Clinipace Recently Awarded $2.8 Million to Manage Three New Clinical Projects

Clinipace Recently Awarded $2.8 Million to Manage Three New Clinical Projects

Projects include electronic data capture (EDC), data management services, clinical monitoring, and biostatistics for several early-stage clinical trials and registries

Morrisville, N.C. (PRWEB) February 26, 2009 -- Clinipace (http://www.clinipace.com), a growing clinical research solutions company, today announced that it has been awarded three new projects in 2009 worth, in aggregate, more than $2.8 million.

With a focus on emerging and mid-tier life science firms who are looking for a better way to manage their clinical trials, Clinipace is able to fill operational gaps while boosting sponsor visibility and project efficiencies through its web-based TEMPO™ research platform (http://www.clinipace.com).

"These new clients appreciate that we're a technology-centric service company, and that we think differently than traditional service providers," said Jeff Williams, Chief Executive Officer at Clinipace. "During the evaluation process, our team worked really hard to understand our prospective clients' challenges, and we're excited that our particular formula of technology and research services was a compelling value for them."

Clinipace recently launched a "Right-Sized" approach to managing clinical trials and registries, which optimizes trial resources through the right mix of technology and services. Smaller life science firms are becoming increasingly wary of receiving over-priced, over-stuffed project budgets typically found in the bids of traditional service providers, and Clinipace's unique model, along with its fixed-price guarantee, were key factors in being selected to help these clients.

"Committed to full transparency, efficiency and lower cost, all of our services are built upon our TEMPO™ web-based platform," explains Williams. "With our technology-based service model we're able to save companies 30-50% vs. what a traditional CRO would charge without compromising quality or service-levels. In today's environment that is not only important, it's absolutely vital to our clients," continues Williams.

About Clinipace

Clinipace (http://www.clinipace.com) is an experienced clinical research solutions company providing on-demand software and clinical services for phase I-IV clinical trials, registries, and investigator-initiated grant management programs. We serve biopharmaceutical and medical device companies as well as academic medical centers. Optimized by TEMPO™, our web-based software platform, we deliver services such as EDC, ePRO, grant management, data management, monitoring, site management, and biostatistics at a 30% - 50% savings compared to similar service providers. Learn more at clinipace.com (http://www.clinipace.com).

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Contact Information David Levin

Clinipace

http://www.clinipace.com

919-724-4043

Rick Fraunfelder, M.D. of the Casey Vision Correction Center in Portland, Oregon, Joins Elite Group of Surgeons Listed at Trusted LASIK Surgeons

Rick Fraunfelder, M.D. of the Casey Vision Correction Center in Portland, Oregon, Joins Elite Group of Surgeons Listed at Trusted LASIK Surgeons

Trusted LASIK Surgeons launched its revolutionary Trusted LASIK Surgeons directory service and website at www.TrustedLASIKSurgeons.com in order to provide a resource for consumers seeking to improve their vision and find a highly qualified surgeon who can help improve their chances of attaining 20-20 vision. What sets the Trusted LASIK Surgeons directory apart is a unique screening process ensuring that only those who are among the best in LASIK eye surgery and laser eye surgery in the United States are listed. Refractive eye surgeons, such as Dr. Frederick Fraunfelder, are screened based on their experience, research, publications, lectures, and patient care standards. Trusted LASIK Surgeons believes Doctor Fraunfelder's research, teaching, surgical skills, and other professional accomplishments place him among the top LASIK surgeons in the United States. His practice at Casey Vision Correction Center of the Oregon Health & Science University serves Portland, Beaverton, Gresham, Hillsboro, Lake Oswego, and Salem, as well as communities throughout Oregon.

