Stem Cell Clinic

Orgenesis Acquiring Tamir, And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha

By adminApril 15, 2020Stem Cell Treatment

Orgenesis to Acquire Tamir Biotechnology's Assets for $19 Million

Orgenesis Inc. (ORGS) reported that it has signed a deal with Tamir Biotechnology Inc., under which the former will acquire the assets of the latter, including its broad spectrum antiviral platform ranpirnase. The deal is cash- and stock-based and is expected to be worth nearly $19 million. Orgenesis plans to merge ranpirnase with its co-developed Bioxome technology for improving payload delivery direct to the cells.

Combined with ranpirnase, Bioxomes have showed the ability to fuse with cell membranes and delivering an intracellular cargo, mimicking the working of natural exosomes. Bioxomes, when loaded with predesignated genetic material, proteins, signaling molecules and drugs, copy the natural membrane fusion capacities of exosomes. This feature may help in providing more efficient antiviral results.

TamirBio is a clinical-stage company focusing on developing treatments for viruses and other pathological conditions. Its lead asset, ranpirnase, is a ribonuclease and belongs to a superfamily of enzymes which may catalyze the degradation of RNA. It may also mediate in different essential biological activities, such as the regulation of cell proliferation, differentiation, maturation and death. According to Orgenesis, this feature makes it suitable for treating viral and autoimmune diseases which require therapies with anti-proliferative and apoptotic properties.

TamirBio has used these properties for developing topical ranpirnase for treating human papillomavirus, a leading cause of genital warts. The drug candidate has been evaluated in Phase I/II clinical trial for genital warts, and the results demonstrated clear clinical effects. The company plans to hold additional clinical trials. Orgenesis CEO Vered Caplan said, In independent third-party testing, ranpirnase has shown anti-viral activity in multiple viruses. Additionally, over 1,000 patients have been dosed with ranpirnase in previous cancer/mesothelioma clinical trials. Ranpirnase demonstrated a strong safety and tolerability profile that should help accelerate the approval pathway. TamirBio claims that the drug candidate has shown preclinical antiviral activity in such viral diseases as HPV, HIV, Ebola, and SARS.

Orgenesis also provided updates about its operating activities and reported that its research & development labs are still working. In February, the company sold its subsidiary Masthercell Global Inc. to Catalent Pharma Solutions for nearly $127 million. Masthercell was a contract development manufacturing organization. Orgenesiss CGT Biotech Platform mainly consists of three core components, which are POCare Therapeutics, POCare Technologies, and POCare Network. The CGT Biotech Platform aims to decentralize the CGT supply chain.

The company also recently entered into a new joint venture with Revatis. The partnership will work towards providing autologous cell therapies with exosomes and other cellular products obtained from muscle-derived mesenchymal stem cells. The task of making the stem cells will be entrusted to Revatis, which will use its minimally invasive muscle biopsy technique and isolator technology for this purpose. Orgenesis will be responsible for providing clinical and regulatory expertise and access to its point-of-care (PoC) technology. This POCare platform provides access to a global network of hospitals and research institutes which may be used for carrying out clinical trials for developing life-saving therapies.

Teladoc Health Inc. (TDOC) stock showed solid gains as the ongoing pandemic has put a spotlight on telemedicines. The company has seen a surge in the download of its app BetterHelp, which has a virtual behavioral health offering. According to a research note released by Bank of America Global Research, the app had the download volume of nearly 1000 per day in March, which has now surged to over 1800 per day.

While telemedicine has been around for quite some time, the current scenario has led to mass acceptance of this virtual practice. Due to strict restrictions on movement and the unprecedented burden on healthcare services, telemedicine has proved to be a boon for people with non-critical ailments. Under the 1135 waiver authority and the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, the scope of telehealth facilities has been widened to include coverage for office, hospital and other visits equipped with telehealth facilities in the United States and at patients residences.

The Teladoc platform was recently deployed by Tower Health for offering virtual health care for patients suffering from different ailments. Each visit was provided at $45 and is available 24 hours a day, 7 days a week. Apart from COVID 19, some of the other prominent health issues addressed by the platform are flu symptoms, respiratory infection and rashes. Dr. Lewis Levy, chief medical officer of Teladoc, said, There is no doubt that we are seeing positive momentum and that awareness has increased. Telemedicine is now a household term.

It is estimated that the global telehealth market is expected to register 16.9 percent CAGR during the 2020-2025 forecast period. It will likely be worth $55.6 billion by 2025, up from current valuation of $25.4 billion in 2020. The low-risk and high-efficiency nature of these services are making them very popular now.

Pluristem Therapeutics Inc. (PSTI) reported that it has treated its first patient suffering from complications arising from the novel coronavirus. The patient was treated under the FDA Single Patient Expanded Access Program, and PLX cell therapy was used for this purpose. The company is now looking to initiate a multinational clinical trial at the earliest possible.

Pluristem further said that the patient was in critical condition with respiratory failure due to acute respiratory distress syndrome. The patient was in an intensive care unit with mechanical ventilation for three weeks. Single Patient Expanded Access Program is also known as a compassionate use program and is a part of the US Coronavirus Treatment Acceleration Program. The program is mainly aimed at accelerating the development of new therapies for dealing with this disease.

