Cerus Reports US Phase 2 Clinical Trial of INTERCEPTMet Primary Endpoint; VBL Therapeutics Announces Positive Phase 2a Data for VB-111 Print E-mail
By William Kent   
Monday, 22 December 2014 20:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 22, 2014.
Cerus Corporation (NASDAQ: CERS) announced its Phase 2 clinical trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint, with preliminary analysis demonstrating that greater than 75 percent of treated red blood cells continued to circulate 24 hours following transfusion. The investigators plan to submit data from the study for presentation at an upcoming scientific congress.

"We are pleased with the results of this study, which support the future advancement of the INTERCEPT red blood cell program into a Phase 3 study in the United States," said Dr. Laurence Corash, Cerus' Chief Medical Officer. "The data from this study met recommended criteria for a successful red cell recovery study and demonstrate that INTERCEPT red cells behave similarly to untreated red cells when infused into healthy volunteers.”

The randomized, single-blind, controlled, multi-center Phase 2 clinical trial of the INTERCEPT red blood cell system evaluated 26 healthy subjects at two United States clinical trial sites. Each subject received two transfusions of the subject's own red blood cells, one INTERCEPT-treated, and the other a control not treated for pathogen inactivation. Red blood cell units were stored for 35 days prior to transfusion. The primary endpoint of the clinical trial, a mean INTERCEPT red blood cell recovery of greater than 75 percent at 24 hours post-transfusion, was met. The INTERCEPT red blood cells had a recovery of 83% compared to 85% for control red blood cells, and both INTERCEPT-treated and control red blood cells met the criteria for red blood cell recovery recommended by the U.S. Food and Drug Administration.

In Europe, Cerus recently completed a Phase 3 clinical study of the INTERCEPT red blood cell system in patients with acute anemia and plans to file for CE mark approval.


VBL Therapeutics (NASDAQ: VBLT)
,  a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory disease, announced positive results from its exploratory Phase 2a study of VB-111 in patients with recurrent, iodine-resistant differentiated thyroid cancer. VB-111 demonstrated disease stabilization and safety in the study, which was designed to assess the compound's safety and signal of efficacy.

"We are pleased by the results of this study, which suggest that VB-111 is active in patients with advanced thyroid cancer and provide further proof-of-concept support to the unique mechanism of VB-111 and its potency in recurrent cancer indications," said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. "We are excited to see that VB-111 provided disease stabilization for patients who previously progressed after receiving several lines of treatment, and are encouraged by the compound's continuously favorable safety profile. Going forward, we plan to focus our efforts and resources on our pivotal Phase 3 study of VB-111 in recurrent glioblastoma (rGBM), which we plan to initiate in the first half of 2015."

Thirty patients enrolled in the open label, dose-escalating study, most of whom had failed on several therapeutic lines, including tyrosine kinase inhibitors, prior to enrollment. Thirteen patients received a sub-therapeutic single dose of VB-111 at 3X10e12 VPs and seventeen received VB-111 at 10e13 VPs every two months until disease progression. Six patients (35%) in the therapeutic dose cohort (n=17) met the primary endpoint of 6-month progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST), compared to three patients (23%) in the low dose cohort (n=13). VB-111 was well-tolerated in both stages of this study, with no signs of clinically significant safety issues.

Also Monday:

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today announced positive interim results from two studies supporting a short duration, potentially best-in-disease regimen of its proprietary NS5A and nucleotide inhibitors, ACH-3102 and ACH-3422.

Agile Therapeutics, Inc. (Nasdaq:AGRX)
, a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced today that Al Altomari, President and Chief Executive Officer will present at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco.

Amarantus BioScience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the development of diagnostics in Alzheimer's disease and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced the launch of the company's LymPro Test®, a leading, proprietary Alzheimer's blood diagnostic, to the pharmaceutical industry for investigational use in clinical development programs.

Amicus Therapeutics (Nasdaq:FOLD)
, a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases, today announced that the Company was added to the NASDAQ Biotechnology Index (Nasdaq:NBI) (Nasdaq:XNBI), effective prior to the market open on December 22, 2014.

Amicus Therapeutics (Nasdaq:FOLD)
today announced that John F. Crowley, Chairman and Chief Executive Officer, will present a corporate overview at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Tuesday, January 13, 2015 at 10:30 a.m. PT (1:30 p.m. ET).

Apricus Biosciences, Inc. (Nasdaq:APRI)
, a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reviewed its 2014 corporate progress and its clinical development and commercialization plans for 2015.

Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX)
, a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, announced that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq:NBI).

The Cooper Companies, Inc. (NYSE:COO)
will present at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco, Calif., on January 13, 2015. Robert S. Weiss, President and Chief Executive Officer, will represent the Company in a presentation scheduled to begin at 3:00PM PT (6:00PM ET).

The Cooper Companies, Inc. (NYSE:COO)
today announced that it will hold its next annual meeting of stockholders on Monday, March 16, 2015. 

Cutera, Inc. (Nasdaq:CUTR)
, a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced that it started its first customer shipments and deliveries of its picosecond laser platform,

Dermira, Inc. (Nasdaq:DERM)
, a specialty biopharmaceutical company focused on bringing innovative and differentiated medical dermatology products to dermatologists and their patients, today announced that the company was added to the Russell 2000® Index as part of Russell Investments' quarterly addition of select initial public offering (IPO) companies. Dermira joined the index after the equity markets closed on December 19, 2014.

