Georgetown Researchers Lead Discovery Expected To Significantly Change Biomedical Research

Main Category: Biology / Biochemistry

Also Included In: Pharma Industry / Biotech Industry;  Cancer / Oncology

Article Date: 21 Dec 2011 – 0:00 PST

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In a major step that could revolutionize biomedical research, scientists have discovered a way to keep normal cells as well as tumor cells taken from an individual cancer patient alive in the laboratory – which previously had not been possible. Normal cells usually die in the lab after dividing only a few times, and many common cancers will not grow, unaltered, outside of the body.

This new technique, described today online in the American Journal of Pathology, could be the critical advance that ushers in a new era of personalized cancer medicine, and has potential application in regenerative medicine, says the study’s senior investigator, Richard Schlegel, M.D., Ph.D., chairman of the department of pathology at Georgetown Lombardi Comprehensive Cancer Center, a part of Georgetown University Medical Center.

“Because every tumor is unique, this advance will make it possible for an oncologist to find the right therapies that both kills a patient’s cancer and spares normal cells from toxicity,” he says. “We can test resistance as well chemosensitivity to single or combination therapies directly on the cancer cell itself.”

The research team, which also includes several scientists from the National Institutes of Health, found that adding two different substances to cancer and normal cells in a laboratory pushes them to morph into stem-like cells – adult cells from which other cells are made.

The two substances are a Rho kinase (ROCK) inhibitor and fibroblast feeder cells. ROCK inhibitors help stop cell movement, but it is unclear why this agent turns on stem cell attributes, Schlegel says. His co-investigator Alison McBride, Ph.D., of the National Institute of Allergy and Infectious Diseases, had discovered that a ROCK inhibitor allowed skin cells (keratinocytes) to reproduce in the laboratory while feeder cells kept them alive.

The Georgetown researchers – 13 investigators in the departments of pathology and oncology – tried ROCK inhibitors and fibroblast feeder cells on the non-keratinocyte epithelial cells that line glands and organs to see if they had any effect. They found that both were needed to produce a dramatic effect in which the cells visibly changed their shape as they reverted to a stem-like state.

“We tried breast cells and they grew well. We tried prostate cells and their growth was fantastic, which is amazing because it is normally impossible to grow these cells in the lab,” Schlegel says. “We found the same thing with lung and colon cells that have always been difficult to grow.”

“In short, we discovered we can grow normal and tumor cells from the same patient forever, and nobody has been able to do that,” he says. “Normal cell cultures for most organ systems can’t be established in the lab, so it wasn’t possible previously to compare normal and tumor cells directly.”

The ability to immortalize cancer cells will also make biobanking both viable and relevant, Schlegel says. The researchers further discovered that the stem-like behavior in these cells is reversible. Withdrawing the ROCK inhibitor forces the cells to differentiate into the adult cells that they were initially. This “conditional immortalization” could help advance the field of regenerative medicine, Schlegel says.

However, the most immediate change in medical practice from these findings is the potential they have in “revolutionizing what pathology departments do,” Schlegel says.

“Today, pathologists don’t work with living tissue. They make a diagnosis from biopsies that are either frozen or fixed and embedded in wax,” he says. “In the future, pathologists will be able to establish live cultures of normal and cancerous cells from patients, and use this to diagnose tumors and screen treatments. That has fantastic potential.”

This research was funded by grants from the National Institutes of Health, Department of Defense fellowship funding, and an internal grant from Georgetown Lombardi’s Cancer Center Support Grant from the National Cancer Institute.

Georgetown University and the National Institutes of Health have filed two patent applications on technologies described in this paper. The inventors for the patent application related to immortalization of non-keratinocyte technology described in this paper which is jointly owned by Georgetown and NIH include Schlegel, Xuefeng Liu and Alison McBride. Sandra Chapman and McBride are co-inventors on a separate patent application filed by the National Institutes of Health related to keratinocyte technology described in this paper.

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Georgetown University Medical Center. “Georgetown Researchers Lead Discovery Expected To Significantly Change Biomedical Research.” Medical News Today. MediLexicon, Intl., 21 Dec. 2011. Web.
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FDA’s Gobburu Joins University Of Maryland School Of Pharmacy Faculty

Main Category: Pharmacy / Pharmacist

Also Included In: Regulatory Affairs / Drug Approvals

Article Date: 21 Dec 2011 – 1:00 PST

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Joga Gobburu, PhD, MBA, FCP, a leading U.S. Food and Drug Administration (FDA) scientist for more than a decade, has joined the faculty of the University of Maryland School of Pharmacy, where he will establish a research and education program in the emerging field of pharmacometrics.

Pharmacometrics measures and evaluates existing information on a given drug, a disease, and experiments, including clinical trials, to lay the groundwork for strategic decisions on drug regulation and/or drug development.

Gobburu explains: “Pharmacometrics quantifies all the information generated from hundreds of experiments conducted to develop a drug petri dish, animal, human trials, etc. In this [drug] development process, you end up with siloed information. Pharmacometrics, together with translational medicine, transforms the ‘siloed’ information into intelligence to support decisions.”

