Spanish Nurse Outcomes, Watershed Moment in Ebola Outbreak (CMRX, NLNK, TKMR, INO, SRPT, BCRX, IBIO, HEB, GSK) |
Posted: October 20, 2014 |
On October 06, Spanish nurse Teresa Romero Ramos tested positive for Ebola virus. She became the first known person to contract Ebola outside of West Africa in this current outbreak. Teresa Romero contracted the deadly virus after she treated two missionaries who had been repatriated from West Africa. The missionaries later died from the virus. Today, Teresa Romero tested negative for the virus, according to the Spain's Special Ebola Committee. The result suggests she is no longer infected - although a second test is required before she can be declared free of Ebola. She has received two main treatments in her battle against Ebola, for which there is still no vaccine. The first was an IV drip with the antibodies of an Ebola survivor. She also received an experimental anti-viral drug, favipiravir, which is active against many RNA viruses. The drug called Avigan (generic name Favipiravir) is developed by Japan’s Fujifilm Holdings Corp’s subsidiary Toyama Chemicals. The drug inhibits replication of viral genetic material by blocking the enzyme RNA polymerase that is required for multiplication of viral particles after they infect the cells. It also has an inhibitory action against different strains of influenza virus that are currently resistant to other antiviral drugs. U.S. President Obama has appointed former White House official Ron Klain as the so-called "Ebola Czar". He will be responsible for overseeing all efforts to contain the spread of Ebola in the United States. Nina Pham, a nurse at Texas Health Presbyterian Hospital in Dallas, is the first person to ever contract Ebola from another person in the United States. She helped care for Thomas Eric Duncan, the first person ever diagnosed with Ebola in the United States. Duncan died recently. According to the National Institutes of Health (NIH), Pham’s condition is “fair.” She was transferred to NIH’s special containment unit on Thursday October 16. Amber Vinson, also a nurse who contracted Ebola while caring for Thomas Duncan at Texas Health Presbyterian Hospital Dallas, traveled by air from Cleveland to Dallas on Oct. 13, with a low-grade fever, a day before she showed up at the hospital reporting symptoms. She was transferred to Emory. The number of people quarantined in Ohio after the visit from Amber Vinson, who tested positive for Ebola, has risen from one to three. Several pharmaceutical and biotechnology companies have been enlisted in the fight against the deadly virus.
CMRX, a biopharmaceutical company, said that it has worked closely with the FDA to develop a Phase 2 clinical trial protocol to assess the safety, tolerability, and efficacy of brincidofovir in patients who are confirmed to have Ebola Virus Disease. An investigational new drug (IND) application for brincidofovir (BCV) for Ebola Virus Disease (EVD) has been authorized by the FDA. The FDA has authorized a Phase 2 protocol for CMRX's BCV for Ebola Virus Disease to begin immediately. Brincidofovir tablets are available for immediate use in clinical trials.
CMRX is a biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. More about Chimerix, Inc. (CMRX) at www.chimerix.com. *
The FDA has given permission for NLNK to proceed to Phase 1 clinical trials with their Ebola vaccine candidate. This vaccine has shown promise in both pre- and post-exposure vaccination of non-human primates exposed to lethal doses of the Ebola virus, and FDA permission allows NLNK to proceed to human clinical trials. Furthermore, Canadian health minister Rona Ambrose recently said that human testing of an experimental Ebola vaccine developed by the Canadian health agency and licensed to NLNK has begun.
NLNK is a biopharmaceutical company focused on discovering, developing and commercializing novel immuno-oncology products to improve treatment options for patients with cancer. More about NewLink Genetics Corporation (NLNK) at www.linkp.com. *
The FDA has authorized TKMR to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections. TKM-Ebola is an investigational anti-Ebola virus RNAi therapeutic, being developed under an FDA approved Investigational New Drug application, which is currently the subject of a partial clinical hold under which the FDA has allowed the potential use of TKM-Ebola in individuals with a confirmed or suspected Ebola virus infection. Expanded access is the use of an investigational drug outside of a clinical trial to treat a patient, with a serious or immediately life-threatening disease or condition, who has no comparable or satisfactory alternative treatment options.
TKMR is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle (LNP) delivery technology to pharmaceutical partners. More about Tekmira Pharmaceuticals Corp. (TKMR) at www.tekmira.com *
INO recently said that it will advance its DNA vaccine for Ebola into a phase I clinical trial. INO‘s Ebola vaccine was designed using the SynCon technology to provide broad protective antibody and T-cell responses against multiple strains of Ebola virus. INO‘s SynCon(R) technology has been the basis for immunotherapy and vaccine products which have demonstrated the ability to activate immune responses against multiple disease-specific antigens and elicit broad protection against diverse unmatched strains of pathogens in humans.
