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medical updates


Source: Mauna Kea Technologies
13 May 2010

Mauna Kea Technologies' Cellvizio Significantly Improves Biliary Cancer Detection Rates

Data announced in an oral presentation at Digestive Disease Week 2010

PARIS (May 13, 2010) — New data from a multi-centric international registry study show that cellular-level imaging with Mauna Kea Technologies' Cellvizio®, the world's smallest microscope, appears to significantly improve a physician's ability to diagnose or rule out early forms of bile duct cancer during a standard endoscopic diagnostic exam.

Lead investigator Yang K. Chen, MD, FACP, FASGE, AGAF announced preliminary results of the study during an oral presentation (Abstract #788c) at Digestive Disease Week 2010, which took place in New Orleans from May 1-5. The study also showed that investigators have standardized and validated the criteria (the "Miami Classification") by which they can interpret images captured by Cellvizio, the probe-based confocal laser endomicroscopy (pCLE) system, to identify or rule out potential malignancy in the bile and pancreatic ducts.

"By using the Cellvizio mini-probe, we can visualize the cells and vessels lining the bile ducts and pancreatic ducts – thus providing key cellular-level information we need to differentiate malignant and pre-malignant tissue in these difficult-to-reach areas," said Dr. Chen who is Director of the Digestive Health Center and Gastrointestinal Endoscopy Services, University of Colorado Hospital in Aurora, Colorado and Professor of Medicine, Division of Gastroenterology and Hepatology, University of Colorado Denver. "After nearly four decades of using conventional biopsy methods to diagnosis bile duct pathology, our ability to detect cancer is still less than 50% sensitivity. Using probe-based confocal endomicroscopy earlier in the diagnostic algorithm may help to overcome this quandary by allowing us to identify and treat patients with pancreaticobiliary disease more quickly and effectively."

Physicians enrolled more than 100 subjects in the ongoing longitudinal registry. As of February 2010, 52 of the patients qualified for inclusion in this preliminary analysis. Of the 52 patients, 39 (75%) had confirmed malignancy (25 cholangiocarcinomas and 14 other kinds of pancreatobiliary cancers).

Investigators used the Cellvizio system and Mauna Kea Technologies' CholangioFlex probe, which magnifies tissue up to 400 times its actual size, to gather 132 pCLE videos from the 52 subjects during standard Endoscopic Retrograde Cholangiopancreatography (ERCP) imaging procedures. These videos were then randomized, blindly assessed and scored using the standardized Miami Classification for image interpretation.

When investigators combined three criteria (especially epithelial structures, thick white bands, and dark clumps) in their image analysis, sensitivity reached 87% with a positive predictive value (proportion of patients with a positive test who are correctly diagnosed) of 83%. The best combination of Miami Classification image interpretation criteria for predicting malignancy will be determined at the end of the study.

Most studies on conventional bile duct biopsy techniques report an average follow up period of one year; this means that some patients with a negative biopsy may in fact have cancer that remained undetected because they did not reach one year of follow up. In this study a follow-up period of one year was required in all patients to confirm negative findings, and this portion of the study continues.

About Bile Duct Cancer (Cholangiocarcinoma)

Cholangiocarcinoma is a cancer of the bile ducts, which drain bile from the liver into the small intestine. The American Cancer Society (ACS) estimates that about 2,000 to 3,000 people in the U.S. develop bile duct cancer each year. Advanced bile duct cancer is associated with only a 2% five-year relative survival rate, according to the ACS. The prognosis improves when bile duct cancer is found earlier, however, current testing methods have been limited and obtaining an accurate diagnosis has been difficult to date.

About Cellvizio

Cellvizio, the world's smallest and most flexible microscope, is the first system designed to provide real time live images of internal human tissues at the cellular level during endoscopic procedures. This new method, known as probe-based Confocal Laser Endomicroscopy (pCLE), allows physicians to visualize an area of interest and use this information in the overall assessment of the patient's condition, which may aid in real-time treatment decisions. This new, advanced imaging technique helps physicians to detect abnormalities more effectively so patients may be treated earlier and may undergo fewer endoscopic procedures. Physicians and thought leaders at almost 100 top medical institutions around the world have completed over 4,000 of these procedures and have published more than 35 peer-reviewed papers on the technology in major medical journals. Cellvizio, which delivers up to 12 microscopic images per second and can be used with almost any endoscope, has premarket notification 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI and pulmonary tracts.

About Mauna Kea Technologies

Mauna Kea Technologies is a medical device company based in Paris, France. With its flagship Cellvizio systems, the company leads the growing endomicroscopy imaging market, enabling physicians to visualize, diagnose and treat directly inside the body in real time, pathologies that may not be seen using other imaging techniques. Investors include Psilos Group, Seventure and Creadev. For more information about Mauna Kea Technologies visit www.maunakeatech.com.

Media Contact:

Erich Sandoval / Lazar Partners Ltd.
E-mail: esandoval@lazarpartners.com / Tel: 917-497-2867

Source: Mauna Kea Technologies
30 November 2009

Cellvizio's in Vivo Microscopic Images Depict Easily-Recognizable Features of Malignant and Benign Tissues in Bile and Pancreatic Ducts

Preliminary Data From International, Multi-Centric Registry Presented During an Oral Presentation at GASTRO 2009

LONDON, Nov. 23, 2009 (GLOBE NEWSWIRE) -- Clinical investigators have defined a series of descriptive criteria which may improve how physicians interpret confocal microscopic images of tissue inside the bile and pancreatic ducts with Cellvizio(R), the world's smallest microscope. These findings are a result of the preliminary results of a multi-centric international registry study presented today during an oral presentation at the GASTRO 2009 conference, taking place in London, England from November 21-25. The investigators are currently evaluating those unique features on the larger set of data from the study to determine the predictive value of the criteria in determining malignancy.

