Paula Grisanti, Opinion contributor Published 6:20 a.m. ET Nov. 9, 2020

This year, Nov.17 has been designated World Cord Blood Day, an annual event to raise awareness for the life-saving benefits of cord blood transplants while educating parents, health professionals and the general public about the need to preserve these precious cells.

Cord blood transplants are being used to treat more than 80 different diseases and conditions including blood cancers like leukemia and lymphoma, neuroblastoma (the most common cancer in infants), bone-marrow failure disorders, inherited blood disorders and rare immune system disorders. They are also showing new promise for conditions that have never had treatment options, like autism and brain injury.

The first cord blood stem cell transplant, an international effort between physicians in the U.S. and Europe, was performed in France in 1988. Stem cells collected from a newborns umbilical cord blood were used to save the life of her brother, a 5-year-old with Fanconi Anemia. Since then, there have been more than 40,000 cord blood transplants performed worldwide.

Now standard of care for cancers of the blood and a host of other life-threatening diseases, blood forming stem cells for transplantation can be collected from bone marrow, circulating bloodor a newborn babys umbilical cord blood. Some experts believe cord blood contains nearly 10 times the number of stem cells found in bone marrow.

Because umbilical cord stem cells are less mature than adult bone marrow stem cells, they are also less likely to be rejected and can be used when there isnt a perfect match.

Between these threeoptions, the easiest collection by far is from umbilical cord and placental tissue after a baby is born and the umbilical cord has been cut, at no risk to mother or child, in a process that typically takes 5 to 10 minutes. The cells are then frozen in liquid nitrogen and can be stored indefinitely in private or public cord blood banks.

To store your babys cord blood for use by your child and your family only, you make arrangements with a private cord blood bank ahead of delivery to collect and store the cells; the cost to you includes a collection fee of $1,500 to $2,000 and an annual storage fee of $100 to $125.

If you cant afford or dont wish to save your babys cord blood stem cells, you can donate them to a public cord blood bank at no cost to you or your family.

Its the equivalent of registering these potentially life-saving cells with the national bone marrow registry; they will be available to the families of other children who need to find a bone marrow match after a devastating diagnosis. Without information and education, however, 95% of all cord blood is discarded as medical waste.

Right now, there is no public cord banking option in Kentucky, although public cord blood banking is highly recommended by both the American Academy of Pediatrics (AAP) and the American Medical Association (AMA). There are fewer than 25 public or hybrid cord blood banks in the U.S., many limited to a specific geographic area. None of them include Kentucky.

The chances of finding a bone marrow match in your family are only about 25%, making the bone marrow and umbilical cord blood registries a lifeline in desperate situations. Odds are worse for African Americans and other ethnic minorities who are underrepresented on the registry and ethnicity matters in a bone marrow transplant.

Donating cord blood cells to a public bank adds to the library of cells that may save someones life and increases the chance of a match for all of us. Who benefits most? Children, patients with rare human leukocyte antigen (HLA) types and ethnic minorities.

We need to do two things: Make public cord blood banking an option in the commonwealth of Kentucky, and then encourage conversations between health care providers and expectant parents about preserving these life-saving cells.

There are 28 states with legislation that ask or mandates physicians to talk to expectant parents about cord blood banking. Kentucky is not one of them, but most of our surrounding states have such legislation in place.

Through a long-standing relationship between the National Stem Cell Foundationand world-renowned cord blood expert Dr. Joanne Kurtzberg, we have a path forward for training hospitals and collecting cells for storage at the Carolinas Cord Blood Bank (CCBB), one of the largest public cord blood banks in the world. Dr. Kurtzberg directs both the Pediatric Blood and Marrow Transplant (PBMT) program at Duke University and the CCBB.

She performed the worlds first unrelated cord blood transplant in 1993, paving the way for this now routine source of donor cells for children who need a bone marrow transplant and dont have a matched donor. She established the CCBB in 1998.

Paula Grisanti is CEO of the National Stem Cell Foundation.(Photo: provided)

While weve initiated discussions between Louisville hospital systems and the CCBB, we need to begin the process of education for parents, nursing and medical school students, residents, midwives, practicing OB-GYNs and the general public.

What a waste to discard these life-saving cells the future of current and developing therapies for disabling and life-threatening diseases depends on our ability to make sure that doesnt happen.

Dr. Paula Grisanti is CEO and a founding member of the National Stem Cell Foundation, headquartered in Louisville, Kentucky. She holds a D.M.D. and MBA from the University of Louisville and has been actively involved in new venture start-ups for most of her career.