Portland, OR (PRWEB) February 26, 2009 -- Trusted LASIK Surgeons (http://www.trustedlasiksurgeons.com) announced today that Frederick Fraunfelder, M.D. (http://trustedlasiksurgeons.com/portland_lasik_surgeon_RIck_Fraunfelder_M_D.htm) has joined the Trusted LASIK Eye Surgeons Directory (http://www.trustedlasiksurgeons.com/find_a_lasik_eye_surgeon.htm), an informational resource for consumers searching for highly qualified LASIK and refractive eye surgeons. Dr. Rick Fraunfelder's practice serves patients seeking LASIK eye surgery in Portland, Beaverton, Gresham, Hillsboro, Lake Oswego, and Salem (http://trustedlasiksurgeons.com/portland_lasik_surgeons.htm). Dr. Fraunfelder also treats those seeking in vision correction surgery throughout Oregon (http://trustedlasiksurgeons.com/oregon_lasik_surgeons.htm), and in cities in Washington like Vancouver.

Trusted LASIK Surgeons directory service is designed to feature only those LASIK eye surgeons who are among the best in the United States. To accomplish this, Trusted LASIK Surgeons screens each laser eye surgeon based on experience, premier patient care, and professional credentials. In Trusted LASIK Surgeon's opinion, Dr. Fraunfelder's outstanding achievements place him among the top LASIK and vision correction surgeons in the United States.

The most significant professional qualifications that set Dr. Rick Fraunfelder apart from nearly all other LASIK Surgeons are his experience as a principal investigator for an FDA study for Nidek and member of the FDA Ophthalmic Devices panel study, his academic appointment at Casey Eye Institute, and his extensive research. At the Casey Eye Institute at Oregon Health & Science University, Dr. Fraunfelder serves as an as a Associate Professor of Ophthalmology, Cornea/External Disease, Ocular Oncology, and the Refractive Surgery Director of the Cornea/ External Disease/Refractive Surgery Division. Dr. Fraunfelder is also a leading expert in medication side effects and interactions. He directs the National Registry of Drug-Induced Ocular Side Effects, which is the only database designed to gather data on the side effects of drugs on the eye, and regularly teaches and lectures his peers on the side effects of medications on the eye.

Dr. Rick Fraunfelder serves on several editorial boards, including Drugs of Today, EyeNet, Drugs of the Future, and the Physicians Desk Reference. He also is a reviewer of articles for over 10 scientific journals related to eye care including the American Journal of Ophthalmology, Archives of Ophthalmology, Cornea, and the Journal of Refractive Surgery.

Dr. Fraunfelder is extensively published, with over 62 peer-reviewed scientific journal articles published, 26 text book chapters, and 3 books to his credit. He has presented over 12 lectures on research topics at major eye meetings in the United States and internationally and over 25 lectures at local and regional meetings to fellow eye doctors. These collective accomplishments have earned him the respect of his peers world-wide.

Over his career, Dr. Fraunfelder has performed over 5,000 LASIK and laser vision surgery procedures. With over 10 years of experience in refractive surgery including laser vision surgery procedures like LASIK and PRK, Dr. Fraunfelder has the proven know-how to provide patients with the highest eye care available when it comes to their vision correction.

Rick Fraunfelder, M.D., performs LASIK and other laser vision and refractive surgery procedures on patients with nearsightedness (myopia), farsightedness (hyperopia), astigmatism (blurred vision), and presbyopia. Dr. Fraunfelder's practice, at Casey Vision Correction Center, provides premier patient care, including "All-Laser" or "Bladeless" LASIK and use of Wavefront Based ("Optimized") LASIK and PRK. Dr. Fraunfelder offers not just LASIK and PRK (laser eye surgery procedures), but limbal relaxing incisions and cataract lens implant procedures to give patients a full range of options when it comes to choosing the right vision correction procedure.

Dr. Fraunfelder has also helped new patients who have had significant problems with LASIK or other vision correction procedures performed by another surgeon. Moreover, Dr. Fraunfelder has been selected by other eye surgeons, optometrists, opticians, employees of companies that specialize in refractive surgery instrumentation or their family members to perform their LASIK or other refractive surgery procedure.

Certified by the American Board of Ophthalmology, this highly qualified refractive eye surgery specialist is a recipient of an Achievement Award by the American Academy of Ophthalmology. He is also an active member of the International Society of Refractive Surgery, the American Society of Cataract and Refractive Surgery, and numerous other international and national professional organizations dedicated to eye care. Locally, Dr. Fraunfelder is a member of the Oregon Academy of Ophthalmology and the Oregon Medical Association.

