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Citius Pharmaceuticals Brings on Myron S. Czuczman, MD as Chief Medical Officer (CMO) and Executive Vice President – BioSpace

CRANFORD, N.J., July 14, 2020 /PRNewswire/ --Citius Pharmaceuticals, Inc.. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that Myron S. Czuczman, M.D., has joined the company as Chief Medical Officer (CMO) and Executive Vice President. Dr. Czuczman was most recently Therapeutic Area Head, Vice President, Clinical Research and Development Global Lymphoma/CLL Program at Celgene Corporation. At Celgene, he was responsible for worldwide clinical development in Lymphoma/CLL and for the development of all compounds from Proof-of-Principle through registration globally.

Myron Holubiak, Citius CEO stated, "We are honored to have a colleague as qualified as Dr. Czuczman join the Citius team. He will be enormously helpful in furthering our development program for our planned iPSC-derived mesenchymal stem cell (iMSC) for the treatment of ARDS associated with CoVid-19. This, coupled with the advanced Phase 3 trials underway for Mino-Lok and preparing an IND for Mino-Wrap, add to the importance of bringing in an executive of Dr. Czuczman's expertise, experience, and caliber to the team."

Prior to his tenure at Celgene, Dr. Czuczman served as Chief, Lymphoma/Myeloma Service in the Department of Medicine and Head of the Lymphoma Translational Research Laboratory in the Immunology Department at Roswell Park Comprehensive Cancer Center in Buffalo, NY where he attained the title of tenured Professor of Medicine and Oncology prior to joining Celgene.

Dr. Czuczman received his M.D. from Pennsylvania State University of Medicine after graduating magna cum laude in Biochemistry from the University of Pittsburgh. He completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York, NY.

Dr. Czuczman was a Founding Member and reviewer forthe National Comprehensive Cancer Network (NCCN) Lymphoma Guidelines compendium panel for nearly twenty years and he has greater than 180 peer-reviewed publications. He is a Diplomate in Internal Medicine, and is Board Certified in Medical Oncology and received numerous awards and accolades during his academic career.

About Citius Pharmaceuticals, Inc. Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Mino-Lok Mino-Lok is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients, for whom venous access presents a challenge. There are currently no approved therapies for salvaging infected CVCs.

About Citius iMSC Citius's planned mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs produced from this clonal technique are differentiated from adult donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, iMSCs exhibit superior potency and high cell viability. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

About Acute Respiratory Distress Syndrome (ARDS) ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

Safe Harbor This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.

Factors that could cause actual results to differ materially from those currently anticipated are: our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned Novecite therapy for ARDS; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:

Andrew Scott Vice President, Corporate Development (O) 908-967-6677 x105 ascott@citiuspharma.com

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Citius Pharmaceuticals Brings on Myron S. Czuczman, MD as Chief Medical Officer (CMO) and Executive Vice President - BioSpace

Advanced Therapy Medicinal Products Market Break Down By Leading Companies, Countries, Applications, Challenges, Opportunities And Forecast 2020-2026…

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Advanced Therapy Medicinal Products market.

Trusted Business Insights presents an updated and Latest Study on Advanced Therapy Medicinal Products Market 2019-2026. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Advanced Therapy Medicinal Products market during the forecast period (2019-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Advanced Therapy Medicinal Products Market Market Research and Industry Forecast Report, 2026 (Includes Business Impact of COVID-19)

Industry Insights, Market Size, CAGR, High-Level Analysis: Advanced Therapy Medicinal Products Market

The global advanced therapy medicinal products market size was valued at USD 3.14 billion in 2019 and is projected to expand at a CAGR of 17.4% during the forecast period. Recent advancements in biological therapies have resulted in a gradual shift toward personalized medicine from the conventional one-size fits all approach. The advanced therapy medicinal product (ATMP) landscape is one of the active spaces in this new trend. These products offer solutions for conditions with negligible therapeutic alternatives as well, which is one of the major growth drivers for the market. Although the regulation for ATMPs is currently in its nascent stage, it is a constantly developing area. The number of Investigational New Drug (IND) applications for these therapies continues to increase. Post-approval of Yescarta, Center for Biologics Evaluation and Research has received around 150 INDs in fiscal year 2018. According to the Alliance for Regenerative Medicine (ARM), more than 1,000 clinical trials were carried out for the ATMP designation to the products, by January 2019, globally.