INO is revolutionizing the fight against cancer and infectious diseases. INO‘s immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. More about Inovio Pharmaceuticals, Inc. (INO) at www.inovio.com. *
SRPT reported the publication of results from two single ascending-dose studies that demonstrated no clinical or toxicologic safety concerns with the company’s drug candidates for the treatment of Ebola and Marburg virus, respectively. These drug candidates use SRPT’s advanced and proprietary PMOplus(R) chemistry, which is also the basis of the company’s clinical-stage influenza drug candidate, AVI-7100. SRPT believes these promising early clinical safety results, coupled with the strong safety and efficacy data generated from animal studies for all four PMO compounds, reinforce the use of SRPT’s PMOplus(R) chemistry platform to pursue potential treatments for deadly infectious diseases such as Ebola and Marburg
SRPT is focused on developing first-in-class RNA-based therapeutics to improve and save the lives of people affected by serious and life-threatening rare and infectious diseases. More about Sarepta Therapeutics, Inc. (SRPT) at www.sarepta.com. *
BCRX is developing BCX4430 as a treatment for hemorrhagic fever viruses, including Ebola virus and Marburg virus disease. BCRX's BCX4430 is an RNA dependent-RNA polymerase inhibitor that has demonstrated broad-spectrum activity against more than 20 RNA viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses.
BCRX designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. More about BioCryst Pharmaceuticals, Inc. (BCRX) at www.BioCryst.com. *
IBIO confirmed the applicability of its issued U.S. iBioLaunch(TM) platform patents and related proprietary technology to further development and production of antibodies that target the Ebola virus. IBIO has offered to assist the U.S. government by making its proprietary technology available for emergency use to enable the manufacture and yield optimization of certain experimental antibody-based drugs that address the current Ebola virus outbreak, to the extent such assistance is requested by the government.
IBIO owns the iBioLaunch(TM) platform, which is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. More about iBio, Inc. (IBIO) at www.ibioinc.com. *
Recently, HEB said that the Company and U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) scientists have agreed to test Alferon(R), the only multi-species, natural alpha interferon (IFN) commercially approved in the U.S. and Ampligen(R), an experimental drug, to be evaluated against the deadly Ebola virus, which has been and remains a major focus of efforts at USAMRIID, a unit of the Department of Defense responsible for medical biological defense research. HEB‘s Alferon(R) N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon(R) N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older. HEB‘s Ampligen(R), an experimental therapeutic, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation.
HEB is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. More about Hemispherx Biopharma, Inc. (HEB) at www.hemispherx.net *
GSK is working closely with the World Health Organization (WHO), regulators and other partners to respond to the outbreak, to accelerate development of the company's investigational Ebola vaccine and to ramp up production as quickly as possible. According to GSK, development of the vaccine candidate is progressing at an unprecedented rate, with first phase 1 safety trials with the vaccine candidate underway in the USA, UK and Mali, and further trials due to start in the coming weeks. Initial data from the phase 1 trials are expected by the end of the year and if successful, the next phases of the clinical trial programme will begin in early 2015 which will involve the vaccination of thousands of frontline healthcare workers in the three affected countries – Sierra Leone, Guinea and Liberia. If the vaccine candidate is able to protect these healthcare workers as GSK hopes it will, it could significantly contribute to efforts to bring this epidemic under control.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. More about GlaxoSmithKline plc (GSK) at www.gsk.com. *
CRWE is currently developing its CRWE Network ( www.CRWE-PR.com ), a growing network of website communities, which business model is based on selling advertising to businesses targeting both locally and nationally CRWE and PolarWeb Media, LLC reported a Joint Venture agreement to engage in increasing web traffic to selected websites. CRWE will receive 50% of the revenues generated by PolarWeb Media through the use of the CRWE Network, with PolarWeb Media having the remaining 50%. PolarWeb Media, LLC will focus on driving traffic and generating ad revenues. CRWE has included the City of Mount Vernon, NY ( www.mountvernon.ny.crwe-pr.com ) to the CRWE Network. The city of Mount Vernon is ideally located to provide easy access to a number of historical sites and museums. The Bronx Zoo, George Washington Bridge and the New York Botanical Garden are ideal destinations for a day trip with family and friends. With an estimated population in 2013 (U.S. Census Bureau) of approximately 68,224, represents an important marketplace for the CRWE Network, which business model is based on selling advertising to businesses targeting both locally and nationally The CRWE Network has reached the 1428th community website in the U.S., associated with 3309 ZIP Codes, and includes coverage of the greater state of California, Northern and Southern Nevada, New York State, Wellington in Florida, Hattiesburg in Mississippi and 10 provinces in Canada.
CRWE provides marketing solutions that boost customer awareness and merchant visibility on the Internet. More about Crown Equity Holdings Inc. (CRWE) at www.crownequityholdings.com ** Disclaimer: The assembled information disseminated by CRWE-PR Finance is for information purposes only, and is neither a solicitation to buy nor an offer to sell securities. Crown Equity Holdings Inc. (CRWE) will receive 50% of the revenues generated by PolarWeb Media through the use of CRWE’s sites, with PolarWeb Media having the remaining 50%. Entire Disclaimer at www.finance.crwe-pr.com/disclaimer
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Chimerix, Inc. (CMRX)
NewLink Genetics Corporation (NLNK)
Tekmira Pharmaceuticals Corp. (TKMR)
Inovio Pharmaceuticals, Inc. (INO)
Sarepta Therapeutics, Inc. (SRPT)
BioCryst Pharmaceuticals, Inc. (BCRX)
iBio, Inc. (IBIO)
Hemispherx Biopharma, Inc. (HEB)
GlaxoSmithKline plc (GSK)
Crown Equity Holdings Inc. (CRWE)
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