Dr. Fraunfelder is also dedicated to helping others less fortunate. His charitable contributions extend from local schools and the Lions Bank of Oregon, where he serves on the Medical Advisory Committee, to Orphans Over Seas, a charity which helps children and single parents all over the world.

"We are honored to have Dr. Fraunfelder join our Trusted Lasik Directory. The Casey Eye Institute has a long history of contributions to the field of refractive surgery beginning with the excimer laser FDA studies initiated by Dr. Larry Rich in the early 1990's. Rick Fraunfelder continues this strong tradition. He also brings the unique perspective of serving on the FDA advisory panel which oversees the approval of ophthalmic laser systems," commented James J. Salz, M.D., Chief Executive Officer of Trusted LASIK Surgeons.

"Eyesight is a precious gift. I am fortunate to practice in a field that permits me with an opportunity to help patients attain better vision" said Rick Fraunfelder, M.D., Associate Professor of Ophthalmology of Casey Eye Institute. "The Trusted LASIK Surgeons website attracts patients who are looking to find a LASIK specialist who has professional qualifications that exceed those of the typical LASIK doctor. I am honored to be included among the highly distinguished group of surgeons listed at the Trusted LASIK Surgeons"

Visit Portland, OR LASIK Eye Surgery Expert Rick Fraunfelder profile page at Trusted LASIK Surgeons (http://trustedlasiksurgeons.com/portland_lasik_surgeon_RIck_Fraunfelder_M_D.htm)

To see learn more about LASIK and refractive expert Rick Fraunfelder, M.D., and the Casey Vision Correction center, please visit Casey Vision Correction Center website of Portland, OR (http://www.ohsucasey.com/patient/cvcc.asp)

To ask Dr. Rick Fraunfelder a question or schedule an appointment, Contact Dr. Rick Fraunfelder at Casey Vision Correction Center in Portland, Oregon (http://www.ohsucasey.com/patient/cvcc.asp)

For more on why consumers should consider surgeons listed in the Trusted LASIK Surgeons directory for their vision correction needs, please visit:

Why choose a Surgeon from the Trusted LASIK Surgeon's Directory (http://www.trustedlasiksurgeons.com/why_use_a_trusted_lasik_surgeon.htm)

The screening process and standards used by Trusted LASIK Surgeons are located at How Are LASIK Eye Surgeons Qualified at Trusted LASIK Surgeons? (http://www.trustedlasiksurgeons.com/how_are_lasik_surgeons_qualified_at_tls.htm)

To find a highly accomplished LASIK and refractive specialist in your local area who has been qualified and listed in the Trusted LASIK Surgeons directory, please visit Trusted LASIK Surgeons Directory (http://www.trustedlasiksurgeons.com/find_a_lasik_eye_surgeon.htm)

SOURCE: Trusted LASIK Surgeons

About Trusted LASIK Surgeons, Inc.

Trusted LASIK Surgeons, Inc. (Trusted LASIK Surgeons) is a premier LASIK, laser eye surgery, and refractive eye surgery directory service whose primary mission is to assist consumers in finding the best and most qualified LASIK and vision correction surgeons in their local area in the United States. To accomplish this, Trusted LASIK Surgeons uses a unique screening process where each prospective LASIK eye surgeon must meet the minimum required qualifications set by Trusted LASIK Surgeons. These qualifications for these doctors are based on experience (not just in LASIK but complete refractive care), research (including FDA approval studies for manufacturers and academic appointments at major universities), publications and lectures (to their peers, not to the public via infomercials) and patient care standards (treating other eye professionals and managing complications from patients first operated on by someone else). All refractive eye surgeons listed at Trusted LASIK Surgeons have qualified, been accepted, and have subscribed to our services. For more information on why we believe consumers interested in LASIK should consider an eye surgeon listed in the Trusted LASIK Surgeon's directory, please visit our website at www.TrustedLASIKSurgeons.com.

