Akari Therapeutics Reports Third Quarter 2019 Financial Results And Highlights Recent Clinical Progress – BioSpace

- New data demonstrate dual role of C5 and LTB4 in both bullous pemphigoid (BP) and atopic keratoconjunctivitis (AKC). There are no U.S. Food and Drug Administration (FDA)-approved treatments for either disease.

- Clinical progress across our target conditions

- Continued advancement of clinical programs

- Over 20 cumulative patient-years of nomacopan treatment data with no reported drug related serious adverse events in any patients treated to date across the four conditions

NEW YORK and LONDON, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced financial results for the third quarter ended September 30, 2019 and recent clinical progress.

We are excited about the positive clinical data we are accumulating in patients treated with nomacopan across our target rare disease indications. The rapid and sustained clinical clinical improvement combined with the positive long-term safety profile we have observed in patients, helps to offer further validation of nomacopans unique method of action as an inhibitor of both the complement and leukotriene pathways, said Clive Richardson, Chief Executive Officer of Akari Therapeutics. We look forward to further progress across both our topical and subcutaneous clinical programs in 2020 as we look to drive nomacopan through the clinic and towards helping patients afflicted by these rare and debilitating inflammatory conditions. In addition, we seek to partner those programs in which a joint development approach can produce a faster outcome.

Third Quarter 2019 and Recent Business Highlights

Akaris strategy is to focus on orphan inflammatory diseases with significant unmet medical need, where the role of the complement and leukotriene systems are implicated. Akaris lead programs are in BP, AKC, and HSCT-TMA where clinical data with nomacopan has shown rapid and sustained clinical improvement in patients. These diseases have no approved treatments.

Further evidence for potential therapeutic benefits of inhibition of C5 and LTB4 by nomacopan

In the last three months, the Company has announced preclinical data in both BP and AKC demonstrating the likely combined role of C5 and LTB4 in these two severe inflammatory conditions:

Pediatric HSCT-TMA

Phase II clinical trial in patients with BP

Phase I/II clinical trial in patients with AKC

Paroxysmal nocturnal hemoglobinuria (PNH) program

Third Quarter 2019 Financial Results

About Akari Therapeutics

Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's lead drug candidate, nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan is currently being clinically evaluated in four indications: bullous pemphigoid (BP), atopic keratoconjunctivitis (AKC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal hemoglobinuria (PNH). Akari believes that the dual action of nomacopan on both C5 and LTB4 may be beneficial in AKC and BP. Akari is also developing other tick derived proteins, including longer acting versions.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements related to the offering, the expected gross proceeds and the expected closing of the offering. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result therefrom; our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us; difficulties enrolling patients in our clinical trials; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected; risks associated with the departure of our former Chief Executive Officers and other executive officers; risks associated with the SEC investigation; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

For more informationInvestor Contact:

Peter VozzoWestwicke(443) 213-0505peter.vozzo@westwicke.com

Media Contact:

Sukaina Virji / Nicholas Brown / Lizzie SeeleyConsilium Strategic Communications+44 (0)20 3709 5700Akari@consilium-comms.com

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Akari Therapeutics Reports Third Quarter 2019 Financial Results And Highlights Recent Clinical Progress - BioSpace

Stem Cell Banking Market Anticipated to Grow at a Significant Pace by 2028 – Weekly Spy

The research provides in-depth study and analysis on Stem Cell Banking market. This report also gives complete overview of the global market, covering the different aspects such as product definitions along with leading market players. To get better perspectives of global market, relevant chart and graphs are included in the report.

Stem cell banking or preservation is a combined process of extraction, processing and storage of stem cells, so that they may be used for treatment of various medical conditions in the future, when required. Stem cells have the amazing power to get transformed into any tissue or organ in the body. In recent days, stem cells are used to treat variety of life-threatening diseases such as blood and bone marrow diseases, blood cancers, and immune disorders among others.

Stem Cell Banking market report gives the reasonable picture of the current industry situation which incorporates authentic and anticipated market estimate in terms of esteem and volume, technological advancement, macroeconomic and governing factors in the market. The report provides detailed statistics and strategies of the best key players in the industry. The report additionally gives a broad study of the distinctive market sections and areas.