With the approval of Luxturna, Yescarta, and Kymriah, this market has witnessed several acquisitions intended for market entry or expansion in the sector. For example, acquisition of Kite Pharma by Gilead Life Science, Juno Therapeutics by Celgene, and AveXis by Novartis are some of the notable acquisitions that took place in recent times. These acquisitions indicate the rising interest of major pharma companies in advanced therapy medicinal products. Although the companies have successfully secured product approvals in the past years, the high cost of therapies and challenges with respect to financial sustainability are anticipated to slowdown product adoption. Several products have been pulled off from the market as they were not considered financially viable for the developers as well as the payers. Moreover, some companies like Fibrocell have also witnessed the wind-down of their product operations. Despite the above-articulated challenges, this field is constantly expanding owing to the health benefits offered by these new classes of therapies, along with benefitting society and the healthcare system in context to healthcare outcome and resource availability. Considering the efficiency and clinical benefits of advanced therapy medicinal products, various stakeholders of the market are constantly designing strategies to overcome the existing challenges and spur advanced therapy medicinal products usage. Therapy Type Insights of Advanced Therapy Medicinal Products Market

Over the past few years, there has been a notable increase in the clinical development of advanced therapies, including gene therapies, cell therapies, and tissue engineering products. Several products have already secured approval in U.S., China, Europe, South Korea, Japan, Australia, Canada, India, and New Zealand. As a result, a substantial number of well-established as well as start-up pharma companies, universities, and hospitals are shifting their focus from conventional therapies to advanced therapies. Cell therapies held the largest revenue share of the advanced therapy medicinal products market in 2019. Increased funding from governments as well as private organizations to support cell therapy clinical trials, improving the legal framework for cell therapy manufacturing and implementation, and proven efficacy of products are some of the key drivers for the growth of the segment.

Based on cell types, stem cell therapies held the dominant revenue share in 2019 owing to the presence of a substantial number of approved therapies. The entry of new players such as Celularity, Rubius Therapeutics, Century Therapeutics, Fate Therapeutics, ViaCyte, Magenta Therapeutics, ReNeuron, Promethera Biosciences, Frequency Therapeutics, and Cellular Dynamics in the recent years reflects the expanding stem cells business operations. Currently, the number of approved gene therapy is limited, however, a substantial number of products is anticipated to receive regulatory approvals in the forthcoming years. Growing R&D activities in gene therapy trials have resulted in an increase in market activities by the key stakeholders operating in the ATMP market. For instance, in April 2019, Catalent announced to acquire Paragon Bioservices to expand its business footprint in the gene therapy arena.

Regional Insights of Advanced Therapy Medicinal Products Market

The presence of a substantial number of approved ATMPs for use in U.S. has contributed to the large revenue share of this region. The recent approval of products like Kymriah, Yescarta, and Zolgensma has propelled the investment in the U.S. ATMP market. Furthermore, the U.S. FDA has announced that it has over 800 active Investigational New Drug applications on file by 2020 and the agency showed interest to receive more than 200 applications per year. In 2017, an estimated 391 gene therapy companies were operating in the U.S. market. In September 2019, around a hundred more companies including Big Pharma companies had entered the market. These factors are anticipated to accelerate the North America market at a lucrative CAGR in the forthcoming years. Europe is the second-largest pharmaceutical market globally, with Western Europe accounting for the large proportion of drug revenue. In the forthcoming years, cell therapy developers are anticipated to account for a major share of Europes drug revenues. In addition, the presence of a substantial number of academic institutes engaged in conducting early-stage cell therapy research is anticipated to boost the regional revenue growth. Furthermore, global companies are expanding their cell therapy manufacturing capabilities across Europe, thereby driving the regional market growth.

