Business, Drugs and Pharmaceuticals, Free News Articles, Reports and Studies

iCell Gene Therapeutics Announces cCAR-T Clinical Publication in the Stem Cell Reviews and Reports Journal

STONY BROOK, N.Y. -- iCell Gene Therapeutics, a clinical stage biopharmaceutical company focused on immunotherapies for hematologic malignancies, solid tumors, organ rejections and autoimmune disorders, today announced the publication of their clinical study utilizing cCAR T-cell immunotherapy to successfully treat a patient with lupus. Their CAR is directed against CD19 and BCMA surface proteins generating a cCAR with dual expression of CD19 and BCMA CAR molecules. Their cCAR is one of a kind in the family of engineered CAR T-cells researchers are studying.

Their report "Treatment of Systemic Lupus Erythematosus Using BCMA-CD19 Compound CAR" published on August 30, 2021, shows the clinical success of cCAR in treating a patient with Systemic Lupus Erythematosus (SLE).

According to Dr. Yupo Ma, founder of iCell Gene Therapeutics, "After a single infusion of CD19-BCMA cCAR the patient achieved undetectable levels of autoantibodies that mediate SLE, successfully treating the patient's SLE for 2 years without the need for additional medications."

The publication is available online at https://doi.org/10.1007/s12015-021-10251-6.

About SLE

Systemic lupus erythematosus (SLE) is an antibody-mediated autoimmune disease, in which autoantibodies attack its own tissues, resulting in widespread tissue damage in the affected organs including kidneys, lungs, joints, brain and blood vessels. According to the Lupus Foundation of America, it estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus.

About CD19-BCMA cCAR Therapy

iCell has developed a novel compound Chimeric Antigen Receptor (cCAR)approach. In this approach, the cCAR T cells express two distinct and fully functional CAR molecules, one that targets the molecule CD19 present on B cells and one that targets BCMA, which is present on plasma cells. In their recently published paper, researchers have shown that this cCAR led to rapid and dramatic decreases in B cell levels and levels of "autoantibodies" (antibodies that attack the body's own cells) in a patient with SLE.

As B cells are part of the normal immune system, it is preferable that the elimination of B cells be temporary. After 9 months of B cell depletion, the patient's B cells returned to normal. Importantly, the levels of autoantibodies remained undetectable. Based on these results, the researchers concluded that cCAR effectively "reset" the antibody-producing populations. In this "reset," the problematic cell populations were removed, leaving behind a fresh, clean slate. From this, new B cells and plasma cells were eventually formed, which did not have the same autoantibody-producing properties. Because of this, the patient has not had further lupus symptoms despite receiving no additional medications for over 2 years.

Given the prevalence of antibody-mediated disorders, this cCAR may prove useful for a variety of different medical conditions.

Sjögren's Syndrome, autoimmune hemolytic anemia, neuromyelitis optica spectrum disorder, celiac disease, type 1 diabetes, inflammatory bowel disease, rheumatoid arthritis, psoriasis, and multiple sclerosis all incorporate autoantibody formation in disease pathogenesis. Additionally, organ rejection following transplantation may be mediated by antibodies. By "resetting" the immune system prior to organ transplantation, this antibody-mediated rejection may be avoided. More research is needed on the long-term efficacy and safety of this treatment, but future applications of cCAR has a large window of opportunity.

About iCell Gene Therapeutics

iCell Gene Therapeutics, located in Stony Brook, New York, is a clinical-stage biopharmaceutical company developing first-in-class chimeric antigen receptor engineered cells. Their main focuses are on autoimmune disorders, AML, and T-cell malignancies. Their current clinical trials utilize their CARvac, T-cell targeted CARs, cCARs and non-gene edited universal CARs engineered as treatments for cancer, organ rejections and autoimmune diseases. These studies are ongoing in the US and China for their use.

For more information, please visit http://icellgene.com/

CONTACT:
Media and Investors
Kevin Pinz
Tel: (631) 538-6218
Kevin.pinz@icellgene.com

RELATED LINKS:

https://www.lupus.org/resources/how-many-people-have-lupus-in-the-united-states

https://www.lupus.org/resources/what-is-lupus

Related link: http://icellgene.com/

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Books and Publishing, Business, Drugs and Pharmaceuticals, Free News Articles

Kalyagen Announces Release of Free eBook on How to Optimize Health Using Stem Cells

AUSTIN, Texas -- Kalyagen® has announced the release and availability of a free eBook, "The Stemregen Effect - Tapping into the Power of Your Own Stem Cells," which provides an overview of how stem cells are the body's repair system and how STEMREGEN®, a natural stem cell enhancer, has been documented to increase the number of circulating stem cells by stimulating Endogenous Stem Cell Mobilization (ESCM).

