|BioLineRx Will Present Safety, Efficacy Clinical Data for Novel Stem Cell Mobilization Treatment; Lilly to Present New Clinical Data at 75th American Diabetes Association Scientific Sessions|
|By Marilyn Mullen|
|Wednesday, 27 May 2015 19:05|
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 27, 2015.
BioLineRx Ltd. (NASDAQ: BLRX) (NASDAQ: BLRX), announced positive safety and efficacy Phase 1 clinical data of its lead clinical candidate, BL-8040, as a novel approach for mobilization and collection of bone-marrow stem cells from the peripheral blood circulation, will be presented in an oral presentation at the 20th Annual Congress of the European Hematology Association (EHA) to be held June 11-14, 2015 in Vienna, Austria. Data to be presented include response rates and additional pharmacodynamic studies done on the collected cells. In addition, positive preclinical data from studies supporting BL-8040's mechanism of action as a treatment for acute myeloid leukemia (AML) will be highlighted in a poster presentation. The molecular and cellular mechanisms by which BL-8040 affects AML cells will be presented.
BL-8040 will be featured in the following sessions: (Abstract # S800) Monotherapy Treatment with a Single Dose of the CXCR4 Antagonist BL-8040 as a Novel Method for Mobilization of Human HSPC and MSC; Results of a Phase 1 Healthy Volunteers Study
Presenter: Yaron Pereg, PhD – Project Leader
Session: Stem Cell Transplantation: Clinical
Date and Time: Sunday, June 14, 8:00 a.m. – 8:15 a.m. CEST
Location: Room Lehar 1 + 2
(Abstract # P171) The CXCR4 Antagonist BL-8040 Directly Affects AML Blasts by Inducing their Terminal Differentiation and Blocking Survival Signals
Presenter: Yaron Pereg, PhD – Project Leader
Session: Acute Myeloid Leukemia - Biology
Date and Time: Friday, June 12, 5:15 p.m. – 6:45 p.m. CEST
Location: Poster area (Hall C)
New clinical data demonstrating the range of treatment options represented in Lilly's (NYSE: LLY) diabetes portfolio will be presented in 79 abstracts on June 5-9, at the 75th American Diabetes Association (ADA)® Scientific Sessions in Boston. These presentations reflect Lilly's efforts to enhance scientific knowledge and improve current approaches to diabetes management. Thirty-five of the abstracts will be presented as part of the Boehringer Ingelheim-Lilly Diabetes alliance.
"The Scientific Sessions are an important opportunity for researchers and healthcare and industry professionals to come together and share learnings and advances in diabetes care," said David Kendall, M.D., vice president of Medical Affairs, Lilly Diabetes. "We look forward to communicating significant new data that showcase the full range of our diabetes portfolio."
Among the data being presented at this year's Scientific Sessions are:
Basal Insulin Peglispro -- Lilly will share new efficacy and safety data for its investigational basal insulin peglispro (BIL), including two late-breaking abstracts and the first data presentations from the seven Phase III IMAGINE trials in patients with type 1 and type 2 diabetes. A total of 19 abstracts will be presented, including three oral presentations:
Saturday, June 6, 1:45 to 3:45 p.m., "Basal Insulin Analogs: New Evidence" Oral Session
1:45 p.m.: Basal Insulin Peglispro (BIL) is Superior to Insulin Glargine (GL) in Reducing HbA1c at 52 Weeks in Insulin-Naïve T2D Patients (Pts) Treated with Oral Antihyperglycemic Medications (OAMs): IMAGINE 2 (Lead author: M.J. Davies) [Presentation No. 93-OR]
2 p.m.: Reduced Intra-subject Variability of Basal Insulin Peglispro (BIL) Compared to Insulin Glargine in Patients with Type 1 Diabetes Mellitus (T1DM) (Lead author: T. Heise) [Presentation No. 94-OR]
2:15 p.m.: Greater HbA1c Reduction with Basal Insulin Peglispro (BIL) v Insulin Glargine (GL) in an Open-label, Randomized Study in T1D Patients (pts): IMAGINE 1 (Lead author: S. K. Garg) [Presentation No. 95-OR]
Additional data showing BIL's effect on hypoglycemia, liver enzymes and lipids will also be presented.
