Peregrine Reports Data on Bavituximab; Keryx Reports Zerenex Phase 2 Results Print E-mail
By Staff and Wire Reports   
Wednesday, 09 April 2014 19:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 9, 2014.
Peregrine Pharmaceuticals (NASDAQ: PPHM)
announced data from studies validating the immune-stimulatory mechanism of action of bavituximab and demonstrating that the combination of a preclinical phosphatidylserine (PS)-targeting antibody with the immune checkpoint inhibitors anti-CTLA-4 or anti-PD-1 antibodies yielded superior anti-tumor immune responses in animal models of melanoma and colon cancer compared to anti-CTLA-4 and PD-1 antibodies alone. These data were presented yesterday and today as a late-breaking poster presentation and a poster presentation, respectively at the 105th Annual Meeting of the American Association for Cancer Research (AACR) being held in San Diego, California from April 5-9, 2014. Bavituximab is an investigational immunotherapy currently being evaluated in second-line, non-small cell lung cancer (NSCLC) as part of the SUNRISE pivotal Phase III clinical trial.

"Data from these combination studies are compelling as they provide further evidence that support the immune-stimulatory effects of bavituximab in reducing the prevalence of key immunosuppressive checkpoints in the tumor environment, reducing tumor-suppressive factors, reducing immune suppressor cells and providing increased tumor-specific immunity," said Jeff T. Hutchins, Ph.D., vice president of preclinical research at Peregrine. "These data also show that when combined with downstream immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS targeting mediates an improved protective tumor-specific immunity following tumor rechallenge. While these new downstream checkpoint inhibitors have been shown to strengthen the tumor-killing activity of T-cells and thus extend survival in some patients, there remains a need to increase the number of responders that mount anti-tumor T-cell responses in order to maximize the effects of these downstream checkpoint inhibitors. We believe a PS-targeting antibody, such as bavituximab, plays a key role in reducing tumor suppression and driving a more inclusive immune-mediated response. Insights from these data will influence our future clinical development plans including the soon to be opened investigator-sponsored trial assessing the potential of bavituximab and an anti-CTLA-4 antibody in patients with advanced melanoma."

In a poster titled: "Targeting of Phosphatidylserine by Monoclonal Antibodies Enhances Activity of Immune Checkpoint Inhibitors in Tumors," scientists from Peregrine Pharmaceuticals, led by Bruce Freimark, Ph.D., director of pre-clinical research oncology, reported that animals treated with the PS-targeting antibody ch1N11, the preclinical equivalent to bavituximab, in combination with anti-CTLA-4 or anti-PD-1 in melanoma and colon cancer tumor models demonstrated greater delayed tumor growth and suppression than anti-CTLA-4 or anti-PD-1 alone. Results also showed that the combination with anti-CTLA-4 reduced M2 macrophages in the melanoma tumor model, an important cell type responsible for facilitating tumor growth and proliferation. In addition, in the preclinical melanoma model, the combination of ch1N11 with anti-CTLA-4 or anti-PD-1 antibody developed protective tumor-specific immunity to tumor re-challenge than either the anti-CTLA-4 or anti-PD-1 antibody alone. Lastly, results showed that the combination treatment of ch1N11 and anti-PD-1 led to a proportional increase in tumor infiltrating cytotoxic T-cells, while decreasing PD-L1 expression on tumor derived CD45 cells such as tumor, endothelial and stromal cells as compared to anti-PD-1 alone.

"We now have compelling evidence from these preclinical studies in multiple tumor models that PS-targeting antibodies mediate a fundamental immune-stimulatory shift in the tumor environment, facilitating increased antigen presenting cells as well as tumor-specific cytotoxic T-cells," said Peregrine's Dr. Freimark. "With the use of immunohistochemical staining, we have seen that tumors from animals treated with ch1N11 in combination with anti-PD-1 antibody showed faster and more complete T-cell and macrophage tumor infiltration rates, which correlate with decreased tumor cells, than anti-PD-1 alone. We look forward to further exploring the potential of the bavituximab with other immune checkpoint inhibitors."