"The tiny Cellvizio mini-probe easily fits into narrowing bile and pancreatic ducts and offers us clear, reproducible microscopic images with definable features of this suspicious tissue for the first time," said lead investigator Yang Chen, MD, FACP, FACG, Clinical Practice Director of the Division of Gastroenterology and Director of Endoscopy, the University of Colorado Hospital, Aurora, Colorado. "Once the full data analysis is complete, we will have a much greater understanding of how to properly interpret these in vivo microscopic images, so we can differentiate malignant from benign tissues in real time. Ultimately, we believe this new imaging tool will help us identify and treat patients with pancreaticobiliary disease more quickly and effectively, which is crucial given how fast pancreatic and bile duct cancers advance."

Tissue sampling techniques traditionally used to diagnose pancreatic or bile duct cancer are associated with low sensitivity, around 50 percent, which means nearly one out of two cancers are missed in this difficult to image area.

The Cellvizio ERCP registry study was a longitudinal registry of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) imaging procedures to investigate whether their bile and/or pancreatic ducts had narrowed into strictures because of cancer or inflammation. In this study, the Cellvizio mini-probe was used along with the ERCP procedure to offer physicians a microscopic-level view of the tissue lining these ducts so they could identify and document suspicious lesions, rather than take random tissue samples. A follow-up period of one year was included in the study to confirm negative findings.

In this preliminary analysis, 77 patients with indeterminate strictures in their bile or pancreatic ducts underwent an evaluation with the Cellvizio system during ERCP. Physicians were able to insert the mini-probe through a catheter or a cholangiopancreatoscope (CP) in all 77 patients. At the time of this presentation, 42 of the patients either had tissue confirmed malignant or had undergone a follow-up exam showing benign tissue more than three months after the initial procedure.

"We are encouraged by these interim results as we believe Cellvizio(R) is aiding physicians in identifying the cause of the stricture that is seen in the bile duct, and the interpretation criteria presented should help in documenting their diagnosis," said Sacha Loiseau, Founder, President and CEO of Mauna Kea Technologies. "We are committed to realizing Cellvizio's potential in ERCP clinical practice through our efforts to offer physicians an effective tool that complements current practice and that may improve how they diagnose and determine treatment for pancreaticobiliary and other gastrointestinal diseases."

Three additional United States (U.S.) sites (Beth Israel Deaconess Medical Center, Boston; New York Presbyterian Hospital/Columbia University Medical Center, New York; University of Pittsburgh Medical Center, Pittsburgh) and two European sites (Klinikum rechts der Isar, Munich, Germany; Insitut Paoli-Calmettes, France) are participating in the study, which ultimately enrolled 130 patients. Enrollment closed in early October, but follow up continues in the study and full results will be announced at a later date. This study was conducted under local IRB approval at each participating center, and each patient included in the study provided adequate informed consent.

About Pancreatic Cancer:

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Depending on the extent of the cancer at the time of diagnosis, the prognosis is generally regarded as poor; less than 5 percent of those diagnosed are still alive five years after diagnosis. Estimated new cases and deaths from pancreatic cancer in the U.S. in 2009: New cases: 42,470; Deaths: 35,240. In the United Kingdom (UK), pancreatic cancer is the fifth most common cause of cancer death. In 2007, more than 7,700 people in the UK died from pancreatic cancer. Worldwide, more than 230,000 people were diagnosed with pancreatic cancer in 2002, that latest year that worldwide statistics are available.

About Cholangiocarcinoma:

Cholangiocarcinoma is a cancer of the bile ducts, which drain bile from the liver into the small intestine. Cholangiocarcinoma has an annual incidence of 1-2 cases per 100,000 in the Western world, but rates of cholangiocarcinoma have been rising worldwide over the past several decades.

About Mauna Kea Technologies and Cellvizio:

Mauna Kea Technologies believes that in continuously pushing the limits of observation of life and by helping physicians design new medical references and guidelines, it can improve patient care and reduce healthcare costs. Its flagship product, Cellvizio(R), is the world's smallest and most flexible microscope and the first system designed to provide live, real-time images of internal human tissues at the cellular level during endoscopic procedures. This new, advanced imaging technique helps physicians more effectively assess the tissues of interest and differentiate normal versus abnormal tissues that may be indicative of cancer, so patients potentially can be treated earlier and may undergo fewer biopsies. Physicians and thought leaders at more than 60 top medical institutions around the world have completed over 3,000 of these procedures and have published more than 25 peer-reviewed papers on the technology in medical journals. Cellvizio has premarket notification 510(k) clearance from the United States Food and Drug Administration and the European CE-Mark for use in the gastrointestinal and pulmonary tracts. For more information visit www.maunakeatech.com.

CONTACT: Lazar Partners
Media Contact: Erich A. Sandoval 917-497-2867 esanodval@lazarpartners.com

First Standard Treatment Improves Survival for People with Advanced Biliary Tract Cancer

14 May 2009

Treatment with the drugs cisplatin (Platinol) and gemcitabine (Gemzar) increased survival and slowed cancer growth for people with biliary tract cancers (gallbladder and bile duct cancers) that could not be removed with surgery. Patients who received these two drugs were 32% less likely to die from the disease and 30% less likely to have the cancer grow than the patients who received only gemcitabine.

What this means for patients

“Based on these findings, we can now establish the first-ever standard of care for advanced biliary tract cancers. We found treatment with gemcitabine and cisplatin greatly slowed cancer growth and increased survival,” said lead author Juan Valle, MD, Senior Lecturer and Medical Oncologist at the University of Manchester and the Christie National Health Service Foundation Trust in Manchester in the United Kingdom.