Market Share Insights of Advanced Therapy Medicinal Products Market

Currently, this market is a very active space. Recent approvals of ATMPs have prompted an unprecedented expansion in this area. Conventional drug makers are striving to gain a competitive advantage, considering ATMP as a lucrative source of revenue in the future healthcare systems. Companies are investing enormously in clinical trials of ATMP post the success of approved products. Some major players are Spark Therapeutics, Inc.; Bluebird Bio, Inc.; Novartis AG; UniQure N.V.; Celgene Corporation; Gilead Lifesciences, Inc.; Kolon TissueGene, Inc.; JCR Pharmaceuticals Co., Ltd.; MEDIPOST; Vericel Corporation; PHARMICELL Co., Ltd; and Organogenesis Inc. The companies are adopting various operating models to accelerate the product manufacturing process. While some companies undertake in-house production of therapies, a substantial number of players are preferring third-party service providers, including Contract Manufacturing Organizations (CMOs). The gene therapy contract development market space is driven by the surging demand that stems from the expansion of drug development pipeline and the rise in the number of start-ups that embrace human-testing but lack production capacities. On the other hand, several companies have marked their presence in the space by acquiring small and emerging CAR T-cell therapy developers.

Segmentations, Sub Segmentations, CAGR, & High-Level Analysis overview of Advanced Therapy Medicinal Products Market Research Report This report forecasts revenue growth at global, regional, and country levels and provides an analysis of latest industry trends in each of the sub-segments from 2015 to 2026. For the purpose of this study, this market research report has segmented the global advanced therapy medicinal products market report on the basis of therapy type and region:

Therapy Type Outlook (Revenue, USD Million, 2019 2030)

Cell Therapy

Stem Cell Therapy

Non-stem Cell Therapy

CAR-T Therapy

Gene Therapy

Tissue Engineered Product

Quick Read Table of Contents of this Report @ Advanced Therapy Medicinal Products Market Market Research and Industry Forecast Report, 2026 (Includes Business Impact of COVID-19)

Trusted Business Insights Shelly Arnold Media & Marketing Executive Email Me For Any Clarifications Connect on LinkedIn Click to follow Trusted Business Insights LinkedIn for Market Data and Updates. US: +1 646 568 9797 UK: +44 330 808 0580

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Advanced Therapy Medicinal Products Market Break Down By Leading Companies, Countries, Applications, Challenges, Opportunities And Forecast 2020-2026...

Stem cell breakthrough: Japanese scientists discover way …

A new way of creating stem cells that is cheaper, faster and more efficient than before could transform the ability of scientists to develop "personalised medicine" where a patients own healthy skin or blood cells can be used to repair damaged tissues, such as heart disease or brain injury.

Japanese scientists announced today that they had created stem cells which are essential for bodily repair by simply bathing blood cells in a weakly acidic solution for half an hour, triggering a remarkable reversion to the cells original embryonic state.

Researchers in Britain said they were astonished by the ease with which their colleagues in Japan had created embryonic-like stem cells with the ability to develop into any of the dozens of highly specialised cells of the body, ranging from cardiac-muscle cells to the nerve cells of the brain and spinal cord.

It opens up the prospect of doctors taking small samples of skin or blood from a patient and using the tissue to create stem cells that could be injected back into the same patient as part of a "self-repair" kit to mend damaged organs without the risk of tissue rejection.

The stunning breakthrough was even more striking in that it was made by a young Japanese researcher called Haruko Obokata of the Riken Centre for Developmental Biology in Kobe who could not at first believe her own results and when she did finally believe them she found it just as difficult to persuade her colleagues that they were not a mistake

"I was really surprised the first time I saw [the stem cells] Everyone said it was an artifact there were some really hard days," Dr Obokata said. Although the research was carried out on mouse cells, it should also work with human cells, she said.

"Its exciting to think of the new possibilities this finding provides us not only in areas like regenerative medicine but perhaps in the study of cell senescence [ageing] and cancer as well. As regards human cells, that project is underway," she added.

Previously, stem cells with the ability to develop into any specialised tissue a phenomenon called pluripotency could only be created either by extracting them from early embryos or by genetically manipulating adult cells to create so-called induced pluripotent stem (iPS) cells.

However, creating and destroying human embryos raises ethical questions for many people and is fraught with practical difficulties, while using iPS cells in human medicine is raises safety concerns about using genetically modified cells. Both techniques are also costly, inefficient and time-consuming.

The new approach, based simply on bathing blood or skin cells in a weak solution of citric acid for 30 minutes, is not only much quicker and cheaper than the previous two techniques, it is also so simple that it could be carried out in labs without any particularly specialised knowledge or equipment.

No hype, just the advice and analysis you need

To test that the cells were truly pluripotent, Dr Obokata and her colleagues labelled them with a green fluorescent gene, injected them into early mouse embryos and found that they colonised every tissue of the developing foetus, even its umbilical cord which does not happen with classical embryonic stem cells and iPS cells.

