SAN CARLOS, Calif., May 05, 2020 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced data from a recent animal study performed by the Company that demonstrate meaningful improvements in heart function for subjects treated with its allogenic (from another donor, or off the shelf) neurokinin 1 receptor positive mesenchymal stem cell (NK1R+ MSC) program for heart failure, known as CardiALLO. In addition, the Company is planning further exploration and discussion with the U.S. Food and Drug Administration (FDA) on the use of its allogenic cells for COVID-19 related Acute Respiratory Distress Syndrome (ARDS).
In the 26 animals treated with both low dose and high dose NK1R+ MSC, echocardiographic measures of cardiac ejection fraction, fractional shortening and cardiac outflow were meaningfully improved, with all three measures being statistically significant for both dosage levels over control animals.
The CardiALLO cell therapy is being developed initially to treat heart failure patients whose cells do not qualify for its lead autologous cell therapy, CardiAMP (BCDA-01).
BioCardia Chief Scientific Officer Ian McNiece, PhD, said, In light of these positive data on our allogenic NK1R+ MSC therapy, we expect to meet our internal timeline to complete our submission to the FDA for our first indication for CardiALLO, and potentially receive IND acceptance by the end of the second quarter. The MSCs that were studied are subtypes of MSC that we have delivered previously in our co-sponsored trials, which we believe have enhanced potency over MSC generated from unselected bone marrow cells. We look forward to seeing additional data from this animal study that are currently being analyzed, including histology and pathology of the heart and lungs.
COVID-19 Induced Acute Respiratory Distress Syndrome (ARDS) Exploration
The Company also intends to submit an IND for the use of its NK1R+ MSC delivered via intravenous (IV) infusion for Acute Respiratory Distress Syndrome (ARDS) caused by COVID-19.
Based on preliminary clinical reports on COVID-19, respiratory failure complicated by ARDs is the leading cause of death for COVID-19 patients.1 ARDS is a type of respiratory failure characterized by the rapid onset of widespread inflammation in the lungs.
The anti-inflammatory effects of MSC have been well-documented and MSC have been shown to reduce inflammation and injury in models of lung disease.2 The specific MSCs used in BioCardias allogenic cell therapy are expanded from cells selected for the presence of the NK1 receptor, which is known to bind to substance P, an important neuropeptide associated with inflammation throughout the body and a primary mediator of inflammation in the airways.3,4
Our NK1R+ allogenic MSC may have more potential than other MSC approaches being advanced today due to their interaction with Substance P, said BioCardia CEO Peter Altman, PhD. This COVID-19 related work will be the Companys first clinical investigation outside of the cardiac space and our first exploring therapy for the lung. A recent patent publication (US 2020/0101113 A1) shows that BioCardia has long intended for these remarkable reparative cells to be targeted for respiratory disorders, in addition to cardiovascular disease. Addressing inflammation in the lungs is an important contribution we may be able to make using our NK1R+ allogenic MSC therapy.
The Companys allogenic cells are expected to be manufactured at BioCardias clinical stage cell manufacturing facility in San Carlos, California.
About BioCardiaBioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the Companys biotherapeutic product candidates in clinical development. The Company's approved products include the Helix transendocardial delivery system and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix System and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the development of NK1R+ cells for the treatment of heart failure and ARDS secondary to COVID-19, potential FDA IND acceptances, and potential FDA filings, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on April 9, 2020, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact: Michelle McAdam, Chronic Communications, Inc.michelle@chronic-comm.com(310) 902-1274
Investor Contact: David McClung, Chief Financial Officerinvestors@BioCardia.com(650) 226-0120
Read more:
- Mesenchymal stem cell based therapies for uveitis: a systematic review of preclinical studies | Eye - Nature.com - April 10th, 2024
- Development of exosome therapy to treat inflammatory bowel disease by VesiCURE Therapeutics - StreetInsider.com - April 10th, 2024
