Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients.
The results are highly significant in all parameters and show much more efficacy than any other treatment in progressive MS, Dimitrios Karussis, lead principal investigator and director of the MS Center at Hadassah Medical Center in Jerusalem, told BioWorld.
Karussis explained that there are currently very effective medications for stopping relapses and slowing the progression of relapsing remitting MS, but not very successful ones for progressive disease. The only registered treatment for primary progressive MS, Roche Holding AGs Ocrevus (ocrelizumab), slows down the progression rate by 20% to 25%, he said. For secondary progressive MS, Novartis AG's Mayzent (siponimod) also slows progression by about 20%, he added.
To determine whether NG-01 might one day prove more effective, the phase II study enrolled 48 people with progressive MS who were randomized into three groups and assigned to receive either an intrathecal or I.V. dose of NG-01 or a placebo injection. The study lasted for 14 months and met all of its primary endpoints.
Researchers said no serious treatment-related safety issues were detected. Only 6.7% and 9.7% of patients experienced disease progression in the intrathecal and I.V. NG-01 treatment groups, respectively, compared to 41.9% in the placebo group (p=0.0003 and p=0.0008). Also, 58% of the patients treated intrathecally with NG-01 did not show any evidence of disease activity during the entire the treatment period, compared to 9.7% in the placebo treated group (p<0.0001).
Trial participants treated with NG-01 demonstrated a significant improvement in walking ability, as measured by 25-foot walking time (P=0.0017), the company said. Investigators also found that intrathecal administration of NG-01 was also more efficacious than I.V. delivery in several key parameters of the disease, such as relapse rate (89% decrease in the relapse rate), functional MRI, monthly changes of the MRI T2 lesion load and the 9-hole peg test vs. the placebo-treated group.
The strengths of our trial include the inclusion of patients with active progressive multiple sclerosis, for which existing immunotherapies are usually ineffective, the double-blind design making this the first randomized controlled trial comparing intrathecal versus intravenous methods of NG-01 administration and single versus repeated treatment; and the robust, though short-term (6-12 months), clinical benefits observed in several disease activity parameters, including newer biomarkers, such as functional MRI-network connectivity, OCT, and cognitive testing, Karussis told BioWorld.
Separately, he said this trial provides encouraging results and suggests a potential for a new approach that may not only slow down the progression of the disease but even induce improvement and promote repair mechanisms in progressive MS.
Following the encouraging phase II data, Neurogenesis CEO Tal Gilat told BioWorld the next step is to start a multicenter phase IIb in the U.S., Europe and Israel, which will focus on improvement and repair in progressive MS patients, he said. The company has already had a pre-IND meeting with the FDA.
NG-01 is Neurogenesis lead product. Besides being tested in progressive MS patients, it was also tested in two phase IIa trials in amyotrophic lateral sclerosis.
Given our positive outcomes in two open-label trials in ALS with long follow-up periods, we are now considering what would be the best route to clinically advance NG-01 also for the ALS indication, Gilat said.
The Jerusalem-based biotech focuses on developing cell therapies for neurodegenerative diseases with an approach for sustained delivery of high levels of remyelinating growth factors using the patients own stem cells.
Neurogenesis licensed NG-01 from Hadasit, the technology transfer company of Hadassah Medical Center, to advance the cell therapy candidate.
The biotech used its Neuralyzed Cell platform to identify, culture and enhance a subpopulation of bone marrow cells towards remyelinating cells that also possess neurotrophic immunomodulatory and neuroprotective properties. The NG-01 cell population is injected directly into the central nervous system through the cerebrospinal fluid, where the cells home-in on a damaged area, take up residence and produce large amounts of neurotrophic factors.
Neurogenesis helped optimized the cell manufacturing process to become highly efficient and scalable, Gilat said. By manufacturing the required treatments from one bone marrow extraction, storing the vials in cryopreservation, and shipping them to the hospital only when required, we enable high consistency of quality across injections, while lowering manufacturing costs as well as enabling treatment schedule flexibility.