The Japanese scientists, who collaborated with Charles Vacanti of Harvard Medical School in Boston, said that in addition to blood cells, they have also created stem cells from the brain, skin, muscle, fat, bone-marrow, lung and liver tissues of newborn mice. They have called the technique stimulus-triggered acquisition of pluripotency (STAP) and believe there may be other ways of shocking adult cells to revert to their embryonic condition other than bathing them in a weak acid solution.

Professor Vacanti said: "It may not be necessary to create an embryo to acquire embryonic stem cells. Our research findings demonstrate that creation of an autologous pluripotent stem cell a stem cell from an individual that has the potential to be used for therapeutic purpose without an embryo, is possible."

Scientists in Britain said the findings were extraordinary and unexpected. The results rewrite the rulebook on how the specialised cells of the mammalian body are meant to behave once they have travelled down what was thought to be the one-way street of cell differentiation, they said.

"Obakatas approach in the mouse is the most simple, lowest cost and quickest method to generate pluripotent cells from mature cells," said Professor Chris Mason, an expert in regenerative medicine at University College London.

"If it works in man, this could be the game changer that ultimately makes a wide range of cell therapies available using the patients own cells as starting material the age of personalised medicine would have finally arrived," Professor Mason said.

"Who would have thought that to reprogram adult cells to an embryonic stem cell-like (pluripotent) state just required a small amount of acid for less than half an hour? An incredible discovery," he added.

Professor Robin Lovell-Badge, head of stem cell biology at the MRCs National Institute for Medical Research in north London, said: "It is going to be a while before the nature of these cells are understood, and whether they might prove to be useful for developing therapies, but the really intriguing thing to discover will be the mechanism underlying how a low pH [acidic] shock triggers reprogramming. And why it does not happen when we eat lemon or vinegar or drink cola?"

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Stem cell breakthrough: Japanese scientists discover way ...

Types of Stem Cells

Totipotent SCs:

These cells have total potentiality to form a complete full organism. Totipotent SCs are well known for their capability of differentiating into all cell types and lineages that can form different types of tissues and organs. Totipotent SCs have unlimited capability, and in the early stages of embryonic development. They can differentiate to extra embryonic membranes and tissues, the embryo, the postembryonic tissues and final organs.

More specialized cells in generating different types of tissues and organs. These types of cells can differentiate into any cells type but are incapable of producing a whole organism. Pluripotent SCs can give rise to types of cells that develop from the three germ layers (ectoderm, mesoderm, and endoderm). Induced Pluripotent stem cells (iPSCs) are a type of Pluripotent stem cells generated by the genetic introduction of 4 genes encoding for transcription factors that can induce the conversion of adult cells into Pluripotent stem cells.

These SCs are more specialized cells that are usually found in different organs of the human body. They are capable of forming cells from more than one germ layer and differentiating to different cell types within the same organ or tissue. Pluripotent and multipotent SCs share common characteristics and can be easily confused with one another. Accordingly, the classification of either type depends solely on the differentiation potential of each type of cell. Furthermore, the differentiation potential of multipotent SCs is not easily understood for several reasons. These include the fact that their physiological sites of survival referred to as stem cell niches usually differ from one site to another. In general, individual multipotent stem cells, that are part of a homogenous population of SCs, are usually committed to forming one cell lineage, compared to pluripotent SCs that have the potential to form more than one cell lineage.

These cells are commonly found in specific organs and tissues of adult organisms and are limited to differentiating to one cell type only, depending on a complex structure of intrinsic and extrinsic factors. These SCs are responsible for the steady state of self-renewal through constant regeneration and repair of that organ.

There are two main sources of stem cells:

Pluripotent cells that exist in the early stages of embryonic development, specifically in the inner mass of blastocysts, and go on to form all the cells of the adult body. These cells no longer exist after five days of development.

SCs that can be found in almost all body tissues including blood, brain, liver, intestine, or skin. They are more tissue specific cells committed to become a cell from their own tissue of origin, but cannot go to form all tissues of the body.

Based on the differentiation potentiality of SCs, they can be categorized into hematopoietic stem cells (HSCs) and non-hematopoietic stem cells (NHSCs). HSCs are cells that give rise to blood cell lineages and are capable of differentiating to white blood cells (WBCs), red blood cells (RBCs), and platelets. NHSCs are cells that give rise to tissues and organs other than blood.