"Supporting stem cell physiology is a new paradigm in health and wellness," said Christian Drapeau, CEO and Chief Scientist of Kalyagen®. "The latest scientific evidence indicates that this may very well be the best strategy to assist the body in regaining and maintaining optimal health."

The link between a lower number of circulating stem cells and the development of age-related diseases has been well-studied with numerous degenerative conditions, including diabetes, cardiovascular diseases, atherosclerosis, Alzheimer's disease, rheumatoid arthritis, pulmonary diseases, erectile dysfunction, and kidney disease. Increasing the number of circulating stem cells has been documented to enhance tissue repair or improve the course of disease formation in cases of acute myocardial infarction and many other degenerative conditions.

"Kalyagen has been inundated with questions regarding the stem cell repair system and how STEMREGEN naturally helps the body to release stems cells," said Herbert Dogan, CMO of Kalyagen®. "We are pleased to announce the release of our new publication which helps to answer all of these questions."

The eBook is available for download for free at https://www.kalyagen.com/the-stemregen-effect/.

STEMREGEN® is a unique and patent-pending blend of proprietary plant-based extracts documented to support ESCM and increase the number of circulating stem cells, supporting the natural ability of the body to repair and stay healthy. Ingredients in STEMREGEN® have been investigated in more than eight clinical studies for their effect on stem cell function, of which five were randomized, double- blind, placebo-controlled human clinical trials. STEMREGEN® has wide application in antiaging and overall health maintenance.

About Kalyagen

Kalyagen® was founded by Christian Drapeau, author of the bestseller Cracking the Stem Cell Code. Kalyagen® is a leader in the research and development of natural products aimed at supporting stem cell function of the body. Stem cells constitute the natural repair system of the body, and stem cell enhancers have been documented to strongly contribute to improving health and quality of life. STEMREGEN® is the first product developed by Kalyagen®. STEMREGEN® is a unique blend of proprietary plant-based extracts documented to support Endogenous Stem Cell Mobilization and provide other health benefits.

For more information, please visit our Website: https://www.kalyagen.com/

MEDIA CONTACT:

Biomics, LLC (dba Kalyagen®)

Herbert Dogan, Chief Marketing Officer (310-433-8072), hgd@kalyagen.com

Social media: @kalyagen #stemthetideoftime #stemthetide #thestemregeneffect

Disclaimer: None of the statements contained in this press release have been evaluated by the U.S. Food and Drug Administration. The products and information in the release are not intended to diagnose, treat, cure or prevent any disease.

Related link: https://www.kalyagen.com/

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Business, Drugs and Pharmaceuticals, Free News Articles, NonProfit and Charities

Live-Online C. diff. Symposium developed to support and guide patients, families, and caregivers through a C. difficile illness

TAMPA, Fla. -- The C Diff Foundation will host a free, live-online, and interactive symposium on Friday, July 16, 2021, from 1 to 3 p.m. EDT. Sponsored by Seres Therapeutics, the event is designed for patients who are being treated for a C. diff. infection (CDI) in addition to those who are recovering or who have experienced CDI recurrences. The patients, family members, and caregivers will all benefit from the information and up-to-date data presented.

Presenters are among some of the top C diff. thought leaders and include healthcare professionals, practitioners, and educators who are helping to change the way individuals maneuver through a C. difficile infection, worldwide.

Unlike other presentations on this topic, C. diff. Survivors will share their C. diff. infection journeys to provide a real-world perspective on the patient experience. Other topics addressed will include creating a culture for patient-centered care, C. diff. innovations, diagnostics, research, environmental safety, clinical trials, and studies, C diff. in pediatric patients and more.

