Oncothyreon And Celldex Therapeutics Announce Initiation Of Immunotherapy Clinical Trials; NPS Initiates Study of Teduglutide Print E-mail
By William Kent   
Monday, 10 November 2014 20:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 10, 2014.
Oncothyreon Inc. (Nasdaq: ONTY)
and Celldex Therapeutics, Inc., (Nasdaq: CLDX) announced they have initiated a combined clinical trial of ONT-10 and varlilumab. ONT-10 is a therapeutic vaccine targeting the tumor-associated antigen MUC1. Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes.

ClinicalTrials.gov: NCT02270372 is an open-label Phase 1b study of ONT-10 administered at the recommended single agent dose in combination with varlilumab at two dose levels in up to 42 patients with advanced breast or ovarian cancer. The primary objective of the trial is to determine the safety and tolerability of the combined therapy. Additional objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses, T-cell activation markers and levels of regulatory T-cells, and anti-tumor effects.

The Phase 1b trial will be conducted by Oncothyreon under the terms of a previously announced collaboration agreement between Oncothyreon and Celldex. The two companies will jointly own the data from the trial and will make any plans for potential future development of the combination therapy together. Under the agreement, neither company has granted the other a license, or any other rights, to its product candidate.


 
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NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
, announced the company has initiated a global registration study of teduglutide in pediatric patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

The 12-week, open-label study evaluating teduglutide will be conducted at sites throughout the US and Europe. The primary outcome measures are the number of reported adverse events and changes in parenteral and enteral support requirements, respectively. Additional information about the trial, including a detailed listing of study sites, is available at the National Institutes of Health’s clinical trial registry, which can be found here: http://clinicaltrials.gov/show/NCT01952080

“We are particularly proud to advance teduglutide in pediatric Short Bowel Syndrome, as it may bring us one step closer to fulfilling a significant unmet need among children across the globe who face a life burdened by this rare disease,” said Roger Garceau, MD, FAAP, executive vice president and chief medical officer of NPS Pharmaceuticals. “We look forward to reporting top line results following the completion of the study in late 2014 or early 2015.”

The four-cohort study is expected to enroll up to 36 patients. Non-randomized subjects will receive teduglutide in each of the three active cohorts for 12 weeks. The study will attempt to enroll a fourth cohort of patients in an observational arm that would receive a current standard of care with parenteral support and will be considered a safety control group. All subjects will be screened prior to the start of treatment to establish baseline characteristics including safety, eligibility and nutritional support parameters. Eligibility includes a current history of SBS for a minimum of 12 months prior to screening, which resulted from a major intestinal resection and SBS requiring stable administration of parenteral support for a minimum of three months prior to enrollment, based upon the opinion of the investigator.



Also Monday:



Accuray Incorporated (Nasdaq:ARAY)
, announced today that its management is scheduled to participate in the Brean Capital 2014 Life Science Conference in New York City on Monday, November 24, 2014.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced its financial results for the third quarter and nine months ended September 30, 2014.

Athersys, Inc. (Nasdaq:ATHX)
today announced its financial results for the three months ended September 30, 2014.

Caliber Imaging & Diagnostics (OTCQB:LCDX)
, formerly Lucid, Inc., announced it will exhibit its VivaScope® system at the Society for Neuroscience 2014 Annual Meeting at the Walter E. Washington Convention Center in Washington, DC on November 16-19.

Cara Therapeutics, Inc. (Nasdaq:CARA)
, a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced financial results for the third quarter ended September 30, 2014.

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 reported financial results for the three and nine months ended September 30, 2014.

Cellular Biomedicine Group Inc. (Nasdaq:CBMG)
, a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced that Dr. William (Wei) Cao, Chief Executive Officer of the Company, will present "Preclinical and Clinical Results of Mesenchymal Progenitor Cell Treatment for Knee Osteoarthritis" at the 7th Annual World Congress of Regenerative Medicine & Stem Cells (RMSC-2014).

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
, a developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, today reported financial results for the third quarter and nine months ended September 30, 2014.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT)
today is presenting its late-breaking poster at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston November 7-11, 2014.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, today reported financial results for the quarter ended September 30, 2014, as well as recent highlights.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today provided a corporate update and reported financial results for the third quarter ending September 30, 2014.