Pluristem focuses on using PLX cell treatment regimen. These cells are available off the shelf and may be manufactured in bulk quantities. Pluristem CEO and President Yaky Yanay said, We are receiving many inquiries and requests for treatment from healthcare providers and families worldwide. In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries. PLX cells are allogeneic mesenchymal-like cells and demonstrate immunomodulatory properties.

Pluristem Therapeutics is mainly invested in developing regenerative medicines and placenta-based cell therapy products. The company has solid development pipeline and has several products in late-stage clinical trials. PLX cell drug candidates are expected to work by releasing different therapeutic proteins in response to radiation damage, inflammation, muscle trauma and ischemia. Pluristem also owns and manages a GMP certified research and manufacturing facility.

Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts work to be ahead of the curve.

That means that when the catalyst comes that will make or break a stock, weve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Orgenesis Acquiring Tamir, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha

Clinical Research Forum to Host Virtual Top Ten Clinical Research Achievement Awards – Business Wire

By adminApril 15, 2020Stem Cell Treatment

WASHINGTON--(BUSINESS WIRE)--The Clinical Research Forum (CR Forum), along with the Clinical Research Foundation, has announced it will broadcast its annual Top Ten Clinical Research Achievement Awards ceremony virtually this year, and will be available to view on Wednesday, April 15 at 11 a.m. Eastern Time. Participants may register for the event by contacting admin@clinicalresearchforum.org.

The Top Ten Clinical Research Achievement Awards support clinical researchers and advocates in their important and difficult mission of researching and delivering new treatments for ailments across the globe. By recognizing outstanding achievement in clinical trials and highlighting the best success stories in clinical research, the awards draw attention to the importance of and our national investment in clinical research. The virtual nature of this years event, a result of the current Coronavirus (COVID-19) outbreak, further illustrates how essential clinical research is for public health.

These awards highlight ten studies that demonstrate a vital impact on patient care. Submissions for the Top Ten Awards program come from United States-based academic, medical, and/or health centers and include research that crosses multiple disciplines of medicine.

The published clinical research was evaluated by CR Forum leadership, led by Board Chair Dr. Harry Selker, Vice Chair Dr. Herbert Pardes, and Top Ten Clinical Research Achievement Awards Program Chair Dr. E. Albert Reece, along with the entire CR Forum Board. Each study considered for an award this year contained high-caliber research and shows promise of providing much needed relief for patients suffering from disease.

The CR Forum is pleased to announce the following recipients of the Top Ten Clinical Research Achievement Awards:

Three of the studies will receive recognition and cash awards in addition to recognition as one of the Top Ten Clinical Research Achievements Award for 2020.

Research and delivery of new treatments takes years to achieve. This vital work depends on funding from multiple sources, including the National Institutes of Health (NIH), pharmaceutical companies, foundations, patient advocacy organizations, and other sources. CR Forum recognizes that clinical researchers need encouragement, recognition, and continued funding to carry out the needed work to improve treatment for patients across the globe. Global investment in clinical research has paid dividends for patients world-wide.

Past award winning studies include:

For more information, please visit our website at http://www.clinicalresearchforum.org/2020Top10Awards.

About the Clinical Research Forum

The mission of the Clinical Research Forum is to provide leadership to the national and clinical translational research enterprise and promote understanding and support for clinical research and its impact on health and healthcare. For more information, visit http://www.clinicalresearchforum.org.

Stem cell therapies slowly gain traction as viable treatments for brain disorders – Science Magazine

By adminApril 15, 2020Stem Cell Medicine

Jack PriceMIT Press2020288 pp.Purchase this item now

In the late 19th century, the Spanish neuroanatomist Santiago Ramn y Cajal documented, in exquisite detail, the fantastical, uncharted landscapes of the human brain. The ornate cellular structures he drew were, according to Cajal, fragile and irreplaceable. Brain cells, he stated, may die and cannot be regenerated. Cajal then threw down the gauntlet, asserting that it was the job of the science of the future to change, if possible, this harsh decree.

Jack Prices engaging bookThe Future of Brain Repairdetails past, present, and future attempts to address Cajals formidable challenge. In so doing, it provides a vibrant and compelling guide to the important and rapidly evolving fields of stem cellbased therapies and brain repair, which together, he believes, are poised to deliver unprecedented changes to the management of brain diseases.

Unlike the diverse blood cells generated throughout life by specialized stem cells in bone marrow, the two known brain stem cell typestucked into the underside of the dentate gyrus of the hippocampus and surrounding the ventricles of the forebrain in the subependymal zonedifferentiate into a much more restricted set of cells. This intrinsic lack of versatility, coupled with the fact that brain cells are postmitotic and consequently unable to divide, underlies the brains inability to efficiently repair itself.

Two broad strategies for repair are suggested. The first would be to bypass endogenous neural stem cells by introducing non-native brain cells. The second would be to coax native cells into a different set of behaviors.

