|Lilly's Abemaciclib in Phase 1 Study; Hemispherx Collaborates With the Swiss DoD to Study Alferon(R)|
|By Staff and Wire Reports|
|Wednesday, 14 May 2014 19:04|
Lung cancer patients with metastatic squamous cell carcinoma have seen few treatment advancements over the last two decades, leaving these patients with a poor prognosis. This is in contrast to the progress seen in nonsquamous non-small cell lung cancer (NSCLC). Results from the largest ever Phase III trial in first-line squamous NSCLC announced by Eli Lilly and Company (NYSE: LLY) provide the first detailed look at a potential new treatment option for these patients.
Necitumumab (IMC-11F8) is a recombinant human IgG1 monoclonal antibody designed to target the human epidermal growth factor receptor 1 (EGFR). In the Phase III SQUIRE trial, patients with stage IV metastatic squamous NSCLC showed a statistically significant improvement in overall survival (HR=0.84, p=0.012) with a median survival of 11.5 months when receiving necitumumab in combination with gemcitabine and cisplatin as a first-line treatment, as compared to 9.9 months for those treated with chemotherapy alone. Consistent efficacy results were observed across endpoints and subgroups. Grade 3 or higher adverse events occurring more frequently in patients on the necitumumab arm were hypomagnesemia and rash. The SQUIRE study results (Abstract #8008) were released in advance of the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Ill. Additional safety and efficacy information will be presented at the meeting.
"The SQUIRE trial results offer an important step in our pursuit of improving outcomes for patients with advanced squamous NSCLC," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "With these findings, Lilly anticipates a regulatory submission of necitumumab before the end of 2014."
Lung cancer is the leading cause of cancer death in the U.S. and most other countries. NSCLC is much more common than other types of lung cancer, and accounts for 85 percent of all lung cancer cases. Patients with squamous cell carcinoma represent about 30 percent of all patients affected by NSCLC. Advanced squamous NSCLC represents a high unmet medical need. Improving treatment in this setting has been particularly challenging as patients often have co-morbidities and, unlike nonsquamous NSCLC, research has yet to confirm a molecular oncogenic target that could drive treatment decisions for patients with this disease.
"While there have been several attempts to make progress to address this unmet need, clinical advances in squamous non-small cell lung cancer have been minimal in the last twenty years," said Nick Thatcher, Ph.D., FRCP., professor of oncology, University of Manchester, Christie Hospital NHS Trust in Manchester, United Kingdom and the SQUIRE principal investigator. "The addition of necitumumab to the current chemotherapy regimen of gemcitabine and cisplatin opens the door to a potential new approach to treat patients with advanced squamous NSCLC."
Hemispherx Biopharma, Inc. (NYSE: HEB), announced that it has entered into a formal collaborative research agreement to test Alferon N Injection®, the only multi-species, natural alpha interferon commercially approved in the U.S. It will now be evaluated against wild type and Tamiflu® (oseltamivir)-resistant H7N9 influenza virus under the DEA (Data Exchange Agreement) Annex for Medical Preparedness and Bio-Defense Agreement between the Swiss Surgeon General and the US Department of Defense.
The increasing prevalence of Tamiflu®-resistant Influenza A Virus, particularly against H7N9, has been widely reported and is due in large part to the fact that just a single-step mutation in this genetically unstable virus can make it resistant to Tamiflu®.
This collaboration is intended to extend the results announced at the 53rd annual meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado September 13-15, 2013. These experiments were conducted by Professor Juergen Richt, DVM, Ph.D., Director of the U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD) and demonstrated that Alferon® N is a potent inhibitor of both wild-type influenza virus H7N9 as well as Tamiflu®-resistant influenza strains.
According to a new study by the non-profit Cochrane Collaboration, global network of health care academics, Tamiflu® is not proven to reduce flu complications, like pneumonia and hospital stays, raising questions about Tamiflu® use against pandemics. As published in the British Medical Journal (BMJ 2014;348:g2545/Ibid g2547), examination of earlier clinical studies found prophylactic reduction in symptoms of only 55% and no indication that Tamiflu® is effective in reducing complications, key components in reducing the morbidity and rate of pandemic spread of influenza. The studies also question the risk/benefit ratio provided by Tamiflu.