To register for this global live-online event, visit: https://cdifffoundation.org/patient-family-caregiver-symposium-july-16-2021/

About Clostridioides difficile Infection (CDI)

Clostridioides (formerly Clostridium) difficile, also known as C. difficile, C. diff., is one of the most common cause and leading healthcare-associated infection in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the United States and is associated with approximately 20,000 deaths. (Guh, 2020, New England Journal of Medicine). Based on internal estimates including a recurrence rate of approximately 20 percent, the C Diff Foundation believes that the annual incidence in the U.S. approaches 600,000.

About Seres Therapeutics

Seres Therapeutics is a late-clinical stage biotechnology company with a strong development pipeline and rigorous scientific underpinning, working to revolutionize treatment of a wide range of diseases by modulating the function of the human microbiome.

It reported positive, topline results from the pivotal Phase 3 ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection (CDI).

For more information: https://www.serestherapeutics.com/

About the C Diff Foundation

C Diff Foundation, a 501(c)(3) nonprofit, is the leading patient and healthcare organization educating and advocating for C. difficile (Clostridioides difficile, C. diff., CDI, CDAD) prevention, treatments, clinical trials, diagnostics, support, and environmental safety worldwide. Their Mission continues to move forward and grow through research conducted by government, industry, and academia strengthening the advocacy on behalf of patients, families, caregivers, healthcare professionals, and researchers worldwide.

For more information: https://cdifffoundation.org/

Follow C Diff Foundation:

Twitter @cdiffFoundation #cdiffpatientfamilycaregiver #cdiff2021 #cdiffwalks2021

C Diff Foundation(TM) is a trademark of the C Diff Foundation, established 2012 in the U.S.

Related link: https://cdifffoundation.org/

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Business, Drugs and Pharmaceuticals, Free News Articles, Product Launches

Pure MHC, LLC Announces Launch of its Peptide HLA Immunotherapy Data Resource following Collaboration with LifeNet Health

AUSTIN, Texas -- Pure MHC, LLC, a target discovery and development company, today announced the launch of its Peptide HLA Immunotherapy Data Resource ("PHIDR"), built through its collaboration with a trusted provider of transplant solutions and a leader in regenerative medicine, LifeNet Health.

The PHIDR healthy tissue database and repository will guide T Cell Receptor (TCR)-based immune therapy development to disease-specific targets by enabling developers to identify HLA/peptide complex targets found on healthy tissues. By screening potential target candidates against PHIDR, developers can confidently select, qualify, and focus efforts on those biomarker targets that minimize off-target or bystander effects.

The PHIDR database is representative of the full healthy human immunopeptidome as it includes HLA/peptide complexes expressed on multiple tissue samples from all over the body, with a focus on the vital organs. In addition to the peptide database, PHIDR includes a repository of matched cryopreserved tissue samples that enable complimentary orthogonal target validation techniques, including proteomics-based target quantification, genomics, and transcriptomics, on an as-needed basis.

For nearly 40 years, LifeNet Health has advanced medicine through the life-changing power of organ and tissue donation. Thanks to selfless donors, scientific discovery is advanced.

LifeNet Health LifeSciences has accelerated preclinical research and discovery through its growing portfolio of primary human cells and biospecimens for solutions that expedite research and allow the scientific community to develop and enhance new, safe therapies and medical breakthroughs.

"We are excited to offer access to the PHIDR database and repository to collaborators through our Pure MHC Solutions contract research arm," said Pure MHC President Kris Looney. "We could not have successfully built this resource without our collaborators at LifeNet Health. To be able to develop such a valuable resource for therapeutic development aligns nicely with LifeNet Health's mission to help patients live longer, healthier, and enjoy more active lives."

"We are proud to partner with Pure MHC and congratulate them on achieving success in their research efforts. Thanks to selfless donors, LifeNet Health is able to offer partners more than 40 types of biospecimens for research with over 200 protocols in place to meet the individual needs of researchers advancing scientific discovery," said Louis Dias, Vice President and General Manager of LifeNet Health LifeSciences. "The LifeNet Health LifeSciences team provides access to rare patient disease populations and enables researchers to unlock discoveries faster and with greater precision - offering the hope of new therapies to patients in need."