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It's time for Kentucky to talk to expectant parents about benefits of cord blood banking - Courier Journal

NEW YORK, Nov. 11, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") today announced that it will host a CD33 program update featuring two key opinion leaders (KOLs) today, November 11th at 4:15 PM ET. The event will feature KOLs Dr. Ehab Atallah from the Medical College of Wisconsin, the senior investigator of the Actimab-A CLAG-M combination trial and Dr. Gary Schiller from the University of California Los Angeles Health, the principal investigator for the Actimab-A venetoclax combination trial as well as members of Actinium's management team. Both KOL's will review data that was included in abstracts accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting. They will also provide their perspectives on the treatment landscape and medical need each trial potentially addresses.

Actimab-A AML Combinations Update Call DetailsWebcast link:https://ir.actiniumpharma.com/presentations-webinarsDate: November 11, 2020Time: 4:15 PM ET

Dr. Ehab Atallah, MD, is a Professor of Medicine and Section Head of Hematological Malignancies at the Medical College of Wisconsin Division of Hematology and Oncology, specializing in leukemia and myelodysplastic syndromes at Froedtert Hospital. Dr Atallah, as senior investigator, will review the Phase 1 data from the Actimab-A CLAG-M combination trial in relapsed or refractory acute myeloid leukemia (R/R AML) that demonstrated 100% remission in the third and planned final dose cohort. Further, 83% of patients (10/12) who received 3 or fewer prior lines of treatment achieved CR or CRi. Notably, 70% of CR/CRi patients (7/10) were MRD negative indicating a deep remission with no detectable disease. Dr. Atallah will also discuss the trial data in the context of data available for other treatment options, including recently approved and novel agents in development, in the fit R/R AML population.

Dr. Gary Schiller, MD, is the Director of Bone Marrow/Stem Cell Transplantation and Professor of Hematology-Oncology at UCLA. Dr. Schiller, a well-published clinical investigator in acute and chronic leukemias and other hematologic malignancies, is the principal investigator on the Phase 1/2 clinical trial of Actimab-A and venetoclax. Dr. Schiller will discuss the lack of viable treatment options for R/R AML and the available opportunity for combination regimens such as Actimab-A plus venetoclax. Last week, the company announced that first-in-human data in this combination trial had been accepted for poster presentation at ASH in December. The trial is in the dose escalation phase with proof of concept data expected in 2021.

CD33 Program ASH Abstract Links

Oral Presentation Title: A Phase I Study of Lintuzumab Ac225 in Combination with CLAG-M Chemotherapy in Relapsed/Refractory AMLPublication Number: 165Link: https://ash.confex.com/ash/2020/webprogram/Paper137218.html

Poster Title: Lintuzumab-225Ac in Combination with Venetoclax in Relapsed/Refractory AML: Early Results of a Phase I/II StudyPublication Number: 2875Link: https://ash.confex.com/ash/2020/webprogram/Paper141132.html

About Actinium's CD33 Program

Actinium's CD33 program is evaluating the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 or Ac-225. CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as patients with multiple myeloma. The CD33 development program is driven by data from over one hundred and twenty-five treated patients, including a Phase 1/2 trial where Actimab-A produced a remission rate as high as 69% as a single agent. This clinical data is shaping a two-pronged approach for the CD33 program, where at low doses the Company is exploring its use for therapeutic purposes in combination with other modalities and at high doses for use for targeted conditioning prior to bone marrow transplant.Actinium currently has multiple clinical trials ongoing including the Phase 1 Actimab-A CLAG-M and Phase 1/2 Actimab-A venetoclax combination trials and is exploring additional CD33 ARC combinations with other therapeutic modalities such as chemotherapy, targeted agents or immunotherapy.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:Clayton RobertsonActinium Pharmaceuticals, Inc.crobertson@actiniumpharma.com

Hans VitzthumLifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 430-7578

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Actinium to Host KOL Call on November 11th Featuring Actimab-A AML Combination Trials - Salamanca Press

Bone marrow aspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.Europe and North America spearheaded the market as of 2016, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.

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In 2016, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy.

Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others

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Bone Marrow Processing System Market Industry Outlook, Growth Prospects and Key Opportunities - The Daily Philadelphian

SAN DIEGO, Nov. 11, 2020 /PRNewswire/ -- Angiocrine Bioscience Inc., a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation for AB-205, for "the treatment of organ vascular niche injuries to prevent or reduce severe regimen-related toxicities (SRRT) in patients with Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) undergoing high-dose therapy (HDT) and autologous hematopoietic stem cell transplantation".Based on its Phase 2 trial results, Angiocrine expects to initiate a single pivotal registration Phase 3 trial in 2021 involving leading cancer centers in North America and Europe.

Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205

"The RMAT designation speaks to the clinical meaningfulness and the promising efficacy data and safety profile of AB-205 based on our Phase 1b/2 study.This is an important step in accelerating the development of AB-205 towards its first market approval," commented Paul Finnegan, MD, Angiocrine's CEO."We appreciate the thorough assessment provided by the FDA reviewers and the support from our partner, the California Institute for Regenerative Medicine."Angiocrine was awarded a $6 million grant from CIRM in 2019 for the clinical development of AB-205.

About Regenerative Medicine Advanced Therapy (RMAT) DesignationEstablished under the 21st Century Cures Act, the RMAT designation was established to facilitate development and expedite review of cell therapies and regenerative medicines intended to treat serious or life-threatening diseases or conditions. Advantages include the benefits of the FDA's Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval.

About HDT-AHCT High-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT) is considered a standard-of-care therapy for patients with aggressive systemic Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).Although efficacious and considered a potential cure, HDT-AHCT is associated with severe regimen-related toxicities (SRRT) that increase patient morbidity and risk for mortality, especially in the aging population. Effective prevention of SRRT may lead to more patients being eligible for a potential cure through HDT and stem cell transplantation.

About SRRT Consequences of Diffuse Injury to the Organ Vascular NichesThe human body is capable of renewing, healing and restoring organs.For example, the human oral-GI tract renews its lining every 3 to 7 days. Both the organ renewal and healing processes are dependent on organ stem cell vascular niches made up of stem cells, endothelial cells (cells that line blood vessels) and supportive cells.When tissues are injured, the vascular niche endothelial cells direct the stem cells, via angiocrine factor expression, to repair and restore the damaged tissue. This restorative capacity is most active during childhood and youth but starts to diminish with increasing age.HDT provided to eradicate cancer cells also cause diffuse, collateral damage to vascular niches of multiple healthy organs. In particular, the organs with the highest cell turnover (ones with most active vascular niches) are severely affected.Specifically, the oral-GI tract, dependent on constant renewal of its mucosal lining, starts to break down upon vascular niche injury.The mucosal breakdown can cause severe nausea, vomiting and diarrhea. In addition, the bacteria in the gut may escape into the circulation, resulting in patients becoming ill with endotoxemia, bacteremia or potentially lethal sepsis.HDT-related vascular niche damage can also occur in other organs resulting in severe or life-threatening complications involving the lung, heart, kidney, or the liver.Collectively, these complications are known as severe regimen-related toxicities or SRRT.SRRT can occur as frequently as 50% in lymphoma HDT-AHCT patients, with increased rate and severity in older patients.

About AB205AB-205 is a first-in-class engineered cell therapy consisting of proprietary 'universal' E-CEL (human engineered cord endothelial) cells.The AB-205 cells are intravenously administered after the completion of HDT on the same day as when the patient's own (autologous) blood stem cells are infused. AB-205 acts promptly to repair injured vascular niches of organs damaged by HDT.By repairing the vascular niches, AB-205 restores the natural process of tissue renewal, vital for organs such as oral-GI tract and the bone marrow. Successful and prompt organ restoration can prevent or reduce SRRT, an outcome that is beneficial to quality of life and cost reductive to the healthcare system.

About CIRMThe California Institute for Regenerative Medicine (CIRM) was established in November, 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for California universities and research institutions.With over 300 active stem cell programs in their portfolio, CIRM is the world's largest institution dedicated to stem cell research. For more information, visit http://www.cirm.ca.gov.

About Angiocrine Bioscience Inc.Angiocrine Bioscience is a clinical-stage biotechnology company developing a new and unique approach to treating serious medical conditions associated with the loss of the natural healing and regenerative capacity of the body.Based on its novel and proprietary E-CEL platform, Angiocrine is developing multiple therapies to address unmet medical needs in hematologic, musculoskeletal, gastrointestinal, soft-tissue, and degenerative/aging-related diseases.A Phase 3 registration trial is being planned for the intravenous formulation of AB-205 for the prevention of severe complications in lymphoma patients undergoing curative HDT-AHCT.This AB-205 indication is covered by the Orphan Drug Designation recently granted by the US FDA.In addition, Angiocrine is conducting clinical trials of local AB-205 injections for the treatment of: (1) rotator cuff tear in conjunction with arthroscopic repair; and, (2) non-healing perianal fistulas in post-radiation cancer patients.

For additional information, please contact:

Angiocrine Bioscience, Inc.John R. Jaskowiak(877) 784-8496IR@angiocrinebio.com

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Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL Cell Therapy) to...