Trusted LASIK Surgeons, Inc.

(800) 483-8028

About Casey Vision Correction Center

In the Northwest, Casey Vision Correction Center has been an innovator in laser vision correction surgery. The internationally recognized Casey team performed the first PRK in the Northwest in December 1994 and the first LASIK in the area in October 1996. Its reputation rests securely on the abilities of our team of corneal specialists, all of whom are highly skilled, well respected surgeons and clinicians who combine the best possible medical care with a sincere concern for the well being of their patients. Casey Vision Correction Center's tradition of excellence stems from the depth of its surgeons' experience and its affiliation with Casey Eye Institute and Oregon Health & Science University, an academic center of excellence devoted to health care. Casey Vision Correction Center is committed to remaining on the leading edge of eye care technology, being leaders in innovation and scientific training, and providing patient care of the highest possible quality. For more information about the Casey Vision Correction Center, please visit: www.ohsucasey.com/patient/cvcc.asp

Casey Vision Correction Center

Casey Eye Institute- Marquam Hill

3375 S.W. Terwilliger Blvd.

Portland, Oregon 97239

Phone: (503) 494-3937 or (800) 842-3937

About Casey Eye Institute

At Casey Eye Institute, the mission is simple: to provide excellent eye care in a quality, cost-effective environment that combines education, research, clinical leadership and service to the community. The Casey Eye Institute is an academic regional eye center dedicated to preventing blindness through research, and to bringing advanced technology to the Pacific Northwest through continuing education of physicians. We are also committed to affordable eye care through collaborative programs and to sharing resources with community providers. Casey Eye Institute is the only free-standing academic eye research center west of Salt Lake City and north of San Francisco. For more information about the Casey Eye Institute, please visit www.ohsucasey.com.

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Contact Information James J. Salz, M.D.

Trusted LASIK Surgeons, Inc.

http://www.TrustedLASIKSurgeons.com

+1 (800) 483-8028

Online Marketing Dept.

LanceThink Media

http://www.LanceThinkMedia.com

+1 (800) 846-6208

Free Bodybuilding Supplements Available Through Research Project

Free Bodybuilding Supplements Available Through Research Project

New website is conducting research on consumer expectations and purchasing trends within the dietary supplement industry. Take their survey and register to win free bodybuilding supplements.

Aurora, CO (PRWEB) February 26, 2009 -- Bodybuilding Supplements include a wide variety of nutritional supplements including protein powders and drinks, vitamin / mineral preparations, sports nutrition products (like creatine and nitric oxide boosters), and even some of the most elite and highly touted steroid alternatives and prohormones.

According to the most recent estimations, the dietary supplement industry is more than a $21 billion dollar industry. Of which, bodybuilding specific supplements make up a significant portion. In other words, bodybuilding supplements are a substantial part of our national economy and the overall health of America. However, research leading to new advancements in bodybuilding and sports specific supplements is behind the times in most cases. This may be what leads consumers to the black market scene and ultimately use of anabolic steroids.

A consumer research team is conducting an online survey to gather important information regarding consumers' expectations when using bodybuilding supplements. And in return have partnered up with some of the top supplement retailers, wholesalers and manufacturers from around the World to bring you free supplements.

To take part in this important research, visit freebodybuildingsupplements.com (http://www.freebodybuildingsupplements.com) and complete the online survey. The survey, which takes only about 4 minutes to complete, is followed by a registration form. Completion of the survey and short form qualifies you for the drawing for Free Supplements.

For more information about this survey and the research team conducting it, please visit www.freebodybuildingsupplements.com.

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Contact Information Jim Hayward

Free Bodybuiliding Supplements

http://www.freebodybuildingsupplements.com

303-951-6315

Clinical Guidelines for Treating Chronic Pain Highlight Opioid Addiction Risk Assessment

Clinical Guidelines for Treating Chronic Pain Highlight Opioid Addiction Risk Assessment

Expert panel finds that SOAPP® is likely to be helpful for risk assessment and stratification

Newton, MA (PRWEB) February 25, 2009 -- Inflexxion, Inc., a company that creates scientifically validated and cost-effective solutions for critical areas of health care, is pleased to announce that its Screener and Opioid Assessment for Patients with Pain (SOAPP) has been identified by an expert panel as likely to be helpful for assessing the risk of opioid addiction in patients with chronic non-cancer pain.

