Daewoong to conduct phase 1 trials of stem cell COVID-19 therapy in Indonesia – The Korea Herald

Daewoong headquarters in Gangnam-gu, Seoul (Daewoong Pharmaceutical)

Its Indonesian arm Daewoong Infion has been conducting research for the efficacy of the pipeline DWP710 (mesenchymal stem cell) for treating the ongoing coronavirus pandemic, jointly with the Indonesian Health Ministry.

In the animal tests, Daewoong Infion was able to confirm DWP710s antiviral effects and the increased rate of survival in animals showing accute respiratory disease syndrome who were treated with the pipeline.

The DWP710 was used on animal models infected with lipopolysaccharide, an inflammation-inducing substance.

Compared with the placebo group, the test group given DWP710 had 30 percent increase in survival rate, while demonstrating close to full-recovery of lung tissue, Daewoong said.

After the conclusion of phase 1 trials on human patients in Indonesia, they will carry out phase 2 clinical trials in Korea within 2020.

According to Koreas revised bio law, the health authorities can give conditional approval for drugs that have passed phase 2 clinical trials to expedite their use at hospitals fighting COVID-19.

In Korea, Daewoong has pending clinical phase 1 trials for niclosamide, an antiviral reportedly more potent than remdesivir.

Daewoong Therapeutics, the research and development subsidiary of Daewoong Pharmaceutical is responsible for the niclosamide research while the parent company Daewoong will jointly carry out the clinical trials.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)

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Daewoong to conduct phase 1 trials of stem cell COVID-19 therapy in Indonesia - The Korea Herald

Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19…

NEW YORK, July 06, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that an expanded access protocol (EAP) has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP.

The protocol was filed with the United States Food and Drug Administration (FDA) and provides physicians with access to remestemcel-L for an intermediate-size patient population1 under Mesoblasts existing Investigational New Drug (IND) application. According to the FDA, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

MIS-C is a life-threatening complication of COVID-19 in otherwise healthy children and adolescents that includes massive simultaneous inflammation of multiple critical organs and their vasculature. In approximately 50% of cases this inflammation is associated with significant cardiovascular complications that directly involve heart muscle and may result in decreased cardiac function. In addition, the virus can result in dilation of coronary arteries with unknown future consequences. Recent articles from Europe and the United States have described this disease in detail.2-5

Mesoblast Chief Medical Officer Dr Fred Grossman said: The extensive body of safety and efficacy data generated to date using remestemcel-L in children with graft versus host disease suggest that our cellular therapy could provide a clinically important therapeutic benefit in MIS-C patients, especially if the heart is involved as a target organ for inflammation. Use of remestemcel-L in children with COVID-19 builds on and extends the potential application of this cell therapy in COVID-19 cytokine storm beyond the most severe adults with acute respiratory distress syndrome.

Remestemcel-L Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor and is administered in a series of intravenous infusions. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

1.www.clinicaltrials.gov; NCT04456439 2.Lancet2020; May 7. DOI: https://doi.org/10.1016/S0140-6736(20)31094-1 3.Lancet. 2020; (May 13) https://doi.org/10.1016/S0140-6736(20)31103-X 4.https://www.nejm.org/doi/full/10.1056/NEJMoa2021756 5.https://www.nejm.org/doi/full/10.1056/NEJMoa2021680

About Mesoblast Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19...

Covid-19 Impact on Canine Stem Cell Therapy Market in 2026 Trends Analysis, Top Manufacturers, Shares, Growth Opportunities, Statistics – Owned

Persistence Market Research (PMR) has published a new research report on canine stem cell therapy. The report has been titled, Canine Stem Cell Therapy Market: Global Industry Analysis 2016 and Forecast 20172026.Veterinary research has been used in regenerative and adult stem cell therapy andhas gained significant traction over the last decade.

Canine stem cell therapy products are identified to have gained prominence over the past five years, and according to the aforementioned research report, the market for canine stem cell therapy will expand at a moderate pace over the next few years.

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Company Profiles

Key Questions Answered in Market Report:

Though all animal stem cells are not approved by FDA, veterinary stem-cell manufacturers and university researchers have been adopting various strategies in order to meet regulatory approvals, and streamline and expedite the review-and-approval process. The vendors in the market are incessantly concentrating on research and development to come up with advanced therapy, in addition to acquiring patents.

In September 2017, VetStem Biopharma, Inc. received European patent granted to the University of Pittsburgh and VetStem received full license of the patent then. This patent will eventually provide the coverage for the ongoing commercial and product development programs of VetStem and might be also available for licensing to other companies who are rather interested in this field.