Parkinsons disease, a progressive movement disorder caused by the incremental destruction of dopaminergic neurons, has provided a fertile testing ground for the first strategy. The first human neural transplantation experiments conducted during the 1980s, which used dopamine-producing cells from human fetal brain cells or from patients own adrenal medullas, failed to meet expectations. It appeared as if not any old cells would do. Although a proof of concept for the feasibility of such approaches was provided, a more precisely defined and renewable source of donor cells was lacking, as was an accompanying robust and affordable commercial-scale manufacturing process.

In the 1990s, researchers showed that neural progenitor cells could be cultured as neurospheresballs of cells that maintain self-replication and multipotency over protracted durations. This discovery led, in 2006, to the first human neural stem cell transplant in a group of children with Batten disease, a rare neurodegenerative disorder. The results, again, were disappointing: the overall survival of treated patients showed no discernible improvement over that of untreated patients. Similar studies in patients with ischemic stroke have proved more promising, but researchers suspect improvements in these cases resulted from the grafts secretion of neuroprotective proteins rather than from cell replacement.

Two other innovations, however, have the potential to address Cajals regenerative vision. The first is our ability to culture embryonic stem cells (ES cells) to produce billions of pluripotent stem cells, which are, in turn, capable of producing every cell type in the human body. Therapies derived from ES cells have been shown to be highly effective in animal models of Parkinsons disease, with evidence suggesting that the transplanted neurons exert their effect by synthesizing dopamine.

The second innovation issues from the work of Shinya Yamanaka, who demonstrated in 2006 that terminally differentiated cells of any type can be reprogrammed into induced pluripotent stem cells (iPSCs) through the administration of just four transcription factors. iPSCs may then be converted into select cell types using different transcription factor cocktails.

Although not without complicationsextended culture of iPSCs has been shown, for example, to result in mutations in P53 and other oncogenesES cells and iPSCs have the potential to transform the science of brain repair and regenerative medicine by enabling the generation and therapeutic deployment of relevant neuronal subtypes in a scalable and low-cost manner. These cells have the additional advantage of retaining the capacity to build new tissues from scratch.

Perhaps most interesting, however, is the recent convergence of pluripotent stem cells with gene editing. Together, these technologies offer the possibility of augmenting natural neural stem cell behavior.

ACKNOWLEDGMENTSThe reviewer is a shareholder of Sangamo Therapeutics.

The reviewer is the executive vice president of research and development at Sangamo Therapeutics, Brisbane, CA, USA.

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Stem cell therapies slowly gain traction as viable treatments for brain disorders - Science Magazine

CareDx Introduces AlloCell: Cell Therapy SurveillanceCareDx Announces Collaborations to Develop Cellular Therapy Diagnostics – BioSpace

By adminApril 15, 2020Stem Cell Medicine

SOUTH SAN FRANCISCO, Calif., April 14, 2020 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, announced today a biopharma research partnership for AlloCell. AlloCell is a surveillance solution for patients who have received engineered-cell transplants for allogeneic cell therapy.

Allogeneic cell therapy is a rapidly growing area of clinical development with research underway for applications in oncology, cardiovascular, neurological, autoimmune, and infectious disease. In oncology, initial CAR T-cell therapies were created by genetically modifying a patients own immune cells to target specific cancer cells before transplanting them back into the patient. With allogeneic therapies, the CAR T-cells are manufactured from cells of healthy donors for off-the-shelf use in patients, simplifying the manufacturing process, and reducing patients wait time from diagnosis to treatment.

CareDx has over 20 years of expertise in transplant monitoring, enabling the development of AlloCell to monitor allogeneic cell therapies in partnership with cellular therapy companies.

Allogeneic CAR-T is the next stage of immuno-oncology therapy, and we expect it to have a transformative impact on our patients with an increasing range of indications, said Stefan Ciurea, MD, Associate Professor in the Department of Stem Cell Transplantation and Cellular Therapy from The University of Texas MD Anderson Cancer Center. However, with many different cell therapy constructs expected and variability in patients responses to therapy, there is a significant need for a standardized diagnostic measurement of cellular kinetics and persistence to help personalize treatment. AlloCell has the potential to have significant clinical utility to help manage these allogeneic cell therapy patients.

With the goal of improving transplant patient outcomes at the core of what we do, we are glad to begin cellular therapy collaborations to help patients with life-saving immune cell transplants, said Peter Maag, CEO of CareDx.

About CareDxCareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: http://www.CareDx.com.

CONTACTS:

CareDx, Inc.Sasha KingChief Marketing Officer415-287-2393sking@caredx.com

Investor RelationsGreg Chodaczek347-620-7010investor@caredx.com

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CareDx Introduces AlloCell: Cell Therapy SurveillanceCareDx Announces Collaborations to Develop Cellular Therapy Diagnostics - BioSpace

NantKwest and ImmunityBio Announce Therapeutics and Vaccines for Combatting COVID-19; Clinical Trials Anticipated to Begin This Quarter – BioSpace

By adminApril 15, 2020Stem Cell Medicine

EL SEGUNDO, Calif.--(BUSINESS WIRE)-- NantKwest, Inc. (NASDAQ: NK) and ImmunityBio, Inc., clinical-stage immunotherapy companies within the NantWorks family of companies, today announced they are in active discussions with the U.S. Food and Drug Administration (FDA) for vaccines and therapeutics to combat COVID-19.

