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Alzamend Shares Rise After FDA Gives Positive Response to Pre-IND Filing for Immune-Boosting Alzheimer's Vaccine

Source: Streetwise Reports

October 1, 2021 (Investorideas.com Newswire) Shares of Alzamend Neuro Inc. traded 36% higher after the company reported that the U.S. FDA responded favorably to its Pre-IND application for AL002, a cell-based therapeutic vaccine designed to restore patients' immunological systems, providing them with the ability to combat Alzheimer's Disease. The FDA has granted the firm approval to initiate a combined Phase 1/2 clinical trial in Q1/22.


Early clinical-stage biopharmaceutical company Alzamend Neuro Inc. (ALZN:NASDAQ), which concentrates its efforts on the development of therapeutics to treat neurodegenerative diseases and psychiatric disorders, today announced that "it has received a written response to its meeting request relating to its Type B Pre‑Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) providing a path for Alzamend's planned clinical development of AL002."

The company indicated that "AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient's immunological system to combat Alzheimer's Disease (AD)." The firm advised that AL002 works essentially by reducing beta-amyloid plaque.

The company's CEO Stephan Jackman stated, "We appreciate the thorough and meaningful response from the FDA, which provides us with the information and clarity needed to submit the IND application to initiate a clinical trial for AL002…Preclinical work supports AL002 being associated with a positive anti-inflammatory response and a decrease in brain amyloid contents."

"Based on AL002's positive toxicology results, the biologic nature of this product and the urgent need to deliver treatments for Alzheimer's to patients, Alzamend proposed, and the FDA agreed, to conduct a combined Phase 1/2 study. We appreciate the FDA's recommendations, guidance and other helpful advice. We plan to augment our proposed clinical trial protocols and proceed accordingly," CEO Jackman added.

Alzamend Neuro advised that based upon written feedback from the FDA, it expects that it will file its IND by the end of November 2021 and would then target commencement of the AL002 clinical trial in Q1/22.

The company explained further that AL002 is engineered to prevent the formation and break down of beta-amyloids which can form build up in the brain to form plaque. Alzamend noted that this build-up of plaque subsequently blocks neurological brain signals and ultimately leads to symptoms and onset of AD.

According to the company's website, AD affects more than 6.2 million people in the U.S. and is expected to increase to as many as 13 million by 2050. In addition, the disease impacts an even higher number of individuals and family members who serve as caregivers.

Alzamend Neuro is a preclinical stage biopharmaceutical company headquartered in Tampa, Fla. The firm is engaged in creating new medicines and treatments for psychiatric disorders and neurodegenerative diseases. The firm listed that its investigative drug pipeline currently includes AL001, which it described as "a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate" and AL002 as discussed for AD. The company advised that it licensed each of these product candidates from the University of South Florida Research Foundation Inc.

Alzamend Neuro started off the day with a market cap of around $198.1 million with approximately 86.9 million shares outstanding. ALZN shares opened only slightly higher today at $2.29 (+$0.01, +0.44%) over yesterday's $2.28 closing price. The stock has traded today between $2.2201 to $3.57 per share and closed at $3.08 (+$0.80, +35.09%).

Disclosure:

1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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