The emerging field is cutting into an enormously expensive 98 percent failure rate of drug development experiments. “To learn from the failures, you must look at the failures and improve. It is the equivalent of business intelligence for R&D,” says Gobburu. “We can sometimes use these approaches to gain further insights into the clinical trials thereby alleviating the need for additional clinical trials. So it cuts down the number of clinical trials, making the approval faster and conducting smaller studies.”

“We are very excited to have the opportunity to expand our clinical science faculty and expertise” saysMagaly Rodriguez de Bittner, PharmD, CDE, FAPhA, professor and chair of the Department of Pharmacy Practice and Science. “Dr. Gobburu brings national and international recognition to the Department and the School of Pharmacy. In addition, with Dr. Gobburu’s joint appointment in the Department of Medicine at the School of Medicine we will have the opportunity to increase collaboration among the two departments.”

Gobburu joined the FDA in 1999 as a pharmacometrics reviewer, became team leader in 2005, and director in 2007. He was appointed senior biomedical research scientist at the FDA. Under his direction, a division of pharmacometrics was formed at the FDA and several policies were established. In that division, he established standardized disease databases.

Thomas Laughren, MD, director of FDA’s Division of Psychiatry Products, says, “We will miss him greatly. However, the standards he has implemented will continue, and I know he will make major contributions in his new roles at the University of Maryland.”

Gobburu is eager to stretch the already high standards of the graduates from the School of Pharmacy, which is one of the leading pharmacy schools in the United States. “There is a gap in academic institutions in [pharmacometrics],” he says. U.S. pharmacy school graduates today “do not understand drug development well. They know the theory of how to perform an analysis, how to interpret an experiment, write a report. But they do not know the business of drug development. To me, in order for a scientist to be influential, he or she should know the environment.”

Gobburu wants his graduates to know the principles of negotiations and leadership in the field. “I want to create the world’s most useful pharmacometrics and translational medicine program. I would like to produce scientific leaders in this field,” he says.

Ivan Nestorov, PhD, director of pharmacometrics at the pharmaceutical firm Biogen-Idec, says, “Within any scientific discipline, there are very few individuals who are capable of grasping, developing, and promoting both the fundamental methodology and its practical applications. Joga turned out to be one of those individuals in the discipline of pharmacometrics. With his bold concepts, deep insights, and unrelenting energy, he was able to win the recognition of the discipline in the regulatory world. Now, as an academic, he will undoubtedly bring a new impetus and novel directions to the development and implementation of the pharmacometric methodology and the training of professionals in the field.”

Gobburu obtained a BPharm and an MSc in chemistry from the Birla Institute of Technology and Science in Pilani, India, in 1992. He earned a PhD in pharmaceutical sciences from North Dakota State University in 1996 and completed two postdoctoral fellowships, one at the University at Buffalo, the State University of New York; and another at the Center for Drug Development Science, Georgetown University in Washington, D.C., and the FDA. Most recently, he received an MBA from Johns Hopkins University.

He has received numerous FDA awards such as the Outstanding Achievement Award. In 2008, he received the Outstanding Leadership Award from the American Conference on Pharmacometrics and the Tanabe’s Young Investigator Award from the American College of Clinical Pharmacology. Gobburu is on the editorial boards of the journal Clinical Pharmacology & Therapeutics and the Journal of Clinical Pharmacology. He has published more than 60 papers and book chapters, and has directed the doctoral research of two graduate students and mentored 16 postdoctoral fellows. He is a frequent speaker at national and international scientific conferences.

Although a young discipline, pharmacometrics has helped industry make the drug development decisions, and thus processes, more efficient. “We have put tools together because FDA has access to all the application data,” Gobburu says. “For example, we built a pharmacometrics disease model and published it in a peer reviewed journal so all the industry can now use that tool to guide their efforts. It’s a free service.”

He said he also was attracted to the University of Maryland School of Pharmacy because of the opportunity to train future leaders on pharmacometrics and translational medicine. He devoted himself to the discipline at FDA “because I believe in it. I saw value in it. And, I was lucky to get support for scientists there to work on it. But I was thinking ‘what if I did it full time?’. My goal is not only to create a program but to create an institute for translational medicine including experts from across the University and solve problems of mutual interest that can have a bearing on public health; how drugs are used in hospitals, and the way they are developed.”

“With Dr. Gobburu’s vast experience in clinical trial design, the School of Pharmacy is demonstrating its commitment to improving the drug development and regulation process,” says Natalie D. Eddington, PhD, FAAPS, FCP, professor and dean of the School of Pharmacy. “As a leader in the field of pharmacometrics, Dr. Gobburu’s expertise will enhance our educational and research programs and will lead to substantial partnerships with the pharmaceutical industry and other collaborators.”

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Article adapted by Medical News Today from original press release. Source: University of Maryland Baltimore

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University of Maryland Baltimore

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University of Maryland Baltimore. (2011, December 21). “FDA’s Gobburu Joins University Of Maryland School Of Pharmacy Faculty.” Medical News Today. Retrieved from
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UCF Nanotechnology May Speed Up Drug Testing

Main Category: Pharma Industry / Biotech Industry

Article Date: 21 Dec 2011 – 0:00 PST

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Testing the effectiveness of new pharmaceuticals may get faster thanks to a new technique incorporating quantum dots developed at the University of Central Florida.

