Nektar Offers Data on Sub-Study of Phase 3 BEACON Study of NKTR-102; NewLink Genetics Sinks On Temporary Halt Of Ebola Trial Print E-mail
By Josh Gee   
Thursday, 11 December 2014 19:03
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 11, 2014.
Nektar Therapeutics (NASDAQ: NKTR) today presented biomarker data from a sub-study of the Phase 3 BEACON study of etirinotecan pegol (NKTR-102) which collected and analyzed circulating tumor cell (CTC) samples from patients in the study.  A total of 80% of the 852 patients enrolled in the BEACON trial participated in the CTC sub-study.  Among the 627 patients who participated and had evaluable baseline samples, CTCs were detected in 97% of these samples.

For the 611 evaluable baseline patient samples which yielded CTCs, potential NKTR-102 target-specific pharmacodynamic biomarkers (Top1, Top2, and Ki67) were detected in the majority of samples. The pharmacodynamic biomarkers assessed in the CTC sub-study were chosen because of their potential ability to predict response to topoisomerase 1 inhibition as well as to measure chemo-sensitivity in metastatic cancer patients.1,2,3,4

"We were encouraged to find that the CTC sub-study confirmed the presence of several potential target-specific pharmacodynamic biomarkers, such as topoisomerase 1, in the patients enrolled in our study," said Ivan Gergel, MD, senior vice president drug development and chief medical officer of Nektar Therapeutics. "The analysis from the BEACON CTC sub-study could help us better understand which additional patient populations would benefit from NKTR-102. We expect topline results from the BEACON study to be available in the first quarter of 2015."

The data were presented during the 2014 San Antonio Breast Cancer Symposium (SABCS) in San Antonio.

NKTR-102 is the first long-acting topoisomerase 1 inhibitor with an extended half-life and a unique molecular structure that is designed to concentrate the drug in tumors. It is currently being evaluated in the Phase 3 BEACON (BrEAst Cancer Outcomes with NKTR-102) study in patients with locally recurrent or metastatic breast cancer who previously have been treated with anthracycline, taxane or capecitabine (ATC). CTCs are cancer cells shed from either the primary tumor or its metastases that circulate in the peripheral blood. CTCs are emerging tumor biomarkers, collected through a minimally invasive blood draw, providing a "liquid" biopsy sample and allowing for post-treatment monitoring of patients.


 
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NewLink Genetics Corp (NASDAQ: NLNK)
shares fell sharply after a trial of its Ebola vaccine was temporarily halted over safety concerns at a Swiss hospital University of Geneva Hospital halted the Phase I trial "as a precautionary measure" after four patients in the study developed joint pain, according to a report by Reuters that said the trial will resume next month.

Marie-Paule Kieny, vaccine expert at the World Health Organization, said after the delay the trial will continue as originally planned, according to Reuters.

NewLink announced a licensing agreement with Merck covering the Ebola vaccine last month and said the U.S. National Institutes of Health will launch a Phase II trial of the vaccine in early 2015.

NewLink changed hands recently at $35.63, down 3.4 percent.



Also Thursday:



Advaxis, Inc. (Nasdaq:ADXS)
, a clinical-stage biotechnology company developing cancer immunotherapies, announced today that its Lm-LLO immunotherapy technology is featured in an article in the December 2014 issue of Nature Biotechnology.

Air Methods Corporation (Nasdaq:AIRM)
, the global leader in air medical transportation, today announced that Jay Francis has been appointed as president of Sundance Helicopters.

Amarantus BioScience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the development of diagnostics and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced the appointment of Elise Brownell, Ph.D., to the newly created position of Senior Vice President of Operations and Program Management.

Amicus Therapeutics (Nasdaq:FOLD)
, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that it has conducted a successful pre-submission meeting with the European Medicines Agency (EMA) to discuss the registration of migalastat HCl ("migalastat") monotherapy for the treatment of Fabry disease.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services and mobile tools for medical groups and health systems, and Women's Health USA (WHUSA), a leading provider of business and clinical management services for physicians, today announced that WHUSA has selected the athenaOne® suite of services to support its network of over 250 providers, serving more than 300,000 patients in Connecticut.

AXIM Biotechnologies (OTC:AXIM)
is extremely proud to announce the newest appointments to the Company's Advisory Board: Dr. Arno Hazekamp, Ph.D., and Mr. Warren C. Hutchins.

BioReference Laboratories, Inc. (Nasdaq:BRLI)
announced today it plans to issue earnings results for the fourth quarter and year end for 2014 before the open of market trading on Thursday, December 18, 2014.

ChemoCentryx, Inc., (Nasdaq:CCXI)
, a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced that it will host a conference call and webcast on Friday, December 12, 2014 at 8:30 a.m. Eastern Time (ET) to present top-line results from its Phase II trial with CCX140, an inhibitor of the chemokine receptor known as CCR2, in patients with diabetic nephropathy.

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that initial immunohistochemistry (IHC) screening data from the NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial was presented at the 2014 San Antonio Breast Cancer Symposium (SABCS).

Herborium® Group, Inc. (OTC Pink: HBRM)
, a Botanical Therapeutics® Company and the provider of unique all  botanical medicines (Botanical Therapeutics®)  announced today that HUT Group, LLC. , the UK's leading multi-website online retailer of Health and Beauty products is expending the marketing and sales of AcnEase®, Herborium's unique acne treatment  on its leading platforms with a goal of  £500,000.00 ($785,000.00) in sales within  next 18-24 months.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 35 new employees. Pursuant to NASDAQ Marketplace Rule 5635(c)(4), the equity awards were granted under the Intuitive Surgical, Inc. 2009 Commencement Incentive Plan, which the Board of Directors of Intuitive Surgical, Inc. adopted for the granting of equity awards to new employees.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM)
, a leading national hospital medicine and post-acute physician group practice company, announced today that it is continuing its investment in the behavioral health market with the acquisition of North Carolina Elderly Psychiatric Services (NCEPS) in Raleigh, North Carolina.

Karyopharm Therapeutics Inc. (Nasdaq:KPTI)
, a clinical-stage pharmaceutical company, today announced the initiation of the SADAL study, (Selinexor and Dexamethasone in Aggressive Lymphoma), a registration-directed, Phase 2b study of Selinexor (KPT-330), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Macrocure Ltd. (Nasdaq:MCUR)
, a clinical-stage biopharmaceutical company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that it has completed its mechanism of action ("MOA") study.

Medical Marijuana, Inc. (OTC Pink:MJNA)
is pleased to inform shareholders and the general public that HempMeds™ – a corporate portfolio company of Medical Marijuana, Inc. – is dramatically expanding its brand presence though natural hemp cannabidiol (CBD) education at the American Academy of Anti-Aging Medicine (A4M) World Congress in Las Vegas, Dec. 11-13.

Radius Health, Inc. (Nasdaq:RDUS)
announced today that it presented data from a Phase 1 clinical study on estrogen receptor engagement by the investigational drug RAD1901, a tissue-selective estrogen receptor degrader (SERD), in a poster presentation at the 2014 San Antonio Breast Cancer Symposium (SABCS).

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, received approval from the New York State Department of Health to offer, market and report results of the Company's ResponseDX® tests to healthcare providers in the State of New York.

Vical Incorporated (Nasdaq:VICL)
today announced the completion of enrollment in a Phase 1/2 trial of its Vaxfectin®-formulated therapeutic vaccine for herpes simplex virus type 2 (HSV-2), the predominant cause of recurrent genital herpes. The enrollment was completed on schedule as originally planned.




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