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Some of the leading key players profiled in this study:Cordlife, ViaCord (A Subsidiary of PerkinElmer), Cryo-Save AG, StemCyte India Therapeutics Pvt. Ltd., Cryo-Cell International, Inc., SMART CELLS PLUS, Vita 34, LifeCell, Global Cord Blood Corporation, CBR Systems, Inc

What the report features:-

Global analysis of Stem Cell Banking market from 2017 2027 illustrating the progression of the market.

Forecast and analysis of Stem Cell Bankingmarket by Dosage, Route of Administration and Application from 2017 2027

Forecast and analysis of Stem Cell Banking market in five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America

The market of stem cell banking is anticipated to grow with a significant rate in the coming years, owing to factors such as, development of novel technologies for stem cell preservation and processing, and storage; growing awareness on the potential of stem cells for various therapeutic conditions. Moreover, increasing investments in stem cell research is also expected to propel the growth of the stem cell banking market across the globe. On other hand rising burden of major diseases and emerging economies are expected to offer significant growth opportunities for the players operating in stem cell banking market.

The Global Stem Cell Banking Market is characterized by the presence of a large number of global, regional, and local players and is highly-competitive. These international players are increasingly focusing on expanding their geographical presence and they have huge production facilities located across the world. Several vendors are increasingly competing against each other based on factors such as innovations, price, and quality of the product. Vendors with better financial and technological resources can withstand changes in different market conditions when compared to their competitors.

The various factors supporting the markets growth and those posing threat are studied in detail in this report. Additionally, the market study segments the Global Stem Cell Banking Market based on end-users, verticals, and size. In these sections, it shields various factors impelling the markets trajectory across the segments. Furthermore, it recognizes the most lucrative of them all to help investors take the well-informed decision.

The Global Stem Cell Banking Market Analysis to 2025 is a specialized and in-depth study of the biotechnology industry with a focus on the global market trend. The stem cell banking market report aims to provide an overview of global stem cell banking market with detailed market segmentation by source, service type, application, and geography. The global stem cell banking market is expected to witness high growth during the forecast period. The stem cell banking market report provides key statistics on the market status of the leading market players and offers key trends and opportunities in the market.

Relating to the latest hierarchy in the global Stem Cell Banking market, the report summaries some of the crucial players operative in the market. Discriminating information about the significant players including their revenue, business segmentation, product portfolio, and financial overview has been integrated in the report. Latest improvements in the industry have been taken into concern while anticipating the future perspective of the market. The report also exemplifies the various marketing channels prevailing in the global market and conveys information about few of the critical distributors functioning in the market. The report assists as a helpful guide for the new as well as prevailing players in the market.

Market Segmentation:

The global stem cell banking market is segmented on the basis of source, service type, and application. The source segment includes, placental stem cells (PSCS), dental pulp-derived stem cells (DPSCS), bone marrow-derived stem cells (BMSCS), adipose tissue-derived stem cells (ADSCS), human embryo-derived stem cells (HESCS), and other stem cell sources. Based on service type the market is segmented into, sample processing, sample analysis, sample preservation and storage, sample collection and transportation. Based on application, the market is segmented as, clinical applications, research applications, and personalized banking applications.

This report includes several arrangements, definitions, the chain assembly of the industry in one piece, and the various uses for the global market. This section also integrates an all-inclusive analysis of the different enlargement plans and government strategies that influence the market, its cost assemblies and industrialized processes. The second subdivision of the report includes analytics on the Global Stem Cell Banking Market based on its size in terms of value and volume.

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The most crucial key factors in the businesses have been elaborated to get ample and accurate data of market dynamics. Rising needs and popularity of Stem Cell Banking Market sector is driving the flow of the market towards progress. In addition to this, it lists the factors which are restraining the growth of the market.

Reason to Buy

Save and reduce time carrying out entry-level research by identifying the growth, size, leading players and segments in the global Stem Cell Banking Market

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Develop/modify business expansion plans by using substantial growth offering developed and emerging markets.

Scrutinize in-depth global market trends and outlook coupled with the factors driving the market, as well as those hindering it.