Some drug testing can take a decade or more, but UCF associate professor Swadeshmukul Santra and his team have created an electronic quantum dots (Qdots) probe that “lights up” when a drug it is delivering attaches to cancer cells. The research appears online in this month’s Biomaterials.

A researcher can use a microscope to see where and how much of the drug has been delivered because the probe emits a reddish color under special lighting or via MRI because of its optical and magnetic components.

As the drug testing continues, images can be taken over and over without any loss of optical or MRI signal. Researchers can then measure the size of the tumor and number of cancer cells that “light up” compared with the original untreated tumor.

This provides a way to determine whether the drug is doing what it is supposed to be doing in the targeted areas. The technique is much easier than the current process of removing treated cancer tumors and weighing them at regular intervals to determine the drug’s efficiency in an animal.

“Many people in my area have been studying this approach for years,” Santra said. “But we have now moved it into a live cell, not just in test tubes.”

Sudiptal Seal, the director of UCF’s NanoScience Technology Center and nanoscience scientist believes Santra’s research is significant.

“This is indeed a major breakthrough in Qdot research,” Seal said. “This new diagnostic tool will certainly impact the field of nanomedicine.”

Santra and his team used semiconductor Qdots to create the probe. Because of their small size and crystal-like structure, Qdots display unique optical and electronic properties when they get excited. These unique properties make them ideal for sustained and reliable imaging with special lights.

For this research funded by the National Science Foundation and National Institutes of Health, the UCF-led team used a superparamagnetic iron oxide nanoparticle core decorated with satellite CdS:Mn/ZnS Qdots which carried the cancer-fighting agent STAT3 inhibitor. The Qdot optical signal turned on when the probe bonded with the cancer cells.

“The potential applications for drug testing specifically for cancer research are immediate,” Santra said.

Collaborators on the research included: Andre J. Gesquiere also of UCF, James Turkson of the University of Hawaii, Glenn A. Water of the University of Florida and Patrick T. Gunning from the University of Toronto.

Santra has his own team of students and scientists at the UCF NanoScience Technology Center, which has been studying nanotechnology, quantum dots and their applications for years. The team focuses on the engineering of nanomaterials for bioimaging and sensing, drug delivery and anti-microbial applications.

Santra joined UCF in 2005 after working as a research assistant professor at the University of Florida. He has a Ph.D. from the Indian Institute of Technology Kanpur and served as a postdoctoral fellow at the University of Florida. He has written dozens of articles and book chapters on nanoscience and nanotechnology. Santra also holds eight US patents in nano-bio and biomedical fields.

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APA
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During Pregnancy, Majority Of B.C. Women Take Prescription Drugs

Main Category: Pregnancy / Obstetrics

Also Included In: Pharmacy / Pharmacist;  Anxiety / Stress;  Sleep / Sleep Disorders / Insomnia

Article Date: 20 Dec 2011 – 0:00 PST

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Almost two-thirds of women in British Columbia filled at least one prescription at some point in their pregnancy, including drugs with potential risks, according to a new study by University of British Columbia researchers.

The study, published online in the journal Clinical Therapeutics, is the first of its kind in Canada. Researchers analyzed population-based outpatient prescription claims data for patterns of prescription drug use during pregnancy in B.C. from 2001 to 2006.

The researchers found that 63.5 per cent of pregnant women in B.C. filled at least one prescription. One in thirteen – or 7.8 per cent – filled a prescription for a medicine known to be risky in pregnancy – most often for select medicines for anxiety, insomnia and depression. Drugs that are strictly contraindicated in pregnancy, however, were filled in less than 0.5% of pregnancies.

“Although much remains to be understood about the appropriateness of medicine use that actually occurs among pregnant women in B.C., one encouraging finding from our study is that existing use of medicines with known risks declines dramatically when women become pregnant,” says co-author Steve Morgan, an associate professor in the School of Population and Public Health (SPPH) and Associate Director of the Centre for Health Services and Policy Research (CHSPR).

On average, pregnant women filled 2.6 different types of drugs, while 15 per cent used five or more prescription medications during their pregnancy. Prescriptions most frequently filled during pregnancy were for antibiotics (30.5 per cent), respiratory drugs (25.7 per cent), dermatologics (13.4 per cent), and drugs that act on the nervous system (12.8 per cent).

Other study findings include:

  • The use of medicines in pregnancy slightly increased over time, going from 63 per cent of women in 2001 to 66 per cent in 2006.
  • Women aged 20 years or younger were most likely to take prescription drugs during pregnancy (69 per cent) while the lowest rate occurred among those aged 30 to 35 years (62 per cent).
  • Prescription medication use was also high in the first three months immediately following delivery, a period when women may be breastfeeding, with 61.3 per cent of women filling prescriptions.

“Since pregnant women are normally excluded from clinical trials of new drugs and post-market study is limited, there is little evidence on the risks and benefits of many of the most commonly used drugs in pregnancy,” says lead author Jamie Daw, a researcher at CHSPR, part of SPPH. “Given the prevalence of prescription drug use, more research is needed to help pregnant women and their physicians make informed decisions.”

