Tryton Medical Announces European Launch Of Stent System For Bifurcation Lesions
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Sally-Ann Roberts and Dorothy Roberts McEwen LCSW, sisters of ABC’s Good Morning America co-anchor Robin Roberts recently became participants and volunteer spokespersons for the Sister Study. Conducted by the National Institute of Environmental Health Sciences (NIEHS), one of the National Institutes of Health, the Sister
Study is a prospective observational study that will help researchers learn how environment and genes affect the chances of getting breast cancer. The study which is in its final phase of recruitment is committed to enrolling 50,000 diverse women who have never had breast cancer but whose sisters had the disease.
Like their sister, Sally-Ann and Dorothy are no strangers to working hard everyday to change the lives of others. Sally-Ann is co-anchor on New Orleans’ CBS Eyewitness Morning News and leads a non-profit organization, Each One Save One; and Dorothy is a healthcare administrator as assistant director at South MS Regional Center. As Sister Study spokespersons, the duo will encourage more women to enroll in this important effort, which researchers hope will identify causes of breast cancer and yield information that will help prevent breast cancer for generations to come.
Breast cancer hit close to home when their younger sister, Robin was diagnosed in 2007. It was natural for them to be strong for one another through Robin’s recovery but they were less accustomed to sometimes feeling helpless as they watched their sister battle the disease. Sally-Ann, 54, and Dorothy, 51, both decided that enrolling in the Sister Study would be a way to honor Robin, contribute to a good cause and hopefully help scientists learn about the causes of the disease.
“I learned about the Sister Study while interviewing another study spokesperson on the show,” said Sally-Ann. “I immediately felt that this was an opportunity for me to help answer questions about why Robin may have gotten breast cancer while I had not.” She added, “Future generations will truly benefit from the collective efforts of sisters participating in this study.” While on air, Sally-Ann promised to join the Sister Study and did in fact honor that promise.
The news segment not only encouraged women of New Orleans to enroll, increasing local enrollment by 29%, but Sally-Ann’s commitment motivated her younger sister Dorothy to enroll and also become a spokesperson. As a social worker Dorothy understands the need for research, but wasn’t sure about participating herself. But, like other women who hear about the Sister Study, she overcame her initial reluctance to participate.
“When I compared the amount of time it takes to participate in the Sister Study to the countless hours my sister Robin spent fighting breast cancer, I got past my hesitation and signed up,” said Dorothy. “It’s so important to develop solutions that will answer questions about the environment, genes and breast cancer.” She added, “Unless a wide range of women take their place in research helping to answer these
questions, being able to prevent this disease in the future becomes nearly impossible. Sally-Ann and I are encouraging more women to participate, and make a difference in the fight against breast cancer.”
Sally-Ann and Dorothy will tell their stories and reach out to women in their communities and beyond. The three sisters will also be featured in the October issue of Essence Magazine.
Fewer than 20% of women with breast cancer have any family history of the disease, and less than half of all women diagnosed with breast cancer have any of the known risk factors. Sister Study researchers believe there is much more to be learned about how environment and genes are related to breast cancer risk. Sisters of women with breast cancer have about twice the risk of developing breast cancer themselves, as compared to most women so studying these sisters may provide important clues to breast cancer causes. Important clues will also come from studies that include a wide range of women from different backgrounds which is why the researchers are so committed to enrolling a diverse cohort.
Women ages 35 to 74 may be eligible to join the study if they have never had breast cancer themselves; their sister (living or deceased) related to them by blood, had breast cancer; and they live in the United States or Puerto Rico. The study is quickly approaching the goal of enrolling 50,000 diverse women, but to ensure the results benefit all women, researchers are asking African Americans, Latinas, Asians, Pacific Islanders and Native Americans to enroll immediately. Caucasian women with a high school degree or less, or who are between the ages of 65-74 are also still needed.
The study is no longer enrolling new volunteers who are Caucasians 35-64 years old with more than a high school degree - these women are already well represented in the study group. During the remaining months of enrollment, the Sister Study is making special outreach to women who have ever held blue collar or non-traditional jobs, because of the wide-range of environmental and chemical exposures that might be found at work.
Dale Sandler, Ph.D., Chief of the Epidemiology Branch at NIEHS and Principal Investigator of the Sister Study said, “After four years, we are almost at our goal of 50,000 participants and the team is working extremely hard to wrap up recruitment during these last few months of 2008.” She added, “Over time, we look forward to continuing to follow the participants and having results that could benefit our daughters and granddaughters.”
Sister Study partners include NIH’s National Center on Minority Health and Health Disparities, the American Cancer Society, Sisters Network Inc., Susan G. Komen for the Cure, Breast Cancer Network of Strength, and the Intercultural Cancer Council. In addition to working with its national partners, the Sister Study works with local, regional, and national organizations to inform diverse women about the study.
To volunteer or learn more about the Sister Study, visit http://www.sisterstudy.org, (for Spanish http://www.estudiodehermanas.org), or call toll free 1-877-4SISTER (877-474-7837). Deaf/Hard of Hearing call 1-866-TTY-4SIS (866-889-4747). All activities are available in English and Spanish.