- Adipose Derived Stem Cell Therapy Market Will Show the Highest Growth Rates, Incredible Demand by 2031 - WhaTech - April 3rd, 2024
- Injectable microspheres adhering to the cartilage matrix promote rapid reconstruction of partial-thickness cartilage defects - ScienceDirect.com - March 30th, 2024
- Safety and Potential Effect of Intrauterine Infusion of Autologous Adipose Tissue-Derived Regenerative Cells in ... - Cureus - March 30th, 2024
- Instructing iPS cell-derived mesenchymal stem cells to inhibit abnormal bone formation in FOP - Medical Xpress - March 28th, 2024
- Clinical application of mesenchymal stem cell in regenerative medicine ... - March 22nd, 2024
- Mesenchymal Stem Cells: The Past Present and Future - March 22nd, 2024
- CytoMed Diversifies into Regenerative Medicine after Research Collaboration with Singapore's Sengkang General ... - Yahoo Finance - March 20th, 2024
- Overexpression of Wnt5a promoted the protective effect of mesenchymal stem cells on Lipopolysaccharide-induced ... - BMC Infectious Diseases - March 20th, 2024
- Mesenchymal Stem Cells: What We Have Learned and How to Manage Them - MDPI - March 17th, 2024
- Mesenchymal stem cells and their microenvironment - March 17th, 2024
- Mesenchymal stem/stromal cells as a valuable source for the treatment ... - March 17th, 2024
- Proteomic characterization of hUC-MSC extracellular vesicles and evaluation of its therapeutic potential to treat ... - Nature.com - March 13th, 2024
- The impact understanding of exosome therapy in COVID-19 and preparations for the future approaches in dealing with ... - Nature.com - March 13th, 2024
- CytoMed Therapeutics Limited Announces Research Collaboration with Singapore Sengkang General Hospital to ... - Yahoo Finance UK - March 7th, 2024
- CytoMed Therapeutics Limited Announces Research Collaboration with Singapore Sengkang General Hospital to ... - Yahoo Finance - March 6th, 2024
- Combatting osteoarthritis with cartilage replacement therapy - Drug Target Review - March 3rd, 2024
- Ethical considerations in Stem Cell therapy for ALS - Cyprus Mail - February 27th, 2024
- Therapeutic Solutions International Files Patent on Facilitating Effects of JadiCells on Gene Therapy Mediated Cell ... - Business Wire - February 27th, 2024
- Stem Cell Therapy for Ulcerative Colitis - Health Central - February 27th, 2024
- Expanding the Horizons of Cell and Gene Therapy - RegMedNet - February 24th, 2024
- Early differentiation of mesenchymal stem cells is reflected in their dielectrophoretic behavior | Scientific Reports - Nature.com - February 22nd, 2024
- Orthopaedics Department's Regenerative Research Highlighted at ORS Annual Meeting - InventUM - University of Miami - February 20th, 2024
- Cellular uptake and in vivo distribution of mesenchymal-stem-cell-derived extracellular vesicles are protein corona ... - Nature.com - February 18th, 2024
- New University spin-out developing novel adult stem cell-based Therapies - News - University of Liverpool - News - February 15th, 2024
- Examining the potential of the common bovine as a potential therapeutic research model - Medical Xpress - February 15th, 2024
- Intentional Interference: Genetic Engineering Medium Aids The Transfection Of MSCs With siRNA - BioProcess Online - February 15th, 2024
- Cellular senescence is associated with osteonecrosis of the femoral head while mesenchymal stem cell conditioned ... - Nature.com - February 9th, 2024
- Stem Cell Therapy for Crohns Disease Shows Promising Results - RegMedNet - February 9th, 2024
- Targeted transcriptomic analysis of synovial tissues from horses with septic arthritis treated with immune-activated ... - American Veterinary Medical... - February 7th, 2024
- Mesenchymal Stem Cell Immunomodulation: Mechanisms and ... - Cell Press - February 7th, 2024
- New Cell Therapy for ARDS: A Groundbreaking Development and Other Respiratory Health Breakthroughs - Medriva - February 7th, 2024
- Effective treatment of optic neuropathies by intraocular delivery of MSC-sEVs through augmenting the G-CSF ... - pnas.org - January 31st, 2024
- Global Stem Cell Therapy Industry Outlook to 2028, Driven by Therapeutic Innovations and Clinical Advancements ... - Yahoo Finance - January 29th, 2024
- Out-of-this-world study will test how stem cells function in space - YP - January 29th, 2024
- The Applications of Cell Therapy - Technology Networks - January 26th, 2024
- STEM CELL THERAPY FOR MS COST: WHAT YOU NEED TO KNOW? - Island Echo - January 24th, 2024
- Understanding Neuromyelitis Optica: Role of NF-B and Therapeutic Potential - Medriva - January 20th, 2024