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Stem Cell Banking Market Anticipated to Grow at a Significant Pace by 2028 - Weekly Spy

Stempeutics to receive US patent for Stempeucel – BSI bureau

Stempeucel has been developed for the treatment of Critical Limb Ischemia (CLI)

Stempeutics Research announced that the United States Patent and Trademarks Office (USPTO) issued notice of allowance to grant the US patent for Management of Critical Limb Ischemia (CLI) using Pooled Mesenchymal Stromal Cell product Stempeucel

Stempeucel for the treatment of CLI is a breakthrough treatment option which directly addresses the root cause of the disease, unlike other drugs that typically treat the symptoms and not the disease itself.

Critical Limb Ischemia (CLI) is a progressive form of peripheral arterial disease, which blocks the arteries in the lower extremities, resulting in reduced blood flow. It is a debilitating disease which affects patients with severe pain in the feet or toes. Insufficient supply of blood flow results in the development of sores and wounds in legs and feet. If left untreated, patients may finally have to undergo the amputation of the affected limb as the last treatment option. In the US, the most common current treatments for CLI are characterized by high rates of primary amputations, multiple procedures and high rates of procedure-related complications. In such cases, the disease not only affects the quality of life but also increases the economic burden of patients.

Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors. The companys proprietary pooling approach allows an efficient manufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients. This approach also allows more than one million patient doses from a single set of master cell banks, which is unique in regenerative medicine. The proprietary technology allows Stempeucel to extend the therapeutic potential of the drug across multiple disease categories.

Commenting on the US patent, B N Manohar, CEO of Stempeutics said, This very important patent comes at the right time, just ahead of our planned PreIND meeting with US FDA. The patent being granted by USPTO is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores the global leadership in allogeneic, pooled MSC technology. We believe that the Stempeucel product is a game- changer offering an advanced therapeutic treatment for millions of patients suffering from this dreadful disease.

Prof. Polani Seshagiri, a Stem Cell and Developmental biologist from the Indian Institute of Science-Bangalore, said, I am impressed with the scientists working at the cutting-edge stem cell biotechnology at Stempeutics. In an industry that demands constant technological and scientific advances, a robust patent portfolio covering core innovations strengthens Companys competitive edge. Stempeutics through its research innovations is demonstrating a firm commitment in bringing new generation of stem cell-based biologics in order to address unmet medical needs

Stempeutics is currently conducting a Phase 4 trial for CLI due to Buergers Disease and a Phase 3 trial for CLI due to Atherosclerotic Peripheral Arterial Disease in India.

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Stempeutics to receive US patent for Stempeucel - BSI bureau

How Stem Cells Can Heal The Body – Version Weekly

Stem cells from the patients body when isolated and administered at an appropriate time and at the right place, with the right dose, is expected to help the patient in various ways

Stem Cells In The Body

All humans are born and develop from a small tiny structure called an egg. The cells in the egg have a tremendous potential to develop, multiply and form different cells that are functional in the body. These cells are called mother cells or in scientific terms, they are called stem cells. And all human beings have these stem cells preserved in the body. It is these cells that help us in every day wear and tear and also for tissue repair.

The Body Can Heal Itself

Most of the cells in our body have a definite lifespan that need to be replaced by new cells. The stem cell reserves in the body make up for this and it is done without our knowledge! In fact, any cut or injury, external or internal is healed by the bodys innate mechanism. Our intelligent body recognises the signal of injury and recruits the required stem cells. These stem cells transform themselves into the cells that are required for the repair of the injury and it is always many types of cells in various permutations and combinations.

Where Stem Cells Reside

Bone marrow can be considered as the manufacturing unit of stem cells as it is continuously making blood cells and keeps our circulatory system working perfect all the time. Circulating blood is another source of stem cells, because it works as a courier, carrying cells and other essential enzymes, hormones from one organ to the other in the body. The body converts all the extra material into fat which gets accumulated around the belly. This fatty tissue works like a fixed deposit of stem cells.

Stem cells either from the donor (allogenic) or from the patient (autologous) are being used for more than 50 years and especially for treatment. Blood cancers and other blood-related diseases can be cured using a perfect matched donor stem cells obtained from bone marrow. Patients suffering from organ cancers like breast cancer etc. are given autologous stem cells as a supportive treatment along with chemotherapy and/or radiation.

Protocols for these treatments are standardised globally and considered as standard-of-care. In recent years, umbilical cord blood derived stem cells are being used as an alternative to bone marrow, especially in the paediatric age group. People fall victim to numerous degenerative diseases which occur, as the repairing stem cell system from the body fails slowly with age. Stem cells from the patients body when isolated and administered at an appropriate time and at the right place, with the right dose, is expected to help the patient in various ways. It may also replace, rejuvenate or restore the damaged tissues.