TAIPEI, Nov. 9, 2020 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") announced today that they have signed an exclusive agreement with GPCR Therapeutics, Inc. ("GPCR"), a leading Korean biotechnology company, for the continued development of Burixafor worldwide and the commercialization of Taigexyn (nemonoxacin) in South Korea.

Burixafor is a highly potent CXCR4 inhibitor currently under clinical development. It can be used as a stem cell mobilizer for hematopoietic stem cell transplantation and a chemosensitizer in hematological and solid tumors. It can also be used for stem cell collection in healthy individuals for personalized regenerative medicine. Taigexyn is a novel safe and effective antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria.

Under the terms of the agreement, GPCR Therapeutics will be wholly responsible for the development, registration, and commercialization of Taigexyn in S. Korea and Burixafor worldwide. Apart from upfront fees, TaiGen will receive shares of GPCR Therapeutics as well as future milestone and royalty payments.

GPCR Therapeutics is a world leader in the field of GPCR heteromer science and hasproprietary expertise and technology applicable to the development of this class of anti-cancer targets. CXCR4 antagonism is a well-accepted avenue towards cancer therapy and GPCR Therapeutics is well experienced and possesses the necessary know-how to develop Burixafor in the oncology field.

Dongseung Seen, CEO of GPCR Therapeutics, said, "This collaboration with TaiGen, which is a leading biotech company engaged in innovative molecular-based platforms with strong R&D capabilities, will lead to a long-term strategic and productive partnership. Further, it is our goal that our work together will position us to be a pre-eminent developer of anti-CXCR4 oncology drugs."

Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, "This agreement and collaboration with GPCR is a tremendous progress in the continued development of Burixafor. Through the collaboration with GPCR Therapeutics, a novel and effective treatment for cancer patients possessing CXCR4 heteromers is on the horizon while a highly effective antibiotic will enter the S. Korea market to address their unmet medical needs in the near future."

About Burixafor

A stem cell mobilizer, Burixafor, is TaiGen's first fully in-house developed product, a First-in-Class drug with an IND under US FDA. With a variety of potential applications in a number of disease indications, if proven effective in clinical trials, Burixafor will be able to address several unmet medical needs. The molecule is a potent and selective chemokine receptor antagonist which can rapidly mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor also has potential application in chemosensitization treatment of leukemia patients, delaying relapse after chemotherapy.

About Taigexyn

Taigexyn is a novel non-fluorinated quinolone available in both oral and intravenous formulations. The oral formulation of Taigexyn have received market approval in Taiwan and mainland China shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. TaiGen partnered with Zhejiang Medicaine Co., Holding Distribution, R-Pharm of Russia, Productos Cientficos S.A. de C.V., Luminarie Canada Inc. and GPCR Therapeutics, Inc. in 36 countries worldwide. In addition to the oral formulation, TaiGen granted NDA approval for intravenous formulation in Taiwan and is going to obtain the market approval in mainland China.

About GPCR Therapeutics, Inc.

Based in Seoul, S. Korea, GPCR Therapeutics is a biopharmaceutical company developing drugs based on the novel science of GPCR (G Protein-Coupled Receptor) heteromers. GPCR Therapeutics is specifically focused on the development of cancer therapeutics with a precision oncology approach.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Taigexyn and Burixafor, TaiGen has two other in-house discovered NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. TG-1000 is currently in Phase 1 clinical study in China and is granted IND approval by FDA in the U.S., and Furaprevir is currently in Phase 3 clinical development.

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TaiGen Partners with GPCR to develop Burixafor & Taigexyn(R) - PRNewswire

REGINA -- Saskatchewans hockey community is mourning the loss of Rick Schwartz, who died suddenly in his Regina home on Monday evening from a heart attack at age 59.

To the public, Schwartz is known as the father of a Stanley Cup champion. His son, Jaden, is a member of the St. Louis Blues who won the cup in 2019.

Schwartz is also known for the dedication that he and his wife, Carol, have for the Mandi Schwartz Foundation. It is named after their daughter who lost a public battle to cancer in 2011. The foundation has focused on advocating for bone marrow drives and donations.

However, to those closest to Schwartz, hes being remembered as a man who put family and community before anything.

FAMILYS FIRST

Ramona and Patrick Vigneron, who are long-time close family friends of the Schwartzes, say theyll remember Ricks jokes, smile and laughter the most.

And just how much he absolutely loves his family, Ramona said. He always said familys first.

Schwartz had three children: Jaden, Rylan and Mandi.

The two families would travel together, often to watch their children play hockey. Some of their trips took them to Colorado, North Dakota, St. Louis and Germany.