Trulicity™ (dulaglutide) -- Lilly will present nine abstracts for Trulicity, a once-weekly, glucagon-like peptide-1 receptor agonist (GLP-1 RA) injectable prescription medication to improve blood sugar in adults with type 2 diabetes along with diet and exercise. Among these presentations are new data comparing the safety and efficacy of Trulicity to other common diabetes medicines in multinational patient populations, and a meta-analysis showing no increased risk of cardiovascular events in patients taking Trulicity. Select presentations are as follows:
Saturday, June 6, 11:30 a.m. to 1:30 p.m., General Poster Session -- Efficacy and Safety of Once-weekly Dulaglutide versus Once-daily Liraglutide in Japanese Patients with Type 2 Diabetes (Lead author: T. Takamura) [Poster No. 1111-P]
Once Weekly Dulaglutide Does Not Increase the Risk for CV Events in Type 2 Diabetes: A Pre-Specified CV Meta-Analysis of Prospectively Adjudicated CV Events (Lead author: K.C. Ferdinand) [Poster No. 1127-P]
Monday, June 8, 8 a.m. to 10 a.m., "Update on GLP-1 Receptor Agonists" Oral Session -- Efficacy and Safety of Once-Weekly Dulaglutide vs. Insulin Glargine in Combination with Metformin and/or a Sulfonylurea in Predominantly Asian Patients with Type 2 Diabetes (Lead author: W. Wang) [Presentation No. 280-OR]
Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, today announced its slate of director nominees for election at its next Annual and Special Meeting ("ASM") of shareholders to be held on July 14, 2015.
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based revenue cycle management applications and telehealth products and services for healthcare organizations, confirmed that its Annual Meeting of Stockholders will be held on May 28, 2015 at 10:00 am eastern time as previously noticed to its stockholders in its Proxy Statement dated April 17, 2015.
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients, today announced that Peter Maag, PhD, CEO and President, and Ken Ludlum, Chief Financial Officer, will be presenting at the following upcoming investor conferences: The Jefferies 2015 Global Healthcare Conference in New York City on June 1, 2015 at 1:30pm PT/4:30pm ET; The JMP Life Sciences Conference in New York City on June 23, 2015 at 12:30pm PT/3:30pm ET.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that Anthony Marucci, Co-founder, President and Chief Executive Officer, will present a corporate overview at the Jefferies 2015 Global Healthcare Conference on June 3, 2015 at 3:30 p.m. EDT in New York City.
Coherus BioSciences, Inc. (Nasdaq:CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced that it will present at the Jefferies 2015 Global Healthcare Conference on Wednesday, June 3rd at 3:00 pm ET in New York City.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that John McDermott, Chief Executive Officer, is scheduled to present at the Jefferies 2015 Global Healthcare Conference in New York, NY.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the development of programmed cellular therapeutics for the treatment of severe, life-threatening diseases, today announced the closing of an underwritten public offering of 6,900,000 shares of its common stock, which included 900,000 shares that were issued pursuant to the full exercise of the underwriters' option to purchase additional shares, at a public offering price of $5.00 per share.
iCAD, Inc. (Nasdaq:ICAD) announced today that it is withdrawing its full year 2015 financial guidance due to general uncertainty related to reimbursement for non-melanoma skin cancer in the United States.
IRADIMED CORPORATION (Nasdaq:IRMD), the only known provider of non-magnetic intravenous (IV) infusion pump systems that are designed to be safe for use during magnetic resonance imaging (MRI) procedures, announced today that the United States District Court for the Southern District of Florida granted motions to dismiss all claims alleged against the Company, its officers and directors in the Lam Civil Action matter.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced the presentation of clinical data for its lead drug candidate, Selinexor (KPT-330), a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound, during a Karyopharm-sponsored event scheduled for Monday, June 1, 2015 from 6:00 – 7:30 p.m. CT, immediately following formal programming for the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting.