About Pure MHC

Pure MHC, LLC is a platform technology company funded and managed by Emergent Technologies, Inc. with expertise in disease-specific target identification and validation as well as immunotherapeutic drug development for cancer, infectious and autoimmune diseases and allergy. The Pure MHC target discovery technology was developed by Chief Scientist William Hildebrand, Ph.D., of the University of Oklahoma Health Sciences Center. Visit: www.puremhc.com

About LifeNet Health LifeSciences

LifeNet Health LifeSciences is an innovative leader, trusted collaborator, and reliable solutions provider - committed to advancing science, accelerating discovery, and optimizing outcomes. Leading the way in human in vitro biology, LifeSciences' game-changing innovations, currently under development, include models for the metabolic disease and oncology therapeutic areas and their related tools. For more information, go to www.LNHLifeSciences.org.

About Emergent Technologies

Emergent Technologies, Inc. is an innovation solutions and technology commercialization leader headquartered in Austin, Texas. Visit: www.etibio.com

Related link: https://puremhc.com/

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Alliances and Partnerships, Business, Drugs and Pharmaceuticals, Free News Articles, Surgery and Neurotechnology

Pure Transplant Solutions Announces Collaboration with the University of Alabama at Birmingham to Develop Memory B Cell-Directed Diagnostics for HLA-Sensitized Patients

BIRMINGHAM, Ala. -- Pure Transplant Solutions, LLC (PTS), a collaboration driven biotechnology company focused on the development of human leukocyte antigen (HLA)-based diagnostics and therapeutics within the field of transplantation, is proud to announce that it has entered into a collaboration agreement with The University of Alabama at Birmingham (UAB), a leading institution in transplant research, to develop a new class of transplant diagnostics aimed at the detection and identification of HLA-specific memory B cells which are poised to produce HLA-specific immunoglobulin injurious to transplanted grafts.

The research is being led by Dr. Frances Lund, Charles H. McCauley Professor and Chair Department of Microbiology, Dr. John Killian, resident in the Department of Surgery, and Dr. Rico Buchli, VP of Products and Services at PTS, and focuses on using PTS's newly created Class I and Class II biotinylated soluble HLA (sHLA) proteins to understand the breadth and specificity of HLA-reactive B cells in sensitized individuals. These proprietary HLA molecules can be utilized in standard flow cytometry workflows for easy processing and analysis that the parties hope will provide a new tool for clinicians and researchers to use when caring for transplant patients.

Almost all previous work on HLA sensitized individuals has relied upon assays that detect circulating anti-HLA antibodies. The goal is to determine the reactivities of HLA-reactive B cells in these sensitized patients and compare these reactivities to those that are present among circulating anti-HLA antibodies. Using panels of biotinylated HLA molecules in combination with various tetramerized fluorescent reagents allows the interrogation of the specific B cell receptors expressed by HLA-reactive B cells.

"Prevention of B cell activation and proliferation is crucial for the survival of a transplant patient. For patient monitoring, identifying the right approach to immune profiling at each stage of clinical development-including the later stages, when it is often considered impractical to include these approaches-may be critical for identifying predictors of rejection responses, or monitoring immunosuppression efficacy", said Dr. Buchli. "Flow cytometric analysis using our fluorescent tagged HLA products have the capabilities needed to meet the increased demands to detect, identify, and monitor HLA-specific memory B cells."

"Our research at the University of Alabama at Birmingham seeks to improve the success of organ transplants," said John Killian, Jr., M.D., a research resident in the UAB Department of Surgery. "One problem is that following pregnancy or transplant, patients form antibodies against non-self HLA molecules. These antibodies comprise a major barrier to transplantation, and they exacerbate gender and racial disparities for thousands of people who await a life-saving transplant. Thus, we want to understand the breadth and specificity of HLA-reactive memory B cells in sensitized women. Pure Protein's extensive selection of recombinant HLA molecules will be integral to our projects, allowing us to pair fluorescence-activated cell sorting of HLA-reactive B cells with subsequent analysis of recombinant-antibody specificities. An improved understanding of the phenotype and specificity of HLA-reactive B cells will offer new opportunities to diagnose and treat HLA sensitization."

About Pure Transplant Solutions, LLC

Pure Transplant Solutions, LLC was founded in 1999 in order to leverage the leading research in HLA protein of parent company, Pure Protein, LLC, into solutions to address a growing list of needs in organ transplantation. Visit: www.puretransplant.com

About Pure Protein, LLC

Pure Protein, LLC is a biotechnology company funded and managed by Emergent Technologies, Inc. that is focused on the development and commercialization of proprietary technologies related to the human leukocyte antigen (HLA) system, formed and exclusively licensed from the University of Oklahoma. Pure Protein, in conjunction with its affiliates and subsidiaries, aims to bring novel therapies and diagnostic tools to patients across a wide range of application areas spanning from therapeutic development in the fields of oncology, autoimmunity, and infectious disease, to antibody mediated rejection in transplantation.