The most common side effect that people in this study experienced was low white blood cell count, although it did not cause symptoms for most people.

Source: http://www.cancer.net/patient/ASCO+Resources/Research+and+Meetings/ASCO+Annual+Meetings/
Gastrointestinal+Cancers/First+Standard+Treatment+Improves+Survival+for+People+with+Advanced+Biliary+Tract+Cancer

Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial).

Author(s): J. W. Valle, H. S. Wasan, D. D. Palmer, D. Cunningham, D. A. Anthoney, A. Maraveyas, S. K. Hughes, M. Roughton, J. A. Bridgewater; Christie Hospital NHS Trust, Manchester, United Kingdom; Imperial College Healthcare Trust, London, United Kingdom; University of Birmingham , Birmingham, United Kingdom; Royal Marsden Hospital, London, United Kingdom; St. James' University Hospital, Leeds, United Kingdom; Castle Hill Hospital, Hull, United Kingdom; University College London, London, United Kingdom

Abstract:

Background: There is no established standard chemotherapy for pts with inoperable ABC. We previously reported an improvement in progression-free survival (PFS) in a randomised phase II trial of 86 pts (ABC-01) using gemcitabine/cisplatin (GemCis) vs. gemcitabine (Gem) (Valle ASCO-GI 2006, abstr. 98). This study was extended into ABC-02, a phase III trial, to recruit a further 314 pts with overall survival (OS) as the primary end-point. Methods: Consenting pts with histologically/cytologically-confirmed ABC, aged ≥18 years, ECOG performance status 0 - 2, and adequate haematological, hepatic and renal function were randomised to receive either Cis (25 mg/m2) followed by Gem (1000 mg/m2 D1, 8 q21d) for 8 cycles, or Gem alone (1000 mg/m2 on D1, 8, 15 q28d) for 6 cycles, stratified by extent of disease, site of primary tumour, ECOG score and centre. The trial had an 80% power to detect an OS hazard ratio of 0.73.

Results: From May 2005 to October 2008, 324 pts were randomised to ABC- 02 from 34 UK centres. We report the pre-planned combined analysis of ABC-01 and ABC-02 based on 410 pts (GemCis=206/Gem=204). Patient characteristics: median age 64 yrs (range 23-85); male (47%); metastatic disease (75%), locally advanced (25%); gallbladder (36%), bile duct (59%), ampulla (5%); and ECOG 0-1 (87%), 2 (12%). With a median follow-up of 6.1 months and 263 deaths, the median OS was greater with GemCis than Gem, 11.7 vs. 8.2 months (log rank p=0.002), with hazard ratio 0.68 (95%-CI 0.53, 0.86). The median PFS was greater with GemCis than Gem, 8.5 vs. 6.5 months (log rank p=0.003), with hazard ratio 0.70 (95%-CI 0.56, 0.88).Toxicity was similar between the arms (by week 12, 57% had a grade 3/4 toxicity in each arm), though there was a slight excess of neutropenia using GemCis. Conclusions: This is the largest ever study in ABC and demonstrates a clear survival advantage for GemCis without added clinically significant toxicity, setting a new international standard of care.

Source: http://www.abstract.asco.org/AbstView_65_30777.html

Study Shows that Ginger Can Reduce Nausea from Chemotherapy

People with cancer who received ginger supplements along with drugs that lower nausea and vomiting, called antiemetics, reported less nausea from chemotherapy than patients who did not receive a ginger supplement. Patients took the ginger supplements three days before starting chemotherapy. In this study, the 0.5 gram (g) and 1.0 g doses reduced nausea the most.

What this means for patients

“As many as 70% of patients who receive chemotherapy have nausea and vomiting. We found that patients who received traditional antinausea drugs along with ginger supplements before chemotherapy had less nausea associated with their chemotherapy,” said lead author Julie Ryan, MD, PhD, Assistant Professor of Dermatology and Radiation Oncology at the University of Rochester in Rochester, New York. “However, as with all supplements, patients should speak with their doctors before taking ginger.”

Source: http://www.cancer.net/patient/ASCO+Resources/Research+and+Meetings/ASCO+Annual+Meetings/
Complementary+and+Alternative+Medicine+(CAM)/Study+Shows+that+Ginger+Can+Reduce+Nausea+from+Chemotherapy

New Treatment For Hepatocellular Carcinoma - Liver Tumors

September 22, 2008 - 10:46 AM

Results of new research from Zurich have been published in a paper in Digestion, Vol. 78, No. 1, 2008, entitled "Chemoembolization Combined With Pravastatin Improves Survival In Patients with hepatocellular carcinoma". The authors explain:

"Pravastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, has been shown to inhibit growth and to induce apoptosis in human hepatocellular carcinoma (HCC) cells. However, the potential benefit of pravastatin in HCC patients has still not been characterized, which prompted us to test the efficacy of pravastatin in patients with advanced HCC."

The results showed that by adding chemoembolization (TACE) to the drug treatment, patients nearly doubled survival from 12 months to 21 months. Although not a cure, a doubling of survival shows the benefits of chemoembolization which delivers a chemotherapy drug directly to the solid tumor in the liver rather than sweeping the entire body with chemotherapy. The use of chemoembolization and radioembolization to liver tumors has been very successful in Europe and Dr. Andrew Kennedy at Wake Radiology in Cary, NC has published significant papers on radioembolization using SIR spheres.

Patients with primary liver tumors, intrahepatic cholangiocarcinoma, or with metastatic tumors from colorectal cancer (mCRC) can benefit by these treatments which make dangerous surgical resection - often determined to be impossible in these cases - unnecessary.