Sister Study
Other news:
The UK’s ten million Smokers may see pictures of rotting teeth, throat cancer, and indications of male impotence (erectile dysfunction) on cigarette packets they buy at the beginning of October. The Department of Health (DoH) says “The warnings illustrate the devastating effects that tobacco can have on health.”
Written warnings were introduced in January 2003. The DoH says they have been a great success. It says over 90,000 smokers have been moved by written warnings and consequently called the NHS Smoking Helpline (Tel - (0800 169 0 169).
There are 1.9 million fewer smokers today in the United Kingdom, compared to 1982. However, the DoH says smoking is still the nation’s biggest killer. In England alone smoking is responsible for the premature deaths of 87,000 people annually.
The DoH says it expects the graphic pictures should have an even bigger impact on both triggering smokers into action (to giving up) and putting off want-to-be smokers from ever starting. These visual warnings will be changed periodically, for maximum effect. Research suggests that smokers remember the negative effects for longer if they are exposed to images, compared to written sentences.
Sir Liam Donaldson, Chief Medical Officer said:
“I welcome the introduction of picture warnings on tobacco product packaging, which show smokers the grim reality of the effects smoking can have on their health. This will help to maintain the momentum of the increasing number of people who have given up smoking following England going smoke free in 2007. Written health warnings have encouraged many smokers to stop smoking. These new stark picture warnings emphasize the harsh health realities of continuing to smoke. I hope they will make many more think hard about giving up, and get the help they need to stop smoking for good.”
The Department of Health, in a recent press release, quotes Michael Shepherd, 39, who was diagnosed with throat cancer two years ago. Michael hopes that the new warnings will help make smokers realize that the risks they are taking are real. He hopes that, unlike him, they can stop before it is too late.
Michael Shepherd said “Before I was diagnosed with cancer, I felt I was invincible. I was a big strong bloke working at a trade I loved; I had a huge circle of friends and money to spend. Now I’m on invalidity benefits, and live on state handouts. I hate it and would do anything to get back into work. All this has happened to me because of smoking. I never realized you could get cancer so young. The doctors saved my life, but what I’ve got now is a hard struggle. I will keep on and I will fight to get better, if only for my daughter’s sake.”
In 2001 Canada introduced graphic warnings. Official reports indicate that 31% of Canadian ex-smokers gave up because they had seen the pictures, and 27 per cent reported they had helped them to stay smokefree. The following countries use graphic warning on tobacco products - Australia, Brazil, Canada, India, New Zealand, Singapore, Venezuela, Thailand and Uruguay.
According to local NHS Stop Smoking Services around England 350,000 smokers in the UK stopped smoking. If you are a smoker and wish to give up you can join them and find out more - order a free DVD which explains the different types of NHS support available to help smokers who want to quit - call 0800 169 0 169.
The images come from an image bank stipulated by the European Union. The warnings ‘Smoking kills’ and ‘Smoking seriously harms you and others around you’ will continue to be used on the front of tobacco packs.
List of warnings:
1. Smokers die younger
2. Smoking clogs the arteries and causes heart attacks and strokes
3. Smoking causes fatal lung cancer
4. Smoking is highly addictive, don’t start
5. Stopping smoking reduces the risk of fatal heart and lung diseases
6. Smoking can cause a slow and painful death
7. Smoking causes ageing of the skin
8. Smoking can damage the sperm and decreases fertility
9. Smoking may reduce the blood flow and cause impotence
10. Smoking contains benzene, nitrosamines, formaldehyde and hydrogen cyanide
11. Smoking when pregnant harms your baby
12. Protect children, don’t make them breathe your smoke
13. Your doctor or pharmacist can help you stop smoking
14. Get help to stop smoking
15. Your doctor or pharmacist can help you stop smoking (alternative for retail travel sector)
Information about free NHS stop smoking support
– The NHS Smoking Helpline (0800 169 0 169) provides expert, free, and friendly advice to smokers and those close to them. Advisers go through the range of options available from the NHS and can also refer callers to a local NHS Stop Smoking Service.
– Local NHS Stop Smoking Services offer ongoing free face-to-face support and advice close to people’s homes. There are over 150 throughout the country, offering a range of services including one-to-one or group support sessions with trained stop smoking advisors. Research shows that smokers are up to four times more likely to successfully stop smoking if they use their local NHS Stop Smoking Service together with Nicotine Replacement Therapy (NRT) than they are if they use willpower alone. Call 0800 169 0 169 or visit www.nhs.uk/gosmokefree, or ask your local GP or pharmacist for details.
– The NHS also offers an interactive stop smoking support programme, Together, which helps smokers to quit by providing advice at key stages of the quitting process through a range of communication methods including email, text messages, information packs and phone calls. Call 0800 169 0 169 or visit www.nhs.uk/gosmokefree for details.
