April 6, 2012

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On May 15, 2012, the FDA Blood Products Advisory Committee will meet from 8:30 a.m. to approximately 5:00 p.m. to discuss the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test.

The meeting will take place at the Hilton Washington DC/North, 620 Perry Pkwy., Gaithersburg, MD, Tel: 1-301-977-8900 .

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made on or before May 8, 2012 by submitting them to:
Bryan Emery or Rosanna Harvey
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1277
FAX: 301-827-0294
or via e-mail: Bryan.Emery@fda.hhs.gov or email: Rosanna.Harvey@fda.hhs.gov

Oral presentations at the meeting from the public will be scheduled between approximately 1:30 p.m. and 3:15 p.m. Those individuals interested in making formal oral presentations should notify Bryan Emery or Rosanna Harvey on or before April 30, 2012, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. Those making a request to speak will be notified regarding their request by May 1, 2012.

For those unable to attend in person, the meeting will also be Webcast.

FDA intends to make background material available to the public on its Web site no later than 2 business days before the meeting. If FDA is unable to post the background material prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and be posted on FDA’s Web site after the meeting.

On May 16, 2012, in the afternoon, the committee will hear update presentations on HHS activities related to the evaluation of the blood donor deferral policy for men who have had sex with other men.

The notice and complete description of the May 15 and May 16 meetings is available on the FDA web site.

Please check the agency’s Web site and call the FDA Advisory Committee Information Line 1-800-741-8138 (301-443-0572  in the Washington, DC, area) code 3014512391 for up-to-date information on this meeting.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Bryan Emery or Rosanna Harvey at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings.

There is no cost or registration requirement to attend FDA advisory committee meetings.

Please note that FDA cannot be responsible for providing access to electrical outlets at the meeting.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDA Patient Network News, a twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

Abbott's hepatitis C combinations promising in phase II

Abbott Laboratories has reported encouraging data with two of its combination therapies for hepatitis C virus, which suggest it can achieve high cure rates in treatment-naïve patients.

The company said that the phase II trials indicate it is a step closer to achieving sustained virologic responses (SVR) after just 12 weeks of therapy using combinations of orally-active antiviral drugs and without any need for injectable interferon-based treatment.

The first study, known as Co-Pilot, looked at the combination of the HCV protease inhibitor ABT-450 (boosted with low-dose ritonavir) with ABT-333, a non-nucleoside HCV NS5B polymerase inhibitor, plus ribavirin in 50 HCV patients.

After 12 weeks' treatment, 93 to 95 per cent of patients who had not been treated earlier for HCV achieved an SVR, depending on the dose used.

The SVRs appeared to be independent of the HCV subtype or the patient's IL28B genotype, a factor which has been shown to affect a patient's response to HCV protease inhibitor drugs. For those who had not responded to earlier interferon-based therapy with SVR rate was 47 per cent.

The second study, called Pilot, studied the ritonavir-boosted ABT-450 given alongside another non-nucleoside HCV NS5B polymerase inhibitor called ABT-072 and ribavirin in 11 treatment-naïve HCV patients.

The trial found that 100 per cent of patients achieved an SVR at 12 weeks, with 91 per cent maintaining the response out to 24 weeks.

"We are extremely encouraged to see this level of sustained response with only 12 weeks of therapy in patients who were new to treatment, and to see a response in patients who had failed past treatment because options to cure this population are limited," commented Fred Poordad of Cedars-Sinai Medical Center in Los Angeles, US, who was the lead investigator for Co-Pilot and an investigator for Pilot.

Current treatments for HCV remain interferon-based and a significant number of HCV patients are unable or unwilling to take interferon due to contraindications and/or side effects, according to Abbott.

The company is racing to develop non-interferon-based HCV regimens against the likes of Vertex Pharma, Bristol-Myers Squibb, Gilead Sciences and Merck & Co.

The results are scheduled to be presented later this month at the European Association for the Study of the Liver (EASL) meeting in Barcelona, Spain.