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APA
University of British Columbia. (2011, December 20). “During Pregnancy, Majority Of B.C. Women Take Prescription Drugs.” Medical News Today. Retrieved from
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During Pregnancy, Majority Of B.C. Women Take Prescription Drugs

Main Category: Pregnancy / Obstetrics

Also Included In: Pharmacy / Pharmacist;  Anxiety / Stress;  Sleep / Sleep Disorders / Insomnia

Article Date: 20 Dec 2011 – 0:00 PST

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Almost two-thirds of women in British Columbia filled at least one prescription at some point in their pregnancy, including drugs with potential risks, according to a new study by University of British Columbia researchers.

The study, published online in the journal Clinical Therapeutics, is the first of its kind in Canada. Researchers analyzed population-based outpatient prescription claims data for patterns of prescription drug use during pregnancy in B.C. from 2001 to 2006.

The researchers found that 63.5 per cent of pregnant women in B.C. filled at least one prescription. One in thirteen – or 7.8 per cent – filled a prescription for a medicine known to be risky in pregnancy – most often for select medicines for anxiety, insomnia and depression. Drugs that are strictly contraindicated in pregnancy, however, were filled in less than 0.5% of pregnancies.

“Although much remains to be understood about the appropriateness of medicine use that actually occurs among pregnant women in B.C., one encouraging finding from our study is that existing use of medicines with known risks declines dramatically when women become pregnant,” says co-author Steve Morgan, an associate professor in the School of Population and Public Health (SPPH) and Associate Director of the Centre for Health Services and Policy Research (CHSPR).

On average, pregnant women filled 2.6 different types of drugs, while 15 per cent used five or more prescription medications during their pregnancy. Prescriptions most frequently filled during pregnancy were for antibiotics (30.5 per cent), respiratory drugs (25.7 per cent), dermatologics (13.4 per cent), and drugs that act on the nervous system (12.8 per cent).

Other study findings include:

  • The use of medicines in pregnancy slightly increased over time, going from 63 per cent of women in 2001 to 66 per cent in 2006.
  • Women aged 20 years or younger were most likely to take prescription drugs during pregnancy (69 per cent) while the lowest rate occurred among those aged 30 to 35 years (62 per cent).
  • Prescription medication use was also high in the first three months immediately following delivery, a period when women may be breastfeeding, with 61.3 per cent of women filling prescriptions.

“Since pregnant women are normally excluded from clinical trials of new drugs and post-market study is limited, there is little evidence on the risks and benefits of many of the most commonly used drugs in pregnancy,” says lead author Jamie Daw, a researcher at CHSPR, part of SPPH. “Given the prevalence of prescription drug use, more research is needed to help pregnant women and their physicians make informed decisions.”

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Article adapted by Medical News Today from original press release. Click ‘references’ tab above for source.

Visit our pregnancy / obstetrics section for the latest news on this subject.
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University of British Columbia. “During Pregnancy, Majority Of B.C. Women Take Prescription Drugs.” Medical News Today. MediLexicon, Intl., 20 Dec. 2011. Web.
20 Dec. 2011. <http://www.medicalnewstoday.com/releases/239374.php>


APA
University of British Columbia. (2011, December 20). “During Pregnancy, Majority Of B.C. Women Take Prescription Drugs.” Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/239374.php.

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New Light On Medicinal Benefits Of Plants

Main Category: Biology / Biochemistry

Also Included In: Genetics;  Pharma Industry / Biotech Industry

Article Date: 19 Dec 2011 – 0:00 PST

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Scientists are about to make publicly available all the data they have so far on the genetic blueprint of medicinal plants and what beneficial properties are encoded by the genes identified.

The resources, follow a $ 6 million initiative to study how plant genes contribute to producing various chemical compounds, some of which are medicinally important.

“Our major goal has been to capture the genetic blueprints of medicinal plants for the advancement of drug discovery and development,” said Joe Chappell, professor of plant biochemistry in the University of Kentucky College of Agriculture and coordinator for the Medicinal Plant Consortium (MPC).

Project partner Dr Sarah O’Connor at the John Innes Centre will now work with her research group towards the first full genetic sequence of a medicinal plant and will also experiment with combining beneficial properties from different plants to create the first new-to-nature compounds derived from plants. A priority focus will be compounds with anticancer activity.

“Fewer and fewer new drugs have been successfully making it to the marketplace over the last 10 years, in large part because of a reliance on chemical synthesis for making new chemicals,” said Chappell.

“Somehow in our fast-track lives, we forgot to take advantage of the lessons provided by Mother Nature. That is all changing now with the recognition that two-thirds of all currently prescribed drugs can be traced back to natural sources and the development of resources such as those in the MPC to facilitate new drug discovery activities.”

Some well-known medicines have come from plants. The once ubiquitous foxglove gives us the cardiac muscle stimulant digoxin. The periwinkle plant offers a source for the widely used chemotherapy drugs vincristine and vinblastine. These and many other medicinal plants, often commonly found in household gardens and flower boxes, harbour a wealth of compounds ripe for medicinal applications.

“Just as the sensory properties of plants interact with and trigger your sense of smell, plants’ natural compounds can target and cause a reaction within your body. This gives them tremendous pharmaceutical potential,” said Chappell.

During this two-year project researchers set out to develop a collection of data that would aid in understanding how plants make chemicals, a process called biosynthesis. This knowledge ultimately could make it possible to engineer plants to produce larger quantities of medicinally useful compounds as well as different versions with other therapeutic potential.