Leveraging ImmunityBios expertise in vaccine development and natural killer cell activation, with a broad platform of immunomodulators currently in clinical trials for cancer and infectious diseases, and NantKwests extensive experience in off-the-shelf, cell-based therapeutics, the companies are combining their resources to design and develop therapeutics and vaccines for COVID-19.

Were in a race against time, but I am confident that, as a result of the incredible hard work the NantKwest, ImmunityBio, and the global scientific communities are undertaking, we will find effective therapeutics and vaccines against this coronavirus, said Patrick Soon-Shiong, M.D., Chairman & CEO of NantKwest and ImmunityBio.

Therapeutics:

The biological, immunological, and physiological status of the patients medical state should inform the treatment strategy to reverse the infectivity and tissue damage caused by this virus. ImmunityBio and NantKwest have developed immunomodulator regimens for COVID-19 based on the biological stage of the patients infection - from the mild, moderate to the severe or critically ill state.

In the mild-to-moderate stage of infection, we believe that the patients infection and viral load could be mitigated with natural killer (NK) and T cell stimulation. Hence, in this early-moderate stage of the disease, we are proposing clinical trials of N-803 alone, and a second trial of haNK alone, or haNK combined with convalescent plasma, said Dr. Soon-Shiong.

Investigational New Drug (IND) applications with the FDA for these trials are pending. ImmunityBios Il-15 superagonist N-803 is currently being used in clinical trials for other indications and has achieved Breakthrough Therapy Designation from the FDA[1] for the treatment of BCG-unresponsive non-muscle invasive bladder carcinoma in situ (NMIBC-CIS) patients. It has also demonstrated encouraging results in lowering the viral load in SHIV-infected monkeys[2], as announced last month at the Annual Conference on Retroviruses and Opportunistic Infections (CROI)[3].

In patients requiring ventilatory support in the severe state of COVID-19 disease, we are exploring the use of bone marrow-derived allogenic mesenchymal stem cells (BM-Allo-MSC) to mitigate the cytopathic storm, said Dr. Soon-Shiong.

NantKwest has proprietary isolation and expansion methods for growing MSCs and is using ImmunityBios automated, closed system (GMP-in-a-Box) to safely and rapidly grow these stem cells from a bone marrow cell bank in approximately 7-9 days. NantKwest has filed an IND with the FDA and anticipates beginning trials in Q2 2020.

Vaccines: Developing a platform for both initial immunizations and subsequent booster injections

First generation Adenovirus platforms (Ad5) currently in use are disadvantaged by inducing adenovirus neutralizing antibodies, thus limiting multiple doses and reducing the immune response to the antigen of interest. ImmunityBio has overcome this obstacle through the development of a second generation Ad5 platform. Through multiple deletions in the adenovirus genome, this next generation platform establishes a vector that is immunologically quiet as it relates to adenovirus protein production in the host dendritic cell and enables this same Ad5 vector to serve both as a prime and a boost treatment, even in patients with pre-existing adenovirus immunity. This second-generation Ad5 [E1-, E2b-, E3- deleted] platform has demonstrated safety in Phase I and Phase II studies in immunosuppressed cancer patients.

Furthermore ImmunityBio has extensive infectious disease experience with this second generation Ad5 platform and has published several peer-reviewed articles on studies demonstrating humoral and cell mediated immunity in H1N1 Influenza[4], HIV[5], SIV[6], Lassa Fever[7], Chikungunya, and Zika virus infections.

While development of therapies is urgently needed in this crisis, as urgent is the need to develop a vaccine with long-lasting cell-mediated immunity. Developing vaccines in the time of pandemics requires novel approaches and the use of modernized genomics, molecular dynamics, and vectors that are proven to induce cell-mediated immunity, with mass scale production capabilities. In 2009, with the H1N1 crisis, the scientific team developing this second generation Ad5 platform demonstrated that such a vaccine for the H1N1 pandemic could be developed in six weeks from identification of the H1N1 sequence. This experience in 2009 allows ImmunityBio to respond as rapidly as possible to the COVID-19 pandemic, continued Dr. Soon-Shiong. I view the spike (S) protein and the nucleocapsid (N) protein as the equivalent of a neoantigen in cancer. A recent study by the National Cancer Institute (NCI) in patients with advanced cancer, published in The Oncologist[8] reported positive evidence that this platform could induce antigen-specific T cell immunity, even in the face of previous adenoviral immunity, said Dr. Soon-Shiong. Together with our scientific collaborators at the NCI, we have recently published evidence[9] that the Ad5 platform can successfully induce cell-mediated immunity following the administration of Ad5-Neoantigens, with total remission of the tumor in pre-clinical models. Based on these findings, we are hopeful that the Ad platform could induce a similar immune response to this novel Coronavirus antigen.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cellsas well as their activity against a broad range of cancershas been tested in phase I clinical trials in Canada and Europe, as well as in multiple phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwests NK cells as well as other therapeutics as part of the NANT Cancer Vaccine platform as a cancer treatment.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Annual Report on Form 10-K for the year ended December 31, 2019. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