Abbott's hepatitis C portfolio is expected to be one of the main assets of the company's pharmaceutical operations, which are due to be spun out into a new company called AbbVie later this year. Analysts have predicted peak sales for the portfolio upwards of $2bn a year.

Published: 05/04/2012

Source

Also See:

  1. In hepatitis C: Curing the incurable
  2. EASL 2012: Enanta Announces Positive Phase 2 Results From Interferon-Free Combination Studies with ABT-450 for Hepatitis C Treatment to be Presented at EASL
  3. EASL 2012: Abbott hepatitis drug 93% effective in small study
  4. EASL 2012: Abbott to Present Positive Phase 2 Results from Multiple Interferon-Free Studies of Combination Regimens for the Treatment of Hepatitis C
  5. EASL: Abbott and Enanta Present Positive 12-Week Results and 3-Day Resistance Data From Phase 2 Study of ABT-450/r for Treatment of Hepatitis C

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April 5, 2012

Contact: John Ascenzi, Children's Hospital of Philadelphia, 267-426-6055or ascenzi@email.chop.edu

Researchers have generated a new type of human stem cell that can develop into numerous types of specialized cells, including functioning pancreatic beta cells that produce insulin. Called endodermal progenitor (EP) cells, the new cells show two important advantages over embryonic stem cells and induced pluripotent stem cells: they do not form tumors when transplanted into animals, and they can form functional pancreatic beta cells in the laboratory.

Powerful new tool for modeling how diseases develop

“Our cell line offers a powerful new tool for modeling how many human diseases develop,” said study leader Paul J. Gadue, PhD, a stem cell biologist in the Center for Cellular and Molecular Therapeutics at The Children’s Hospital of Philadelphia. “Additionally, pancreatic beta cells generated from EP cells display better functional ability in the laboratory than beta cells derived from other stem cell populations.”

In addition to producing beta cells, the researchers also directed EP cells to develop into liver cells and intestinal cells—both of which normally develop from the endoderm tissue layer early in human development.

Gadue and colleagues are publishing their study Friday, April 6 in the journal Cell/Stem Cell.

Reprogramming human stem cells into EP cells

The researchers manipulated two types of human stem cells—embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs)—to become EP cells. Because both stem cell populations proliferate in great numbers and potentially generate all types of tissue, they offer enormous promise for scientists to precisely control cell development, both for the study of basic biology and for future cell-based treatments.

ESCs are derived from human embryos, typically unused embryos from fertility treatments that are donated for research purposes, while iPSCs are engineered from human somatic cells, such as skin cells or blood cells. Researchers have learned how to reprogram somatic cells to become pluripotent. Like ESCs, iPSCs are able to develop into many other types of human cells. However, when undifferentiated ESCs or iPSCs are transplanted in animal studies, they form teratomas, tumors containing many different cell types. Therefore, it has been critical that any cell type generated from ESCs or iPSCs and used for transplantation is stringently purified to exclude undifferentiated cells with tumor-forming potential.

In the current study, the researchers used signaling molecules called cytokines to steer ESCs and iPSCs into becoming EP cells, committed to developing into endoderm, one of the three tissue layers found in early human development. The EP cells have nearly unlimited potential for growth in the laboratory.

Benefits of EP cells

Both in cell cultures and when transplanted into animals, the study team showed that EP cells can differentiate into multiple cell types, representing those found in the liver, pancreas and intestine. Importantly, undifferentiated EP cells did not form teratomas in the team’s transplantation studies.

In cell culture, the researchers differentiated the EP cells into beta cells—insulin-expressing cells similar to those found in the pancreas. Those engineered beta cells passed an important test—when stimulated by glucose, they were able to release insulin, a function that is impaired or absent in patients with diabetes. While the cells achieved only 20 percent of normal function, this result is an improvement over that seen in similar cells derived directly from ESCs or iPSCs, which typically respond very poorly or not at all to glucose.

Future research directions

Gadue stressed that these promising early results are only the first steps in researching EP cells. Further work may focus on taking cells from individual patients with genetic forms of diabetes or liver disease to derive EP cell lines. The EP cell lines can then be used to model the development and progression of the patient’s disease and discover new therapies for that particular disease.