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Types of Stem Cells

Placental Stem Cell Collection and Storage Market Emerging Trends, Strong Application Scope, Size, Status, Analysis and Forecast to 2025 – Apsters…

A detailed research on Placental Stem Cell Collection and Storage market recently added by Market Study Report, LLC, puts together a concise analysis of the growth factors impacting the current business scenario across assorted regions. Significant information pertaining to the industrys size, share, application, and statistics are also summed in the report in order to present an ensemble prediction. In addition, this report undertakes an accurate competitive analysis illustrating the status of market majors in the projection timeline, while including their expansion strategies and portfolio.

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Placental Stem Cell Collection and Storage Market Emerging Trends, Strong Application Scope, Size, Status, Analysis and Forecast to 2025 - Apsters...

Cell Separation Technology Market Potential Growth, Share, Demand And Analysis of Key Players- Research Forecasts To 2027 – 3rd Watch News

Cell Separation Technology Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019 2027

Transparency Market Research (TMR)has published a new report on the globalcell separation technology marketfor the forecast period of 20192027. According to the report, the global cell separation technology market was valued at ~US$ 5 Bnin 2018, and is projected to expand at a double-digit CAGR during the forecast period.

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Overview

Cell separation, also known as cell sorting or cell isolation, is the process of removing cells from biological samples such as tissue or whole blood. Cell separation is a powerful technology that assists biological research. Rising incidences of chronic illnesses across the globe are likely to boost the development of regenerative medicines or tissue engineering, which further boosts the adoption of cell separation technologies by researchers.

Expansion of the global cell separation technology market is attributed to an increase in technological advancements and surge in investments in research & development, such asstem cellresearch and cancer research. The rising geriatric population is another factor boosting the need for cell separation technologies Moreover, the geriatric population, globally, is more prone to long-term neurological and other chronic illnesses, which, in turn, is driving research to develop treatment for chronic illnesses. Furthermore, increase in the awareness about innovative technologies, such as microfluidics, fluorescent-activated cells sorting, and magnetic activated cells sorting is expected to propel the global cell separation technology market.

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North America dominated the global cell separation technology market in 2018, and the trend is anticipated to continue during the forecast period. This is attributed to technological advancements in offering cell separation solutions, presence of key players, and increased initiatives by governments for advancing the cell separation process. However, insufficient funding for the development of cell separation technologies is likely to hamper the global cell separation technology market during the forecast period. Asia Pacific is expected to be a highly lucrative market for cell separation technology during the forecast period, owing to improving healthcare infrastructure along with rising investments in research & development in the region.

Rising Incidences of Chronic Diseases, Worldwide, Boosting the Demand for Cell Therapy

Incidences of chronic diseases such as diabetes, obesity, arthritis, cardiac diseases, and cancer are increasing due to sedentary lifestyles, aging population, and increased alcohol consumption and cigarette smoking. According to the World Health Organization (WHO), by 2020, the mortality rate from chronic diseases is expected to reach73%, and in developing counties,70%deaths are estimated to be caused by chronic diseases. Southeast Asia, Eastern Mediterranean, and Africa are expected to be greatly affected by chronic diseases. Thus, the increasing burden of chronic diseases around the world is fuelling the demand for cellular therapies to treat chronic diseases. This, in turn, is driving focus and investments on research to develop effective treatments. Thus, increase in cellular research activities is boosting the global cell separation technology market.

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Increase in Geriatric Population Boosting the Demand for Surgeries

The geriatric population is likely to suffer from chronic diseases such as cancer and neurological disorders more than the younger population. Moreover, the geriatric population is increasing at a rapid pace as compared to that of the younger population. Increase in the geriatric population aged above 65 years is projected to drive the incidences of Alzheimers, dementia, cancer, and immune diseases, which, in turn, is anticipated to boost the need for corrective treatment of these disorders. This is estimated to further drive the demand for clinical trials and research that require cell separation products. These factors are likely to boost the global cell separation technology market.

According to the United Nations, the geriatric population aged above 60 is expected to double by 2050 and triple by 2100, an increase from962 millionin 2017 to2.1 billionin 2050 and3.1 billionby 2100.