With the celebrations hed always include family and friends, Ramona said.

Whether it was during the kids minor hockey days in Wilcox or watching a Stanley Cup Championship, Schwartz always provided a fun time for those around him.

One of the most entertaining things you could do is watch a hockey game with Rick with one of the kids playing, Patrick said.

It was great watching games with Ricky because he got pretty emotional as he watched the boys and Mandi play, Ramona said. It was really part of Rickys life, you could just see him come to life watching the kids play.

BONE MARROW DRIVES

In honour of Mandi, the Schwartz family launched a foundation that is often involved in bone marrow drives in hopes of helping people who need a donor find their perfect match.

Rick was determined to make sure Mandis foundation continued on with the stem cells, and match program was very important, Ramona said.

Bone marrow drives continue at Yale University, where Mandi played. The St. Louis Blues also held a drive in 2013. Four years later, an 18-year-old woman was able to find her perfect match from a man who was swabbed at that Blues game.

The Schwartz family hosted both the donor and the recipient, both from the United States, in 2019 for the annual Run for Mandi in Saskatchewan.

ATHOL MURRAY COLLEGE OF NOTRE DAME

Rick and Carols three children all attended Athol Murray College of Notre Dame in their childhood and teenage years.

They participated in multiple sports, but hockey was the biggest. Its been about a decade since any of the kids played there, but the Schwartzes have always stayed involved in the community.

The great thing about Rick was that he loves hockey, Rob Palmarin, the president of Athol Murray College of Notre Dame, said. Hed still come out to our arena and would visit with our coaches who were the coaches of his sons and daughter, and our hockey staff. He was a frequent visitor to our arena so he was just one of the family.

After Mandis passing in 2011, the Schwartz family helped to honour her at the school.

The Schwartz family has set up an endowment fund and that supports a number of our female athletes, particularly hockey players, on an annual basis, Palmarin said. That came out of the tragedy of Mandi Schwartz dying of cancer in 2011. So its been almost a decade of them working to keep her memory alive.

Palmarin said Rick and Carol were role models of parents who had children playing hockey.

One of the mottos painted in the rink at Notre Dame reads Never Lose Heart.

That motto is painted up there not only as an inspiration to our student athletes when they practice and play, but its also an inspirational motto for all of us to remember the Notre Dame Hounds family, both living and deceased, Palmarin said. Rick is now going to be part of that.

RECENT MEMORIES

Most recently, Schwartz worked with the Saskatchewan Safety Council. Patrick worked there with him for the past five years.

Weve got a couple of projects on the board right now and Im not sure where theyre going to end up, but well try to make them work for him, Patrick said.

Ramona said right now, the Schwartz family is cherishing the time they were able to spend together over the summer.

One of the blessings of COVID-19 was that Rylan came home from Germany and then Jaden came home from St. Louis and they were with their parents for literally four months, Ramona said. Carol kept repeating these last few days it has been awesome how much time Rick got to spend with his sons for the last four months.

She said the memories of playing golf and cards will long be remembered by the family.

The death is a shock. Theres a lot of people who have been affected by Ricky and just how passionate he is, Ramona said. He has a heart of gold.

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'A heart of gold': Rick Schwartz remembered for his commitment to family, community - CTV News

VANCOUVER, Washington, Nov. 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it completed an additional non-dilutive convertible debt offering with an institutional investor, which provides $25 million of immediately available capital. The note has a two-year maturity, bears interest at the rate of 10% per annum and is secured by all assets of the Company, excluding its intellectual property. The note may be converted at the option of the investor into shares of the Companys common stock at a conversion price of $10.00 per share.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very pleased with the institutions demonstration of confidence and their understanding of leronlimabs positioning on its regulatory trajectory. This infusion of capital will enable us to accelerate efforts to file BLAs in Canada and the U.K. for leronlimab as a combination therapy for HIV patients with one dose (one 350 mg subcutaneous injection) per week. We continue to expedite enrollment in CD12 (currently at 260 patients), in addition to now accelerating a COVID-19 trial for long-hauler patients, who have no alternative therapy and are rapidly emerging as a widespread health concern. We are well-positioned to supply $2 billion worth of leronlimab to treat COVID-19, if emergency use authorization is approved in the next 2-4 months based on anticipated successful CD12 results.

About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals and clinics throughout the U.S., which are identified on the Companys website under the Clinical Trial Enrollment section of the homepage; an interim analysis on the first 195 patients was conducted mid-October and is expected to occur again after enrollment reaches 293 patients.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102mmulholland@cytodyn.com

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