The grant follows the development of cellular therapy for the treatment of ALS in which the company presents a breakthrough, watch an interview with Assaf Shiloni, CEO of KadimaStem
After a year of revolution, the biotechnology company wants to continue its momentum, enjoys a strategic investment from Ilex Medical, is preparing for a broad clinical trial and is aimed at the large pharma companies, watch an interview with the company’s CEO Assaf Shiloni.
KadimaStem develops stem cells for the treatment and healing of cells for terminal muscular dystrophy (ALS) and diabetes, the company has performed a number of clinical trials and intends to start trials in humans with ALS in which the company can receive orphan drug status.
Announces today the receipt of approval for a grant from the Israel Innovation Authority for a total budget of NIS 10 million (net grant in the amount of NIS 4 million). The grant will be used primarily to submit IND for the company’s AstroRx® product for a second clinical trial (Phase IIa) in humans in the United States, as well as to expand the production of the cellular off-the-shelf product (AstroRx) and to make the required validations for the patient.
The company estimates that the said clinical trial is expected to begin in early 2023.
This grant joins another grant received by the company about two months ago (December 2021) for the development of quantitatively increased production capabilities of embryonic stem cells used as a starting material for astrocyte formation, in bio-reactors and large vessels as well as the freezing of astrocytes as a “frozen shelf product”.
Receiving the grants is of great value in terms of supporting the company’s capabilities to further develop the company’s groundbreaking cell therapy which as completed is expected to be in line for hundreds of thousands of ALS patients worldwide.
KadimaStem completed a clinical trial (Phase I / IIa, the first of its kind in the world in 2019, in which the company’s central nervous system support cells (AstroRx) were injected into the spinal fluid in a standard lumbar puncture procedure in 10 patients. As well as clinically significant efficacy in slowing the rate of disease progression for 3 months after treatment as measured by the ALSFRS-R. Prolong the therapeutic effect.
Assaf Shiloni, CEO of KadimaStem: “This grant is an important expression of confidence on the part of the Israeli Innovation Authority and the potential of its unique clinical platform to provide millions of patients worldwide with groundbreaking and life-saving treatments for ALS and other neurodegenerative diseases. Much towards the second clinical trial in humans – Phase IIa – in ALS. This grant gives us the necessary resources to advance towards an international clinical trial of the company’s flagship product – AstroRx® “along with the preparations the company has begun for a possible IPO in which NASDAQ”.