- Faculty member Arnold Caplan passes away The Daily The Daily - The Daily | Case Western Reserve University - January 18th, 2024
- Effects of fine particulate matter on bone marrow-conserved hematopoietic and mesenchymal stem cells: a systematic ... - Nature.com - January 11th, 2024
- Expression of HLA-DR by mesenchymal stromal cells in the platelet lysate era: an obsolete release criterion for MSCs ... - Journal of Translational... - January 11th, 2024
- NurOwn and its exosomes for ALS given patents in Europe, elsewhere - ALS News Today - January 8th, 2024
- Single-cell analysis reveals the stromal dynamics and tumor-specific characteristics in the microenvironment of ovarian ... - Nature.com - January 8th, 2024
- First in Class Combination Stem Cell and Exosome Therapy to Treat Pulmonary Fibrosis in Long Haul Covid Patients ... - Yahoo Finance - January 4th, 2024
- Choosing the Right Excipients for MSC and iPSC Therapies - Pharmaceutical Technology Magazine - January 4th, 2024
- Mitochondria Transplantation Therapy It's Farther Along Than You Think - BioProcess Online - January 2nd, 2024
- Embryonic-stem-cell-derived mesenchymal stem cells relieve experimental contact urticaria by regulating the functions ... - Nature.com - December 21st, 2023
- Type I collagen and fibromodulin enhance the tenogenic phenotype of hASCs and their potential for tendon ... - Nature.com - December 19th, 2023
- Could the 'central dogma' of biology be misleading bioengineers? - Phys.org - December 13th, 2023
- The Risks of Stem Cell and Exosome Treatments for Long COVID: A Call for Stricter Regulations - Medriva - December 13th, 2023
- Mesenchymal stem cells from biology to therapy - PMC - December 11th, 2023
- The Safety and Efficacy of Human Umbilical Cord-Derived ... - Cureus - December 5th, 2023
- The pivotal role of Nrf2 signal axis in IDD | JIR - Dove Medical Press - December 5th, 2023
- Futuristic Novel Therapeutic Approaches in the Treatment of ... - Cureus - December 3rd, 2023
- Cartilage's Contribution in Otology: A Comprehensive Review of Its ... - Cureus - December 3rd, 2023
- Mesenchymal stem or stromal cells: a review of clinical applications ... - November 29th, 2023
- Comparative evaluation of 3D-printed and conventional implants in ... - Nature.com - November 29th, 2023
- Expression of E-cadherin and N-cadherin in Epithelial-to ... - Cureus - November 29th, 2023
- Enhancing the immunosuppressive properties of human umbilical cord mesenchymal stem cells - Phys.org - November 29th, 2023
- 'Great Potential' in Stem Cell Therapies for Knee Osteoarthritis ... - Pain News Network - November 25th, 2023
- Dietary Sources, Bioavailability, and Functions of Ascorbic Acid ... - Cureus - November 25th, 2023
- FY 2024 VA-Funded Projects - VA's Office of Research and Development - November 25th, 2023
- Real-world data suggest effectiveness of the allogeneic ... - Journal of Translational Medicine - November 23rd, 2023
- Mesenchymal Stem Cells: Characteristics, Function, and Application - November 23rd, 2023
- Combined application of therapeutic viruses and nanomaterials to ... - News-Medical.Net - November 23rd, 2023
- Progress in the Development of Stem Cell-Derived Cell-Free ... - Dove Medical Press - November 23rd, 2023
- Improving the therapeutic efficacy of oncolytic viruses for cancer ... - Journal of Translational Medicine - November 23rd, 2023
- 11.22.23 -- How To Lose A Batch In 10 Days - BioProcess Online - November 23rd, 2023
- The Pros and Cons of Mesenchymal Stem Cell-Based Therapies - November 19th, 2023
- Leptin's influence on MMP-1 expression | JIR - Dove Medical Press - November 15th, 2023
- TWIST1 and TSG6 are coordinately regulated and function as ... - Science - November 11th, 2023
- Association between severe acute malnutrition in childhood and ... - BioMed Central - November 11th, 2023
- Global Market for Treatments for Syndromes of Progressive Ataxia and Weakness Disorders - Yahoo Finance - November 11th, 2023
- Stem Cell Restore Reviews - Does It Work? Real Green Valley ... - The Daily World - November 11th, 2023
- Biological and genetic characterization of a newly established ... - Nature.com - November 11th, 2023
- Placental Stem Cell Collection and Storage Industry Scope ... - Argyle Report - November 9th, 2023
- In Vitro Evaluation of Light-Induced Cytotoxic Property: Synergistic ... - Cureus - November 9th, 2023
- UF professor launches nonprofit to equalize cell-based therapy access - Mainstreet Daily News Gainesville - November 7th, 2023
- Who are the leading innovators in cell immunomodulation for the ... - Pharmaceutical Technology - November 7th, 2023
Recent Comments