iBio to Receive US Patent for Influenza Therapeutic; BrainStorm Reports Closing of Enrollment of NurOwn Print E-mail
By William Kent   
Tuesday, 11 August 2015 18:32
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 11, 2015.
iBio, Inc. (NYSE MKT: IBIO), a leader in plant-based biotechnology for developing and manufacturing biopharmaceutical products, received notice that its application for a U.S. patent for a monoclonal antibody targeting influenza is scheduled to result in issuance of a new patent on August 26.
   
The patent, US 9,155,201 entitled "Human Neuraminidase Antibody and Methods of Use Thereof," includes claims for a method for treating influenza infection using a monoclonal antibody against the influenza neuraminidase protein. Neuraminidase is an influenza protein that is essential for viral replication and release from cells. Antibodies based on this invention are potential therapeutic agents against highly pathogenic H5N1 influenza, including strains resistant to drugs such as oseltamivir (marketed as Tamiflu®), and have blocked the replication of multiple influenza strains, including drug-resistant isolates. These and other anti-influenza antibodies have been produced using iBio's proprietary iBioLaunch™ technology, and have demonstrated safety and therapeutic efficacy in highly predictive animal models infected with a variety of influenza types.
   
"The antibody covered by this patent is designed to block critical functions of the influenza virus necessary for virus replication," said Wayne P. Fitzmaurice, Ph.D., iBio's vice president of intellectual property. "Current public health strategies for influenza include annual preventative vaccination and
in some cases, the use of small molecule drugs for treatment of infected individuals. However, because preventive vaccination reaches only a part of the population, vaccines vary in effectiveness to prevent disease, and drug-resistant influenza strains pose increased risk, there is a global need for new, more effective therapeutic biologics that block the replication of influenza virus directly in those who become infected."
   
According to BCC Research, the global influenza market will grow to nearly $6 billion in 2018. Because influenza continues to be a significant public health threat, efforts continue by government agencies and

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disease prevention organizations to support and
fund research and development programs, and pandemic prevention.
   
"This patent is an important addition to our portfolio of intellectual property covering infectious disease product applications of our core pharmaceutical technology, the iBioLaunch platform," stated Robert Erwin, iBio's president. "In addition to using our technology to advance our proprietary product candidates for treatment of chronic fibrotic diseases to clinical trials, our iBioLaunch platform is being applied to antibodies and antibody fusion proteins to target pathogens such as influenza, Ebola virus, anthrax, and others for which it provides technical and economic advantages for product optimization and commercial manufacturing."
   
iBioLaunch gene expression technology has previously been used for the development and successful Phase 1 clinical evaluation of vaccine candidates targeting H1N1 influenza and avian H5N1 influenza. Additional infectious disease applications of the technology are in development including a transmission blocking vaccine for malaria in a Phase 1 clinical trial and a National Institutes of Health sponsored clinical program for a vaccine against anthrax.
   
   
   
   
   
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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that it has completed enrollment in its ongoing randomized, double-blind placebo-controlled phase 2 clinical trial of NurOwn® in amyotrophic lateral sclerosis (ALS). The targeted enrollment of 48 subjects has been achieved.
    
BrainStorm Cell Therapeutics  --  "Completion of enrollment in this phase 2 trial is a major corporate milestone for BrainStorm," stated CEO Tony Fiorino, MD, PhD. "We continue to expect the last subject to be treated early in the fourth quarter of this year and top line results to be available shortly after the follow-up period is complete. This study has attracted much interest from both patients and physicians, and we anticipate it to give us valuable insights into the safety and efficacy of NurOwn® in ALS. Given the limited treatment options for patients with ALS, we are hopeful that this study will move NurOwn® another step closer to becoming a treatment for ALS."
   
Merit Cudkowicz, MD, Professor of Neurology at Harvard Medical School, Director of the ALS Clinical at Massachusetts General Hospital ALS Clinic, and a principal investigator for the trial, stated, "I want to thank the participants and their families for being part of this study and helping develop new therapies for ALS. Completion of enrollment is a very important milestone. We look forward to completing close follow-up and learning the results of this study."
   