The Cochrane reviewers examined all 107 existing clinical reports on Tamiflu® and another less widely used flu drug (Relenza® (zanamivir)). Evidence from the trials reviewed showed Tamiflu® and Relenza® alleviated flu-like symptoms in adults about half a day faster than in those taking a placebo. The Cochrane reviewers and the BMJ have also called on governments and health policy decision makers throughout the world to review their guidance on the use of Tamiflu® in light of the recent findings.
Col. Dr. Sergei Bankoul, M.D., Swiss Armed Forces Logistics, Medical Services Directorate, Head of Medical CBRN Defense of the Armed Forces and Senior Consultant to the Swiss Surgeon General, Major General Andreas Stettbacher, said, "We need an effective, convenient-to-use, and widely administrable preventative and therapeutic for pandemic influenza outbreak to accompany the commitment the Swiss Military has made to a rapid, point-of-care diagnostic test for H7N9 to provide a '1:2 punch' to a pandemic threat or outbreak and under our Agreement with the US Department of Defense. Based on research to date, Alferon® is a promising drug candidate."
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases, today announced that William D. "Chip" Baird, Chief Financial Officer, will present a corporate overview at the UBS Global Healthcare Conference on Wednesday, May 21, 2014 at 12:00 p.m. ET.
Akers Biosciences, Inc. (AIM:AKR.L) (Nasdaq:AKER), a leading designer and manufacturer of rapid diagnostic screening and testing products, reports its financial results for the first quarter ended March 31, 2014.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, today reported financial results for the first quarter ended March 31, 2014.
Celsus Therapeutics Plc (Nasdaq:CLTX), an emerging growth, development-stage biotech company, announced today that the annual general meeting of its shareholders will be held on Thursday, June 19, 2014 at 10:00 a.m. (Local Time, BST in UK), at 53 Davies Street, Mayfair, London W1K 5JH, United Kingdom.
Cellectar Biosciences, Inc. (OTCQX:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, is providing an overview of its development programs and financial results for the first quarter 2014.
Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (Nasdaq:MYGN), today announced the online publication of a new study in the journal Annals of the Rheumatic Diseases for Crescendo's Vectra DA blood test.
CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that the Company has dosed the first patients in its Phase 2b clinical trial with its lead product candidate, PRO140.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today reported financial results for the first quarter ended March 31, 2014.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of equipment, instruments and solutions to advance life science, will present at the SeeThruEquity Third Annual Microcap Investor Conference in New York City on Wednesday, May 28, 2014.
Inogen, Inc. (Nasdaq:INGN) along with the Technology Management Program at UC Santa Barbara's College of Engineering today announced that Ali Bauerlein, Brenton Taylor, and Byron Myers will be presented with the prestigious Venky Narayanamurti Entrepreneurial Leadership Award commonly known as "The Venky" at a ceremony this evening.
Kips Bay Medical, Inc. (Nasdaq:KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting surgery, today announced that Lawrence H. Cohn, M.D. has been engaged as a consultant to provide medical advisory services.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced that six studies performed by various U.S. and international medical facilities have been presented at the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) this week.
Pacific Biosciences of California, Inc., (Nasdaq:PACB) provider of the PacBio® RS II system, announced today that its Single Molecule, Real-Time (SMRT®) DNA Sequencing technology will be featured in seven podium and 13 poster presentations at the 2014 American Society for Microbiology (ASM) annual meeting in Boston.
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests that help guide cancer therapy selection, today announced execution of a commercial agreement with DxM Diagnostico Molecular ("DIFRA"), a leading distributor for cancer testing in Mexico, to offer the ResponseDX testing services to patients throughout Mexico.
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it will present two posters featuring Triferic™ clinical data at the 51st ERA-EDTA Congress in Amsterdam The Netherlands, May 31 – June 3, 2014.
StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today provided a business update and reported financial results for the first quarter ended March 31, 2014.
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced its financial and operating results for the first quarter ended March 31, 2014 and provided a corporate update.
TriVascular Technologies, Inc. (Nasdaq:TRIV) today reported financial results for the three months ended March 31, 2014.