In a poster titled: "Phosphatidylserine-Targeting Antibody Synergizes with anti-PD-1 Antibody to Inhibit Tumor Growth in K1735 Mouse Melanoma Model," researchers from the University of Texas Southwestern Medical Center summarized their findings that PS-targeting antibodies block PS-mediated tumor immunosuppression while reactivating tumor immunity at multiple levels. Specifically, results showed that a PS-targeting antibody repolarized tumor-associated macrophages (TAM) from an M2 to a M1-phenotype, decreased the presence of myeloid-derived suppressor cells (MDSC), promoted dendritic cell maturation into cells having the phenotype of functional antigen presenting cells and elicited antitumor T cell immunity. In addition, statistically signifcant differences were seen in T-cell mediating markers IL-2 and gamma-interferon with the ch-1N11 and PD-1 combination. Researchers concluded that the combination of bavituximab with the anti-PD-1 checkpoint blockade should synergistically induce potent long-lasting antitumor immunity.



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Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX)
announced that Phase 2 clinical results of Zerenex™ (ferric citrate coordination complex) in non-dialysis dependent chronic kidney disease (NDD-CKD) patients with elevated serum phosphorus and iron deficiency anemia has been selected as a Late Breaking oral presentation at the National Kidney Foundation 2014 Spring Clinical Meeting, taking place April 22-26, 2014 in Las Vegas, NV.

This presentation, entitled "Zerenex™ (Ferric Citrate) for the Treatment of Iron-Deficiency Anemia and Reduction of Serum Phosphate in Non-Dialysis Dependent CKD," will be made during the Late Breaking Session on Friday, April 25, 2014, from 9:30am - 11:00am PDT, by Dr. Geoffrey Block, Director of Clinical Research at Denver Nephrology and Co-Chairman for this study.

In addition to the late-breaking oral presentation, the following four abstracts have also been selected for poster presentation during the meeting.

* "Phosphorus Binding with Ferric Citrate is Associated with Fewer Hospitalizations and Reduced Hospitalization Costs," R. Rodby, poster number 422; * "Economic Impact of Ferric Citrate Versus Standard of Care for Hemodialysis Patients," S. Brunelli, poster number 156; * "Phosphorus Binding with Ferric Citrate Reduces Erythropoiesis-Stimulating Agent (ESA) and IV Iron Usage and Cost in Patients with ESRD," R. Rodby, poster number 415; and * "Oral Ferric Citrate Eliminates the Need for Intravenous (IV) Iron in Dialysis Patients," M. Sika, poster number 79.



Also Wednesday:



Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that the independent Data and Safety Monitoring Board (DSMB) for the company's ixCELL-DCM Phase 2b clinical trial has recommended continuing the study without modification as planned following an interim review of unblinded safety data from the trial.

Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, a biopharmaceutical company dedicated to the development and commercialization of novel therapies for patients with debilitating rare diseases, today announced that patient enrollment has been initiated in Japan in a clinical trial of lomitapide as an adjunct treatment to reduce low-density lipoprotein cholesterol (LDL-C) in Japanese patients with homozygous familial hypercholesterolemia (HoFH).

American CryoStem Corporation (OTCQB:CRYO)
, a leading biotechnology developer and global licensor of patented adipose tissue-based adult stem cell technologies, today announced that the Company has been selected as an "Incubator Company of the Year" by the New Jersey Incubation Network ("NJBIN").

Analogic Corporation (Nasdaq:ALOG)
, enabling the world's medical imaging and aviation security technology, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the handheld Sonic Window™ ultrasound system, an imaging device for visualizing vasculature and guiding peripheral intravenous access (PIV).

Analogic Corporation (Nasdaq:ALOG)
, enabling the world's medical imaging and aviation security technology, announced today that it has entered into a distribution agreement with D&K Technologies, developer of the BioJet™ Solution, a revolutionary 3D MRI transrectal ultrasound (TRUS) fusion technology.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported financial results for the fiscal 2014 third quarter ended February 28, 2014.