Digestion - International Journal of Gastroenterology, Vol. 78, No.1, 2008

Source: http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ArtikelNr=156702&Ausgabe=239999&ProduktNr=223838

Leptin enhances cholangiocarcinoma cell growth

Cancer Res. 2008 Aug 15; 68(16):6752-61

Fava G, Alpini G, Rychlicki C, Saccomanno S, DeMorrow S, Trozzi L, Candelaresi C, Venter J, Di Sario A, Marzioni M, Bearzi I, Glaser S, Alvaro D, Marucci L, Francis H, Svegliati-Baroni G, Benedetti A Department of Gastroenterology, UniversitÓ Politecnica delle Marche, Ancona, Italy. giammarcofava@hotmail.com Cholangiocarcinoma is a strongly aggressive malignancy with a very poor prognosis. Effective therapeutic strategies are lacking because molecular mechanisms regulating cholangiocarcinoma cell growth are unknown. Furthermore, experimental in vivo animal models useful to study the pathophysiologic mechanisms of malignant cholangiocytes are lacking. Leptin, the hormone regulating caloric homeostasis, which is increased in obese patients, stimulates the growth of several cancers, such as hepatocellular carcinoma. The aim of this study was to define if leptin stimulates cholangiocarcinoma growth. We determined the expression of leptin receptors in normal and malignant human cholangiocytes. Effects on intrahepatic cholangiocarcinoma (HuH-28) cell proliferation, migration, and apoptosis of the in vitro exposure to leptin, together with the intracellular pathways, were then studied. Moreover, cholangiocarcinoma was experimentally induced in obese fa/fa Zucker rats, a genetically established animal species with faulty leptin receptors, and in their littermates by chronic feeding with thioacetamide, a potent carcinogen. After 24 weeks, the effect of leptin on cholangiocarcinoma development and growth was assessed. Normal and malignant human cholangiocytes express leptin receptors. Leptin increased the proliferation and the metastatic potential of cholangiocarcinoma cells in vitro through a signal transducers and activators of transcription 3-dependent activation of extracellular signal-regulated kinase 1/2. Leptin increased the growth and migration, and was antiapoptotic for cholangiocarcinoma cells. Moreover, the loss of leptin function reduced the development and the growth of cholangiocarcinoma. The experimental carcinogenesis model induced by thioacetamide administration is a valid and reproducible method to study cholangiocarcinoma pathobiology. Modulation of the leptin-mediated signal could be considered a valid tool for the prevention and treatment of cholangiocarcinoma.

PMID: 18701500 [PubMed - in process]

Source: http://www.biowizard.com/pmabstract.php?pmid=18701500

Bold cancer therapy begins crucial trials
In human test, world may soon know if the hype about nanoshells was deserved

By ERIC BERGER Copyright 2008 Houston Chronicle
July 31, 2008, 12:40AM

The buzz surrounding gold nanoshells, a radical new approach to treating cancer, began shortly after their creation in Houston a decade ago.

The work by Rice University scientists prompted U.S. Rep. John Culberson, a nanotechnology enthusiast whose district includes Rice, to declare that cancer was "cured." And when the National Institute of Cancer announced a massive influx of funding into nanotechnology -- the control of matter on the atomic and molecular scale -- nanoshells became its poster child.

But cancer hasn't been cured, and drugs touted as magic bullets litter the history of cancer research. So what of nanoshells? Are they all sizzle, no substance?

It's a question that's not yet answerable but may be soon. Without fanfare, the Houston company formed to develop nanoshells, Nanospectra Biosciences, has just begun its first human clinical trial, treating a patient with head and neck cancer.

The company hopes to heat nanoshells in the tumor with near-infrared light, burning the cancerous growth away.

For the company and for Houston, the trial marks a big step.

Nanoshells -- tiny spheres of glass coated with gold -- are the first engineered nanomaterial to enter into human trials. And discoveries made in Houston labs are typically developed by biotechnology firms elsewhere, such as Boston or San Diego.

"I'm thrilled," said Naomi Halas, the Rice chemist who created nanoshells in 1997 and realized a few years later their potential to treat cancer. "There's no question it's been a long road, but we always knew it was going to be that way."

The road for any potential medical therapy from a basic science lab into a hospital is always a long and tortuous one.

After conceiving a use for a new technology, a scientist must jump numerous hurdles to reach clinical trials: find medical collaborators, get research funding, obtain venture capital funding, find biotech professionals to create a company that will manufacture the new device or drug, run countless animal tests and finally get U.S. Food and Drug Administration approval for human tests.

And that's just the big stuff, not the countless details.

"Unfortunately, the development of drugs and devices is not at all an efficient process," said Dr. Robert Bast, vice president for translational research at The University of Texas M.D. Anderson Cancer Center.

Classified as a 'device'

On average, it takes nine to 15 years to bring a drug from the laboratory into the clinic, Bast said.

Nanoshells have a key advantage, however. The FDA has classified them a "device" rather than a "drug," because gold does not react with the body. Devices are subject to a streamlined approval process.

It's easy to find drugs that will kill cancer cells. The difficulty has always been twofold: running the drugs past the body's immune system, and then selectively delivering the lethal compounds only to cancer cells and not healthy tissues.

Nanoshells appear to meet both criteria. The body's immune system ignores nanoshells. And because of their tiny size -- about half that of the smallest bacteria -- they're typically only ingested by cancer cells.

That's because the blood vessels that "feed" tumor cells are generally larger and more leaky than healthy cells' blood vessels, allowing nanoshells to slip in.