Through its new ecommerce website, http://www.hlaprotein.com/, Pure Protein now offers academic and commercial researchers the ability to purchase individual HLA reagents to detect, profile, and monitor allele-specific immune responses, as well as HLA peptide epitope binding services to aide in improving the design of vaccination and therapeutic targeting strategies.

About the University of Alabama Birmingham

Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center with over $600 million in research awards annually, as well as Alabama's largest employer, with some 23,000 employees, and has an annual economic impact exceeding $7 billion on the state. The pillars of UAB's mission include education, research, innovation and economic development, community engagement, and patient care. Learn more at https://www.uab.edu/.

Related link: https://www.puretransplant.com/

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Business, Drugs and Pharmaceuticals, Free News Articles, Patent and Trademark

Zeteo Biomedical Receives US Patent for Innovative Sublingual Delivery Device for Vaccines and Pharmaceuticals

AUSTIN, Texas -- Zeteo Biomedical, a privately held, biomedical device company, announced today it has been awarded a United States Patent for its "Oral Delivery Device and Methods" (US Patent 10238577). This latest patent expands the capabilities of Zeteo's ZEOx1™ Delivery Platform to systemically deliver drugs or biologics, into the body non-invasively via the sublingual route.

Sublingual delivery has emerged as a viable route of administration for vaccines and medications for pain, cardiovascular, allergy, seizure, sedation and emesis. The sublingual route avoids first pass metabolism and provides rapid systemic uptake into the body providing advantages over traditional oral medications.

Zeteo's latest innovations expand its ZEOx1 Hydra™ sublingual delivery device family that include configurations for mono-dose disposable and mono-dose reloadable dispensers for vaccines, drugs, biopharmaceuticals, biologics and botanical liquid formulations. "We see expanding demand for metered dose sublingual delivery devices that are easy to use, convenient to carry, deliver a precise dose and can be self-administered," said Timothy Sullivan, President of Zeteo Biomedical.

Zeteo's delivery device technology and product integration services enable pharmaceutical and biotech manufacturers to develop drug/device combination products that can extend or establish market exclusivity and competitive differentiation for new or existing drugs and biologics. The shift to developing value added, patient-centric products benefit the consumer through improved compliance and health outcomes while building brand value for the pharmaceutical or biotech manufacturer. Zeteo's delivery platforms and products are designed to meet the diverse demands of consumers and pharma manufacturers in globally competitive markets.

About Zeteo Biomedical LLC

Zeteo Biomedical™ is a biomedical device technology company based in Austin, Texas. Zeteo provides patient-centric delivery device technology and unit dose fill/finish packaging for pharmaceuticals, biopharmaceuticals, biologics and botanicals for intranasal, nose-to-brain, ophthalmic, sublingual, and animal care product applications.

For more information, please visit the Zeteo website at: https://www.zeteobiomed.com/

Media Contact
Cathy Diehl
Zeteo Biomedical LLC
+(1) 512-614-0144
zeteo@zeteobiomed.com

*LOGO link for media: https://www.send2press.com/300dpi/20-1117s2p-zeteo-biomedical-300dpi.jpg

Related link: https://www.zeteobiomed.com/

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Business, Drugs and Pharmaceuticals, Free News Articles, Patent and Trademark

Caisson Biotech, LLC and Heparinex, LLC Announce Positive Examination Report of European Patent and the Discovery of a New Class of Sugar Polymers

AUSTIN, Texas -- Caisson Biotech and parent company Heparinex are pleased to announce that they have received a positive examination report from the European Patent Office for a patent covering the chemoenzymatic production of heparosan utilized in the HEPtune® drug delivery platform. Once certified, the new patent family will increase patent coverage across Europe, adding to the U.S. holdings.

The HEPtune platform, which utilizes heparosan, a naturally occurring polysaccharide, has been validated as a novel half-life extension and drug delivery alternative to commonly used polyethylene glycol (PEG). Unlike PEG, heparosan is naturally found in humans, is completely biodegradable, and will not trigger anaphylactic shock or anti-drug antibodies. The HEPtune platform has been applied to numerous drug classes including biologics, and small molecules via nanocarriers, including liposomes.