To develop the resources, the researchers studied the genes and chemical profiles of 14 plants known for medicinal properties or compounds with biological activity. These included plants such as foxglove, ginseng, and periwinkle. The findings will help researchers discover how nature’s chemical diversity is created and enable them to uncover new drug candidates or increase the efficacy of existing ones.

“The current understanding of molecules and genes involved in the formation of beneficial compounds is very incomplete,” said O’Connor, who is also a lecturer in chemical sciences at University of East Anglia.

“However, the ability to conduct genome-wide studies of model plant species has resulted in an explosive increase in our knowledge of and capacity to understand how genes control biological processes and chemical composition”.

The MPC project includes participants from the University of Kentucky, Michigan State University, Iowa State University, the University of Mississippi, Purdue University, Texas A&M University, Massachusetts Institute of Technology, and the John Innes Centre in Norwich. The researchers represent a broad spectrum of expertise from plant biology and systematics to analytical chemistry, genetics and molecular biology, and drug development from natural products.

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More information about the MPC and the resources provided are available at the following websites:
http://medicinalplantgenomics.msu.edu;
http://metnetdb.org/mpmr_public/.

Funding was provided by the National Institutes of Health (NIH) and the American Recovery and Reinvestment Act (ARRA
Norwich BioScience Institutes
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Boehringer Ingelheim Completes Patient Entry For Phase III Trial Programme In Hepatitis C

Main Category: Liver Disease / Hepatitis

Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry

Article Date: 19 Dec 2011 – 1:00 PST

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Boehringer Ingelheim announced that the final patient has been randomised to treatment in the large-scale Phase III clinical trial programme for BI 201335, its investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).

The extensive study programme is underway at more than 350 sites in 15 countries and together encompasses nearly 2,000 treatment-experienced as well as treatment-naïve patients. Key regions in the programme include the European Union, Japan, U.S., Canada, Taiwan, Korea and Russia.

The programme consists of three Phase III trials, that will be conducted to evaluate BI 201335 plus the standard backbone treatment, pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. Most HCV patients are infected with genotype-1 virus and belong to the most challenging HCV group to treat. The study programme evaluates “sustained viral response” (SVR) as the primary clinical endpoint, which is considered viral cure. Results from the Phase III studies are expected in the first half of 2013.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the entire BI 201335 programme. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.

“We are progressing our BI 201335 programme with a high priority to leverage its potential to improve cure rates in HCV treatment,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “We believe our HCV-pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide.”

Phase IIb results presented last month showed that the interferon-free combination of BI 201335, with Boehringer Ingelheim’s polymerase inhibitor BI 207127 (SOUND-C2), led to 76% of patients achieving a virological response at week 12, with 59% achieving SVR12 (undetectable virus, 12 weeks post-treatment) with 16 weeks treatment. These results were presented at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, alongside SILEN-C1 and SILEN-C3 study results which showed the potential for BI 201335/ PegIFN/RBV to shorten treatment duration and improve the likelihood of viral cure (SVR). These Phase IIb results provide a strong basis for further development as BI 201335 progresses through Phase III.

SOUND-C2

SOUND-C2 is an open-label, randomised, Phase IIb study where 362 treatment-naïve GT1 HCV patients were randomised into five interferon-free treatment groups, each with 120mg BI 201335 once daily but with different dosing of BI 207127 and treatment durations as follows:

BI 201335 120mg QD + BI 207127 600mg TID + RBV for 16 weeks;

BI 201335 120mg QD + BI 207127 600mg TID + RBV for 28 weeks;

BI 201335 120mg QD + BI 207127 600mg TID + RBV for 40 weeks;

BI 201335 120mg QD + BI 207127 600mg BID + RBV for 28 weeks; or

BI 201335 120mg QD + BI 207127 600mg TID without RBV for 28 weeks.

SILEN-C1

SILEN-C1 is a double-blind, placebo-controlled trial, that randomised 429 treatment-naïve GT1 HCV patients (1:1:2:2) to receive either placebo or BI 201335 120 mg with three days Lead-in (LI) of PegIFN/RBV, BI 201335 240 mg QD with three days LI or BI 201335 mg 240mg QD without LI. In each treatment group, BI 201335 was given for 24 weeks together with PegIFN/RBV for 24 or 48 weeks. Patients were evaluated for SVR according to various baseline characteristics.

SILEN-C3

In this open-label Phase II trial, 159 treatment-naïve GT1 HCV patients were randomised to receive 120 mg QD BI 201335 for 12 or 24 weeks, each after three days lead-in (LI) with pegylated interferon and ribavirin (PegIFN/RBV). In both groups, PegIFN/RBV was given for 24 weeks. Patients who did not achieve an eRVR, continued PegIFN/RBV to week 48. eRVR was defined as viral load less than 25 IU/mL at week 4 and undetectable at weeks 8-20.

About Hepatitis C Virus (HCV)

HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant. The number of individuals chronically infected with HCV globally has been estimated at 170 million, with 3-4 million new infections occurring each year. Only about 20 – 45% of patients clear the virus in the acute phase. Of the remaining chronically infected patients, 20% will develop cirrhosis within a mean of 20 years. The mortality rate after cirrhosis has developed is 2-5% per year. End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world.