Brooks Automation, Inc. (Nasdaq:BRKS)
, a global provider of automated sample storage solutions to the Life Sciences industry, the University of Oxford and UK Biocentre announced today that Brooks has been selected to provide multiple automated sample management systems, which will form an integral part of a new Bioresource facility.

Caliber Imaging & Diagnostics (OTCQB:LCDX)
, formerly Lucid, Inc., has received the "Product of the Year 2013" Award from the German journal Aesthetic Dermatology for its VivaScope® system.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the appointment of M. Michelle Berrey, M.D., M.P.H. to the position of President and Chief Executive Officer.

CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that Trilochan Sahoo, M.D. FACMG, has recently joined the Company as Director of Cytogenetics.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
today announced that it has closed the previously announced underwritten offering of 2,857,143 shares of its common stock at a price to the public of $3.50 per share for gross proceeds of approximately $10.0 million.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
will host an Investor Meeting on Tuesday, May 6, 2014, at 9:00AM ET, in New York City.

Medgenics, Inc. (NYSE:MDGN) (AIM:MEDU) (AIM:MEDG)
, the developer of Biopump(TM) a novel technology for the sustained production and delivery of therapeutic proteins in patients using ex-vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that all resolutions proposed at the Company's Annual Meeting of Stockholders held yesterday were duly passed.

Medical Marijuana Inc. (OTC Pink:MJNA)
and HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and Medical Marijuana Inc.'s exclusive master distributor and contracted marketing company – proudly announces that Roger Hedgecock, considered the most conservative talk show host in the San Diego region, featured HempMedsPX™ on a recent broadcast of UT-TV's The Roger Hedgecock Show.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 33 countries, today announced that the company's Microcyn® Negative-Pressure Wound Therapy Solution™ received a "strong consensus" rating for use with Kinetic Concepts Inc.'s (KCI) Negative Pressure Wound Therapy with Instillation (NPWTi) as identified in the First International Consensus Guidelines.

The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ)
announced that trading of iKang Healthcare Group, Inc. (Nasdaq:KANG), the largest provider in China's fast growing private preventive healthcare services market, commenced on The NASDAQ Global Select Market on April 9, 2014.

The University of North Carolina at Charlotte and Premier, Inc. (Nasdaq:PINC) today announced a partnership aimed at helping care providers improve population health in communities nationwide.

QIAGEN N.V. (Nasdaq:QGEN) (Frankfurt:QIA)
today reconfirmed plans to release its report on results for the first quarter 2014 on Tuesday, May 6, at 22:00 Central European Time (CET) / 16:00 Eastern Time (ET).

RadNet, Inc. (Nasdaq:RDNT)
and the Kennedy Health System today announced a multi-faceted agreement to provide radiology services throughout southern New Jersey.

Tandem Diabetes Care®, Inc. (Nasdaq:TNDM)
and Capital Royalty Partners II, L.P. and its affiliate funds ("Capital Royalty") today announced that they have amended and restated the term loan facility under which the Company borrowed $30 million in January 2013.

Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP)
, a development stage pharmaceutical company, was spotlighted in the April 7, 2014 issue of BioCentury: The Bernstein Report on BioBusiness.

uniQure N.V. (Nasdaq:QURE)
, a leader in human gene therapy, today announced the appointment of Eric Goossens as its new Chief Operating Officer with a primary responsibility for manufacturing and project management.

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that more than 50,000 ClosureFAST catheters have been successfully reprocessed by its partner, Northeast Scientific, Inc. (NES), since Vascular Solutions launched the reprocessing service for the popular vein ablation catheters in January 2012.

Wellness Center USA, Inc. (OTCQB:WCUI),
a healthcare, medical, and security solutions provider, today announced the closing of its asset acquisition of Stealth Mark Holdings, Inc. (SMI).



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