Finally, although applying this science to cell therapy is years away from practical clinical use, EP cells may offer a powerful starting point for developing tissue replacement treatments, such as supplying beta cells for diabetes patients or hepatocytes (liver cells) for patients with liver disease. “While more work is needed to characterize EP cells, they may offer a potential source of safe, abundant cells for future diabetes treatments,” said Gadue.

Study funding and authors

Financial support for this study came from the National Institutes of Health. Co-authors with Gadue included Deborah L. French, PhD, Xin Cheng, PhD, and Mitchell J. Weiss, MD, PhD, all of The Children’s Hospital of Philadelphia; Darrell Kotton, MD, of Boston University School of Medicine; and M. Cristina Nostro, PhD, of the McEwen Centre for Regenerative Medicine, Toronto, Canada.

More information

“Self-renewing Endodermal Progenitor Lines Generated from Human Pluripotent Stem Cells,” Cell/Stem Cell, published online, April 6, 2012. doi: 10.1016/j.stem.2012.02.024

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Hepatitis C assay important in patient diagnosis

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The Roche Elecsys anti-HCV II assay provides 100% clinical sensitivity for all known genotypes

Edited by the Laboratorytalk editorial team Apr 6, 2012

Roche has extended its serology panel to include a new generation Elecsys anti-HCV II

With an estimated 216,000 individuals chronically infected in the UK (England 161,000, Northern Ireland 4,000, Scotland 39,000, Wales 12,000), hepatitis C (HCV) remains a major public health problem; and HCV-related end stage liver disease and mortality continue to increase1

The Health Protection Agency states that it is necessary to sustain and enhance efforts to raise awareness, prevent new infections, increase diagnosis, and treat more individuals with infection.

The new Roche Elecsys anti-HCV II assay can play an effective part in this strategy, as it is used to demonstrate the presence of antibodies against HCV during acute and chronic stages of disease, and after a passed infection.

Due to the high rate of asymptomatic infections, clinical diagnosis of hepatitis C is difficult and screening assays are of major importance.

The Roche Elecsys anti-HCV II assay provides 100% clinical sensitivity for all known genotypes, leading to early detection of infection and patient-oriented decision making.

With high specificity in blood donors (99.84%) and samples from clinical routine, pregnant women and dialysis patients, use of the Elecsys anti-HCV II assay increases laboratory testing efficiencies.

To optimise workflows and provide operational cost savings, the ready-to-use liquid reagents have a long onboard stability of 31 days on all Roche immunoassay platforms.

The new assay complements the Roche serology assay menu that includes assays for Hepatitis A, Hepatitis B, Hepatitis C, HIV, TORCH, Herpes, Syphilis and other infectious diseases.

Source

DDW to be held May 19-22 in San Diego

Published on April 6, 2012 at 9:59 AM

Thousands of physicians, researchers and academics from around the world will gather in San Diego in May for Digestive Disease Week- (DDW), the premiere scientific conference in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

The latest research in the following GI health topics will be presented during the conference:

  • Technology/devices: capsule endoscope and narrow band imaging
  • Bowel disease: environmental risk factors and hormonal replacement therapy
  • Liver disease: transplantation, acetaminophen use and hepatitis disease progression
  • Colorectal cancer: colonoscopy versus computed tomography colonography
  • Drugs: telaprevir, statin therapy and treatments for ulcerative colitis

MyDDW is now open! Review the abstracts being presented during this year's meeting to begin planning your coverage at http://ddw.apprisor.org/plnWelcome.cfm?CFID=2387556&CFTOKEN=94264968. Please note that data being presented during DDW is embargoed until the time of presentation; visit the DDW website for the complete embargo policy - http://www.ddw.org/press/ddw-media-policies.

Numerous press conferences will be held during the meeting to present the most compelling research in the field. Each press event will be accessible to the media both in-person at the conference and via teleconference. To access to the latest news, research breakthroughs and leading researchers in the field, register to attend DDW this year.

DDW is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract.

