Hello Everyone,
Are you excited yet? I know that I am. This market has been incredible as we head into 2025. We are extremely optimistic about what we are seeing as of late.
Before we get down to business I wanted to let you know I will be dropping a brand new never before seen profile at 8 pm tonight.
Today's profile has been no different than what we have been seeing over the past 2 months.
NLSP gapped up a bit this morning but has bounced as low as 2.10 and as high as 2.66 which occurred late in the session today after 1 pm.
It is up about 30% as I type this.
This is a company that we have looked at several times over the past 2 years and we have seen it take off at times.
There is definitely that volatility factor that we like to see in these ones priced below 5 bucks.
Keep watching this and make sure you read today's news announcement.
NLS Pharmaceutics and Kadimastem Announce the Submission of a Request by Kadimastem and iTolerance, Inc. for an FDA Pre-IND Meeting for an Innovative Breakthrough Type 1 Diabetes Treatment
This submission comes after successful INTERACT meeting with the FDA earlier this year.
- NLS Pharmaceutics and Kadimastem working to close merger by the end of January 2025
ZURICH, SWITZERLAND AND NESS ZIONA, ISRAEL / ACCESSWIRE / December 19, 2024 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP) and Kadimastem Ltd. ("Kadimastem"), a clinical-stage company specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative diseases and diabetes, announced today in collaboration with iTolerance, Inc, ("iTolerance") a Miami-based regenerative medicine company, that a request for a Pre-Investigational New Drug ("Pre-IND") meeting has been submitted by Kadimastem and iTolerance to the U.S. Food and Drug Administration ("FDA") for iTOL102, an investigational biologic consisting of allogenic human stem cell-derived pancreatic islets combined with an immunomodulator for the treatment of Type 1 Diabetes. Kadimastem believes that this collaboration signifies a potentially transformative step in diabetes treatment.
This submission comes after a successful INTERACT ("Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products") meeting, which is a meeting at a specific time early in the product development, between Kadimastem, iTolerance, and the FDA earlier this year. The submission is a significant milestone toward the clinical development of iTOL102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by the Israel-United States Binational Industrial Research and Development Foundation("BIRD"). iTOL102 combines iTolerance's proprietary SA-FasL microgel (known as iTOL-100), an immune modulator, and IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, to generate an innovative treatment intended for the potential cure of type 1 diabetes.
iTOL-100, an immunomodulatory microgel technology being developed by iTolerance is designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem's IsletRx human stem cell-derived islets.
Kadimastem's IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon.
The iTOL102 product was evaluated at the fast-track center for testing at the Diabetes Research Institute ("DRI") at the University of Miami School of Medicine, where it was designated by DRI to be a novel combination of tolerance-inducing agent and human stem cell-derived islets demonstrating functional insulin release and disease reversal in an animal model.
Ronen Twito, Executive Chairman and Chief Executive Officer of Kadimastem, stated, "This requested Pre-IND meeting is a crucial step in our development of iTOL 102 and towards bringing this potential breakthroughtherapy to the market. We are committed to advancing our innovative IsletRx cell product and are excited about the potential of combining it with iTolerance's immunomodulatory technology to create a potential cure for Type 1 diabetes."
iTolerance Chief Executive Officer, Dr. Anthony Japour, added, "The submission of a request for a Pre-IND meeting with the FDA underscores our commitment to addressing the critical need for a diabetes cure with an off-the shelf human allogenic stem cell-derived pancreatic islet product together with iTolerance's proprietary immunomodulator, iTOL-100, that may reduce or obviate the need for life-long immunosuppression following transplantation. By working closely with Kadimastem, we believe we can unlock the potential for cell therapies for the treatment, and potential cure of Type 1 diabetes."
Alexander Zwyer, Chief Executive Officer of NLS Pharmaceutics, commented, "We are confident that our pending merger with Kadimastem, once completed, will add significant value to the combined company's pipeline, bringing valuable assets and a promising growth trajectory. We are working toward the merger closing by the end of January and remain optimistic about the positive impact it will have on our future."
As previously reported, NLS Pharmaceuticals and Kadimastem entered into an agreement and plan of merger in November 2024. The merger is subject to closing conditions, including the approval of the shareholders of each of the NLS Pharmaceutics and Kadimastem.
About Kadimastem
Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications.
IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of Kadimastem and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
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