The other companies operating in the global market for canine stem cell therapy are VETherapy Corporation, Aratana Therapeutics, Inc., Regeneus Ltd, Magellan Stem Cells, Animal Cell Therapies, Inc., and Medrego, among others.

According to the Persistence Market Research report, the globalcanine stem cell therapy marketis expected to witness a CAGR of 4.2% during the forecast period 2017-2026. In 2017, the market was valued at US$ 151.4 Mn and is expected to rise to a valuation of US$ 218.2 Mn by the end of 2026.

Burgeoning Prevalence of Chronic Diseases in Dogs to Benefit Market

Adipose Stem Cells (ASCs) are the most prevalent and in-demand adult stem cells owing to their safety profile, ease of harvest, and use and the ability to distinguish into multiple cell lineages. Most early clinical research is focused on adipose stem cells to treat various chronic diseases such as arthritis, tendonitis, lameness, and atopic dermatitis in dogs.

A large area of focus in veterinary medicine is treatment of osteoarthritis in dogs, which becomes more prevalent with age. Globally, more than 20% dogs are suffering from arthritis, which is a common form of canine joint and musculoskeletal disease. Out of those 20%, merely 5% seem to receive the treatment.

However, elbow dysplasia in canine registered a prevalence rate of 64%, converting it into an alarming disease condition to be treated on priority. Thereby, with the growing chronic disorders in canine, the demand for stem cell therapy is increasing at a significant pace.

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Expensive Nature of Therapy to Obstruct Growth Trajectory

Expensive nature and limited access to canine stem cell therapy has demonstrated to be a chief hindrance forestalling its widespread adoption. The average tier II and tier III veterinary hospitals lack the facilities and expertise to perform stem cell procedures, which necessitates the referral to a specialty vet hospital with expertise veterinarians.

A trained veterinary physician charges high treatment cost associated with stem cell therapy for dogs. Generally, dog owners have pet insurance that typically covers maximum cost associated with steam cell therapy to treat the initial injury but for the succeeding measures in case of retreatment, the costs are not covered under the pet insurance. The stem cell therapy is thus cost-prohibitive for a large number of pet owners, which highlights a major restraint to the market growth. Stem cell therapy is still in its developmental stage and a positive growth outcome for the market cannot be confirmed yet.

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Covid-19 Impact on Canine Stem Cell Therapy Market in 2026 Trends Analysis, Top Manufacturers, Shares, Growth Opportunities, Statistics - Owned

Poseida Therapeutics sets terms for upcoming IPO, aims to raise $150M for cancer treatments – The San Diego Union-Tribune

Poseida Therapeutics, which is developing targeted treatments for blood-based and other cancers, set the terms for its initial public stock offering expected this week, where it is seeking to raise $150 million.

The San Diego-based company has one drug advancing to Phase 2 clinical trials for multiple myeloma, a type of cancer that develops in certain cells in the bone marrow.

The company expects to file for investigational new drug authorization with the U.S. Food and Drug Administration for its myeloma treatment later this year.

It also is developing other cancer therapies, including treatments for solid tumors and prostate cancer.

Poseida Therapeutics looks to become the third San Diego life science company to go public in the past two months, joining Progenity and Avidity Biosciences. Its stock offering highlights that investor appetite for new biotech companies remains strong in the midst of stock market turbulence from the coronavirus pandemic.

At the end of March, the company employed 149 workers, including 86 with advanced college degrees.

Since its inception, the company has raised $334 million from life sciences institutional investors who support its drug development efforts, including $75 million from Swiss pharmaceutical giant Novartis.

Poseida set the price for its initial public stock offering at $14 to $16 per share. It plans to trade under the ticker symbol PSTX on the Nasdaq exchange. If its shares get out at the midpoint of that range, Poseida Therapeutics would achieve a market value of $890 million.

Founded in 2015, Poseida Therapeutics is making its own version of what are called CAR T cells immune cells genetically engineered to fight cancers. It is developing CAR T cell treatments made from cancer patients own cells.

The process produces stem cell memory T cells. These T cells stick around, both replenishing their population and creating more differentiated group of T cells to attack cancers. They can potentially resume activity if the cancer recurs. This persistence makes it possible to produce the activity needed to eradicate tumors, which up to this point has been beyond the reach of this type of therapy.

The company has its roots in Transposagen Biopharmaceuticals, which founder Eric Ostertag ran for 13 years. Poseida was spun out to pursue gene engineering technologies.

Other members of the companys management teams have worked in executive roles at San Diego biotech firms including Amylin Pharmaceuticals, Halozyme Therapeutics and Mirati Therapeutics.

In addition to Novartis, additional investors include Adage Capital, Aisling Capital, Boxer Capital, Fidelity, Longitude Capital, Malin Corp., Millennium Capital, Pentwater Capital, Perceptive Advisors, Schonfeld and Vivo Capital.