This multi-center, randomized, double blind, placebo controlled study is evaluating the safety and efficacy of a single combined intramuscular and intrathecal administration of MSC-NTF cells (NurOwn®) in early-stage ALS patients. After enrolling in the study, subjects are followed for a three months run-in period, during which their bone-marrow is harvested and mesenchymal stromal cells are isolated and expanded. Subjects are then randomized to receive either NurOwn® or placebo, after which they are followed for six months. The primary endpoint of the study is safety, and secondary endpoints are efficacy measures including the ALS Functional Rating Scale (ALSFRS), slow vital capacity (SVC), and grip strength. More information can be found at https://clinicaltrials.gov/show/NCT02017912.
     
In February 2015, the Data Safety and Monitoring Board (DSMB) overseeing the trial completed its first safety review of the trial, and did not find any lab abnormalities, adverse events or significant protocol deviations that would be cause for concern. A second and final DSMB review is planned the fourth quarter of 2015.
  
  
   
  
Also Tuesday:  
   
   
   
   
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced its financial results for the second quarter ended June 30, 2015, in addition to providing a corporate update and anticipated milestones for 2015.
    
AXIM Biotechnologies, Inc. (OTC:AXIM) is a unique biotechnology corporation with a focus on global research, development and production of pharmaceutical, nutraceutical, food and cosmetic products – all derived from industrial hemp.
    
BioMark Diagnostics Inc. (CSE:BUX) (FSE:20B) (OTCQB:BMKDF) is pleased to announce the appointment of Thomas Malcolm, Ph.D., as Chief Scientific Officer and Head of U.S. Operations.
   
Celladon Corporation (Nasdaq:CLDN), today announced financial results for the quarter ended June 30, 2015 and recent corporate updates.
    
Cellular Biomedicine Group Inc. (NASDAQ:CBMG), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced the appointment of Yihong Yao, Ph.D., B.S. as Chief Scientific Officer.
   
Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today reported financial results for the three and six months ended June 30, 2015 and provided an update on its corporate activities and product pipeline.
    
Codexis, Inc. (NASDAQ:CDXS), a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, announces financial results for the three and six months ended June 30, 2015, and raises its revenue and gross margin outlook for 2015.
    
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today reported its financial results and business highlights for the second quarter ended June 30, 2015.
   
Dermira, Inc. (NASDAQ:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced that it has closed its previously announced follow-on public offering of 5,175,000 shares of its common stock, including 675,000 shares sold upon full exercise of the underwriters' option to purchase additional shares of common stock, at a price to the public of $21.50 per share, all of which were sold by Dermira. 
   
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today reported financial results for the quarter ended June 30, 2015, as well as recent highlights.
    
Health Insurance Innovations, Inc. (NASDAQ:HIIQ), a leading developer, distributor, and virtual administrator of affordable health plans today announced financial results for the second quarter ended June 30, 2015.
    
Hemispherx Biopharma, Inc. (NYSE MKT:HEB), reported today that it has executed an agreement with Emerge Health Pty Ltd. ("Emerge") to seek approval of Alferon N Injection® in Australia and New Zealand and to commence distribution of Alferon in both countries on a named-patient basis, where deemed appropriate. 
   
Inogen, Inc. (NASDAQ:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today reported financial results for the three months ended June 30, 2015.
   
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial results for the quarter ended June 30, 2015, as well as recent operational highlights.
   
MedAssets (Nasdaq:MDAS) today announced that it has broadened its purchased services approach through an exclusive partnership with Valify to offer a new web-based analytics solution designed to standardize purchased services spend across the health system enterprise. 
   
Myriad Genetics, Inc. (NASDAQ:MYGN) today announced financial results for its fiscal fourth-quarter and fiscal full year ended June 30, 2015, provided an update on recent business highlights and provided fiscal year 2016 and fiscal first-quarter 2016 financial guidance.
    
Surgical Care Affiliates, Inc. (NASDAQ:SCAI) today announced the closing of the previously announced underwritten secondary public offering of 4,000,000 shares of SCA's common stock by certain affiliates of TPG Global, LLC (the "TPG Stockholders"). 
   
Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced it has gathered a panel of internationally renowned pediatric endocrinologists to share their perspectives, experiences and expertise regarding Pediatric Growth Hormone Deficiency with analysts and investors at a meeting in New York City on September 15, 2015.
  
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced its second quarter 2015 financial results.
   



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