Lumenis Ltd. (Nasdaq:LMNS), the world's largest energy-based medical device company for aesthetic, surgical and ophthalmology applications announced today that the company supported a successful mission to treat children with burn injuries in Armenia.
MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today announced the publication of a nonclinical research paper on MGD006 in Science Translational Medicine. MGD006 is a humanized, Dual-Affinity Re-Targeting (DART®) molecule that recognizes both CD123 and CD3. CD123, the Interleukin-3 receptor alpha chain, is expressed on malignant cells, including leukemic stem cells (LSC), in acute myeloid leukemia (AML) and other hematological diseases.
MannKind Corporation (Nasdaq:MNKD), focused on discovering, developing and commercializing treatments for diabetes, announced today that it will present at upcoming conferences.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced that 18 studies performed by various U.S. and international hospitals were recently presented at the annual Clinical Virology Symposium (CVS) in Daytona Beach, Florida, the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Copenhagen, Denmark, and the Making a Difference in Infectious Diseases (MAD-ID) Conference in Orlando, Florida.
NeoStem, Inc. (Nasdaq:NBS), announced today the pricing of an underwritten public offering of 12,500,000 shares of common stock at a public offering price of $2.00 per share. The gross proceeds to NeoStem from this offering are expected to be $25,000,000 before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company.
NeoStem, Inc. (Nasdaq:NBS), announced today that it is commencing an underwritten public offering of its common stock. The Company intends to use the net proceeds from this offering for working capital, including research and development of cell therapeutic product candidates, especially its lead immuno-oncology program, NBS20, expansion of business units, strategic transactions and other general corporate purposes.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), today announced its slate of director nominees for election at its next Annual and Special Meeting ("ASM") of shareholders to be held on July 14, 2015.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), announces its consolidated financial results for the fourth quarter and fiscal year ended February 28, 2015.
Peregrine Pharmaceuticals (Nasdaq:PPHM) (Nasdaq:PPHMP), a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology (I-O) agent in Phase III development for the treatment of lung cancer, invites investors and the general public to listen to a webcast of its roundtable discussion in conjunction with the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting.
Premier, Inc. (Nasdaq:PINC), a leading healthcare improvement company, today announced that its Chief Operating Officer Michael J. Alkire will present at the Jefferies 2015 Healthcare Conference in New York on Wednesday, June 3, 2015, at 1:30 p.m. EDT.
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT), a clinical-stage oncology and dermatology biopharmaceutical company, today announced that the presentation committee of the 5th European Post-Chicago Melanoma / Skin Cancer Meeting has accepted its abstract titled “Trials in Progress: Intralesional Rose Bengal vs Systemic Chemotherapy for Treatment of Locally Advanced Cutaneous Melanoma.”
Quotient Limited (Nasdaq:QTNT) (Nasdaq:QTNTW), a commercial-stage diagnostics company, today announced that the company's Chairman & CEO, Paul Cowan, will present at the Jefferies 2015 Global Healthcare Conference in New York City at 8:30 a.m. Eastern Time on Thursday, June 4.
Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company developing novel differentiated therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers, today announced that President and Chief Executive Officer, Robert E. Ward, will present at the Jefferies 2015 Health Care Conference on June 2, 2015 at 2:00 p.m. EDT at the Grand Hyatt Hotel in New York City.
The Spectranetics Corporation (Nasdaq:SPNC) today announced that 12-month data from the EXCITE ISR clinical trial were presented by Craig Walker, MD, at New Cardiovascular Horizons (NCVH) in New Orleans.
uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced that its management will present a corporate overview at the Jefferies 2015 Global Healthcare Conference, to be held in New York City, June 1-4, 2015.
Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver therapeutics conveniently through the skin for the treatment of a variety of indications, today announced the election of Joseph "Jay" P. Hagan to its Board of Directors, effective May 22, 2015.