SOAPP is a brief paper-and-pencil self report tool that allows clinicians to assess a patient's risk of addiction before initiating opioid therapy.

The multi-disciplinary panel of experts, convened by the American Pain Society and the American Academy of Pain Medicine, conducted a comprehensive review of the evidence to develop a set of authoritative clinical guidelines on the use of opioid medications to treat chronic non-cancer pain. The guidelines, published in the February 2009 issue of The Journal of Pain (Volume 10, Number 2), recommend that clinicians routinely conduct a complete benefit-to-harm evaluation before starting opioid therapy, and do periodic follow-up screenings of patients who may be at risk for abuse or addiction.

"Proper patient selection is critical and requires a comprehensive benefit-to-harm evaluation that weighs the potential positive effects of opioids on pain and function against potential risks," write the authors. "Thorough risk assessment and stratification is appropriate in every case."

According to the authors, screening tools that assess the potential risks associated with continuous opioid therapy (COT) based on patient characteristics are likely to be helpful for risk stratification. The authors identify SOAPP Version 1 and the revised version, SOAPP-R, as among the tools that appear to have "good content, face, and construct validity."

In addition to SOAPP, the guidelines highlight the utility of Inflexxion's Current Opioid Misuse Measure (COMM)®, a complementary tool for identifying whether a patient, throughout the course of long-term opioid therapy, may be exhibiting aberrant behaviors associated with abuse of opioid medications.

"We at Inflexxion are very pleased to see both SOAPP and COMM included in these recommendations," says Kevin L. Zacharoff, M.D., Director of Medical Affairs at Inflexxion. "These guidelines underscore the importance of risk assessment and reassessment in this patient population. The inclusion of the SOAPP and COMM in these recommendations helps to validate Inflexxion's mission, which is to help to reduce health-related risks, enhance clinical outcomes, and positively influence quality of care."

The SOAPP and COMM tools are available for download at no cost through Inflexxion's PainEDU website (www.PainEDU.org), along with a clinician tutorial that includes video case examples.

SOAPP was developed by Inflexxion with support from the National Institutes of Health (NIH) and an unrestricted educational grant from Endo Pharmaceuticals.

About Inflexxion, Inc.

Founded in 1989, Inflexxion creates innovative behavioral health solutions for prevention, education, and disease management. Our clinically tested programs address substance abuse and addiction, chronic pain management, college health, and other health and wellness issues. Our pharmaceutical risk management division provides Risk Evaluation and Mitigation Strategy (REMS) assistance to companies that research, manufacture, and market opioid pain medications and other therapeutic agents with potential abuse problems. Key offerings include NAVIPPRO(TM), PainEDU.org, painACTION.com, and SOAPP®. Inflexxion is based in Newton, MA.

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Contact Information Lara Romanowski

Inflexxion

http://www.painedu.org

617-614-0406

Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U.S. Based Clinical Trials

Stemedica Advances its Certification to Become a Licensed Manufacturer of Adult Stem Cells for U.S. Based Clinical Trials

Stemedica Cell Technologies, Inc. announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U.S.-based Phase I and Phase II Clinical Trials.

San Diego, CA (PRWEB) February 25, 2009 -- Stemedica Cell Technologies (http://www.stemedica.com), Inc. ("Stemedica") announced today that it has filed with the Food and Drug Branch of the State of California's Department of Public Health for certification as a licensed manufacturer of adult stem cells for U.S.-based Phase I and Phase II Clinical Trials. Readiness for manufacture includes obtaining a California Drug Manufacturing License for the Stemedica facility in San Diego, California.

"Completion of this certification will allow us to manufacture stem cells under contract for clinical trials for Stemedica as well as for other companies and research centers in California and across the United States. This marks a significant milestone along the journey toward the future availability of stem cell treatment for patients who so urgently need it," said Dr. Maynard Howe, Vice Chairman and CEO at Stemedica.