About 24 hours after an IV injection of nanoshells, tests have shown, about 1 percent of them accumulate in tumors while most of the rest wash out of the body.

Potential 'amazing'

That provides a critical mass for the next phase of treatment. Because of their design, nanoshells are incredibly efficient at absorbing near-infrared light, which isn't visible and normally passes harmlessly through the body.

But when shined over a tumor laden with nanoshells, the tiny devices absorb the energy, heat up and fry the tumor.

"The therapeutic potential has always been amazing," said Jennifer West, a Rice bioengineer who initially worked with Halas to develop nanoshells as a cancer therapy. "In all of the animal studies, from mice through dogs, we've seen tremendously high rates of tumor regression."

The next step, of course, is the biggest one. Of drugs that begin human clinical trials, only 11 percent actually receive FDA approval. The odds are also long for devices.

In the first trials, nanoshells will be used to target head and neck cancers. But there's a reasonable chance they can be used to treat a wide variety of tumors, Halas said.

Iron-core nanoshells

M.D. Anderson researchers John Hazle and R.J. Stafford, for instance, are employing a variety of approaches in an effort to make nanoshells a viable treatment for a range of cancers.

One of their methods, which was announced this week, uses nanoshells with iron in their core. This allows magnetic resonance imaging, or MRI, to track the accumulation of nanoshells throughout the body.

This permits Hazle and Stafford to ensure that nanoshells accumulate only in tumors and not healthy tissues.

In other M.D. Anderson tests of dogs with brain cancer, the nanoshells destroyed tumors without harming the animals' brains.

"There's a lot of potential here, but as of right now. nanoshells aren't yet a panacea for all cancer," Hazle said. "We're going to need to find better delivery and better targeting techniques."

Source: http://www.chron.com/disp/story.mpl/front/5916620.html

FDA Approves EOVIST(R) To Detect And Characterize Focal Liver Lesions
Article Date: 09 Jul 2008 - 2:00 PDT

Bayer HealthCare Pharmaceuticals Inc., a leader in diagnostic imaging, announced that the U.S. Food and Drug Administration (FDA) has approved EOVIST(R) (Gadoxetate Disodium) Injection, a gadolinium-based contrast agent, for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease. The approval makes EOVIST the first organ-specific MRI contrast agent approved in the United States in more than a decade.

"The approval of EOVIST in the United States marks a significant achievement in advancing the accurate diagnosis of liver disease," said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals. "This milestone demonstrates Bayer HealthCare Pharmaceuticals' commitment to providing innovative imaging products that can help improve the lives of patients."

EOVIST is a paramagnetic MRI contrast agent that combines features of both an extracellular contrast agent and a hepatocyte-specific agent. EOVIST is administered via an intravenous, bolus injection and has a dual route of excretion with approximately 50 percent eliminated through the liver and 50 percent eliminated through the kidney. Detection and characterization of malignant and benign focal liver lesions with EOVIST may help enhance diagnostic accuracy and increase diagnostic confidence.

"EOVIST-enhanced images can provide more comprehensive information about focal liver lesions in a single, short imaging session than was previously available," said Jeffrey Brown, MD, Professor of Radiology, Washington University School of Medicine, St. Louis. "With the availability of EOVIST, our ability to evaluate patients with benign and malignant focal hepatic lesions will be improved."

The American Cancer Society estimates that 21,370 new cases of primary liver cancer and intrahepatic bile duct cancer will be diagnosed in the United States during 2008, and the incidence of liver cancer continues to increase.(1) Earlier staging of primary tumors with metastases in the liver, such as colon cancer, may improve treatment decisions and, hence, the survival rate. This year, approximately 110,000 new cases of colon cancer will be diagnosed in the United States.(2)

Stefanelli continued, "With EOVIST and Nexavar, Bayer HealthCare Pharmaceuticals is uniquely positioned to help healthcare professionals detect and treat liver cancer." Nexavar(R) (sorafenib), an oral anticancer medicine called a kinase inhibitor, is approved for use in patients with unresectable hepatocellular carcinoma (HCC).

EOVIST is marketed by Bayer HealthCare affiliates outside the United States as Primovist and in Japan as EOB Primovist. It was first approved in 2004 in Europe, and with this FDA approval, is now approved in more than 40 countries.

Clinical Trials Summary

Eight-hundred sixteen (816) patients with suspected or known focal liver lesions were enrolled in two of four non-randomized, intrapatient-controlled studies that evaluated predominantly the detection (Studies one and two) or morphological characterization (Studies three and four) of liver lesions. Studies one and two ("detection" studies) enrolled patients who were scheduled for liver surgery. MRI results were compared to a reference standard that consisted of surgical histopathology and the results from intra-operative ultrasound of the liver. The studies assessed the sensitivity of pre-contrast MRI and EOVIST-contrasted MRI for the detection of liver lesions when each set of images was compared to the reference.

Studies three and four ("characterization" studies) enrolled patients with known or suspected focal liver lesions, including patients who were not scheduled for liver surgery. MRI results were compared to a reference standard that consisted of surgical histopathology and other prospectively defined criteria. The studies assessed the correctness of liver lesion characterization by pre-contrast MRI and EOVIST-contrasted MRI when each set of images was compared to the reference. Lesions were characterized as one of the following choices: hepatocellular carcinoma, cholangiocarcinoma, metastasis, focal lymphoma, adenoma, focal nodular hyperplasia, hemangioma, abscess, focal liver fibrosis, regenerative nodule, focal fat, hydatid cyst, liver cyst, "not assessable," normal, no lesion or "other."