Galectin Therapeutics Inc. (Nasdaq:GALT),
the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported its financial results for the third quarter and nine months ended September 30, 2014.

Green PolkaDot Box Incorporated (OTC:GPDB)
announced today that it intends to launch its Health Merchant program on December 1st, 2014.

Health Insurance Innovations, Inc., (Nasdaq:HIIQ)
, is a leading developer, distributor and virtual administrator of affordable, cloud-based individual health insurance plans and ancillary products.

Hemispherx Biopharma (NYSE:HEB)
announced its financial results for the three and nine months ended September 30, 2014.

ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in innovative medical devices used in vascular therapy, oncology and critical care applications, today announced financial results for the third quarter and nine months ended September 30, 2014.

INC Research Holdings, Inc. (Nasdaq:INCR)
, a leading, global Phase I to IV contract research organization (CRO), today rang the opening bell at The Nasdaq Stock Market to celebrate becoming a public company.

Inogen, Inc. (Nasdaq:INGN)
, a medical technology company offering innovative respiratory products for use in the homecare setting, announced today that it has entered into a primary banking relationship with JPMorgan Chase & Co. to receive credit and treasury services.

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today reported financial results for its third quarter 2014 and provided an update on recent accomplishments.

Lipocine Inc. (Nasdaq:LPCN)
, a specialty pharmaceutical company, today announced financial results for the quarter ended September 30, 2014, as well as recent operational highlights.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 1 clinical trial of its respiratory syncytial virus (RSV) F-protein nanoparticle vaccine candidate (RSV F Vaccine), in healthy children, the first study of this vaccine candidate to be conducted in a pediatric population.

Ocera Therapeutics, Inc. (Nasdaq:OCRX)
, a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that company management will be presenting at the Stifel 2014 Healthcare Conference being held at the Palace Hotel in New York, NY.

OrganiGram Holdings Inc. (TSX-V:OGI) (OTC US:OGRMF)
is pleased to announce that through it's wholly-owned subsidiary, Organigram Inc., it has entered into a binding letter of intent (the "Letter of Intent") with Trauma Healing Centers Incorporated, pursuant to which OrganiGram will be the preferred supplier of medical marijuana to Trauma Healing Centers' patients.

Pacific Biosciences of California, Inc., (Nasdaq:PACB)
provider of the PacBio® RS II Sequencing System, announced that a paper published online today in Nature1 entitled "Resolving the complexity of the human genome using single-molecule sequencing" demonstrates how researchers used Single Molecule, Real-Time (SMRT®) Sequencing technology to identify and resolve missing or misassembled regions of the human genome and to access more complex forms of variation not covered by other sequencing technologies.

Radius Health, Inc. (Nasdaq:RDUS)
, a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive cancers, reported its financial results for the third quarter ended September 30, 2014, and provided recent corporate highlights.

Repros Therapeutics Inc.® (Nasdaq:RPRX)
today announced financial results for the third quarter ended September 30, 2014.

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, reported results for the third quarter ended September 30, 2014.

SG Blocks (OTCQB:SGBX)
, a premier innovator and designer of container-based structures, today announced that in just three months, the firm has completed shipment of all 21 units for oneC1TY, a new development in Nashville, Tennessee.

SmallCapVoice.com, Inc. announced today that a new audio interview with United Cannabis Corp. (OTCQB:CNAB) a leader in the medical cannabis industry by offering patient driven solutions intent on improving biomedical and pharmaceutical pursuits thru the use of Cannabis based research, products and services., is now available.

Swisher Hygiene Inc. (Nasdaq:SWSH)
, a leading service provider of essential hygiene and sanitizing solutions, announced today results for the three and nine months ended September 30, 2014.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
announced today that it will participate in two investor conferences in November.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative clinical-stage biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for cancer and autoimmune diseases, today announced its results for the third quarter ended September 30, 2014 and recent company developments.

TriVascular Technologies, Inc. (Nasdaq:TRIV) and CRG LP and its affiliate funds today announced that they have amended and restated the term loan facility under which TriVascular previously borrowed $40 million in October 2012.

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today reported its financial results and corporate update for the third quarter ended September 30, 2014.




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