To prepare for inspection, Stemedica fully reconstructed its facility according to FDA requirements, which had previously focused on research and development. Stemedica's manufacturing facility now includes a fully compliant manufacturing wing with entry-level gowning rooms, two ISO class 8 sterile gowning suites, an ISO Class 7 Manufacturing Clean Room, an ISO Class 7 Processing Clean Room, a Good Manufacturing Process compliant materials warehouse and a controlled-access Quality Control testing laboratory.

"As soon as Stemedica secures its license from the State of California's Department of Public Health, we plan on filing for one or more IND's (Investigative New Drug) for specific indications with the FDA using our proprietary technology. The final major step by the Food and Drug Branch within the Department of Public Health is an in-depth, in-person inspection by their personnel. We're particularly proud of the fact that we are ready for, and capable of, seeking licensing in California, which has exceptionally stringent standards," said Dr. Alex Kharazi, Vice President, Research & Manufacturing at Stemedica.

"Becoming a Licensed Manufacturer of clinical grade adult stem cells is a significant scientific and medical step forward for the Company," said Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer. "Securing this status will allow us to become a primary CMO (Contract Manufacturing Organization) for other for-profit companies and the many research organizations interested in advancing stem cell research through clinical application. Additionally, achieving this regulatory status within the manufacturing world will provide Stemedica with the foundation to advance its own Phase I and Phase II Clinical Studies once approved by the FDA."

About Stemedica Technologies, Inc.

Stemedica Cell Technologies Inc. (www.stemedica.com (http://www.stemedica.com)) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.

Media Contact for Stemedica: Dave McGuigan -- dmcguigan (at) stemedica.com.

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Contact Information Dave McGuigan

Stemedica Cell Technologies Inc

http://www.stemedica.com

+1 858 658 0910

April 2009 Declared National Safe Handling Awareness Month

April 2009 Declared National Safe Handling Awareness Month

In an act to further education surrounding the safe handling of hazardous drugs in the healthcare setting, April 2009 has been declared the first-ever National Safe Handling Awareness Month with Monday, April 20, 2009 being declared the first-ever National Safe Handling Awareness Day.

Columbus, OH (PRWEB) February 24, 2009 -- In an act to further education surrounding the safe handling of hazardous drugs in the healthcare setting, April 2009 has been declared the first-ever National Safe Handling Awareness Month with Monday, April 20, 2009 being declared the first-ever National Safe Handling Awareness Day.

The proclamation of National Safe Handling Awareness Month follows the need for increased safe handling cognizance given the known risks associated with exposure to hazardous drugs (such as chemotherapy agents). According to an alert published by the National Institute for Occupational Safety and Health (NIOSH), "working with or near hazardous drugs in healthcare settings may cause skin rashes, infertility, miscarriage, birth defects and possibly leukemia or other cancers." Further evidence to support the need to take action in this area may be found below.

In recognition of National Safe Handling Awareness Month, a variety of regional and national continuing education (CE) activities will be scheduled throughout April. The headline event, a complimentary, nationwide CE webcast, will take place on April 20th from 1:00-2:00pm EST. The event will be followed by a live "Ask the Experts" session featuring today's industry thought leaders:

Keynote speakers:

Byron Peters, RPh

Director of Pharmacy

Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO

MiKaela Olsen, RN, MS, OCN

Oncology and Hematology Clinical Nurse Specialist

Johns Hopkins Hospital, Baltimore, MD

Guest Speaker:

James Jorgenson, RPh, MS, FASHP

Executive Director, Pharmacy Services

Clarian Health Partners, Methodist Hospital, Indianapolis, IN

This initiative is supported by an unrestricted educational grant provided by Carmel Pharma, Inc. - the official sponsor of National Safe Handling Awareness Month and the maker of PhaSeal®, the only clinically proven closed-system drug transfer device (CSTD) for the safe handling of hazardous drugs.

Participants may visit www.statce.com/safehandling for more information or to register for the program.