In all four studies, patients underwent a baseline, pre-contrast MRI followed by the administration of EOVIST at a dose of 0.025 mmol/kg body weight, with MRI performed immediately (the "dynamic" phase) and at 10 to 20 minutes following EOVIST administration (the "hepatocyte" phase). Patients also underwent computerized tomography with contrast examinations of the liver. Pre-contrast MRI and EOVIST-contrasted MR images were evaluated in a systematic, randomized, paired and unpaired fashion by three radiologists who were blinded to clinical information. Computed tomography (CT) images were also evaluated by the radiologists in a separate reading session.

EOVIST was generally well-tolerated during the trials. The safety database was based on EOVIST exposure in 1,755 adult subjects who received a dose that ranged from 0.003 to 0.5 mmol/kg body weight; the majority (N=1,365) received the recommended dose of 0.025 mmol/kg body weight.

Overall, 4.3% of subjects reported one or more drug-related adverse reactions during a follow-up period that, for most subjects, extended more than 24 hours after EOVIST administration. These adverse reactions were predominantly of mild to moderate severity. Serious adverse events were reported among six patients and were attributed to underlying conditions or non-MRI procedures. All serious events occurred more than 10 hours following EOVIST administration. The most common adverse reactions at the recommended dose were feeling hot, nausea, headache, injection site reaction (pain, burning, coldness, extravasation), dysgeusia (taste abnormality), flushing, parosmia (smell abnormality), dizziness and vomiting.

About EOVIST(R)

EOVIST is the first gadolinium-based, liver-specific MRI contrast agent approved in the United States. EOVIST enhances the T1-weighted signal. Compared to other extracellular fluid gadolinium-chelate contrast agents, EOVIST exhibits a low-level binding to plasma proteins. The resulting higher relaxivity accounts for the lower dose. The recommended dose of EOVIST is 0.1 mL/kg body weight (0.025 mmol/kg body weight). Based on its structural properties, EOVIST is partially taken up by liver cells, thus enhancing healthy liver tissue (parenchymal enhancement). Lesions with no or minimal hepatocyte function (e.g., cysts, metastases, the majority of hepatocellular carcinomas) will remain unenhanced and will therefore be more readily detected and localized. EOVIST provides useful diagnostic information at the time immediately after contrast administration (dynamic imaging) and, thus, also supports lesion characterization (i.e., distinction of malignant and benign types of liver lesions). EOVIST is marketed by Bayer HealthCare affiliates outside the United States as Primovist(R) and in Japan as EOB Primovist, and is approved in more than 40 countries, including the United States.

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents increase the risk of Nephrogenic Systemic Fibrosis in patients with:

  • acute or chronic severe renal insufficiency (glomerular filtration) rate <30 mL/min/1.73 m2), or
  • acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

In these patients, avoid the use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.

As with other contrast media, the possibility of serious or life- threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered. The most common adverse reactions observed in clinical trials at the recommended dose included feeling hot, nausea and headache.

Source: http://www.medicalnewstoday.com/articles/114315.php

Comprehensive Clinic For Gastrointestinal Cancers Opens At Rush University Medical Center, USA
Article Date: 19 Jul 2008 - 0:00 PDT

Patients benefit from a team approach at the new Coleman Foundation Comprehensive Clinic for Gastrointestinal Cancers at Rush University Medical Center. Experts in gastroenterology, medical oncology, surgery, radiation oncology, pathology and psychosocial oncology as well as nutrition and genetics come together to meet with new patients and develop a defined treatment plan.

This comprehensive clinic dedicated totally to the care of patients that are at risk of, or diagnosed with, gastrointestinal cancers, provides patients with one center for all of their care.

The clinic is one of the few places in the Chicago area to provide a full spectrum of care for patients with gastrointestinal cancers.

"Our team works with each patient to create an individualized treatment plan that offers the latest diagnostic capabilities as well as leading-edge treatment options," said Dr. Sohrab Mobarhan, clinical director. "At the end of a thorough meeting, patients walk away knowing that there is a well-defined treatment plan designed to meet their specific needs."

The clinic provides preventive services and the latest diagnostic and treatment services for all types of gastrointestinal cancers including such cancers as tumors of the colon, rectum, pancreas, esophagus, stomach, small intestine, anus, gallbladder, bile ducts and liver.

Preventive and screening services include colonoscopies to prevent colon and rectal cancer, upper endoscopies to screen for esophageal cancer and Barrett's esophagus, and radiofrequency ablation therapy to prevent esophageal cancer. In addition, genetic counseling, in which family histories are reviewed, and testing are also available to determine an individual's risk for gastrointestinal cancers.

The clinic has access to the most advanced diagnostic and treatment services available, which include interventional endoscopy, radiological testing, multi-detector CT imaging, positron emission tomography (PET), MRIs, image-guided radiotherapy, electron and electron-arc therapy, interstitial brachytherapy and intensity-modulated radiotherapy.

As part of the comprehensive nature of the clinic, a dedicated gastrointestinal cancer nurse is available to answer patient questions, coordinate all appointments, procedures and tests to ensure patients receive quality care in a timely manner.

In addition, Rush is committed to helping patients and their families cope with the psychological, emotional and spiritual effects of cancer. In partnership with the American Cancer Society, Rush offers a patient navigator to assess individual patient needs and provide information about available treatments, community services and programs.

Through Rush's Cancer Integrative Medicine Program, patients have access to therapies that complement their medical treatments, such as acupuncture, biofeedback, nutritional and herbal counseling, massage and yoga.

The Comprehensive Clinic for Gastrointestinal Cancers is also available to provide individuals who have previously been diagnosed with second opinion services.

For more information, or to make an appointment, call (312) 942-2700.