Boehringer Ingelheim in Hepatitis C Virus (HCV)

Boehringer Ingelheim has a dedicated HCV treatment development programme, called HCVersoTM, which at its core, aims to reverse the existing HCV paradigm. The ultimate aim of this programme is to deliver improved HCV treatment outcomes for patients whilst breaking down the barriers of current treatment regimens.

BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim’s own research and development, which has completed clinical trials through Phase IIb (SILEN-C studies). This Phase II programme supports the investigation of BI 201335 in Phase III trials currently ongoing. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase I clinical trials. Phase II trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.

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Article adapted by Medical News Today from original press release. Source: Boehringer Ingelheim

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Boehringer Ingelheim. “Boehringer Ingelheim Completes Patient Entry For Phase III Trial Programme In Hepatitis C.” Medical News Today. MediLexicon, Intl., 19 Dec. 2011. Web.
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Boehringer Ingelheim. (2011, December 19). “Boehringer Ingelheim Completes Patient Entry For Phase III Trial Programme In Hepatitis C.” Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/239435.php.

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Bionovo Initiates Menerba (MF101) Phase 3 Clinical Trial For Menopausal Hot Flashes

Main Category: Menopause

Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry

Article Date: 19 Dec 2011 – 1:00 PST

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Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women’s health and cancer, announced that enrollment has started to the Phase 3 pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba™ (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.

The Phase 3, multicenter, double-blind, placebo-controlled, randomized clinical trial evaluating Menerba is currently open for enrollment. A total of 50 clinical sites in the U.S. will enroll 1,200 postmenopausal women between the ages of 40 and 65 years. Participants will be randomized to Menerba 5g/day, Menerba 10g/day or placebo and treated for 12 weeks. The primary aims of the study are to determine the safety and efficacy of two doses of Menerba compared to placebo after 12 weeks of treatment. Efficacy will be measured by the reduction of moderate to severe hot flushes from baseline to 12 weeks of treatment. Dr. Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University is serving as the Principal Investigator for the study.

“We have had a very busy and productive year preparing for today’s important launch of the late stage clinical trial in the field of women’s health. As predicted from our vast toxicology data and the mechanism of action, we showed that higher doses of Menerba were very safe and demonstrated a level of efficacy similar to hormone therapy. Today we are proceeding with our first pivotal Phase 3 trial of Menerba with great optimism and enthusiasm. We are elated to be one step closer to providing a truly novel agent for the treatment of menopausal hot flashes to the 40 million women in need of this therapy,” said Mary Tagliaferri, M.D., Bionovo’s President and Chief Medical Officer.

“This Phase 3 trial is one of two Phase 3 trials required by the FDA for approval,” said Isaac Cohen, O.M.D., Chairman and Chief Executive Officer of Bionovo. “Menerba (MF101) has an enormous proven market and extraordinary market appeal due to its botanical origins and the safety and efficacy it demonstrated to date. We expect to have top-line data from this study in approximately 18 months.”

About Menerba

Menerba is an oral drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause, which is manufactured from botanical sources. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the products currently on the market which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in traditional Chinese medicine (TCM). Bionovo recognizes the opportunity to commercialize a product that would be as effective as hormone therapy, without the health risks. Menerba has completed a Phase 2 trial with positive results for efficacy and has been evaluated by an independent Data and Safety Monitoring Board and passed through a standard two-round examination for safety. Menerba also has been shown in animal studies to prevent the proliferation of breast cancer and to have a beneficial effect on osteoporosis, though this has not yet been studied in humans.

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Article adapted by Medical News Today from original press release. Source: Bionovo, Inc

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Bionovo, Inc. “Bionovo Initiates Menerba (MF101) Phase 3 Clinical Trial For Menopausal Hot Flashes.” Medical News Today. MediLexicon, Intl., 19 Dec. 2011. Web.
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APA
Bionovo, Inc. (2011, December 19). “Bionovo Initiates Menerba (MF101) Phase 3 Clinical Trial For Menopausal Hot Flashes.” Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/239434.php.

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Celladon Corporation Receives FDA Fast Track Designation For Its Investigational Agent MYDICAR® For The Treatment Of Heart Failure

Main Category: Heart Disease

Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry

Article Date: 19 Dec 2011 – 1:00 PST

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Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that its investigational product candidate MYDICAR® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced heart failure.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

“The positive results of the phase 2 CUPID Trial demonstrated the potential of MYDICAR® to become an important treatment for patients with chronic, advanced heart failure,” said Krisztina Zsebo Ph.D., President and CEO of Celladon Corp. Dr. Zsebo continued, “Today we are pleased that the FDA recognizes the potential benefit of MYDICAR® to address the enormous unmet medical need for additional therapeutics to treat advanced heart failure patients by granting the program Fast Track Status.”

About the CUPID Trial

The previously announced results of the phase 2 CUPID Trial met its primary safety and efficacy endpoints at 6 months for high dose MYDICAR® versus placebo. Additionally, 12 months after receiving a single infusion of MYDICAR®, patients treated with the highest dose versus placebo had an 88 percent risk reduction (Hazard Ratio = 0.12, P=0.003) of major cardiovascular events such as death, need for left ventricular assist device (LVAD) or cardiac transplant, episodes of worsening heart failure and number of heart failure-related hospitalizations.