Global Cell Separation Technology Market: Segmentation

Cell Separation Technology Market by Technology

Cell Separation Technology Market by Application

Cell Separation Technology Market by End User

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Cell Separation Technology Market Potential Growth, Share, Demand And Analysis of Key Players- Research Forecasts To 2027 - 3rd Watch News

Breakthrough Science: Scientists Discover New Method To Solve Male Infertility – International Business Times

KEY POINTS

More than a hundred million men across the world suffer from infertility. Scientists have discovered the answer to treating infertility may be in spermatogonial stem cells (SSC) that are required for generating sperms.

SSCs in the testes can be transferred to test tubes which will then be cultured and nudged until it becomes a fully-fledged sperm. However, identifying the perfect conditions to grow these sperm stem cells in a lab has been a challenge. The experts at the University of California San Diego School of Medicine have now developed a reliable way of doing this.

These specialized cells, which have the potential to help men father children even at the age of 65, continually self-renew themselves to generate more and develop into sperms so prolifically that men and even transgender or gender-fluid individuals produce more than a thousand new sperms every few seconds.

We think our approach -- which is backed up by several techniques, including single-cell RNA-sequencing analysis -- is a significant step toward bringing SSC therapy into the clinic," News Medical quoted Miles Wilkinson, Ph.D., the studys senior author and distinguished Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, University of California San Diego.

The challenge lied in being able to distinguish SSCs from other cells in the testes. But the experts at the University of California San Diego identified a new technique called single-cell RNA sequencing to define the likely molecular characteristics that are specific to the sperm stem cells.

The researchers used their new method to purify the human SSCs and gathered the profile of genes expressed in these cells to make guesses as to the conditions that might best support their growth in laboratory conditions.

After using over 30 human testis biopsies, they were able to determine just the ideal conditions required to culture immature germ cells that have the characteristics of sperm stem cells.

One conditionAKT pathway inhibitionhad the unique ability to selectively support the culture of primitive human undifferentiated spermatogonia (uSPG). This raises the possibility that supplementation with an AKT inhibitor could be used to culture human SSCs in vitro for therapeutic applications, concluded the researchers in their paper published in the journal PNAS.

new study reveals egg cells are very choosy when it comes to the sperm that will fertilize it Photo: TBIT - Pixabay

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Breakthrough Science: Scientists Discover New Method To Solve Male Infertility - International Business Times

Fate Therapeutics Announces Exclusive License Agreement with Baylor College of Medicine for Rejection-resistant iPSC-derived Cellular Therapies -…

July 14, 2020 08:00 ET | Source: Fate Therapeutics, Inc.

License Covers First-in-class Alloimmune Defense Receptors Designed to Protect Allogeneic Cells from Rejection in Immunocompetent Recipients

Preclinical Data Published in the Journal Nature Biotechnology Demonstrate Allogeneic CAR T Cells Overcome Immune Rejection and Exhibit Durable Tumor Eradication

SAN DIEGO, July 14, 2020 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced that the Company entered into an exclusive license agreement with Baylor College of Medicine covering alloimmune defense receptors, a first-in-class approach that renders off-the-shelf allogeneic cell products resistant to host immune rejection. Preclinical studies published in the journal Nature Biotechnology (https://www.nature.com/articles/s41587-020-0601-5) demonstrate that allogeneic cells engineered with a novel alloimmune defense receptor (ADR) are protected from both T- and NK-cell mediated rejection, and provide proof-of-concept that ADR-expressing allogeneic cell therapies can durably persist in immunocompetent recipients.

Allogeneic cell therapy requires a patient to endure systemic lympho-conditioning to suppress the immune system and mitigate cellular rejection, often resulting in severe blood cell deficiencies and related toxicities. There is great interest in strategies that enable allogeneic cells to overcome host immunity and evade immune rejection while maintaining a patients functional hematopoietic system, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. The published preclinical data provide compelling evidence that allogeneic cell therapies armed with novel alloimmune defense receptors can effectively abrogate both T- and NK-cell rejection responses and can persist and remain functional in immunocompetent patients.

ADRs are synthetic receptors that selectively recognize cell surface receptors, such as 4-1BB, that are uniquely expressed on activated lymphocytes, which are responsible for host immune rejection. The published preclinical findings show that the arming of allogeneic T cells with an ADR selectively eliminates alloreactive T and NK cells, while sparing resting lymphocytes. Importantly, in in vivo preclinical models of cancer, allogeneic T cells expressing both an ADR and a CD19-targeted chimeric antigen receptor (CAR) demonstrated increased expansion and persistence, resulting in sustained tumor eradication and a long-term survival benefit compared to conventional CD19-targeted CAR T cells.