About ImmunityBio

ImmunityBio, Inc. is a privately-held immunotherapy company with a broad portfolio of biological molecules at clinical stages of development. The companys goals are to employ this portfolio to activate endogenous natural killer and CD8+ T cells in the fields of cancer and infectious disease. Specifically, ImmunityBios goal is to develop a memory T-cell cancer vaccine to combat multiple tumor typeswithout the use of high-dose chemotherapy. Regarding infectious disease, ImmunityBio is addressing HIV, influenza, and the coronavirus.

ImmunityBios first-in-human platform of technologies has enabled it to achieve one of the most comprehensive, late-stage clinical pipelines, activating both the innate (natural killer cell) and adaptive immune systems. The product pipeline includes an albumin-linked chemotherapeutic (Aldoxorubicin), a novel IL-15 cytokine superagonist (N-803), checkpoint inhibitors, macrophage polarizing peptides, bi-specific fusion proteins targeting TGFb and IL-12, adenovirus, and yeast vaccine therapies targeting tumor-associated antigens and neoepitopes.

In December 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to N-803 for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). Other indications currently at registration-stage trials include BCG-unresponsive papillary bladder cancer, first- and second-line lung cancer, and metastatic pancreatic cancer.

ImmunityBios goal is to develop therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that ImmunityBio will be successful in improving the treatment of various diseases, including, but not limited to the novel coronavirus and cancer. Risks and uncertainties related to this endeavor include, but are not limited to, the companys beliefs regarding the success, cost and timing of its development activities and clinical trials.

[1]: ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in NMIBC December 4, 2019 https://www.businesswire.com/news/home/20191204005300/en/ImmunityBio-Granted-FDA-Breakthrough-Therapy-Designation-N-803

[2]: ImmunityBio Announces Durable Virus Control of SHIV Without Anti-Retroviral Therapy (ART) by Activating NK and Memorty T Cells with N-803, an IL-15 Superagonist March 10, 2020 https://immunitybio.com/immunitybio-announces-durable-virus-control-of-shiv-without-anti-retroviral-therapy-by-activating-nk-and-memory-t-cells-with-n-803-an-il-15-superagonist/

[3]: Combination IL-15 Therapy in a SHIV NHP Model Presented at Conference on Retroviruses and Opportunistic Infections (CROI) March 8-11, 2020 Boston, Massachusetts http://www.croiconference.org/sessions/combination-il-15-therapy-shiv-nhp-model

[4]: Prevention of Influenza Virus Shedding and Protection from Lethal H1N1 Challenge Using a Consensus 2009 H1N1 HA and NA Adenovirus Vector Vaccine. Vaccine. 2011 Sep 16; 29(40): 70207026. Published 2011 Aug 5. doi: 10.1016/j.vaccine.2011.07.073

[5]: Induction and Comparison of SIV Immunity in Ad5 Nave and Ad5 Immne Non-Human Primates Using an Ad5 [E1-, E2b-] Based Vaccine. Vaccine. 2011 Oct 19;29(45):8101-7. doi: 10.1016/j.vaccine.2011.08.038. Epub 2011 Aug 22.

[6]: Control of SIV Infection and Subsequent Induction of Pandemic H1N1 Immunity in Rhesus Macaques Using an Ad5 [E1-, E2b-] Vector Platform.Vaccine. 2012 Nov 26; 30(50): 72657270. Published 2012 Oct 2. doi: 10.1016/j.vaccine.2012.09.058

[7]: Adenoviral Vector-Based Vaccine is Fully Protective Against Lethal Lassa Fever Vhallenge in Hartley Guinea Pigs. Vaccine..2019 Oct 23;37(45):6824-6831. doi: 10.1016/j.vaccine.2019.09.030. Epub 2019 Sep 24.

[8]: A Phase I Trial Using a Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury)Based Immunotherapy Vaccine Regimen in Patients with Advanced Cancer. The Oncol. doi:10.1634/theoncologist.2019-0608

[9]: Efficient Tumor Clearance and Diversified Immunity Through Neoepitope Vaccines and Combinatorial Immunotherapy. Cancer Immunology Research July 2019 DOI: 10.1158/2326-6066.CIR-18-0620

View source version on businesswire.com: https://www.businesswire.com/news/home/20200414005353/en/

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NantKwest and ImmunityBio Announce Therapeutics and Vaccines for Combatting COVID-19; Clinical Trials Anticipated to Begin This Quarter - BioSpace

Leading Urology KOLs Host Live Webinar Entitled The Protect PNS for OAB: A Wireless Uro-Stimulation Injectable Technology on April 29 at 5pm ET -…

By adminApril 15, 2020Stem Cell Medicine

Featuring Office Based Neuromodulation Solutions from Micron Medical

BOCA RATON, Fla., April 14, 2020 (GLOBE NEWSWIRE) -- Micron Medical, a privately-held medical device company engaged in the development, manufacture and pre-commercialization of innovative wireless, injectable electroceutical device solutions for urological conditions, today announced that it will host a webinar entitled The Protect PNS for OAB: A Wireless Uro-Stimulation Injectable Technology, on Wednesday, April 29, 2020 at 5pm Eastern Time.

