Gilead Submits NDA to FDA for Sofosbuvir; Celldex Presents Data on CDX-1127 Print E-mail
By Staff and Wire Reports   
Monday, 08 April 2013 19:30
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 8, 2013

Gilead Sciences (Nasdaq: GILD)
announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

Chronic HCV infection affects up to four million Americans, particularly individuals born between 1946 and 1964. The disease is the leading cause of liver cancer and liver transplantation in the United States. Treatment for HCV currently includes 24-48 weeks of therapy with peg-IFN, which has to be injected and is associated with significant side effects, leaving some patients unable to complete therapy. If approved, sofosbuvir would shorten HCV therapy to 12 to 16 weeks, and depending on the genotype, would either eliminate or reduce the duration of peg-IFN injections.


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Celldex Therapeutics, Inc. (Nasdaq: CLDX)
reported the results of an in vitro study analyzing the activation of human T cells with CDX-1127. CDX-1127 is a monoclonal antibody that binds CD27 and is designed to activate patients' immune cells against their cancer. The study further explored aspects related to both the potency and safety profile of CDX-1127. Results were consistent with earlier work, confirming the mechanism of action for CDX-1127 and providing additional support for continued clinical development of the candidate. The data were presented in a poster (#1239) entitled "Characterization of the Response of Human T cells to an Agonist Human Anti-CD27 mAb" at the American Association of Cancer Research (AACR) Annual Meeting in Washington DC by Tibor Keler, PhD, Senior Vice President and Chief Scientific Officer of Celldex Therapeutics.

"The results of this study confirm that CDX-1127 elicits potent activation of T cells by inducing their proliferation and release of important immune modulating cytokines," said Dr. Keler. "Most importantly, we have shown that the activation is highly regulated, which limits any safety concerns related to non-specific stimulation of the immune system that similar candidates in this class have faced. This finding is supported by the good safety profile seen to date in our ongoing multi-dose Phase 1 human clinical trial. We believe CDX-1127 is an exciting entrant to the field of immunotherapy and look forward to presenting clinical data from planned solid tumor and hematologic expansion cohorts from our Phase 1 study by year-end."

Study results:  This study investigated the mechanistic requirements for T cell activation by CDX-1127 and the resulting characteristics of the activated T cells. Using purified T cells from healthy subjects, the results of this study demonstrated that concomitant signaling through the T Cell Receptor for antigen is required for CDX-1127 drug activity. Therefore, widespread activation of T cells (since the vast majority are not receiving T Cell Receptor signaling) will not be activated by CDX-1127. Importantly, when T cells are activated through T cell receptor stimulation and CDX-1127, they undergo multiple cell divisions, secrete cytokines with a dominant a proinflammatory signature (IFNγ, IL-2 and TNFα), and express activation markers consistent with an activated phenotype. Gene expression microarray analysis revealed modulation of intracellular signaling, protein kinases, growth and cytokine-chemokine pathways. These in vitro characterizations will be used to guide the biomarker analysis of subjects in the CDX-1127 Phase 1 trial to assess in vivo T cell activation. A copy of this poster is available for viewing in the Scientific Publications section of the Celldex website under the header "Human Monoclonal Antibody Programs: CD27."



Also Monday:



AbbVie (NYSE: ABBV)
will announce its first-quarter 2013 financial results on Friday, April 26, 2013, before the market opens.

Amarantus BioScience Holdings, Inc. (OTCQB: AMBS)
, a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today announced a development timeline for its LymPro Blood Test for Alzheimer’s disease (“LymPro”).

Anacor Pharmaceuticals (NASDAQ:ANAC)
today announced that it has signed a research agreement with the Bill & Melinda Gates Foundation (the Gates Foundation) to discover drug candidates intended to treat two filarial worm diseases (onchocerciasis, or river blindness, and lymphatic filariasis, commonly known as elephantiasis) and tuberculosis (TB).

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today announced the presentation of preclinical data on ponatinib (Iclusig™) , at the American Association for Cancer Research (AACR) Annual Meeting 2013, in Washington.

Biostem U.S., Corporation (OTCQB: HAIR) (PINKSHEETS: HAIR)
(Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, today reported that it has reinstated its founder, John Satino as CEO, under whose leadership the Company will launch an aggressive campaign of national expansion and growth into even other fields of regenerative medicine.

Illumina, Inc. (NASDAQ:ILMN)
today announced that it will issue results for first quarter 2013 following the close of market on Monday, April 22, 2013.

MMRGlobal, Inc. (OTCQB: MMRF)
("MMR"), a leading provider of Personal Health Records ("PHRs"), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced a delivery system designed to bill for telemedicine services to patients through the Company's MyMedicalRecords Personal Health Record by charging additional fees on a per patient per month basis to employers, affinity group and membership organization clients as well as physicians, hospitals, ambulatory surgical centers, laboratory systems, pharmacies, mass merchandisers and other healthcare professionals, vendors and providers.

Northwest Biotherapeutics (NASDAQ: NWBO)
(NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, filed its annual report on Form 10K today, reporting its financial results for the year ended December 31, 2012.

NovaDel Pharma Inc. (NVDL.PK)
has signed a definitive agreement to sell its NovaMist™ technology and certain other assets to SUDA LTD, an Australian publicly held pharmaceutical company.

Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) has today announced that its name and trading symbol changes to Tauriga Sciences, Inc. and (OTCQB: TAUG) respectively, will be effective at market open on Tuesday, April 09, 2013 ("tomorrow").

Luminex Corporation (Nasdaq: LMNX)
today announced that it expects to report results for the first quarter of 2013 on Monday, April 29, 2013 after the close of trading.

When Nuvilex, Inc. (OTCQB: NVLX)
started its diabetes studies, it was likely well known then that while its late-stage pancreatic cancer trials are front and center, it is the company's work in diabetes that could put it on the map and really turn some heads.

Retrophin, Inc. (OTCQB: RTRX)
, a biotechnology company focused on the discovery and development of orphan drugs for the treatment of rare and life-threatening diseases for which there are currently no viable patient options, today announced that it sponsored the Seventh International NBIA Disorders Association Family Conference, which was held April 4-7 in San Antonio, TX.

Spectrum Pharmaceuticals (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the Company has initiated a Phase 2 clinical program for SPI-2012 (also referred to as “LAPS-GCSF”), a drug candidate for the treatment of chemotherapy-induced neutropenia that utilizes partner Hanmi Pharmaceutical Company’s proprietary LAPSCOVERY™ Technology.

TelVue® Corporation (PINKSHEETS: TEVE)
-- the innovation leader in Television and Internet Broadcasting for cable operators, media companies and communities -- launched the TelVue AdCaster A1000 Digital Ad Server today at the conference of the National Association of Broadcasters (NAB) in Las Vegas.Immunotech Laboratories, Inc. (PINKSHEETS: IMMB) today announced the company signed an agreement with The Lebrecht Group, a professional law corporation, to provide legal services for Immunotech and to upgrade the company to OTC:BB fully reporting current status.



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