The mean duration of hospitalization in the MYDICAR® high dose group during the 12-month period was 0.4 days per patient compared with 4.5 days per patient in the placebo group. This finding is especially noteworthy because heart failure is the leading cause of hospitalization in Americans 65 years of age and older.

Additionally, the 12-month CUPID data show that heart failure, which is a progressive disease, became stabilized in patients treated with high dose MYDICAR®: heart failure symptoms, exercise tolerance, serum biomarkers and cardiac function essentially improved or remained the same while these parameters deteriorated substantially in patients treated with placebo and concurrent optimal drug and device therapy.

The safety profile from this study was very favorable, with no significant side-effects from MYDICAR® therapy.

About Fast Track

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.

Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:

– Showing superior effectiveness.

– Avoiding serious side effects of an available treatment.

– Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome.

– Decreasing a clinically significant toxicity of an accepted treatment.

A drug that receives Fast Track designation is eligible for some or all of the following:

– More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval.

– More frequent written correspondence from FDA about such things as the design of the proposed clinical trials.

– Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit.

Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

In addition, drugs that are designated as Fast Track will be eligible for priority review of the approval application. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within 60 days based on whether the drug fills an unmet medical need in a serious disease.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

About MYDICAR®

MYDICAR® is a genetically targeted enzyme replacement therapy intended to restore levels of SERCA2a, a regulator of calcium cycling and contractility. SERCA2a levels decline in all forms of late-stage heart failure resulting in deficient heart function. With MYDICAR®, the SERCA2a gene is delivered using a recombinant adeno-associated virus (AAV) as the vector. AAV is a naturally occurring virus not associated with any disease in humans. MYDICAR® is delivered in a single dose directly to the heart during a routine outpatient cardiac catheterization procedure, similar to an angiogram. MYDICAR® is synergistic and additive across current heart failure treatments such as ACE inhibitors, beta-blockers, sprinolactone/diuretics, and biventricular pacing devices. No treatment substitution decision is required by the treating physician.

About Heart Failure

Chronic heart failure is a leading cause of hospitalization and is expected to result in direct and indirect costs of $ 39.2 billion to the U.S. healthcare system in 2010. Nearly 6 million people in the U.S. have heart failure, and at least 670,000 new cases will be diagnosed this year. Heart failure leads to about 280,000 deaths annually. The most common symptoms of heart failure are shortness of breath, feeling tired and swelling in the ankles, feet, legs and sometimes the abdomen. There is no cure.

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Article adapted by Medical News Today from original press release. Source: Celladon Corporation

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Celladon Corporation

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Celladon Corporation. “Celladon Corporation Receives FDA Fast Track Designation For Its Investigational Agent MYDICAR® For The Treatment Of Heart Failure.” Medical News Today. MediLexicon, Intl., 19 Dec. 2011. Web.
19 Dec. 2011. <http://www.medicalnewstoday.com/releases/239433.php>


APA
Celladon Corporation. (2011, December 19). “Celladon Corporation Receives FDA Fast Track Designation For Its Investigational Agent MYDICAR® For The Treatment Of Heart Failure.” Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/239433.php.

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ViroPharma Announces Approval Of Modernized Labeling For Vancocin® (vancomycin Hydrochloride, USP) Capsules

Main Category: Infectious Diseases / Bacteria / Viruses

Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry

Article Date: 19 Dec 2011 – 1:00 PST

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ViroPharma Incorporated (Nasdaq: VPHM) announced the modernization of labeling for Vancocin® (vancomycin hydrochloride, USP) Capsules made effective through the U.S. Food and Drug Administration’s (FDA) approval of a supplemental new drug application (sNDA). The company also provided updates on ViroPharma’s ongoing citizen petition and litigation with the FDA regarding Vancocin.

Vancocin Labeling Changes

Through the sNDA approval, Vancocin’s label for the first time includes clinical safety and efficacy data for Vancocin in treating currently circulating strains of Clostridium difficile, including the BI/NAP1 strain. Vancocin’s labeling now includes important safety and efficacy data from 260 patients with C. difficile associated diarrhea (CDAD) treated with Vancocin in two pivotal studies of Genzyme Corporation’s investigational drug, tolevamer. The Vancocin arm of the trials provides important information to help ensure appropriate use of Vancocin. ViroPharma purchased exclusive rights to the two studies from Genzyme for which it will pay Genzyme royalties of 10 percent, 10 percent and 16 percent on net sales of Vancocin for the three year period following the approval of the sNDA.

“This new label provides physicians a better understanding about how to treat and monitor patients suffering from the serious and often life threatening infections that require oral Vancocin therapy,” said Vincent Milano, ViroPharma’s president and chief executive officer.

Exclusivity Incentives for Antibiotic Treatments

As a result of today’s sNDA approval, ViroPharma believes Vancocin meets the requirements for, and thus has, three years of exclusivity, and that generic vancomycin capsules will not be approved during this period. Under FDA’s regulations, labeling changes based on new clinical investigations that are essential to approval of the sNDA and to which the applicant has exclusive rights may be entitled to three years of exclusivity, and generic drug labeling cannot include information protected by such three-year exclusivity. A generic may seek approval by omitting labeling protected by three-year exclusivity; however, if such omissions render the generic drug less safe or effective, it cannot be approved until the three-year exclusivity expires.