In addition to positive news received by the EPO, Heparinex is excited to announce that it has created a new class of sugar polymers, sulfated hepbiuronic acid (sHBA) that mimic some, but not all, of the desirable activities of heparin, a drug employed to treat many diseases including the fight against severe COVID-19 and influenza. These novel patent-pending drug candidates can quell the initiation of inflammation, but do not inhibit blood coagulation, thus can be used to protect organs such as the lungs, heart, and kidneys that are often damaged by the body's own defenses during disease without the risk of bleeding. The sHBA should be a useful addition to the arsenal of drugs currently dispensed to treat hyper-inflammation spawned by infectious, cardiovascular, and auto-immune diseases.

Heparosan conjugation was developed by Presidential Professor Dr. Paul DeAngelis at the University of Oklahoma Health Sciences Center (OUHSC) and includes a robust U.S. and international patent portfolio. "Our goal is to decipher and harness the natural 'sugar codes' in the body in more selective, customized fashion to target diseases and reduce side effects. We are excited by the possibilities for better medicines", said DeAngelis. He was named as one of the most influential researchers in the world according to a study led by an investigator at Stanford University and published in PLOS Biology.

About Caisson Biotech, LLC

Caisson Biotech, LLC is a collaboration driven biotechnology company specializing in the development of heparosan polymers to improve therapeutic drug delivery and performance. Caisson's HEPtune® technology was invented by Chief Scientist and University of Oklahoma Professor Dr. Paul DeAngelis, a world renowned glycobiology and enzyme specialist. Visit: https://caissonbiotech.com/.

Caisson Biotech is a subsidiary of Heparinex, LLC.

About Heparinex, LLC

Heparinex, LLC is a biopharmaceutical company focused on the novel recombinant synthesis of sugar-based compounds for markets including anticoagulation, inflammation, and cancer treatment. Dr. Paul DeAngelis originally discovered and patented Heparinex's core technology platforms of proprietary carbohydrate production. Visit: https://heparinex.com/.

Heparinex and Caisson are funded and managed by Emergent Technologies, Inc. an innovation solutions and technology commercialization leader headquartered in Austin, Texas. Visit: http://www.emergenttechnologies.com/

Related link: https://caissonbiotech.com/

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Business, Drugs and Pharmaceuticals, Free News Articles

Rescindo Therapeutics’ RSC-57 Receives FDA Orphan Drug Designation and Rare Pediatric Disease Designation for Kabuki Syndrome

CARY, N.C. -- Rescindo Therapeutics Inc., a drug discovery company dedicated to the development of new treatments for rare genetic disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation and Rare Pediatric Disease Designation for the Company's lead drug RSC-57, for the treatment of patients with Kabuki Syndrome.

"We are honored to receive these very important designations for our lead drug for Kabuki Syndrome. The decision validated the urgency and need for treatment of this devastating disease for which there are no FDA-approved therapies," said Dr. Athanasios (Thanos) Maroglou, co-founder, President and CEO of Rescindo. "With RSC-57 being a repurposed drug with a large established safety profile, we hope to proceed with clinical trials rapidly after the completion of our pre-IND package and guidance from the FDA."

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user fees and eligibility for seven years of marketing exclusivity.

Rare Pediatric Disease Designation is granted by the FDA in the case of serious or life-threatening diseases affecting fewer than 200,000 people in the United States, primarily those 18 years of age and younger. The sponsor of a drug with Rare Pediatric Disease Designation may, upon marketing approval, qualify for receipt of a priority review voucher applicable to a subsequent marketing application, which voucher is fully transferable.

About Kabuki Syndrome

Kabuki Syndrome is a rare developmental disorder characterized by intellectual disability, muscle hypotonia, distinctive facial features, short stature, immune deficiency and malformations of the cardiac, renal, gastrointestinal, and/or skeletal systems. Typically diagnosed during early childhood, it is possible to identify KS as early as infancy based on characteristic facial features and associated organ malformations.

The global prevalence of KS is estimated at 1:32,000 births, although its incidence is likely underestimated, as judged by the acceleration of new cases now that genome sequencing is becoming more broadly available. At present, KS has no cure.

About Rescindo Therapeutics Inc.

