski had been CMO and Vice President of Regulatory Affairs.
Dr. Kowalski holds a B.A. from Rutgers University and an M.D. and Ph.D. from the University of Kansas School of Medicine. He completed his postgraduate training in internal medicine and infectious diseases at Duke University and Harvard Medical School and is Board-certified in both.
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release alternatives to currently approved drugs. Each of Eupraxia's product candidates has the potential to address therapeutic areas with high unmet medical need and strives to provide improved patient benefit by delivering targeted, long-lasting activity with fewer side effects.
Eupraxia's lead product candidate, EP-104IAR, is currently in Phase 2 development for the treatment of pain due to osteoarthritis of the knee. The EP-104 platform has expanded into gastrointestinal disease with the launch of a Phase 1b/2a program to treat eosinophilic esophagitis. Eupraxia is also developing a pipeline of later- and earlier-stage long-acting formulations. Potential pipeline indications include candidates for both other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.
This news release includes forward-looking statements and forward–looking information within the meaning of Canadian securities laws. Often, but not always, forward–looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements in this news release include statements regarding the Company's business strategies and objectives, including current and future plans and opportunities, expectations and intentions; statements regarding the Company's Phase 2 clinical trials; the anticipated timing for data readout; the expectations regarding Dr. Kowalski and his role as Chief Medical Officer; the potential of Eupraxia's product candidates; the Company's expectations regarding its product designs, including with respect to patient benefit, duration and effectiveness; and the Company's expectations regarding the potential and advancement of its technology.
Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward–looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company's clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of the COVID-19 pandemic on the Company's operations; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR (www.sedar.com). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement or information can be guaranteed. Except as required by applicable securities laws, forward–looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward–looking statement or information, whether as a result of new information, future events or otherwise.
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Market Cap: | C$163.850M |
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