WHEN:
May 19-22, 2012

WHERE:
San Diego Convention Center, CA

Source: Digestive Disease Week

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Lab Notes: HCV Vaccine on the Horizon

By MedPage Today Staff

Published: April 06, 2012

HCV Vaccine Possibly Within Reach

Researchers have identified a possible new target for the development of a vaccine against the hepatitis C virus (HCV).

Such a vaccine -- which could help control the growing global problem of HCV infection – has been difficult to come by because the virus's constant mutations have thwarted previous attempts to attack it.

Mansun Law, PhD, of the Scripps Research Institute, and colleagues identified a site on the viral envelope involved in fusing the virus to target cells that remains relatively stable, even among divergent strains. Using a technique called exhaustive panning, the researchers identified 73 new antibodies in patients with HCV infection that had neutralizing activity at that site.

One -- AR4A -- stood out from the rest, showing broad neutralizing ability for all 22 HCV strains tested in the lab. The antibody also protected mice from infection with two widely different strains of HCV.

The findings were reported in the Proceedings of the National Academy of Sciences.

-- T.N.

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Hepatitis C screening in jails could help combat epidemic

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Persons released from the criminal justice system may account for a substantial proportion of the 2.7 million to 3.9 million persons infected with HCV in the United States, say authors of a study recently published in JAMA.

Woodruff Health Sciences Center | April 6, 2012

A new Emory University study says screening for hepatitis C virus (HCV) infection in jail detainees could help combat the HCV epidemic in the United States.

According to the article, if 70 percent of approximately one million persons with HCV who pass through correctional facilities are offered HCV testing, and if 70 percent accept such an offer, HCV screening in detainees may lead to the identification of as many as a half million new cases of hepatitis C in the first year of the program. The findings were published in the March 28 issue of JAMA.

“Implementing opt-out HCV screening for persons incarcerated in jail should be seriously considered as a way to increase the number of persons nationwide who know their diagnosis,” says lead author Anne Spaulding, MD, MPH, assistant professor of epidemiology at Emory’s Rollins School of Public Health.

“Jails are an ideal setting for routine infectious disease screening and with new treatments that are curing a substantially greater number of people infected with HCV, there is real potential to reduce the number of cases across the US.”

According to the Centers for Disease Control and Prevention, HCV infection is the most common chronic blood borne infection in the United States and the leading indication for liver transplants. It estimates that at the turn of this century 16 to 41 percent of US inmates had serological evidence of prior HCV exposure and 12 to 35 percent had chronic infection.

The authors say this high prevalence of HCV, coupled with the fact that more than seven million individuals passed through jails and prisons each year in the late 1990s, suggested that persons released from the criminal justice system may account for a substantial proportion of the 2.7 million to 3.9 million persons infected with HCV in the United States.

“Currently, many people first learn they are infected when they go to prison to serve felony sentences. If they had found out about their infection years earlier during a brief jail stay, which most of them have experienced, they could have sought care in the community.”

Seeking treatment for patients while they are in the community could help ease the economic impact of HCV on prison systems.

“HCV prevalence is relatively low in community health centers and the costs associated with treating it will not overwhelm the community system,” explains Spaulding.

“To put the responsibility of treatment on a state prison system - which might need to treat 500 prisoner-patients because of the current high prevalence of HCV in that setting - could cost $25 million, a figure that easily overwhelms a prison system’s operating budget.”

Despite the benefits, Spaulding says there are challenges to public health agencies inviting jails to partner in the widespread implementation of HCV screening. For one, provision of medical screening and treatment is not the primary mission of short-term and long-term correctional facilities.

Jails are also challenged with high volumes of people and entrants may have insufficient time for the counseling and confirmatory testing that are optimal in HCV screening programs.

The authors say these challenges can be overcome, in part, by focusing efforts on detainees with a high pretest probability of having HCV, especially persons born between 1945 and 1965, the range of years that includes an estimated two-thirds of those individuals currently infected with HCV in the United States.

For the full article, please visit: http://jama.ama-assn.org/content/307/12/1259.full

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