EOM Pharmaceutical Holdings Reports FDA Clearance of an IND for a Clinical Trial in Cachectic Cancer Patients

MONTVALE, N.J., May 27, 2026 (GLOBE NEWSWIRE) -- EOM Pharmaceutical Holdings, Inc. (OTC: IMUC) (“EOM”, the “Company”) an innovative clinical-stage biotechnology company focused on developing transformative treatments for chronic inflammatory conditions and retinal diseases, is pleased to announce that the FDA has cleared its Investigational New Drug (IND) application to conduct a three-month Phase 2a clinical study of EOM613 in cachectic cancer patients.

“EOM has designed a Phase 2a clinical trial for the treatment of cancer cachexia patients who currently have no approved therapies,” stated Shalom Z. Hirschman, MD, Chief Medical Officer of EOM. “In previous clinical trials in cachectic AIDS patients and COVID-19 patients, EOM613 treatment was well-tolerated, even in extremely sick patients. A broad-spectrum immune regulating agent that regulates pro-and anti-inflammatory cytokines in patients without the risk of severe side effects could prove to be beneficial in the treatment of cancer cachexia, which is largely a cytokine-driven process. We are pleased to continue to explore the potential use of EOM613 in treating cancer cachexia patients given the promising results in the early exploratory trial in Canada.”

Cancer cachexia is a highly debilitating wasting syndrome exhibited by a large percentage of patients with advanced malignancies, marked by weight loss, muscular weakness, anorexia, anemia, and hypoproteinemia. Cachectic patients often are debilitated and unable to tolerate rounds of chemotherapy. Cancer cachexia is largely an inflammatory process in the body, wherein pro-inflammatory cytokines, including Interleukin-6, TNF-alpha, Interleukin-1-beta and Interferon-gamma, are released within the body. Cytokines induce protein degradation, leading to a loss of muscle mass and weight and hypermetabolism. They also interfere with hypothalamic regulation, leading to reduced food intake in patients with advanced cancers. There is currently no FDA-approved therapy for cancer cachexia.

EOM filed an IND application for the treatment of cachectic cancer patients at the FDA’s Office of Cardiology, Hematology, Endocrinology and Nephrology Diseases (OCHEND) to conduct an open-label Phase 2 trial with Stage 4 cancer patients. The trial’s Principal Investigator, Azriel Hirschfeld, MD, at Hirschfeld Oncology in Brooklyn, NY, is an expert in the treatment of gastrointestinal cancer patients with advanced disease who typically progress to a cachectic condition.

The open-label clinical trial is designed to explore the effect of daily subcutaneous administration of EOM613 over a period of three months on weight, lean body mass, appetite, performance status and standardized measures of patient quality of life. In addition, the safety and tolerability of EOM613 will be assessed. The trial will also explore the number of patients who become eligible for another round of chemotherapy during the study period as a result of functional improvement in strength and performance status. The circulating cytokines of the patients will also be studied at baseline and during the course of the trial. About 20 patients, aged 18-80, are expected to be enrolled into the study. Patients at baseline will have a Karnofsky Performance Score of 40-80% and a life expectancy of at least four months. The trial is anticipated to be initiated early in the third quarter of 2026.

The Company is also planning an additional exploratory, open-label EOM613 clinical trial in Crohn’s disease. This trial is intended to be conducted at clinical sites in New Brunswick and Lakewood, NJ, under Principal Investigator Arkady Broder, MD, Director of Gastroenterology at the St. Peter’s Healthcare System. The trial is planned to enroll 15 to 20 subjects with moderate to severe Crohn’s disease who have failed or could not tolerate at least one conventional therapy. EOM anticipates initiating the trial in the fourth quarter 2026 to test for signs of both clinical remission and endoscopic remission with EOM613 monotherapy treatment and to measure biomarkers such as C-reactive protein, calprotectin and pro-inflammatory serum cytokines.

Crohn’s disease is also a multi-cytokine driven process. The pathophysiology of inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, is known to be largely driven by the release of inflammatory cytokines in the gastrointestinal tract, in particular TNF-alpha, interleukin 12 (IL-12), interleukin-23 (IL-23) and soluble Interleukin 2 receptor (sIL-2R).

About EOM613

EOM’s lead asset, EOM613, is a peptide nucleic acid-based broad spectrum immune regulating agent that acts on both key pro-inflammatory and anti-inflammatory cytokines, with potential therapeutic utility in treating a variety of acute and chronic inflammatory conditions. This agent has been previously shown to regulate cytokine expression in a variety of immune cells in cell culture, and has been previously found to be beneficial in open-label clinical trials in rheumatoid arthritis and AIDS cachexia. In a previously conducted Health Canada-approved clinical trial, EOM613 has also shown beneficial effects in stabilizing the weight and improving the functional status of Stage 4 cancer patients who also had cancer cachexia.

About EOM Pharmaceutical Holdings, Inc.

EOM Pharmaceutical Holdings, Inc. is a clinical-stage company focused on developing novel drugs with the potential to transform therapeutic paradigms and improve quality of life in patients suffering from debilitating and sometimes deadly diseases. The company was founded with a specific vision to pursue innovative approaches to rescue, repair, and restore health of patients with urgent and unmet medical needs. For more information about EOM Pharmaceuticals, please visit www.eompharma.com. 

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify these statements by forward-looking words such as "may," "will," "continue," "anticipate," "intend," "could," "project," "expect" or the negative or plural of these words or similar expressions, and other similar terms. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Statements in this press release that are not historical facts, including statements about future expectations, such as the timing and success of clinical trials, regulatory approvals, potential commercialization, development plans, and the Company’s ability to fund operations, are forward-looking statements.

These forward-looking statements are subject to numerous risks, uncertainties, and assumptions including, but not limited to, risks associated with clinical trials (including the possibility of delays, adverse events, or failure to meet endpoints); EOM's ability to develop and commercialize its product candidates; EOM's ability to obtain and maintain regulatory approval of product candidates; EOM's ability to operate in a competitive industry and compete successfully against competitors that have greater resources; EOM's reliance on third parties; and EOM's ability to obtain and adequately protect intellectual property rights for product candidates. Any forward-looking statements in this press release speak only as of the date of this press release. EOM assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Investor Contact:

Wayne I. Danson, Chief Financial Officer
info@eompharma.com