The Importance of Safe Handling

* The World Health Organization predicts a 50 percent increase of cancer cases over the next 20 years; this, combined with more potent chemotherapy drugs - as well as an increase in the use of hazardous drugs to treat non-malignant illnesses - will continue to elevate risk of exposure.

* Two separate studies investigating the toxicity in healthcare personnel who handle cytotoxic (hazardous) drugs revealed a 40-50 percent increased risk for miscarriage. A total of 7094 pregnancies of 2976 pharmacy and nursing staff were examined.

* A national survey conducted by the Environmental Working Group, the American Nurses Association, Health Care Without Harm and the Environmental Health Education Center at the University of Maryland School of Nursing showed that there are links between nurses' occupational exposure to hazardous drugs and the health problems they develop such as cancer, asthma, miscarriages and children's birth defects.

About Safe Handling Awareness Month

April has been designated the first-ever National Safe Handling Awareness Month in an effort to raise awareness of the occupational risks associated with handling hazardous drugs and educate healthcare providers on the U.S. guidelines and safety measures that may be taken to prevent hazardous drug exposure. As the highlight of National Safe Handling Awareness Month, National Safe Handling Awareness Day will bring together national and regional educational opportunities collectively aimed at preserving the health and wellbeing of the oncology healthcare professionals who devote their lives to helping others. National Safe Handling Awareness Month and National Safe Handling Awareness Day are officially sponsored by Carmel Pharma, the maker of the PhaSeal® System - today's only clinically proven closed-system drug transfer device (CSTD) for the safe handling of hazardous drugs. For additional details on National Safe Handling Awareness Month/Day, visit www.carmelpharmausa.com/aware5 or call 866-487-9250.

About Carmel Pharma (the maker of the PhaSeal® System)

The PhaSeal System is manufactured by Carmel Pharma ab in Gothenburg, Sweden and is distributed from its U.S. affiliate office, Carmel Pharma, Inc., in Columbus, OH. PhaSeal has been in use in the United States since 2000 and implemented in more than 1000 cancer facilities, infusion centers and private practices, including M.D. Anderson and Texas Children's in Houston, TX; City of Hope in Duarte, CA; Dana Farber Cancer Institute in Boston, MA; SwedishAmerican Hospital in Rockford, IL; and Johns Hopkins University in Baltimore, MD, just to name a few. For more information on Carmel Pharma or the PhaSeal System, please visit www.phaseal.com. To request additional product details, high-resolution imagery, story ideas and expert references, or to learn more about the topic of safe handling from today's clinical thought leaders, please contact Emily Frydendal at 614-318-2635.

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Contact Information Laura Gonzalez

STAT CE

http://www.statce.com/safehandling

888-247-8700

UCSF Gallo Study Finds Hormone Disorder Drug Could Help Drinkers Stay Sober

UCSF Gallo Study Finds Hormone Disorder Drug Could Help Drinkers Stay Sober

A drug prescribed for male and female infertility and menstrual disorders could hold the key to a more effective treatment for alcoholism, according to a study by researchers at the UCSF-affiliated Ernest Gallo Clinic and Research Center (www.galloresearch.org).

(Vocus) February 24, 2009 -- A drug prescribed for male and female infertility and menstrual disorders could hold the key to a more effective treatment for alcoholism, according to a study by researchers at the UCSF-affiliated Ernest Gallo Clinic and Research Center (www.galloresearch.org).

The study showed that "alcoholic" rodents, when injected with the drug cabergoline, decreased their alcohol consumption and alcohol-seeking behavior and were less likely to relapse.

Cabergoline, which is marketed under the trade name Dostinex, is approved by the Food and Drug Administration in pill form to treat conditions caused by excess of the hormone prolactin.

The study, led by Dorit Ron, PhD, a principal investigator at the Gallo Center and associate professor of neurology at UCSF, is now on line (February 20, 2009), in the journal "Biological Psychiatry." (See end of news release for link to paper.)

Notably, cabergoline did not impact the rats' consumption of sucrose and, in a subgroup of binge-drinking mice, the drug did not appear to significantly affect intake of water or saccharin.

