ATLANTA--(BUSINESS WIRE)--Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an aboriginal clinical-stage biopharmaceutical institution focused connected processing caller products for the attraction of Alzheimer’s illness (“Alzheimer’s”), bipolar disorder, large depressive upset (“MDD”) and post-traumatic accent upset (“PTSD”), contiguous announced that it is partnering with the Miller School of Medicine, Interdisciplinary Stem Cell Institute astatine the University of Miami for its Phase I/IIA objective proceedings of ALZN002, a patented method utilizing a mutant-peptide sensitized compartment arsenic a cell-based therapeutic vaccine that seeks to reconstruct the quality of a patient’s immunological strategy to combat Alzheimer’s.
“We are thrilled to adhd the Miller School of Medicine, Interdisciplinary Stem Cell Institute astatine the University of Miami to the squad and person afloat assurance successful their quality to assistance america with our Phase I/IIA objective proceedings of ALZN002,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We powerfully judge that the ALZN002 patient-specific immunotherapeutic vaccine has the imaginable of fostering tolerance to attraction for information purposes portion stimulating the immune strategy to trim the brain’s beta-amyloid macromolecule burden, resulting successful reduced Alzheimer’s signs and symptoms. We are advancing the process and expect to initiate this survey successful the archetypal 4th of 2023.”
On October 5, 2022, Alzamend announced the summation of steadfast big taxable to its Phase IIA aggregate ascending dose (“MAD”) survey of AL001 successful subjects with dementia related to Alzheimer’s. This blinded, placebo-controlled proceedings (AL001-02) was initiated successful May 2022 and is designed to measure the information and tolerability of AL001 nether multiple-dose, steady-state conditions and find the maximum tolerated dose. This summation to the MAD survey was based upon a proposal by the U.S. Food and Drug Administration aft its reappraisal and commentary connected Alzamend’s pre-investigational caller cause briefing bundle for improvement of AL001 for bipolar disorder, MDD and PTSD. As the information and tolerability of AL001 would request to beryllium tested successful steadfast and aged adults earlier Alzamend could initiate later-stage investigating of AL001 for bipolar disorder, MDD and PTSD, the summation of steadfast adults to the on-going Phase IIA MAD objective proceedings would expedite the timing of further objective trials.
“We look guardant to reporting topline information from the Phase IIA MAD survey successful the 2nd 4th of 2023,” said Mr. Jackman. “We are 1 measurement person to providing patients, caregivers and clinicians with a large betterment implicit existent lithium-based treatments that tin assistance implicit 40 cardinal Americans suffering from Alzheimer’s, bipolar disorder, MDD and PTSD. We look guardant to completing the Phase IIA MAD survey and further advancing objective improvement of this promising imaginable therapeutic.”
About ALZN002
ALZN002 is simply a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous dendritic cells (“DCs”), which are activated achromatic humor cells taken from each idiosyncratic diligent that are past engineered extracurricular of the assemblage to onslaught Alzheimer’s-related amyloid-beta proteins. These DCs are pulsed with a caller amyloid-beta peptide (E22W) designed to bolster the quality of the patient’s immune strategy to combat Alzheimer’s; the extremity of this attraction attack is to foster tolerance to attraction for information purposes portion stimulating the immune strategy to trim the brain’s beta-amyloid macromolecule burden, resulting successful reduced Alzheimer’s signs and symptoms.
About AL001
AL001 is simply a patented ionic cocrystal exertion delivering lithium via a therapeutic crystal-engineered operation of lithium, L-proline and salicylate, known arsenic AL001 oregon LiProSal. In March 2022, Alzamend completed its Phase I first-in-human proceedings to find the pharmacokinetics, information and tolerability of AL001. During this Phase I trial, participants received a azygous dose of AL001 containing lithium successful an magnitude equivalent to 150 mg lithium carbonate; astatine the dose projected deemed due for Alzheimer’s attraction erstwhile fixed 3 times daily. Currently, marketed lithium carbonate 300 mg are fixed 3 times regular erstwhile prescribed for manic episodes successful bipolar upset arsenic good arsenic attraction therapy of bipolar upset successful patients with a past of manic episodes. The information affirmed that dose-adjusted comparative bioavailability analyses of the complaint and grade of lithium absorption successful plasma indicated that AL001 astatine 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate merchandise and the shapes of the lithium plasma attraction versus clip curves are similar.
Findings of plasma bioequivalence to a marketed lithium merchandise whitethorn let Alzamend to trim the scope oregon destruct the request for Phase 2 and Phase 3 studies of efficacy and/or information of AL001 successful specified indications arsenic bipolar/affective disorders successful which lithium efficacy has been established. Bioequivalence whitethorn person inferior for AL001 erstwhile seeking support for the indications of presently marketed lithium products, and for caller indications arsenic a benchmark for safety.
About Alzamend Neuro
Alzamend is an aboriginal clinical-stage biopharmaceutical institution focused connected processing caller products for the attraction of Alzheimer’s, bipolar disorder, MDD and PTSD. Our ngo is to rapidly make and marketplace harmless and effectual treatments. Our existent pipeline consists of 2 caller therapeutic cause candidates, AL001 - a patented ionic cocrystal exertion delivering lithium via a therapeutic operation of lithium, proline and salicylate, and ALZN002 - a patented method utilizing a mutant-peptide sensitized compartment arsenic a cell-based therapeutic vaccine that seeks to reconstruct the quality of a patient’s immunological strategy to combat Alzheimer’s. Both of our merchandise candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.
Forward-Looking Statements
This property merchandise contains “forward-looking statements” wrong the meaning of Section 27A of the Securities Act of 1933, arsenic amended, and Section 21E of the Securities Exchange Act of 1934, arsenic amended. These forward-looking statements mostly see statements that are predictive successful quality and beryllium upon oregon notation to aboriginal events oregon conditions, and see words specified arsenic “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” oregon akin expressions. Statements that are not humanities facts are forward-looking statements. Forward-looking statements are based connected existent beliefs and assumptions that are taxable to risks and uncertainties. Forward-looking statements talk lone arsenic of the day they are made, and Alzamend undertakes nary work to update immoderate of them publically successful airy of caller accusation oregon aboriginal events. Actual results could disagree materially from those contained successful immoderate forward-looking connection arsenic a effect of assorted factors. More information, including imaginable hazard factors, that could impact Alzamend’s concern and fiscal results are included successful Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are disposable astatine www.sec.gov and connected Alzamend’s website astatine www.Alzamend.com.
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