FEI Company (Nasdaq:FEIC)
announced that Don Kania, President and CEO, is scheduled to present at two investor conferences in the coming weeks.

FutureFuel Corp. (NYSE:FF)
, a manufacturer of custom and performance chemicals and biofuels, today announced its 2015 quarterly dividend program, declaring normal quarterly dividends of U.S. $0.06 per share, with record dates of March 2, 2015, June 1, 2015, September 1, 2015 and December 1, 2015, and payment dates of March 13, 2015, June 12, 2015, September 11, 2015 and December 11, 2015, respectively.

Inogen, Inc. (Nasdaq:INGN)
, a medical technology company offering innovative respiratory products for use in the homecare setting, announced today that the Company's management will be participating in two upcoming investor conferences.

, the only provider of non-magnetic intravenous (IV) infusion pump systems for use during magnetic resonance imaging (MRI) procedures, announced today that it has resumed domestic distribution of its MRI compatible MRidium 3860 IV infusion pump systems.

K2M Group Holdings, Inc. (Nasdaq:KTWO)
, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced the completion of the first surgical case using the Company's CAPRI™ Corpectomy Cage System, an expandable vertebral body replacement device that provides structural stability following a corpectomy or vertebrectomy.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced it has begun shipping AURYXIA™ (ferric citrate) tablets to wholesalers in the U.S. Auryxia is approved for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. Auryxia is the first and only absorbable-iron-based phosphate binder that is clinically proven to effectively control phosphate levels within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL.

Kite Pharma, Inc., (Nasdaq:KITE)
, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 1/2 study of KTE-C19, the Company's investigational anti-CD19 CAR T cell therapy, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL).

Lion Biotechnologies, Inc. (OTCQB:LBIO)
, a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL), today announced the closing of its underwritten offering of 6,000,000 shares of its common stock at $5.75 per share, including 782,608 shares sold pursuant to the exercise in full of the underwriters' option to purchase additional shares, resulting in gross proceeds from the offering of $34.5 million before deducting underwriting discounts and commissions and offering expenses payable by Lion.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced the appointment of Bernard F. Tobin as president of Crescendo Bioscience, effective January 5, 2015.

NanoString Technologies, Inc. (Nasdaq:NSTG),
a provider of life science tools for translational research and molecular diagnostic products, today announced that its management is scheduled to present at the J.P. Morgan 33rd Annual Healthcare Conference in San Francisco.

NewLink Genetics Corporation (Nasdaq:NLNK)
and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services (HHS) has awarded NewLink Genetics' wholly-owned subsidiary, BioProtection Systems, as the prime contractor in a $30 million contract to support the manufacturing and development activities of its investigational rVSV-EBOV (Ebola) vaccine candidate, including clinical development through a new 330-person Phase Ib study.

Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ)
, the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced various changes to its management team and structure designed to further position the Company for continued direct sales success and global growth.

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Nuvilex orphan drug designation for its pancreatic cancer treatment. Nuvilex's pancreatic cancer treatment combines Nuvilex's patented and proprietary cellulose-based encapsulation technology, known as Cell-in-a-Box®, with the cancer prodrug ifosfamide and encapsulated live cells that convert the prodrug into its cancer-killing form.

Oxford Immunotec Global PLC (Nasdaq:OXFD)
, a global, commercial-stage diagnostics company committed to improving patient care by providing advanced, innovative tests in the field of immunology, today announced that Peter Wrighton-Smith Ph.D., Chief Executive Officer, and Rick Altieri, Chief Financial Officer, will present at the 33rd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco, California on Wednesday, January 14, 2015 at 3:00 pm Pacific Time.

Receptos, Inc. (Nasdaq:RCPT)
announced today that the Company has enrolled the first patient in the SUNBEAM Phase 3 trial of RPC1063 in patients with relapsing multiple sclerosis (RMS).

Symmetry Surgical Inc. (Nasdaq:SSRG)
announced today that Company management will ring the Opening Bell at the Nasdaq MarketSite in Times Square, New York at 9:30 a.m. ET on Tuesday, December 23, 2014.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, announced today that the Company has entered into a Manufacturing and Clinical Trial Agreement with the University of Oxford to provide the new TKM-Ebola-Guinea therapeutic product for clinical studies in West Africa.

The Joint Corp. (Nasdaq:JYNT)
, a national healthcare franchisor of chiropractic clinics, today reported financial results for the third quarter and nine months ended September 30, 2014.

Uroplasty, Inc. (Nasdaq:UPI)
and Vision-Sciences, Inc. (Nasdaq:VSCI) entered into a definitive merger agreement under which the two companies will combine in an all-stock transaction to create a new company expected to generate revenue of approximately $50 million for the fiscal year beginning April 1, 2015.

VBL Therapeutics (Nasdaq:VBLT)
, a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory disease, today announced positive results from its exploratory Phase 2a study of VB-111 in patients with recurrent, iodine-resistant differentiated thyroid cancer. VB-111 demonstrated disease stabilization and safety in the study, which was designed to assess the compound's safety and signal of efficacy.

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