The Coleman Foundation Comprehensive Clinic for Gastrointestinal Cancers was made possible in part by a grant from the Coleman Foundation. In recognition of a $5 million grant, all of the medical center's comprehensive cancer programs, or clinics, are named for The Coleman Foundation.

www.rush.edu

Article can be found at: http://www.medicalnewstoday.com/articles/115286.php

Cellvizio(R) Confocal Microscopy improves ERCP bile duct cancer detection, according to new study presented at DDW
Checkbiotech.org article published on May 19, 2008
SAN DIEGO - Doctors may now be able to better diagnose cancer of the bile ducts, one of the most difficult cancers to detect and treat, according to a new study presented today at the Digestive Disease Week(R) (DDW) 2008 conference. The 14-patient clinical trial (Abstract S1161) evaluated the ability of Mauna Kea Technology's Cellvizio(R) confocal microscopy system to detect cancer in biliary tract tissue by examining tissue at the cellular level during Endoscopic Retrograde Cholangiopancreatography (ERCP), a procedure used to diagnose cancer of the bile ducts and pancreas.

Dr. Alexander Meining and colleagues of the Technical University of Munich conducted the study and found that Cellvizio predicted cancer with an accuracy rate of 91.7%, which was superior to the 76.9% accuracy rate of histopathological analysis of biopsied tissue taken from strictures. Usually, the preoperative diagnosis of cancer of the bile ducts, medically known as cholangiocarcinoma, is associated with a low accuracy rate.

"Cellvizio represents a promising diagnostic imaging approach for the detection of cancer even in small ducts such as the biliary system," Dr. Meining said. "This new tool could be of utmost importance as cholangiocarcinoma remains one of the cancers with the poorest prognosis. We believe the potential for improved accuracy of diagnosis is due to the real- time, cellular-level images the technology provides on benign and malignant biliaro-pancreatic strictures."

At the conference, Mauna Kea debuted a specially designed miniprobe enabling its Cellvizio(R) GI System to be used with ERCP. Sacha Loiseau, Ph.D., president and CEO of Mauna Kea Technologies, said: "We now offer mini probes that can enable in vivo microscopy in virtually all segments of the gastrointestinal tract. We have received significant interest from the medical community in our ERCP probe and look forward to working closely with leading experts in the field to expand the body of data validating its utility in improving detection of pancreatic and bile duct cancer."

Cellvizio is the first and only confocal microscopy system that is compatible with most endoscopes. It can also be used with various advanced endoscopic modalities, such as narrow band imaging and autoflorescence imaging, and has 510(k) clearance from the Food & Drug Administration and the European CE-Mark for use in the gastrointestinal and pulmonary tracts. Over 1,000 Cellvizio procedures have been completed to date.

The full article can be viewed here: http://www.checkbiotech.org/orphan_News_treatmentandhealth.aspx?infoId=3379

Hepatitis B tied to bile duct cancer outside liver
Reuters Health article published on April 15, 2008
NEW YORK (Reuters Health) - The results of a study published in the International Journal of Cancer suggest there is an association between hepatitis B virus (HBV) infection and an increased risk of extrahepatic bile duct cancer.

The extrahepatic bile duct collects bile from the liver, but is located outside of the liver. It joins with another duct coming from the gallbladder to form the common bile duct, which carries bile to the small intestine. Cancers of the extrahepatic bile duct are unusual and very difficult to treat.

In a population-based study conducted in Shanghai, Dr. Ann W. Hsing, of the National Cancer Institute, Bethesda, Maryland, and colleagues examined the prevalence of HBV and hepatitis C infection in 417 patients with biliary tract cancers, 517 with biliary stones, and 762 randomly selected healthy comparison subjects.

Among the population controls, HBV infection was detected in 7.3 percent. Patients with extrahepatic bile duct cancer were more likely to test positive for HBV (14.2 percent). This, in turn, resulted in a 2.4-fold increased risk of extrahepatic bile duct cancer.

There was no significant association between HBV and gallbladder cancer, bile duct stones and gallbladder stones.

The team found a low prevalence of HCV infection in this population (2 percent), which limited the ability to estimate the association between this infection and biliary disease.

HBV induces liver cancer primarily by causing chronic inflammation and tissue destruction with regeneration of liver cells, Hsing's team notes. A similar process may be involved in bile duct cancers," they suggest.

SOURCE: International Journal of Cancer, April 15, 2008.

The full article can be viewed here: http://uk.reuters.com/article/healthNews/idUKTON67440620080416

Combining liver cancer treatments doubles survival rates, UVA researchers find
eureckalert.org article published on April 15, 2008
Charlottesville, Va. By combining the use of stents and photodynamic therapy, also called SpyGlass, physicians at the University of Virginia have been able to significantly increase survival rates for patients suffering from advanced cholangiocarcinoma, cancer of the liver bile duct.

Most patients who develop this type of cancer cannot have surgery as it is diagnosed at such a late stage, so there was not much we could do except offer them palliative care, said University of Virginia Gastroenterologist Michel Kahaleh, M.D., lead investigator of the study. By combining therapies, we saw an improved survival rate from just more than 7 months to more than 16 months.

In the study, recently published in the March 2008 issue of Clinical Gastroenterology and Hepatology, 48 patients were treated with advanced cholangiocarcinoma over a five year period. Twenty-nine patients were treated with biliary stents, with the remaining 19 being treated with the stents and photodynamic therapy (PDT). The stents decompress the bile ducts, maintaining liver function. The combined therapy group received treatment every three months, at which time all stents were replaced.

