Clinical Trials

Date: 2015-07-23

Type of information: Presentation of results at a congress

phase: 1

Announcement: presentation of results at the Alzheimer’s Association International Conference 2015 (AAIC) in Washington D.C.

Company: Axon Neuroscience (Slovak Republic)

Product: AADVAC1

Action mechanism:

peptide/immunotherapy product/vaccine. AADvac1 is a candidate therapeutic vaccine for Alzheimer\'s disease that targets misfolded tau protein. The vaccine\'s antigenic determinant is a synthetic peptide derived from a tau protein sequence, which is coupled to keyhole limpet hemocyanin (KLH) and uses aluminum hydroxide (Alhydrogel) as an adjuvant. Based on preclinical results, the intervention is expected to reduce the number of neurofibrillary tangles, remove hyperphosphorylated tau protein and reduce the amount of oligomerized and insoluble pathological tau in the brain, to halt the spread of neurofibrillary pathology through the brain, and thus prevent associated cognitive decline.

Disease: Alzheimer\'s disease

Therapeutic area: Neurodegenerative diseases

Country: Austria

Trial details:

This first-time-in-man study is mainly designed to assess the safety and tolerability of AADvac1 in the treatment of Alzheimer\'s disease. As this study is a Phase I study focused on tolerability and safety, efficacy will be assessed in an exploratory manner.(NCT01850238).

Latest news:

* On July 23, 2015, Axon Neuroscience has presented results from a Phase 1 study with AADVAC1, a vaccine designed to target diseased tau proteins in Alzheimer’s patients. In July 2013, AXON Neuroscience initiated a Phase I study, evaluating its immunotherapy against diseased tau protein. The primary goal of this study was to assess safety and tolerability of this compound. It was performed on 30 patients suffering from Alzheimer’s disease in four different clinical sites in Austria and successfully completed in March of this year. According to coordinating investigator Professor Reinhold Schmidt from Medical University Graz, who presented the results at the at the Alzheimer’s Association International Conference 2015 (AAIC) in Washington D.C., the vaccine is safe and well tolerated in all assessed parameters. Additionally, the treatment induced robust immune response in vast majority of the study participants and the average cognition of patients remained stable over 6 months. The promising results have provided a strong basis for further development of the vaccine clinical program, So this year, Axon Neuroscience is beginning a Phase II study, where the primary goal is to confirm these positive results by assessing safety and immunogenicity on a larger sample of patients with mild Alzheimer’s disease. As a second objective, the study will evaluate the effect of the AADvac1 vaccine in slowing down or halting the cognitive decline in patients over the period of 24 months. A 18-months safety follow-up study (FUNDAMANT) is also ongoing (NCT02031198)

* On July 2, 2015, Axon Neuroscience announced that the company has finished a Phase 1 study with AADVAC1, an active immunotherapy treatment aimed at diseased tau proteins that cause neural degeneration in Alzheimer’s patients. The vaccine is designed to stimulate patients‘ immune systems to attack these diseased proteins, and halt the progress of Alzheimer’s disease. Axon will present its results from the Phase 1 study at the Alzheimer’s Association International Conference (AAIC) at the AXON Neuroscience sponsored Symposium which will be held on July 22, 2015 at 6:00 PM in Marriott Marquis Hotel, Washington, DC. This first-in-man, first-in-class study was designed to assess safety and tolerability of the AADvac1 active vaccine in the treatment of patients with mild-to-moderate Alzheimer\'s disease. Regular review by the Data and Safety Monitoring Board revealed no safety concerns throughout the duration of the study, and it was concluded in general that the vaccine was well tolerated.

Is general: Yes