Rescindo Therapeutics is drug discovery and development company focused on rare genetic diseases to improve peoples' lives.

Rescindo Therapeutics Inc. was founded in 2015 by Dr. Athanasios Maroglou and Dr. Nicholas Katsanis with an objective to discover and develop new drugs for children with rare genetic diseases. Using a novel approach that combines genetics, molecular biology, and high throughput use of model organisms, we accelerate the discovery of new therapies. Together with our academic, private sector partners, and patient advocacy groups, we are working toward bringing new treatments for life-threatening disorders.

Learn more at: https://www.rescindotherapeutics.com/

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Related link: https://www.rescindotherapeutics.com/

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Advertising and Marketing, Business, Drugs and Pharmaceuticals, Free News Articles

Kalyagen Announces Launch of ‘Stem the Tide of Time’ Campaign Featuring NBA Hall of Fame Finalist Marques Johnson

AUSTIN, Texas -- Kalyagen™ is pleased to announce the launch of its "Stem the Tide of Time" social media campaign featuring former UCLA Bruin and Milwaukee Buck All-Star Marques Johnson to promote STEMREGEN®, a natural stem cell enhancer documented to increase the number of circulating stem cells by stimulating Endogenous Stem Cell Mobilization (ESCM).

"The link between a lower number of circulating stem cells and the development of age-related problems has been well documented, and increasing the number of circulating stem cells has also been well documented to enhance tissue repair and improve the course of many age-related conditions," said Christian Drapeau, CEO and Chief Scientist of Kalyagen™. "Stemregen can indeed help to stem the tide of time, and the campaign asks the question "what does Stem the Tide of Time mean to you?"

The campaign, designed to increase awareness of STEMREGEN®, is launching to coincide with Marques Johnson's annual birthday dunk.

"Eleven years and 27,000 minutes of running and jumping up and down NBA floors has taken its toll on my body," said Marques Johnson. "'Stem the Tide of Time' for me means that I can slow or stop the onset of stiffness and soreness so I can participate in the lives of my children and grandchildren in a meaningful way. And with my 65th birthday upon us, we'll see if I've stemmed the tide and can still dunk!"

STEMREGEN® is a unique and patent-pending blend of proprietary plant-based extracts documented to support ESCM and increase the number of circulating stem cells, thereby supporting the natural ability of the body to repair and stay healthy. Ingredients in STEMREGEN® have been investigated in more than eight studies for their effect on stem cell function, of which five were randomized, double- blind, placebo-controlled human clinical trials. STEMREGEN® has wide application in antiaging and overall health maintenance.

About Kalyagen

Kalyagen™ was founded by Christian Drapeau, author of the bestseller Cracking the Stem Cell Code. Kalyagen is a leader in the research and development of natural products aimed at supporting stem cell function of the body. Stem cells constitute the natural repair system of the body, and stem cell enhancers have been documented to strongly contribute to improving health and quality of life. STEMREGEN® is the first stem cell enhancer product developed by Kalyagen™. STEMREGEN® is a unique blend of proprietary plant-based extracts documented to support Endogenous Stem Cell Mobilization and provide other health benefits.

For more information, please visit our Website: https://www.kalyagen.com/.

About Marques Johnson

Marques Johnson is a basketball analyst for the Milwaukee Bucks on Fox Sports Net. He played college basketball for the UCLA Bruins, won a national championship in 1975 and was the College Player of the Year as a senior. A five-time All-Star, he played seven seasons with Milwaukee before finishing his NBA career with the Los Angeles Clippers and the Golden State Warriors. He is currently a finalist for the NBA Hall of Fame and can still dunk at the age of 65.

*VIDEO (YouTube): https://youtu.be/aGJibMXwmuw

Media Contact:
Biomics, LLC (dba Kalyagen™)
Herbert Dogan, Chief Marketing Officer
(310-433-8072)
hgd@kalyagen.com

Social media: @kalyagen #stemthetideoftime #stemthetide

Disclaimer: None of the statements contained in this press release have been evaluated by the Food and Drug Administration. The products and information in the release are not intended to diagnose, treat, cure or prevent any disease.