- Cell Therapy Global Market Report 2021: COVID-19 Growth and Change to 2030 - ResearchAndMarkets.com - Business Wire - July 7th, 2021
- A New Era For FDA Regulation Of Cell And Tissue Products - Law360 - July 7th, 2021
- UM School Of Medicine Researchers Receive NIH Avant Garde Award For Out-Of-Box, Innovative Concept To Cure HIV And Treat Co-Existing Addiction -... - July 7th, 2021
- Antengene Announces Acceptance of IND Application in China for the Phase II Clinical Trial of Single-Agent Selinexor for the Treatment of... - July 7th, 2021
- The Top Doctors in the Twin Cities, 2021 - Mpls.St.Paul Magazine - July 7th, 2021
- The stem cell market was valued at USD 14.7 billion in 2020, and it is expected - GlobeNewswire - June 8th, 2021
- Innovative Regenerative Medicine Therapies Safety Comes First - FDA.gov - June 8th, 2021
- Early Promise of AntiCLL-1 CAR T-Cell Therapy Reported in Pediatric AML - Cancer Network - June 8th, 2021
- Part 3: Moving Forward and Keeping Stem Cell Treatments Safe - MedShadow - June 8th, 2021
- In Some Heavily Pretreated Patients with R/R MM Ide-Cel Continues to Show Deep and Durable Responses - Targeted Oncology - June 8th, 2021
- Innovative research refines the treatment of patients with advanced cancers and the use of immunotherapy - Network News, Press Releases - Hackensack... - June 8th, 2021
- Mustang Bio to Host Key Opinion Leader Webinar on MB-106 CD20-Targeted CAR T for the Treatment of High-Risk B-Cell Non-Hodgkin Lymphomas and Chronic... - June 8th, 2021
- Karen Hasty Named Among 2021 Super Women In Business by Memphis Business Journal - UTHSC News - June 8th, 2021
- High Overall Response Rates Achieved With Cirmtuzumab/Ibrutinib in MCL and CLL - Targeted Oncology - June 8th, 2021
- New Data on KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Versus Sunitinib in First-Line Treatment for Patients With Advanced Renal Cell... - June 8th, 2021
- Chao family gifts to UCI Health for cancer care top $50 million - UCI News - June 8th, 2021
- Sorrento and Researchers at Karolinska Institutet Have Signed a Research Collaboration Agreement on iPSC-Derived Dimeric - GlobeNewswire - June 8th, 2021
- Responses to Tafasitamab/Lenalidomide in DLBCL Sustained at Three Years - Cancer Network - June 8th, 2021
- The regenerative medicine market size to grow at a CAGR of around 30% during the period - GlobeNewswire - June 8th, 2021
- 'Natural Killer Cells' and Other Promising Cancer Treatments - Barron's - April 18th, 2021
- Capturing the Pandemic Experience in Haiku Poetry - Duke Today - April 18th, 2021
- Chemotherapy for Prostate Cancer: When It's Used and What to Expect - Healthline - April 18th, 2021
- Signs that Chemo Is Working: How Effectiveness Is Measured and Defined - Healthline - April 18th, 2021
- Some experts fear next-generation Covid vaccines may be worse - STAT - April 18th, 2021
- How Long is Chemotherapy? What to Expect - Healthline - April 18th, 2021
- Regenerative Medicine - Stem Cell Therapy Little Rock - March 8th, 2021
- Center for Stem Cell Biology & Regenerative Medicine ... - March 8th, 2021
- Dynamic Stem Cell Therapy Offers Regenerative Medicine - Las Vegas Review-Journal - March 8th, 2021
- Anti-EGFR VHH-armed death receptor ligandengineered allogeneic stem cells have therapeutic efficacy in diverse brain metastatic breast cancers -... - March 8th, 2021
- Research Antibodies Market Size to Reach USD 5325.8 Million by 2027 | Increasing R&D Activities in the Fields of Oncology, Neurobiology, and Stem... - March 8th, 2021
- Microwave Processing Isolates Red Ginseng Compounds That Suppress Lung Cancer Metastasis - Genetic Engineering & Biotechnology News - March 8th, 2021
- Longeveron Expands Enrollment Criteria for its Phase 1 RECOVER Trial Evaluating Lomecel-B Infusion to Treat Acute Respiratory Distress Syndrome due to... - March 8th, 2021
- Be The Match BioTherapies Announces Expansion of Multi-Year Strategic Alliance with Orchard Therapeutics to Support European Commercial Launch of... - March 8th, 2021
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2021: Focuses at the key worldwide companies to Define, Describe and Analyses the sales... - March 8th, 2021
- Editing Reproduction: CRISPR and preventing heritable diseases, With Dr. Dietrich Egli and Dr. Sam Sternberg - Columbia University Irving Medical... - March 8th, 2021
- U. Cancer Center pilot projects: investigating cancer connections - The Brown Daily Herald - March 8th, 2021
- COVID-19 can kill heart muscle cells, interfere with contraction Washington University School of Medicine in St. Louis - Washington University School... - March 8th, 2021
- Vaccinating by age groups is unfair, particularly to minorities, advisory panel tells CDC - USA TODAY - March 8th, 2021
- Winter Weather Impacting Blood and Platelet Donations - Milwaukee Community Journal - February 17th, 2021
- Joshua Shirk continues to fight the odds; mom says God placed people where they needed to be to help him - Keyser Mineral Daily News Tribune - February 17th, 2021