Bank of America Securities, Piper Sandler and William Blair are joint underwriters on the initial public stock offering.

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Poseida Therapeutics sets terms for upcoming IPO, aims to raise $150M for cancer treatments - The San Diego Union-Tribune

Delaware Court Grants An Order for the Expedited Briefing Schedule of Hemostemix’s Injunction against Accudata Solutions, Inc. and Hemostemix is in…

Calgary, Alberta--(Newsfile Corp. - July 6, 2020) - Hemostemix Inc. (TSXV: HEM) (OTC: HMTXF) ("Hemostemix" or the "Company") is pleased to announce that the United States District Court for the District of Delaware has granted an order for the expedited briefing schedule on Hemostemix's Injunction application seeking the immediate return of all clinical trial data from Accudata Solutions, Inc. ("Accudata"). The Order directs Defendant Accudata to file an Answering Brief in response to Hemostemix's Motion for Preliminary Injunction on or before July 9, 2020. The Hemostemix Reply Brief in support of its Motion for Preliminary Injunction shall be filed on or before July 13, 2020. The Court scheduled a hearing on the preliminary injunction motion for July 15, 2020 at 8:30 a.m. ET.

Further to its July 3, 2020 news release, Hemostemix filed a Verified Complaint and, on July 2, 2020, Motions for a Preliminary Injunction and Expedited Scheduling seeking to compel the immediate return of all clinical trial data from Defendant Accudata and enjoining Accudata from continuing to divulge and disclose such highly sensitive and confidential information to third parties who have no ownership or custodial right to it. Hemostemix has an absolute ownership right over its data and an absolute right to recover its data upon demand. Despite repeated requests, Accudata has failed and refused to return to Hemostemix its data.

Counsel for Hemostemix received a letter and a purported report on July 5, 2020 from the counsel for Aspire Health Science, LLC ("Aspire") at 10:42 p.m. ET on Sunday July 5, 2020. The document, dated April 30, 2020, is unsigned, was addressed to an individual that is neither a director nor officer of Hemostemix, nor acts for Hemostemix in any capacity, and is unverifiable as the underlying data was not included. Hemostemix cautions that Aspire's new release regarding the report is motivated by Aspire's own purposes and is potentially misleading.

Aspire is continuing to block Hemostemix from obtaining the return of its clinical trial data, and in its place has published a news release regarding the report. It is unclear to Hemostemix the scientific bases of the Aspire news release. Neither Aspire nor any of its agents or representatives have any ownership rights to Hemostemix's clinical trial data, nor do they have any rights whatsoever to publish any type of report or results purported to be related to Hemostemix's ACP-01 clinical trials. Similarly, Aspire has no right to continue to hold such data to the exclusion of Hemostemix.

Hemostemix requires its data to properly assess the midpoint analysis of its ACP-01 clinical trials. Hemostemix is seeking the Delaware Court's immediate intervention to obtain its complete clinical trial data from Accudata. Hemostemix will update the market once it has obtained its data and completed an analysis of its ACP-01 clinical trials including its midpoint analysis.

ABOUT HEMOSTEMIX

Hemostemix is a publicly traded autologous stem cell therapy company. A winner of the World Economic Forum Technology Pioneer Award, the Company developed and is commercializing its lead product ACP-01 for the treatment of CLI, PAD, Angina, Ischemic Cardiomyopathy, Dilated Cardiomyopathy and other conditions of ischemia. ACP-01 has been used to treat over 300 patients, and it is the subject of a randomized, placebo-controlled, double blind trial of its safety and efficacy in patients with advanced critical limb ischemia who have exhausted all other options to save their limb from amputation.

On October 21, 2019, the Company announced the results from its Phase II CLI trial abstract entitled "Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup" which noted healing of ulcers and resolution of ischemic rest pain occurred in 83% of patients, with outcomes maintained for up to 4.5 years.

The Company owns 91 patents across five patent families titled: Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood of Cells of Neural Lineage, and Automated Cell Therapy. For more information, please visit http://www.hemostemix.com.