Our body carnes its own repairing kit in the form of stem cells and the body tries its level best to make use of these stem cells to ward off diseases. However, it is possible that with age, the bodys power to recruit and make use of the stem cells diminishes slowly. This is when dreadful degenerative diseases like diabetes, arthritis, Parkinsons disease and heart problems, set in. Heres what the clinical applications of regenerative medicine have found novel mechanisms of:

It is increasingly observed that this kind of autologous therapy takes care of the root cause of disease and offers benefits to patients to whom there is no further solution in other modalities of treatment.

Since each tissue and organ of our body is made up of cells that are derived from the egg cell, any disease which is due to derangement or degeneration of cells can be cured using autologous cellular therapy. And though the list can be endless, here are some examples where there have been very promising results:

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How Stem Cells Can Heal The Body - Version Weekly

Light-activated pancreatic cells produce insulin on demand – New Atlas

Diabetes is one of the leading health problems in our modern world and requires the careful management of a patients insulin levels. New research from Tufts University may make that process a little easier. In mouse tests, the team implanted beta cells that produce more insulin on demand, when theyre activated by blue light.

At the heart of both types of diabetes is insulin, the hormone that regulates blood sugar levels, allowing cells in the body to properly use it as energy. In type I diabetes, beta cells in the pancreas dont produce enough insulin, sometimes because the immune system destroys those vital beta cells. In type II diabetes, a patients cells stop responding to insulin, or the pancreas cant keep up with demand, meaning blood glucose levels spike to dangerous highs.

Managing the condition requires constant monitoring of blood sugar levels and boosting insulin levels as needed, either by directly injecting the hormone or through drugs that amplify the beta cells production of it.

For the new study, the Tufts researchers engineered pancreatic beta cells that can produce insulin on demand in this case, that demand is pulses of blue light. The beta cells were engineered with a gene that creates an enzyme called photoactivatable adenylate cyclase (PAC) essentially, when these enzymes are activated by blue light, they produce a molecule called cyclic adenosine monophosphate (cAMP).

In turn, this molecule instructs the beta cell to produce more insulin, but interestingly, it will only do so when theres already a high level of glucose. That helps to prevent a common complication of diabetes treatments, where producing too much insulin can cause the body to consume the available glucose too quickly, resulting in low blood sugar.

To test the new technique, the Tufts team implanted their engineered pancreatic beta cells under the skin of diabetic mice. The researchers found that the cells produced between two and three times more insulin when triggered by blue light and high glucose levels. Importantly, when they fired up the blue light while glucose was low, there was no bump in insulin, indicating that the failsafe worked.

In this way, we can help in a diabetic context to better control and maintain appropriate levels of glucose without pharmacological intervention, says Emmanuel Tzanakakis, corresponding author of the study. The cells do the work of insulin production naturally and the regulatory circuits within them work the same; we just boost the amount of cAMP transiently in beta cells to get them to make more insulin only when its needed.

Similar studies have shown promise in managing diabetes with implanted beta cells either synthetic versions or natural ones produced from a patients own stem cells. Theres still plenty of work to do before this type of treatment makes it to human trials, but the researchers say that using light is a step in the right direction.

There are several advantages to using light to control treatment, says Fan Zhang, first author of the study. Obviously, the response is immediate; and despite the increased secretion of insulin, the amount of oxygen consumed by the cells does not change significantly as our study shows. Oxygen starvation is a common problem in studies involving transplanted pancreatic cells.

Ultimately, tiny sources of light could be embedded alongside the cells, allowing doctors to trigger them remotely when needed. Or they could be automatically activated by a glucose sensor, to fully close the loop.

The research was published in the journal ACS Synthetic Biology.

Source: Tufts University

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Light-activated pancreatic cells produce insulin on demand - New Atlas

Future Outlook: Animal Stem Cell Therapy Market 2019- 2025| Research Methodologies Offers High Business Outlook growth – Pledge Times

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Future Outlook: Animal Stem Cell Therapy Market 2019- 2025| Research Methodologies Offers High Business Outlook growth - Pledge Times