Related link: https://www.kalyagen.com/

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Business, Drugs and Pharmaceuticals, Free News Articles

Kalyagen™ Announces Launch of Clinical Trial to Evaluate STEMREGEN® and Stem Cells for Advanced Heart Failure Patients

AUSTIN, Texas -- Kalyagen™, along with the Sociedad Espanola de Medicina Regenerativa y Terapia Celular (the "Spanish Society of Regenerative Medicine and Cell Therapy"), is pleased to announce the launch of a multicenter clinical trial, "The Effect of Stemregen and Adipose Stroma Vascular Fraction (SVF) Either Individually or in Combination in Patient With Heart Failure," to evaluate the use of stem cell therapies in patients suffering from heart failure. STEMREGEN® is a natural stem cell enhancer documented to increase the number of circulating stem cells by stimulating Endogenous Stem Cell Mobilization (ESCM).

"The link between a lower number of circulating stem cells and the development of age-related diseases has been well studied with numerous degenerative conditions, including diabetes, cardiovascular diseases, atherosclerosis, Alzheimer's disease, rheumatoid arthritis, pulmonary diseases, erectile dysfunction, and kidney disease," said Christian Drapeau, CEO and Chief Scientist of Kalyagen™. "From a therapeutic standpoint, increasing the number of circulating stem cells has been documented to enhance tissue repair or improve the course of disease formation in cases of acute myocardial infarction and many other degenerative conditions."

The trial, whose first phase is expected to be completed in the fall of 2021, aims to evaluate the effect of ESCM in cases of heart failure. Forty-five patients who suffered from acute myocardial infarction will be randomly distributed into three groups: i) STEMREGEN® alone, ii) injection of stem cells (SVF), and iii) combined consumption of STEMREGEN® and stem cell injection. The dietary supplement will be provided at a dose of 2 capsules three times a day for 3 to 6 months. Study participants will be evaluated after 1, 3, 6 and 12 months, at which times their NYHA functional classification and echocardiographic parameters will be assessed. The first phase will begin with 15 patients.

"We have had a great deal of success treating patients suffering from advanced heart failure with stem cells," said Miguel Garber, MD, Vice Chairman of the Spanish Society of Regenerative Medicine and Cell Therapy. "Unfortunately, traditional stem cell therapy utilizing Stroma Vascular Fraction is not widely available. We are hopeful that treating patients with STEMREGEN, a much more cost-effective widely-available therapy, can show similar beneficial health outcomes, and that it can further improve patient outcomes when combined with SVF therapy."

STEMREGEN® is a unique and patent-pending blend of proprietary plant-based extracts documented to support ESCM. Ingredients in STEMREGEN® have been investigated in more than eight studies for their effect on stem cell function, of which five were randomized, double-blind, placebo-controlled human clinical trials. STEMREGEN® has wide application in antiaging and overall health maintenance.

More information about the clinical trial can be found at https://clinicaltrials.gov/ct2/show/NCT04515537.

About Kalyagen

Kalyagen™ was founded by Christian Drapeau, author of the bestseller Cracking the Stem Cell Code. Kalyagen is a leader in the research and development of natural products aimed at supporting stem cell function of the body. Stem cells constitute the natural repair system of the body, and stem cell enhancers have been documented to strongly contribute to improving health and quality of life. STEMREGEN® is the first stem cell enhancer product developed by Kalyagen™. STEMREGEN® is a unique blend of proprietary plant-based extracts documented to support Endogenous Stem Cell Mobilization and provide other health benefits. For more information, please visit our Website: https://www.kalyagen.com/

About Miguel Garber

Miguel Garber has over 32 years of experience in internal medicine and cardiology, with expertise in regenerative medicine, training and education, and research. He has more than 14 years working with Stem Cells, Therapeutics Department of American Medical Information Group and Clinica Quirurgica Quantum. Medical Director of Regenerative Medicine Madrid, Professor of Master in Regenerative Medicine and Scholarly Journals Editor. Vice-chairman - Sociedad Espanola de Medicina Regenerativa y Terapia Celular.

Media Contact:
Biomics, LLC (dba Kalyagen™)
Herbert Dogan
Chief Marketing Officer
(310-433-8072)
hgd@kalyagen.com

Social media: @kalyagen #stemthetideoftime #stemthetide

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Disclaimer: None of the statements contained in this press release have been evaluated by the Food and Drug Administration. The products and information in the release are not intended to diagnose, treat, cure or prevent any disease.

Related link: https://www.kalyagen.com/

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