Stephen Deitsch, CEO of Micron Medical, will join Larry Sirls, MD, and Ken Peters, MD, both from Beaumont Health, to discuss Micron Medical's wireless uro-stimulation injectable technology and the current treatment landscape and unmet medical need to treat patients with over-active bladder syndrome (OAB).

The Protect PNS for OAB is an investigational device based on wireless neuromodulation technology and is implanted using a minimally invasive procedure percutaneously through a needle. This technology includes a small injectable device, called a stimulator, and an external transmitter for power that is a fabric antenna placed in clothing. The Protect PNS provides therapy for the relief of OAB symptoms by delivering small controlled electrical pulses to the tibial nerve that travel to the sacral nerve plexus, the group of nerves near the pelvis that control bladder function.

Larry Sirls, MD graduated from the University of Michigan Medical School and completed urology residency training at Henry Ford Hospital. He completed specialty fellowship training in Male and Female Pelvic Reconstructive Surgery, Urodynamics, Female Urology, and Neurourology at Kaiser Permanente Medical Center in Los Angeles. He returned to Detroit in 1993 and has practiced exclusively at Beaumont Hospital Royal Oak since 1996. Dr. Sirls is the Director of Female Pelvic Medicine and Reconstructive Surgery at Beaumont Hospital Royal Oak, is a Professor at the Oakland University William Beaumont Medical School and is the Primary Investigator for the Beaumont Site of the National Institutes of Health Urinary Incontinence Treatment Network, one of only 9 centers in the country selected to perform research on treatment options for urinary incontinence. His areas of interest include reconstructive urology, male and female incontinence and voiding difficulty. He is widely published and is a national thought leader in the evaluation and treatment of male and female pelvic floor disorders. He travels to Sub-Saharan Africa yearly to perform complicated fistula and other reconstructive procedures.

Kenneth Peters, MD, is Chair of Urology at Beaumont Health System in Royal Oak, Michigan, and Medical Director of the Beaumont Womens Urology Center in Royal Oak, a unique multidisciplinary center dedicated to women with chronic pelvic pain and voiding dysfunction. Dr. Peters is also Professor and Chair of Urology at the Oakland University William Beaumont School of Medicine in Rochester, Michigan. He graduated with honors from the University of Michigan in Ann Arbor and earned his medical degree from Case Western Reserve University School of Medicine in Cleveland, Ohio. Dr. Peters subsequently completed his training in surgery and urology at William Beaumont Hospital, where he also completed a fellowship in female urology and urodynamics. A specialist in the treatment of voiding dysfunction and female urology, Dr. Peters is a well-respected clinician, educator, and researcher. He is internationally known for his work on interstitial cystitis, neuromodulation for voiding dysfunction, nerve rerouting surgery to restore voiding in patients with spina bifida, and adult human stem cell injection for stress urinary incontinence. He has published over 100 peer-reviewed articles and book chapters. He has twice won the Society for Urodynamics and Female Urology (SUFU) clinical research award. An active member of many professional organizations, Dr. Peters has served on the Research Council of the American Urological Association. At the 2012 annual meeting of the International Pelvic Pain Society, he was a keynote speaker on the management of chronic pelvic pain. He maintains a private practice in Royal Oak.

About Micron MedicalMicron Medical is a privately held medical device company engaged in the development, manufacture, and pre-commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with convenient, safe, minimally invasive, and highly cost-effective urological solutions that are easily incorporated into their daily lives. Microns goal is to evolve its patented, cutting-edge platform for neuromodulation to standard of care, increasing the accessibility for patients worldwide while lowering the economic impact of urology care management. http://www.micronmed.com

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Leading Urology KOLs Host Live Webinar Entitled The Protect PNS for OAB: A Wireless Uro-Stimulation Injectable Technology on April 29 at 5pm ET -...

Young-onset Parkinson’s may start in the womb – Health24

By adminApril 15, 2020Stem Cell Medicine

People who develop Parkinson's disease at a younger age (before age 50) may have malfunctioning brain cells at birth, according to a study that also identified a drug that may help these patients.

At least 500 000 people in the United States are diagnosed with Parkinson's each year. Most are 60 or older at diagnosis, but about 10% are between 21 and 50.

Parkinson's is a neurological disease that occurs when brain neurons that make dopamine become impaired or die. Dopamine helps coordinate muscle movement.

Symptoms get worse over time and include slow gait, rigidity, tremors and loss of balance. There is currently no cure.

"Young-onset Parkinson's is especially heart-breaking because it strikes people at the prime of life," said study co-author Dr Michele Tagliati, director of the Movement Disorders Program at Cedars-Sinai Medical Center in Los Angeles.

