KDST Kadimahstem Ltd

DGAP-News: Kadimastem Holds Successful Preliminary Meeting with the FDA (INTERACT) Regarding IsletRx for the Treatment of Diabetes

DGAP-News: Kadimastem
Kadimastem Holds Successful Preliminary Meeting with the FDA (INTERACT) Regarding IsletRx for the Treatment of Diabetes

12.10.2021 / 15:55
The issuer is solely responsible for the content of this announcement.


(TASE: KDST), a clinical stage cell therapy company developing cell therapy treatments for ALS and diabetes, announced today that the Company held a preliminary meeting with the FDA (INTERACT) on October 7, 2021 regarding IsletRx, the company's cell therapy product in development for the treatment of diabetes.

During the meeting, Kadimastem received a response document from the FDA noting that the company's clinical development plan for IsletRx was being positively considered. It also included constructive comments and guidelines applicable for the next step pre-IND submission.

This interaction is of great importance to Kadimastem's clinical product development process and is an important milestone for the company. It was Kadimastem's first meeting with the FDA regarding its diabetes project and the FDA's first review of IsletRx, which demonstrated positive results in preclinical trials.

IsletRx is an expanded population of allogeneic stem cells differentiated into functioning insulin producing pancreatic islet cells. The company then uses a proprietary technology to select the purest performing cells from its population and puts them into a microcapsule that protects the cells from being rejected by the body's immune system. The implanted cells have shown in preclinical studies to be able to detect the sugar levels in the body and to, produce, and secrete, on demand, the required amounts of insulin and glucagon, just like a healthy pancreas.

Kadimastem CEO Asaf Shiloni said, "Thanks to Dr. Kfir Molakandov, the Director of Diabetes at Kadimastem, who presented the IsletRx project in an impressive manner, we received a positive response to the company's clinical development outline from the FDA's expert team, who we believe were overall very impressed with our technology. The FDA's expert team provided us with important feedback that we will use to prepare for the next step, our Pre-IND submission for IsletRx. I am convinced that the successful meeting and the relevant feedback will contribute to the continued progress of our product development and if all goes well, ultimately provide a cure for those living with diabetes.'

Kadimastem Chief Scientist Professor Michel Revel said, 'The INTERACT meeting with the FDA is an important step forward and shows that Kadimastem's development plan for its diabetes treatment product, IsletRx, is in the right direction.'

Kadimastem

Sarah Herzl

3

Company Website


News Source: News Direct


12.10.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at


Language: English
Company: Kadimastem
United States
ISIN: IL0011284614
EQS News ID: 1240166

 
End of News DGAP News Service

1240166  12.10.2021 

fncls.ssp?fn=show_t_gif&application_id=1240166&application_name=news&site_id=research_pool
EN
12/10/2021

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Kadimahstem Ltd

Kadimastem Ltd: 1 director

A director at Kadimastem Ltd sold 2,230,144 shares at 1.072ILS and the significance rating of the trade was 72/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearl...

 PRESS RELEASE

DGAP-News: Kadimastem Receives US Patent For Amyotrophic Lateral Scler...

DGAP-News: Kadimastem Kadimastem Receives US Patent For Amyotrophic Lateral Sclerosis (ALS) Treatment 09.08.2022 / 13:00 CET/CEST The issuer is solely responsible for the content of this announcement. (TASE: KDST), a clinical stage cell therapy company developing treatments for ALS and diabetes, has been granted a patent from the United States Patent and Trademark Office for its cell therapy technology for treating ALS and other neurodegenerative diseases. This US patent joins additional patents granted to Kadimastem in the US, Israel and Europe for the treatment of ALS an...

 PRESS RELEASE

DGAP-News: Kadimastem and Implant Therapeutics, Inc. Sign an Evaluatio...

DGAP-News: Kadimastem Kadimastem and Implant Therapeutics, Inc. Sign an Evaluation Agreement Towards the Potential Licensing of “Immune Evasive” Cells 08.06.2022 / 13:00 The issuer is solely responsible for the content of this announcement. If the feasibility study is successful, it would be a significant step forward towards pancreatic tissue engineering that could be used to develop Kadimastem’s IsletRx for diabetes in a way where transplantation would be possible without concern of immune rejection (TASE: KDST), a clinical stage cell therapy company developing a treatme...

 PRESS RELEASE

DGAP-News: Kadimastem Awarded Patent in Japan for AstroRx® For ALS and...

DGAP-News: Kadimastem Kadimastem Awarded Patent in Japan for AstroRx® For ALS and Drug Screening 30.05.2022 / 15:10 The issuer is solely responsible for the content of this announcement. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS, exploring one for multiple sclerosis and developing a potential cure for diabetes, has received a patent from the Japan Patent Office for ® for the treatment of ALS and drug screening. The patent also protects AstroRx® for the treatment of multiple sclerosis. AstroRx® is comprised of a differentiated cell...

 PRESS RELEASE

DGAP-News: Kadimastem Expands R&D Program to Include Multiple Sclerosi...

DGAP-News: Kadimastem Kadimastem Expands R&D Program to Include Multiple Sclerosis 18.05.2022 / 13:00 The issuer is solely responsible for the content of this announcement. (TASE: KDST), a clinical stage cell therapy company developing a treatment for ALS and a potential cure for diabetes, is expanding its R&D activity with the exploration of developing a treatment for Multiple Sclerosis (MS). Kadimastem remains on track to submit IND to the FDA before the end of 2022 to begin a multicenter clinical trial of for ALS in 2023 in the U.S.As part of this initiative, the comp...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch