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.

Among the various types of diseases, cancer remains one of the most leading causes of mortality that people are always suffering from and fighting with. So far, the effective cancer treatment demands accurate medical diagnosis, precise surgery, expensive medicine administration, which leads to a significant burden on patients, their families, and the whole national healthcare system around the world. In order to increase the therapeutic efficiency and minimize side effects in cancer treatment, various kinds of stimuli-responsive drug delivery systems and bioimaging platforms have been extensively developed within the past decades. Among them, the strategy of photoactivated approach has attracted considerable research interest because light enables the precise control, in a highly spatial and temporal manner, the release of drug molecules as well as the activation of bioimaging agents. In general, several appropriate photoresponsive systems, which are normally sensitive to ultraviolet (UV) or visible light irradiation to undergo the multiple reaction pathways such as photocleavage and photoisomerization strategy etc. have been mainly involved in the light activated cancer therapies. Considering the potential issues of poor tissue penetration and high photoctotoxicity of short wavelength light, the recently emerged therapies based on long-wavelength irradiation, e.g., near-infrared (NIR) light (700-1000 nm), have displayed distinct advantages in biomedical applications. The light irradiation at NIR window indicates minimized photodamage, deep penetration, and low autofluorescence in living cells and tissues, which are of clinical importance in the desired diagnosis and therapy. In this review article, we introduce the recent advances in light-activated drug release and biological imaging mainly for anticancer treatment. Various types of strategies such as photocage, photo-induced isomerization, optical upconversion, and photothermal release by which different wavelength ranges of light can play the important roles in the controlled therapeutic or imaging agents delivery, and activation will be systemically discussed. In addition, the challenges and future perspectives for photo-based cancer theranostics will be also summarized. For further resources related to this article, please visit the WIREs website.
© 2016 Wiley Periodicals, Inc.

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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.

To investigate the clinicopathologic characteristics and the prognostic impact of PIK3CA gene amplification in curatively resected esophageal squamous cell carcinoma (ESCC). Using 534 curatively resected ESCCs, the PIK3CA gene copy number was evaluated with fluorescent in situ hybridization. PIK3CA amplification was defined as PIK3CA/centromere 3 ratio is ≥ 2.0 or average number of PIK3CA signals/tumor cell nucleus ≥ 5.0. PIK3CA mutations in exon 9 and 20, encoding the highly conserved helical and kinase domains were assessed by direct sequencing in 388 cases. PIK3CA amplification was detected in 56 (10.5%) cases. PIK3CA amplification was significantly associated with higher T-stage (P=0.026) and pathologic stage (P=0.053). PIK3CA amplification showed a significantly shorter disease free survival (DFS) compared with that of non-amplified group (33.4 vs 63.1 months, P=0.019). After adjusting for gender, tumor location, pathologic stage, histologic grade and adjuvant treatment, PIK3CA amplification was significantly associated with a shorter DFS (adjusted hazard ratio [AHR] 1.53; 95% CI, 1.10-2.17; P=0.02). Though the statistical insignificance, PIK3CA amplification showed tendency of shorter OS (52.1 vs 96.5 moths, P=0.116). PIK3CA mutations were detected in 6 (1.5%) of 388 cases; 5 cases with exon 9 mutations in E545K while one exon 20 mutation in H1047L. PIK3CA amplification is a frequent oncogenic alteration and associated with shorter survival, suggesting its role as a prognostic biomarker in resected ESCC. PIK3CA amplification may represent a promising therapeutic target for ESCC.

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The National Cancer Institute (NCI), in conjunction with blinded university, provides a mechanism to enable public access to the study data, CT radiology images, and pathology images from the National Lung Screening Trial (NLST). Access to the data and images is through the NCI-sponsored, blinded university-hosted The Cancer Imaging Archive (TCIA), a repository of more than 40 study collections of cancer images. Once access to the NLST data has been granted by NCI, a Query Tool within TCIA is used to access the NLST data and images. The Query Tool is a simple-to-use menu-driven database application designed to quickly pose queries and retrieve/save results (from 53,452 NLST participants), download CT images (~20 million available), and view pathology images (~1200 available). NLST study data are contained in 17 Query Tool tables with ~370 variables to query. This paper describes Query Tool design, functionality, and usefulness for researchers, clinicians, and software developers to query data, save query results, and download/view images.

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