"This exciting new research provides hope that one day we may be able to detect and take early action to prevent this disease in at-risk individuals," he said in a hospital news release.

For the study, Tagliati and colleagues generated special stem cells from the cells of patients with young-onset Parkinson's disease. These stem cells can produce any cell type of the human body. Researchers used them to produce dopamine neurons from each patient and analysed those neurons in the lab.

The dopamine neurons showed two key abnormalities: build-up of a protein called alpha-synuclein, which occurs in most forms of Parkinson's disease; and malfunctioning lysosomes, structures that act as "trash cans" for the cell to break down and dispose of proteins. This malfunction could result in a build-up of alpha-synuclein, the researchers said.

"Our technique gave us a window back in time to see how well the dopamine neurons might have functioned from the very start of a patient's life," said senior author Clive Svendsen, director of the Cedars Sinai Board of Governors Regenerative Medicine Institute.

"What we are seeing using this new model are the very first signs of young-onset Parkinson's," Svendsen said in the release. "It appears that dopamine neurons in these individuals may continue to mishandle alpha-synuclein over a period of 20 or 30 years, causing Parkinson's symptoms to emerge."

The study was published in the journal Nature Medicine.

The researchers also tested drugs that might reverse the neuron abnormalities. A drug called PEP005 already approved by the US Food and Drug Administration for treating pre-cancers of the skin reduced elevated levels of alpha-synuclein both in mice and in dopamine neurons in the lab.

The investigators plan to determine how PEP005, which is available in gel form, might be delivered to the brain to potentially treat or prevent young-onset Parkinson's.

They also want to find out whether the abnormalities in neurons of young-onset Parkinson's patients also exist in other forms of Parkinson's.

Horizon Research Fellow job with UNIVERSITY OF LEEDS | 203439 – Times Higher Education (THE)

By adminApril 15, 2020Stem Cell Medicine

Would you like to be involved in cutting edge research to develop novel solutions for smart resorbable bone implants for controllable and fast bone restoration, and to testa new generation acellular scaffold with bone-like architecture? Are you interested in acquiring and/or developing your skills to develop new tissue engineering solutions for in vitro reprogramming of adult stem cells for embedding into the smart implant?

Applications are invited for a Postdoctoral Fellow position working with Prof Peter Giannoudis and Dr Elena Jones on the Horizion 2020project SBR Smart Resorbable Bone and a small industry funded project Greenbone. Based on the St. James Campus, you will co-ordinate projects related to several SBR Work Packages (WPs).

More specifically you will be working on the WPs 6 with the aims to:

You will also be responsible for delivering Greenbone project to assess the biological support that GreenBone scaffold can provide for MSCs and endothelial cells.

Reporting to Dr Jones, your work will be carried out in collaboration with consortium members based in Patras, Greece and Munich, Germany.

Capitalising on the infrastructure and samples collected through the Leeds Institute of Rheumatic and Musculoskeletal medicine based across St Jamess University Hospital and LGI, you will generate primary MSC cells to be used by other consortium partners. You will develop and validate assays to assess the behaviour of MSCs on electrospun biocompatible scaffolds, as well as optimise the MSCs uptake of several bioactive DDRs. In collaboration with partners in Greece and Germany, you will also develop and validate assays for the assessment of MSC functionality on bioactive implants. In Greenbone project, you will be testing the attachment and growth of human bone marrow cells onGreenBone scaffold, as well as the endothelial cell-MSC interactions on the scaffold surface.

The post holder will also liaise with the research group, specifically dedicated to this project, and based in the School of Chemical and Process Engineering, as required.

To explore the post further or for any enquiries you may have, please contact:

Dr Elena Jones, Associate Professor (Non-Clinical)

Tel: +44 (0)113 2065647; email:e.jones@leeds.ac.uk

Professor Peter Giannoudis, Professor of Orthopaedic Surgery

Tel + 44 (0) 113 0113-20-67068; email:P.Giannoudis@leeds.ac.uk.

Further Information

The University of Leeds is committed to providing equal opportunities for all and offers a range offamily friendly policies. The University is a charter member of Athena SWAN and holds the Bronzeaward. The School of Medicine holds theGoldaward. We are committed to being an inclusive medical school that values all staff, and we are happy to consider job share applications and requests for flexible working arrangements from our employees.

Location:Leeds - St James University HospitalFaculty/Service:Faculty of Medicine & HealthSchool/Institute:Leeds Institute of Rheumatic & Musculoskeletal Medicine (LIRMM)Section:Section of Experimental RheumatologyCategory:ResearchGrade:Grade 7Salary:33,797 to 40,322 p.a.Working Time:100% FTEPost Type:Full TimeContractType:Fixed Term (Available immediately on a fixed term basis for 27 months or until 31 December 2023 (wichever is sooner))ClosingDate:Tuesday 21 April 2020Reference:MHLRM1130Downloads:CandidateBrief

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Horizon Research Fellow job with UNIVERSITY OF LEEDS | 203439 - Times Higher Education (THE)

Predictive Submits Emergency Use Authorization Application for Treatment of Acute Respiratory Distress Syndrome Secondary to COVID -19 with Umbilical…

By adminApril 13, 2020Stem Cell Treatment

SALT LAKE CITY, April 13, 2020 (GLOBE NEWSWIRE) -- Predictive Biology, a wholly owned subsidiary of Predictive Technology Group (OTC PINK: PRED) (Predictive or The Company), announced that on April 9th it submitted an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the immediate use of mesenchymal stem cells (MSCs) derived from umbilical cord tissue for the treatment of Acute Respiratory Distress Syndrome (ARDS), secondary to SARS-CoV-2, coronavirus disease 2019 (COVID-19).