Contact: Thomas Smeenk, President, CEO & Co-Founder, TSmeenk@Hemostemix.com 905-580-4170

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Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Information: This news release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information regarding: the dates for the various filings and the hearing in relation to the Verified Complaint and the Injunction Application; its ACP-01 clinical trials and the midpoint analysis, including the assessment of the midpoint analysis and updating the market in relation to its ACP-01 clinical trials; and the commercialization of ACP-01. There can be no assurance that such forward-looking information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects Hemostemix's current beliefs and is based on information currently available to Hemostemix and on assumptions Hemostemix believes are reasonable. These assumptions include, but are not limited to: no applications or motions delaying the date of the filings or the hearing for Hemostemix's Injunction; no delays in the hearing due to the COVID-19 pandemic or other reasons which require a delay of the hearing; the timing of receipt of its full and complete clinical trials data; the results of ACP-01 research, trials and studies being equivalent to or better than previous research, trials or studies as well as management's expectations of anticipated results; Hemostemix's general and administrative costs remaining constant; the receipt of all required regulatory approvals for research, trials or studies as well as any required or desired financings of Hemostemix, including TSX Venture Exchange acceptance and any third party consents; the level of activity, market acceptance and market trends in the healthcare sector; the economy generally; consumer interest in Hemostemix's services and products; competition and Hemostemix's competitive advantages; and obtaining satisfactory financing to fund Hemostemix's operations including any research, trials or studies. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Hemostemix to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: the ability of Hemostemix to complete its current CLI clinical trial, complete a satisfactory futility analysis and the results of such and future clinical trials; litigation and potential litigation that Hemostemix may face; general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of future operations including the actual results of future research, trials or studies; competition; changes in legislation affecting Hemostemix; the timing and availability of external financing on acceptable terms; long-term capital requirements and future developments in the Company's markets and the markets in which it expects to compete; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession; the potential impact that the COVID-19 pandemic may have on Hemostemix may include a decreased demand for the services that Hemostemix offers; and a deterioration of financial markets that could limit Hemostemix's ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in Hemostemix's disclosure documents on the SEDAR website at http://www.sedar.com. Although Hemostemix has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of Hemostemix as of the date of this news release and, accordingly, is subject to change after such date. However, Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/59227

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Delaware Court Grants An Order for the Expedited Briefing Schedule of Hemostemix's Injunction against Accudata Solutions, Inc. and Hemostemix is in...

Growing Demand for Myelofibrosis Treatment Market to Significantly Increase Revenues Through 2022 – Jewish Life News

Myelofibrosis or osteomyelofibrosis is a myeloproliferative disorder which is characterized by proliferation of abnormal clone of hematopoietic stem cells. Myelofibrosis is a rare type of chronic leukemia which affects the blood forming function of the bone marrow tissue. National Institute of Health (NIH) has listed it as a rare disease as the prevalence of myelofibrosis in UK is as low as 0.5 cases per 100,000 population. The cause of myelofibrosis is the genetic mutation in bone marrow stem cells. The disorder is found to occur mainly in the people of age 50 or more and shows no symptoms at an early stage. The common symptoms associated with myelofibrosis include weakness, fatigue, anemia, splenomegaly (spleen enlargement) and gout. However, the disease progresses very slowly and 10% of the patients eventually develop acute myeloid leukemia. Treatment options for myelofibrosis are mainly to prevent the complications associated with low blood count and splenomegaly.

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The global market for myelofibrosis treatment is expected to grow moderately due to low incidence of a disease. However, increasing incidence of genetic disorders, lifestyle up-gradation and rise in smoking population are the factors which can boost the growth of global myelofibrosis treatment market. The high cost of therapy will the growth of global myelofibrosis treatment market.

The global market for myelofibrosis treatment is segmented on basis of treatment type, end user and geography:

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As myelofibrosis is considered as non-curable disease treatment options mainly depend on visible symptoms of a disease. Primary stages of the myelofibrosis are treated with supportive therapies such as chemotherapy and radiation therapy. However, there are serious unmet needs in myelofibrosis treatment market due to lack of disease modifying agents. Approval of JAK1/JAK2 inhibitor Ruxolitinib in 2011 is considered as a breakthrough in myelofibrosis treatment. Stem cell transplantation for the treatment of myelofibrosis also holds tremendous potential for market growth but high cost of therapy is foreseen to limits the growth of the segment.

On the basis of treatment type, the global myelofibrosis treatment market has been segmented into blood transfusion, chemotherapy, androgen therapy and stem cell or bone marrow transplantation. Chemotherapy segment is expected to contribute major share due to easy availability of chemotherapeutic agents. Ruxolitinib is the only chemotherapeutic agent approved by the USFDA specifically for the treatment of myelofibrosis, which will drive the global myelofibrosis treatment market over the forecast period.

Geographically, global myelofibrosis treatment market is segmented into five regions viz. North America, Latin America, Europe, Asia Pacific and Middle East & Africa. Northe America is anticipated to lead the global myelofibrosis treatment market due to comparatively high prevalence of the disease in the region.

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Some of the key market players in the global myelofibrosis treatment market are

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Growing Demand for Myelofibrosis Treatment Market to Significantly Increase Revenues Through 2022 - Jewish Life News