IRVINE, Calif.--(BUSINESS WIRE)--#ClinicalTrials--Immunis, Inc., a private biotech company developing a novel cellular secretome therapy for age and disease-related immune decline, is thrilled to announce that it has received unanimous approval from the Data Safety and Monitoring Board (DSMB) to proceed enrolling the next cohort of patients for its Phase 1/2a clinical trial.
The DSMB is comprised of independent experts in the fields of medicine, investigational drug safety, and ethical patient management who have carefully reviewed the safety and tolerability data from our initial patient cohort. They have concluded that IMMUNA causes no severe adverse events when administered intramuscularly in patients with muscle atrophy associated with knee osteoarthritis. Based on their thorough evaluation and recommendation, the board has granted Immunis the green light to advance to the next phase of our clinical trial, which increases the concentration of IMMUNA administered in patients.
“The DSMB conducts a rigorous evaluation of all trial data after each cohort of participants complete treatment, so to receive unanimous approval from the DSMB on the first cohort is encouraging,” remarks Immunis’ Director of Medical Affairs Erin Curry, PA, MPH. “We are enthusiastic about the potential of IMMUNA to positively transform the lives of elderly patients with muscle atrophy. With the DSMB’s support, we are now poised to move forward confidently to further evaluate the safety and efficacy of IMMUNA at higher dosage levels.”
Immunis will continue to collaborate closely with regulatory authorities and medical experts to ensure the thorough evaluation of IMMUNA’s potential risks and benefits. The Immunis team is eager to continue its mission of bringing novel treatment options to patients and their families.
About Immunis Inc.
Immunis is a private biotechnology company developing a novel immunomodulatory secretome product for the various manifestations of age and disease-related immune decline. The investigational product line leverages Immunis’ leading-edge capabilities in secretome technology to deliver a product of all natural, all human immune modulators in their natural relative physiological concentrations. For additional information about Immunis’ Phase 1/2a clinical trial please visit: https://immunisbiomedical.com/clinical-trials/
Cautionary Note Regarding Forward-Looking Statements
This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.