The pandemic caused by COVID-19 has shown to develop into severe ARDS in 30% of hospitalized patients with a 22%-62% mortality rate (Murthy et al., 2020) for those requiring hospitalization in an intensive care unit. Currently, there is no confirmed treatment that can demonstrate safety or efficacy for the treatment of COVID-19.

Coronavirus can be deadly, in large part because the virus can cause cytokine storms in which the patients own immune system triggers a runaway response causing more damage to the patient, than to the virus it's trying to eliminate, said John Sorrentino, Chairman of Predictive Technology Group. Respiratory distress kills hundreds of thousands of people each year worldwide. There is clinical data from early clinical trials that seem to indicate that the avoidance of the cytokine storm utilizing MSCs may be a critical component for the treatment of COVID-19 infected patients.

A recent review article published in Pain Physician, concluded that, The limited but emerging evidence regarding UC MSC [umbilical cord mesenchymal stem cells] in managing COVID-19 suggests that it might be considered for compassionate use in critically ill patients to reduce morbidity and mortality in the United States.

The proposed IND clinical trial will utilize Predictives proprietary core technology of naturally occurring MSCs derived from umbilical cord tissue (UC-MSCs) to assess the efficacy as an add-on therapy to standard treatment of patients with severe Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19.

Predictives UC MSC product, CoreCyte, [currently regulated by the FDA as a tissue-based product under 21 CFR 1271.3(d)(1) and Section 361 of the Public Health Service Act] has already beenused as an allograft in over50,000 patients. Physicians have reported to Predictive that over 1,100 patients have been treated with CoreCyte via intravenous administration. No serious adverse events have been reported with CoreCyte regardless of the route of administration. If Predictives EUA request is approved, CoreCyte would be available immediately to critically ill patients with ARDS due to COVID-19 infections.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize and personalize precision patient care. The Companys entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests and companion therapeutics in order to support a patient from diagnosis through treatment.

Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictives tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit http://www.predtechgroup.com

About Predictive Biotech, Inc.

Predictive Biotech is a leader in regenerative medicine, its products are derived from tissue sources rich in properties that support the bodys natural ability to heal itself. All products are safely, ethically and minimally processed to deliver allografts that preserve the naturally occurring characteristics and factors of the donor tissue. Predictives signature products are uniquely born from the Whartons jelly layer of the umbilical cord and amniotic fluid and tissue.

With over 100,000 units delivered, product safety and consistency has been realized by thousands of practices throughout the United States. A national network of clinics, health systems, researchers and physicians leverage Predictives four proprietary products: AmnioCyte, AmnioCyte Plus, PolyCyte, and CoreCyte.

Forward-Looking Statements:

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks The Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect The Company's current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect The Company's business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by The Company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Predictive BiotechInfo@predictivebiotech.com888-407-9761

Investor ContactJeremy FefferLifeSci Advisorsjeremy@lifesciadvisors.com212-915-2568

The rest is here:
Predictive Submits Emergency Use Authorization Application for Treatment of Acute Respiratory Distress Syndrome Secondary to COVID -19 with Umbilical...

Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3…

By adminApril 13, 2020Stem Cell Treatment

More than 25 EINDs approved by FDA for leronlimab use in COVID-19 patients

Phase 2 trial - As of last week, 12 patients enrolled from 2 sites; 3 more sites to initiate enrollment this week, for a total of 5 sites

Phase 2b/3 trial - First hospital cleared to enroll patients beginning today

VANCOUVER, Washington, April 13, 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 a comprehensive update and overview of the therapeutic indications from over 30 COVID-19 patients recently treated with leronlimab in over 4 hospitals and clinics throughout the country. More than 25 hospitals, to date, have requested participation in the Companys trials.

Patient enrollment in the Companys two clinical trials and Emergency Investigational New Drug (EIND) is as follows:

-- More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA). -- Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen. -- As of last week, 12 patients have been treated in the Phase 2 trial for mild-to-moderate COVID-19 indications and, because it is a double-blinded, placebo-controlled trial, results are not yet available. -- First site cleared to enroll patients in Phase 2b/3 beginning today.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients and we are in regular contact with the FDA to ensure they receive current patient data. We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as 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, including meeting 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. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting 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 with no reported drug-related serious adverse events (SAEs). 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 five 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 Statements This 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. The Companys 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 Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys 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 Companys 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 Companys 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.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com