In keeping with FDA efforts to facilitate antibiotic approvals as well as preserve the safety and efficacy of current treatments, today’s sNDA approval following ViroPharma’s investment in the Genzyme data accomplishes an objective of the law to incent private industry to address a serious public health need modernizing old antibiotic labeling. The modernized label approved by the FDA contains important new information for prescribers and patients, including:

Clinical safety and efficacy data of Vancocin capsules, including efficacy data for the more lethal, epidemic BI/NAP1 strain;

An instruction to monitor renal function in all patients;

An instruction that elderly patients should not be prematurely discontinued from treatment, or switched to other therapies; and

A specific dosing regimen for CDAD.

ViroPharma believes that attempting to omit Vancocin labeling changes protected by exclusivity would render generic versions of Vancocin less safe and effective. These and other issues regarding the modernized Vancocin labeling and its impact on generic vancomycin applications will be detailed in an upcoming filing to the Vancocin citizen petition. Ultimately, the decision on a grant of three-year exclusivity and its effect on generic vancomycin capsule approvals resides with the FDA.

Citizen Petition Update

Parallel efforts regarding generic vancomycin capsules include ViroPharma’s 2006 citizen petition, which has yet to be answered by FDA. Some recent issues raised in the petition include:

The work of Omar Vesga, M.D., of the Section of Infectious Diseases at University of Antioquia Medical School and Hospital Universitario San Vicente de Paul in Medellin, Colombia, substantiating the concerns of infectious disease experts that generic vancomycin capsules should not be approved without demonstrating in vivo efficacy. Vesga showed generic intravenous vancomycin products, despite meeting all standard tests of generic equivalence, nonetheless fail in vivo (Generic Vancomycin Products Fail In Vivo despite Being Pharmaceutical Equivalents of the Innovator; Omar Vesga, et al.; Antimicrob. Agents Chemother. August 2010 vol. 54 no. 8 3271-3279). This demonstration of generic inequivalence with the simple IV formulations of vancomycin supports the need to require that the more complicated generic vancomycin capsules demonstrate in vivo efficacy.

The United States Pharmacopeia (USP) agrees with ViroPharma that a modern assay to measure vancomycin capsule dissolution is needed. ViroPharma has explained how without such an assay, FDA’s proposed in vitro bioequivalence method for generic vancomycin capsules is unworkable, thus preventing the approval of generic vancomycin capsules.

FDA Advisory Committee experts emphasized the need for particularly rigorous inspections and cGMP compliance for generic vancomycin capsules approved via FDA’s in vitro method. (ViroPharma Incorporated Letter to FDA in re: August 4 meeting of FDA Advisory Committee, Docket No. FDA-2009-N-0664-0047 (Oct 6, 2009)). Vesga’s work further underscores the importance of such measures, but to date FDA has not indicated it will accede to the advice of its Advisory Committee experts.

Litigation Update

ViroPharma has two suits pending against FDA regarding Vancocin. A Freedom of Information Act (FOIA) suit seeking the administrative record of FDA’s development of in vitro dissolution as a bioequivalence method for generic vancomycin capsules is currently pending decision in federal district court. ViroPharma also filed an Administrative Procedure Act (APA) suit alleging that FDA’s in vitro bioequivalence method for generic vancomycin capsules is flawed under the APA. Oral arguments on the district court’s procedural dismissal of this suit are currently scheduled for January 13, 2012 before the United States Court of Appeals for the District of Columbia Circuit.

About Vancocin® (vancomycin hydrochloride, USP) Capsules

Vancocin is indicated for the treatment of C. difficile associated diarrhea (CDAD). Vancocin is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). Vancocin is contraindicated in patients who have experienced a hypersensitivity to vancomycin. Vancocin must be given orally for treatment of staphylococcal enterocolitis and CDAD. Orally administered Vancocin is not effective for other types of infections. Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of Vancocin for active CDAD. Monitoring of serum concentrations may be appropriate in some instances.

Nephrotoxicity has occurred following oral Vancocin therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. Monitor renal function. Ototoxicity has occurred in patients receiving Vancocin. Assessment of auditory function may be appropriate in some instances. Prescribing Vancocin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. In clinical trials, the most common adverse reactions (greater than or equal to 10 percent) were nausea (17 percent), abdominal pain (15 percent), and hypokalemia (13 percent). Patients over 65 years of age may take longer to respond to therapy compared to patients less than 65 years of age. Clinicians should be aware of the importance of appropriate duration of Vancocin treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely.

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Article adapted by Medical News Today from original press release. Source: ViroPharma Incorporated

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ViroPharma Incorporated

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ViroPharma Incorporated. “ViroPharma Announces Approval Of Modernized Labeling For Vancocin® (vancomycin Hydrochloride, USP) Capsules.” Medical News Today. MediLexicon, Intl., 19 Dec. 2011. Web.
19 Dec. 2011. <http://www.medicalnewstoday.com/releases/239432.php>


APA
ViroPharma Incorporated. (2011, December 19). “ViroPharma Announces Approval Of Modernized Labeling For Vancocin® (vancomycin Hydrochloride, USP) Capsules.” Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/239432.php.

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