There is tremendous promise for the use of off-the-shelf allogeneic cells as replacement therapy. One of the most significant barriers to overcome is host immunity, which can prevent the engraftment of allogeneic cells and the long-term replacement of a patients damaged or dysfunctional cells, said Maksim Mamonkin, Ph.D., Assistant Professor, Center for Cell and Gene Therapy, Baylor College of Medicine and the senior author on the Nature Biotechnology publication. We are excited for Fate Therapeutics to explore the use of alloimmune defense receptors in the development of rejection-resistant, iPSC-derived cellular therapies.

About Fate Therapeutics iPSC Product Platform The Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of and plans related to the Companys NK and T-cell product candidates and preclinical research and development programs, and the scope and enforceability of the Companys intellectual property portfolio. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that results observed in preclinical studies of its product candidates may not be replicated in ongoing or future clinical trials or studies, the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and the risk that any of the patents owed or licensed by the Company may be challenged and that such a challenge may be successful, resulting in loss of any such patent or loss or reduction in the scope of one or more of the claims of a challenged patent. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact: Christina Tartaglia Stern Investor Relations, Inc. 212.362.1200 christina@sternir.com

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Fate Therapeutics Announces Exclusive License Agreement with Baylor College of Medicine for Rejection-resistant iPSC-derived Cellular Therapies -...

Citius Pharmaceuticals Brings on Myron S. Czuczman, MD as Chief Medical Officer (CMO) and Executive Vice President – PRNewswire

CRANFORD, N.J., July 14, 2020 /PRNewswire/ --Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that Myron S. Czuczman, M.D., has joined the company as Chief Medical Officer (CMO) and Executive Vice President. Dr. Czuczman was most recently Therapeutic Area Head, Vice President, Clinical Research and Development Global Lymphoma/CLL Program at Celgene Corporation. At Celgene, he was responsible for worldwide clinical development in Lymphoma/CLL and for the development of all compounds from Proof-of-Principle through registration globally.

Myron Holubiak, Citius CEO stated, "We are honored to have a colleague as qualified as Dr. Czuczman join the Citius team. He will be enormously helpful in furthering our development program for our planned iPSC-derived mesenchymal stem cell (iMSC) for the treatment of ARDS associated with CoVid-19. This, coupled with the advanced Phase 3 trials underway for Mino-Lok and preparing an IND for Mino-Wrap, add to the importance of bringing in an executive of Dr. Czuczman's expertise, experience, and caliber to the team."

Prior to his tenure at Celgene, Dr. Czuczman served as Chief, Lymphoma/Myeloma Service in the Department of Medicine and Head of the Lymphoma Translational Research Laboratory in the Immunology Department at Roswell Park Comprehensive Cancer Center in Buffalo, NY where he attained the title of tenured Professor of Medicine and Oncology prior to joining Celgene.

Dr. Czuczman received his M.D. from Pennsylvania State University of Medicine after graduating magna cum laude in Biochemistry from the University of Pittsburgh. He completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York, NY.

Dr. Czuczman was a Founding Member and reviewer forthe National Comprehensive Cancer Network (NCCN) Lymphoma Guidelines compendium panel for nearly twenty years and he has greater than 180 peer-reviewed publications. He is a Diplomate in Internal Medicine, and is Board Certified in Medical Oncology and received numerous awards and accolades during his academic career.

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Mino-LokMino-Lok is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients, for whom venous access presents a challenge. There are currently no approved therapies for salvaging infected CVCs.

About Citius iMSCCitius's planned mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs produced from this clonal technique are differentiated from adult donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, iMSCs exhibit superior potency and high cell viability. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

About Acute Respiratory Distress Syndrome (ARDS)ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.

Factors that could cause actual results to differ materially from those currently anticipated are: our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned Novecite therapy for ARDS; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:

Andrew Scott Vice President, Corporate Development (O) 908-967-6677 x105 [emailprotected]

SOURCE Citius Pharmaceuticals, Inc.

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Cell Separation by Membrane Filtration Technology Market: In-depth Analysis of the Global Industry with Future Estimations till 2029 – Cole of Duty

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