"This is encouraging," says Ron, "because it demonstrates that cabergoline is specific for alcohol, but does not affect general reward or pleasure. One of the problems with some existing drugs to treat alcoholism is a side effect that decreases pleasure, making compliance an obstacle to sobriety."

The research builds on an earlier, provocative finding by Ron and her colleagues regarding the protein GDNF (glial cell line-derived neurotrophic factor), which they had injected into rats' VTA (ventral tegmental area) brain region, associated with drug-seeking behavior.

In this earlier study, the scientists had trained rats to consume alcohol. Some, like humans, drank in moderation, while others binged. But when GDNF was administered, both heavy and light drinkers lost at least some of their craving for alcohol. This effect became apparent within 10 minutes and lasted at least 24 hours, the scientists discovered. Importantly, administration of GDNF into the brain prevented the rats from relapsing after a period of abstinence.

While the discovery broke new ground, the scientists knew that GDNF could not be used to treat alcoholic humans because its molecule is too large to cross the blood-brain barrier. So, in the present study, Ron and her colleagues looked at cabergoline, a compound that has been shown in cells to increase the expression of GDNF.

After establishing that cabergoline treatment resulted in an increase of the level of GDNF and activation of the GDNF pathway in the rats' VTA, the researchers sought to test its impact on rodents' drinking habits.

Rats underwent a two-month training program in which they learned to press a lever to obtain alcohol. Researchers found that when rats were injected with cabergoline, they were less likely to press the lever. The higher the dose of cabergoline, the lower the number of lever presses reported. The researchers also found that binge-drinking mice consumed less alcohol after cabergoline administration.

In further study, the researchers found that cabergoline was effective in reducing both craving for alcohol and relapse to drinking. Relapse is a critical issue for alcoholic patients trying to stay abstinent.

As further evidence of the interplay between cabergoline and GDNF, alcohol intake was tested on mice that had been genetically engineered to have a single copy of the GDNF gene, and therefore less GDNF in the brain. As expected, the scientists found that the drinking habits of these genetically modified mice were not affected by cabergoline.

Although the results of the study offer fresh hope to problem drinkers, Ron cautions that human clinical trials are needed before cabergoline can be safely prescribed. Higher doses of cabergoline have been used to treat Parkinson's disease and have been linked to heart valve problems.

"However," notes Ron, "we show that in mice and rats, a low dose of the drug is enough to reduce excessive alcohol consumption, alcohol seeking and relapse. The dose is similar to what is given to humans for the treatment of hyperprolactinemia."

Cabergoline may eventually be prescribed for other addictions. A pilot study conducted on cocaine addicts, cited in Ron's paper, reported a substantial reduction in cocaine use.

In the United States, 17.6 million people -- approximately one in every 12 adults -- abuses alcohol or is alcohol-dependent, according to the National Institutes of Health. But there are just three medications approved to treat alcohol dependence -- disulfiram (Antabuse), naltrexone (Depade, ReVia), and acamprosate (Campral).

Lead author of the study is Sebastien Carnicella, PhD, postdoctoral fellow at the Gallo Center. Co-authors are Dao-Yao He, PhD, senior research scientist; Patricia Janak, PhD, associate professor of neurology at UCSF; Selena Bartlett, PhD, director of the center's preclinical development group; Carsten Nielsen, PhD, associate research scientist; and Somayeh Ahmadiantehrani, graduate student.

Research was funded by the National Institutes of Health and the State of California for medical research on alcohol and substance abuse through UCSF.

The Ernest Gallo Clinic and Research Center at UCSF is one of the world's preeminent academic centers for the study of the biological basis of alcohol and substance use disorders. It is the only center studying alcoholism in the United States that is based in a department of neurology. Gallo Center discoveries of potential molecular targets for the development of therapeutic medications are extended through preclinical and proof-of-concept clinical studies.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions and excellence in patient care.

Link to paper: http://tinyurl.com/dh6dnk

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Contact Information Jennifer O’Brien

http://www.ucsf.edu

415-476-2557