On April 21, 2016 – Medtronic (NYSE: MDT) reported the launch of the new BarrxTM 360 Express radiofrequency ablation (RFA) balloon catheter, which can help in the treatment of Barrett’s esophagus (Press release, Medtronic, APR 21, 2016, View Source;p=RssLanding&cat=news&id=2159148 [SID:1234511214]).

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The Barrx 360 Express catheter, with its self-adjusting circumferential RFA catheter, lets gastroenterologists and surgeons provide RFA treatment more easily and efficiently. RFA therapy removes diseased tissue while minimizing injury1 to healthy esophageal tissue. This treatment has been shown to reduce the risk of Barrett’s esophagus with low grade dysplasia — a precancerous condition that causes abnormal cell growth in the esophagus, progressing to high grade dysplasia or esophageal adenocarcinoma, a type of cancer — by approximately 90%.2

Esophageal cancer is the fastest-growing cancer in the U.S., having increased sixfold since the 1970s, outpacing breast cancer, prostate cancer and melanoma.3 Barrett’s esophagus, which affects more than 12 million American adults, develops as a result of chronic injury from gastroesophageal reflux disease (GERD).1,4

The new design helps physicians lower procedural time by up to 20 percent 2,5 by reducing procedural steps and enhanced ease-of-use features, including the ability to custom fit the device to various esophagus diameter sizes. With this tool, physicians are able to ablate Barrett’s tissue more efficiently. Using RFA to treat dysplastic Barrett’s tissue has been shown to reduce the risk for progression to high-grade dysplasia and esophageal adenocarcinoma,2,6 the most common type of esophageal cancer in the U.S.
"The biggest advantage of the Barrx 360 Express catheter is that it’s easier to use because of the larger, longer and adjustable balloon size," said Anthony Infantolino, MD, AGAF, FACG, FACP, of Thomas Jefferson University Hospital in Philadelphia. "These new features provide for a reduction in surgery time2,5 and the number of catheters required during RFA procedures, allowing me to concentrate on increasing the quality of the procedure."

"In reducing the progression of dysplastic Barrett’s esophagus to esophageal cancer, the launch of the Barrx 360 Express RFA balloon catheter underscores our commitment to patients," said Vafa Jamali, president, Early Technologies business in the Medtronic Minimally Invasive Therapies Group. "We believe patients and physicians will benefit from the easier-to-use technology of the Barrx 360 Express catheter, which provides a more precise delivery of RF energy to the targeted area."
The company is currently launching the Barrx 360 Express RFA balloon catheter in the United States. The catheter is also expected to be available in the EU, Australia and New Zealand in 2016.

BarrxTM 360 Express radiofrequency ablation (RFA) balloon catheter
Click the image for a larger image.

On April 21, 2016 Helocyte, Inc. a majority-owned subsidiary of Fortress Biotech, Inc. (NASDAQ: FBIO) focused on the acquisition, development and commercialization of novel immunotherapies for the prevention and treatment of cancer and infectious disease (and in particular, cytomegalovirus or "CMV"), reported several corporate and clinical milestones (Press release, Fortress Biotech, APR 21, 2016, View Source;FID=1500083994 [SID:1234511213]).

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In June 2015, Helocyte’s Board of Directors appointed Frank Taffy as President and Chief Executive Officer (and in December 2015, as an additional member of the Board). Mr. Taffy has more than fifteen years of experience in life sciences corporate development and business operations. He identified the Helocyte programs and co-founded the company during his role as Entrepreneur in Residence at Fortress Biotech. Mr. Taffy previously held the positions of Head (Senior Director) of Business Affairs at Forest Laboratories (now Allergan) and Director of Corporate Development at Life Technologies (now Thermo Fisher Scientific), where he also held Board positions on behalf of the company. Mr. Taffy began his career as Counsel for Intellectual Property at Procter & Gamble. He holds a J.D. from Syracuse University College of Law and a B.A. in biochemistry from the University of North Texas.

In June 2015, a Phase 2 study of Helocyte’s PepVax opened for enrollment. The randomized, placebo-controlled, multicenter trial will evaluate the potential of PepVax to reduce the frequency of CMV events in 96 recipients of allogeneic hematopoietic stem cell transplant. The study is supported by funding from the National Cancer Institute. For additional information on the Phase 2 study of PepVax, please visit: View Source

In November 2015, a Phase 2 study of Helocyte’s universal Triplex opened for enrollment. The randomized, placebo-controlled, multicenter trial will evaluate the potential of Triplex to reduce the frequency of CMV events in 115 recipients of allogeneic hematopoietic stem cell transplant. The study is also supported by funding from the National Cancer Institute. For additional information on the Phase 2 study of Triplex, please visit: View Source

In November 2015, the results of a Phase 1 study of Triplex were selected for presentation at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). Triplex is the first CMV immunotherapy that uses a recombinant Modified Vaccinia Ankara (MVA) vector incorporating multiple CMV response antigens. The Phase 1 study demonstrated the safety and marked immunogenicity of Triplex. The complete text of the ASH (Free ASH Whitepaper) abstract can be accessed at: View Source

In December 2015, the results of a Phase 1b study of PepVax were published in The Lancet Haematology. PepVax was observed to be well-tolerated, immunogenic and highly effective in controlling CMV in patients. To our knowledge, PepVax is the first immunotherapy to demonstrate proof of concept for CMV control in the post-transplant setting. PepVax further demonstrated the unexpected clinical outcomes of reduced relapse and increased survival (from underlying cancer). The full text of the Lancet publication can be accessed at: http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(15)00246-X/abstract.

On April 21, 2016 Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) reported that Phase 3 clinical trial data for VYXEOS (cytarabine:daunorubicin) Liposome for Injection (also known as CPX-351), its lead product candidate, will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 3-7, 2016 (Press release, Celator Pharmaceuticals, APR 21, 2016, View Source [SID:1234511211]).

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A late-breaking abstract on the Phase 3 clinical trial was selected for an oral presentation:

Date & Track Time:
Saturday, June 4, 2016 – 3:00pm to 6:00pm CT

Track:
Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Presentation Title:
Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML.

Presenter:
Jeffrey E. Lancet, M.D., H. Lee Moffitt Cancer Center & Research Institute

Abstract #:
7000

Presentation Time:
3:00pm to 3:12pm CT

Location:
Arie Crown Theatre

The aim of this study was to compare the performance of 2- (2D) and 3-dimensional (3D) quantitative computed tomography (CT) methods for classifying lung nodules as lung cancer, metastases, or benign.
Using semiautomated software and computerized analysis, we analyzed more than 50 quantitative CT features of 96 solid nodules in 94 patients, in 2D from a single slice and in 3D from the entire nodule volume. Multivariable logistic regression was used to classify nodule types. Model performance was assessed by the area under the receiver operating characteristic curve (AUC) using leave-one-out cross-validation.
The AUC for distinguishing 53 primary lung cancers from 18 benign nodules and 25 metastases ranged from 0.79 to 0.83 and was not significantly different for 2D and 3D analyses (P = 0.29-0.78). Models distinguishing metastases from benign nodules were statistically significant only by 3D analysis (AUC = 0.84).
Three-dimensional CT methods did not improve discrimination of lung cancer, but may help distinguish benign nodules from metastases.

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On April 21, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that data from three immuno-oncology studies will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will take place June 3 to June 7, 2016 in Chicago (Press release, Immune Design, APR 21, 2016, View Source [SID:1234511207]).

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The ASCO (Free ASCO Whitepaper) presentation details are as follows:

Pilot trial of intratumoral (IT) G100, a toll-like receptor-4 (TLR4) agonist, in patients with Merkel cell carcinoma (MCC): Final clinical results and immunologic effects on the tumor microenvironment (TME).

Abstract # 3021

Session Type: Poster Discussion Session
Session Title: Developmental Therapeutics—Immunotherapy

Date: Sunday, June 05
Time: 8 a.m. — 11:30 a.m. (poster session) / 4:45 p.m. — 6 p.m. (poster discussion)
Location: Hall A (poster session) / Hall B1 (poster discussion)
Poster Board: #343

Presenter: Shailender Bhatia, M.D., University of Washington, Fred Hutchinson Cancer Research Center

Using G100 (glucopyranosyl lipid A) to transform the sarcoma tumor immune microenvironment

Abstract #: 11017

Session Type: Poster Discussion Session
Session Title: Sarcoma

Date: Monday, June 6, 2016
Time: 8 a.m. — 11:30 a.m. (poster session) / 3 p.m. — 4:15 p.m. (poster discussion)
Location: Hall A (poster session) / S406 (poster discussion)
Poster Board: 143

Presenter: Seth M. Pollack, M.D., Fred Hutchinson Cancer Research Center

Single-agent LV305 induces anti-tumor immune and clinical responses in patients with advanced or metastatic sarcoma and other cancers expressing NY-ESO-1

Abstract # 3093

Session Type: Poster
Session Title: Developmental Therapeutics—Immunotherapy

Date: Sunday, June 5
Time: 8 a.m. — 11:30 a.m.
Location: Hall A
Poster Board: 415

Presenter: Neeta Somaiah, M.D. Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center

Additional data than those included in the abstracts may be included in the presentations.