The combined therapy group had survival rates of 16.2 months compared to the stent-only groups 7.4 months. Mortality rates in the group that received PDT was 0, 16, and 56 percent at three, six, and 12 months respectively. Mortality rates in the stent-only group were 28, 52, and 82 percent respectively. Kahaleh said the number of stent-replacement procedures and PDT sessions were the only factors which significantly impacted survival.

Photodynamic Therapy treatment uses a photosensitizing agent (porfimer sodium in this study) which is activated using light of a specific wavelength, which then kills the targeted cells. PDT has been used for more than a decade to destroy cancer cells and reduce tumor size.

Cancer of the liver bile ducts is the second most common liver cancer and has significant mortality and mortality. Of the approximately 2,000 cases diagnosed each year, the vast majority of patients survive up to three months without intervention or four to six months with decompression treatment.

Stents alone do not destroy or shrink the tumors or cancer cells. We were not surprised that the combined therapy offers a significant benefit to the patient, as this is accepted treatment in Europe, said Kahaleh. However the FDA (Food and Drug Administration) wants to see more data so we have completed what we believe is the first published comparative American study on the treatment.

Kahaleh hopes to begin a multi-center trial within six months.

The full article can be viewed here: http://www.eurekalert.org/pub_releases/2008-04/uovh-clc041508.php

Bone Metastasis: Cryoablation may ease cancer pain in bones
MSNBC article reported on November 27, 2007
Freezing tumors may help relieve the extreme pain of cancer that has spread to the bone, which is often untouched by narcotics or radiation, U.S. researchers said on Tuesday. This freezing process, called cryoablation, is often used to destroy kidney, prostate and other tumors, but researchers at the Mayo Clinic in Rochester, Minn., found it eased cancer pain in 80 percent of patients in a small study, and the effect lasted for up to six months.

The full article can be viewed here: http://www.msnbc.msn.com/id/21998072/

High Intensity Focused Ultrasound (HIFU) Clinical Trials in UK for Kidney and Liver Tumors
BBC Reported on November 19, 2007
Scientists at the University of Oxford are trying to harness the energy released when bubbles collapse as a way of killing off cancer cells. They have built a device to beam waves of ultrasound into the body, generating bubbles at the site of a tumour. When these bubbles "pop", they release energy as heat - killing rogue cells. The UK team plans to apply its new technique in clinical trials; it will be used in treating patients with kidney and liver tumours. These clinical trials of High Intensity Focused Ultrasound (Hifu) are being conducted at the Churchill Hospital in Oxford.

The full article can be viewed here: http://news.bbc.co.uk/2/hi/science/nature/7101622.stm

Cannabidiol (CBD) May Stop the Metastasis of Brain and Breast Cancers
BBC Article reported on November 19, 2007
A compound found in cannabis may stop breast cancer spreading throughout the body, US scientists believe. The California Pacific Medical Center Research Institute team are hopeful that cannabidiol or CBD could be a non-toxic alternative to chemotherapy.  CBD works by blocking the activity of a gene called Id-1 which is believed to be responsible for the aggressive spread of cancer cells away from the original tumour site - a process called metastasis.

The full article can be viewed here: http://news.bbc.co.uk/2/hi/health/7098340.stm

Medtronic Receives FDA Marketing Clearance for Complete SE Biliary Stent System
Medtronic Press Release on November 15, 2007

Medtronic, Inc. (NYSE: MDT), announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the Complete SE (self-expanding) Biliary Stent System, which is indicated for use in the palliative treatment of malignant neoplasms in the biliary tree – cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids.

Full article can be viewed here: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1195067517214&lang=en_US

How Radio Waves Can Kill Cancer
ZD Net Reported on November 5, 2007
Scientists at Rice University and the M.D. Anderson Cancer Center in Houston are injecting carbon nanotubes into tumors, then hitting the tumors with radio waves.

Full article can be viewed here: http://healthcare.zdnet.com/?p=430

Combination of Surgery and Radiation Gives Early Survival Advantage in Bile Duct Cancer
Science News Reported on October 31, 2007
Oregon Health & Science University researchers are reporting the discovery of an early survival advantage when a combination of surgery and radiation therapy is used for patients with a rare but deadly bile duct cancer.

Full article can be viewed here: http://www.sciencedaily.com/releases/2007/10/071028135814.htm

Italian Researchers Find New Way to Catch Bile Duct Cancer
China View News reported on November 1, 2007
Italian researchers have found a way to catch one of the rarest but deadliest cancers early enough to save more lives, according to Italian News Agency ANSA.   A team from the universities of Rome and Ancona have found a marker in human bile they claim can identify bile-duct cancer before surgery. The marker is called Insulin-Like Growth Factor-1,or IGF1 for short.   "IGF1 is able to give a definitive diagnosis of bile-duct cancer and marks it out with absolute accuracy from benign diseases of the bile ducts like stones or inflammation," said Domenico Alvaro of Rome's La Sapienza University.

Full article can be viewed here: http://news.xinhuanet.com/english/2007-11/01/content_6986333.htm

Human Genome Sciences Reveals New Options, Promising Results for Chemo Patients
Vitabeat Reported on October 24, 2007

Human Genome Sciences announced on Wednesday that its study on HGS-ETR2 (lexatumumab) proved that it was safe and well tolerated in combination with four different standard chemotherapy regimens in a Phase 1b clinical trial in patients with a wide range of cancer types. Adverse responses were reported for two patients, and stable disease was observed in 22 patients. The trial was the first reported human study of an antibody to TRAIL receptor 2 in combination with chemotherapy.

Full article can be viewed here: http://www.vitabeat.com/human-genome-sciences-reveals-new-options-promsiing-results-for-chemo-patients/v/7154/

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cholangiocarcinoma, or bile-duct (bile duct) cancer, arises from the tissues in the bile duct.