- Evotec and Medical Center Hamburg-Eppendorf Enter Partnership to Develop iPSC-Based Tissue Therapy for Heart Failure - GuruFocus.com - February 7th, 2021
- ProgenCell - Stem Cell Therapies offers an updated Stem Cell Therapy for Anti Aging Protocol - PR Web - January 30th, 2021
- Doctors urge immunocompromised to get COVID vaccine when it becomes available - KMTV - 3 News Now - January 30th, 2021
- Autologous Stem Cell and Non Stem Based therapies Market Share, Size 2021 Global Industry Future Trends, Growth, Strategies,, Segmentation, In-depth... - January 30th, 2021
- Studies Indicating T-Cells May Be Needed For Long-Term Protection From The SARS-Cov-2 Virus - PRNewswire - January 30th, 2021
- Researchers use patients' cells to test gene therapy for rare eye disease - National Institutes of Health - January 30th, 2021
- Two Gene Therapies Fix Fault in Sickle Cell Disease and -thalassemia - MD Magazine - January 30th, 2021
- If I Have Cancer, Dementia or MS, Should I Get the Covid Vaccine? - Kaiser Health News - January 30th, 2021
- L-MIND Trial Results Show CD19 Antibody Is Reasonable in R/R DLBCL - Targeted Oncology - January 30th, 2021
- Profile of T Cells, Broadly Neutralizing Antibodies, Anti-Viral Targets: COVID-19 Updates - Bio-IT World - January 30th, 2021
- HealthLynked's The Future of Healthcare Summit Brings Healthcare Experts and Technology Innovators from Around the World to Naples, Florida - WFMZ... - January 30th, 2021
- Tevogen Bio Secures Funding from Team of Doctors to Support Clinical Trials of Its Investigational Curative T Cell Therapy for COVID-19 - PRNewswire - January 25th, 2021
- Novel Treatment Leads to Dog's Recovery - The Bark - January 25th, 2021
- Identification and Targeting of ThomsenFriedenreich and IL1RAP | OTT - Dove Medical Press - January 25th, 2021
- Regenerative Medicine Market Size Worth $74831.35 Million With CAGR of 22.27% By 2024 | Segmented by Product Type, Top Manufacturers, By End-User... - January 25th, 2021
- Immunotherapy Inches Forward in Development of Myeloid Malignancies - OncLive - January 14th, 2021
- Cytovia Therapeutics Partners with National Cancer Institute to Develop Novel Gene-Edited, iPSC-Derived GPC3 CAR NK Cells for the Treatment of Solid... - January 14th, 2021
- Kaleido Biosciences Announces Positive Interim Results of Controlled Study of KB109 in Patients with Mild-to-Moderate COVID-19 - BioSpace - January 14th, 2021
- Doctors Make Medical Breakthrough In Treating Severe Cases Of COVID - CBS San Francisco - January 9th, 2021
- Mana joins the hectic fight against solid tumors with an 'off-the-shelf' candidate angling for an IND this year - Endpoints News - January 9th, 2021
- Versiti Blood Centers and Noodles & Company Serve Up Thanks to Blood Donors - PRNewswire - December 31st, 2020
- Global CAR-T Pipeline Insight Report 2020: Overview, Landscape, Therapeutic Assessment, Current Treatment Scenario and Emerging Therapies -... - December 31st, 2020
- 2020 health care year in review - Crain's Cleveland Business - December 31st, 2020
- The Top 10 FDA Oncology Drug Approvals of 2020 - Curetoday.com - December 31st, 2020
- Gut microbiota: How does it interact with the brain? - Medical News Today - December 31st, 2020
- Numerous Indian American STEM Researchers Named Fellows of American Association for the Advancement of Sciences - India West - December 31st, 2020
- Four years after devastating spinal injury, former St. Paul's football player reunites with caregivers - NOLA.com - December 24th, 2020
- New Combination Therapy Tested By Children's May Offer Hope For Leukemia Patients - WVXU - December 24th, 2020
- Real-time observation helpful in Stem cell for vascular diseases: Study - Hindustan Times - December 21st, 2020
- NurOwn May Be Given to Early ALS Patients in US Who Finished Phase... - ALS News Today - December 21st, 2020
- Follow the Money: Spatial Omics, CAR-NK Cells, AI-Powered Biology - Bio-IT World - December 21st, 2020
- Explained: Process of transporting stem cell from donor to patient for a successful transplant - Firstpost - December 18th, 2020
- Research That Saves Lives: Four COVID-19 Therapies Being Tested at UVA - University of Virginia - December 18th, 2020
- Even if You've Had COVID-19 You Still Need the Vaccine - Healthline - December 18th, 2020
- What Patients With Cancer, Survivors Need to Know About the Emergency Use Authorization of COVID-19 Vaccine - Curetoday.com - December 16th, 2020
- 2020 at the U: The year in review - University of Miami - December 16th, 2020
- Five Mobile County hospitals to get Pfizer vaccine this week - AL.com - December 16th, 2020
- Donor Stem Cell Transplant Improves Survival in Older Patients with Myelodysplastic Syndrome - Cancer Health Treatment News - December 10th, 2020
- Positive Phase 2 Proof-of-Concept Data for Viralym-M and Burden of Disease Data Presented in Oral Presentations at the 62nd American Society of... - December 10th, 2020
- Dr. Kansagra: Quadruplet Therapy for Newly Diagnosed Multiple Myeloma and Combination CAR T-Cell Opportunities - DocWire News - December 10th, 2020