– The NHS Smokefree campaign has produced a free DVD which provides a ‘behind-the-scenes’ look at the range of free stop smoking support available from the NHS. Real-life quitters talk about how the local NHS Stop Smoking Services, NHS Smoking Helpline and Together Programme worked for them and a doctor explains the different medical treatments to deal with nicotine cravings that are available on prescription from the NHS. Call 0800 169 0 169 to order a copy.
Source - Department of Health (UK)
Written by
Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Other news:
Concert Pharmaceuticals, Inc. announced today that it has initiated a Phase I study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of CTP-347, a novel deuterium-containing serotonin modulator created by Concert researchers. Concert intends to evaluate CTP-347 as a non-hormonal treatment for vasomotor symptoms (VMS or hot flashes) in patients with increased risk of adverse effects due to, or contraindicated to using, hormone therapy, as well as in the larger menopausal population. Results of this Phase I study are expected to be available in the first half of 2009.
“We are pleased to have advanced our first compound from concept to clinical testing in less than two years. We believe our deuterium chemistry platform holds great promise in creating novel compounds with superior safety and efficacy as compared to existing therapies. We look forward to advancing and introducing a number of first-in-class agents for unmet medical needs, of which CTP-347 is our first to enter the clinic,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals.
CTP-347 is Concert’s first compound to advance into clinical trials. CTP-347 is a new chemical entity developed from Concert’s deuterium chemistry platform by replacing key hydrogen atoms of paroxetine with deuterium. Paroxetine has been shown to be an effective treatment for VMS. However, it is a potent and irreversible inactivator of CYP2D6 (cytochrome P450 2D6), a key liver enzyme responsible for the metabolism of many commonly-prescribed drugs. In preclinical testing, CTP-347 demonstrated improved metabolic properties, significantly reducing CYP2D6 inhibition while preserving paroxetine’s pharmacological activity. Based on these results, Concert believes CTP-347 may avoid adverse interactions with many drugs, including tamoxifen and certain antiarrhythmics, beta-blockers, analgesics, and antipsychotics. The Company expects to investigate CTP-347’s drug-drug interaction profile as part of the Phase I study.
Currently, there is no FDA-approved non-hormonal treatment for VMS, a serious and sometimes long-term condition associated with a range of undesirable effects including depression, insomnia and lost productivity. Hormone replacement therapy can effectively treat VMS. However, patients who currently or previously have been treated for cancers of the breast or ovary, or who have a familial history of these cancers, are often advised to avoid hormonal treatment. A non-hormonal therapy may also be preferred by women who experience VMS following menopause in whom hormone therapy is contraindicated or who have concerns about long-term health risks posed by hormone replacement therapy.
About Deuterium
Concert Pharmaceuticals has created a broad pipeline by replacing specific hydrogen atoms in existing, clinically-validated drugs with deuterium atoms, resulting in highly differentiated new chemical entities with potential as best-in-class and first-in-class therapeutic agents. Deuterium is a safe, non-radioactive relative of hydrogen that can be isolated from sea water and has been used extensively in human metabolic and clinical studies. Since deuterium resembles hydrogen, deuterium-modified compounds are expected to fully preserve the pharmacological activity of their hydrogen analogs. An important difference is that deuterium has greater mass than hydrogen and therefore forms stronger chemical bonds. The stronger chemical bond obtained by selective deuterium modification may improve the drug’s metabolic properties, resulting in better safety, tolerability, and efficacy.
About Concert
Concert Pharmaceuticals, Inc. is a clinical stage biotechnology company dedicated to creating new medicines through a novel scientific approach utilizing the naturally-occurring element deuterium. Concert applies its innovative platform to create highly differentiated compounds starting from validated drug molecules, yielding a rich pipeline of new chemical entities (NCEs). Concert leverages decades of pharmaceutical experience to create drug candidates with potential for best-in-class efficacy and safety, while reducing R&D risk, time, and expense. The Company has over 100 patent applications for new drug candidates addressing a broad range of therapeutic areas, including vasomotor symptoms, HIV/AIDS and fibrotic diseases, among others. Since its inception in 2006, Concert has raised more than $96 million and has been financed by leading venture capitalists and institutional investors. A complete listing of Concert’s shareholders and additional corporate information is available online at http://www.concertpharma.com.
CoNCERT and CoNCERT Pharmaceuticals are trademarks of Concert Pharmaceuticals, Inc.
Concert Pharmaceuticals, Inc.
In a study published in the New England Journal of Medicine (NEJM) issue of Sept. 11, 2008, investigators concluded that arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and medical therapy. In an accompanying editorial, however, Robert G. Marx, M.D., an associate attending orthopedic surgeon at Hospital for Special Surgery (HSS) in New York, points out that the study has some weaknesses and argues strongly that arthroscopy does have a role in some patients with osteoarthritis.
“Arthroscopy is still valuable and you have to know when to use it,” said Dr. Marx, who is also director of the Foster Center for Clinical Outcome Research at HSS. “While I do not recommend arthroscopy as a treatment for an arthritic knee, it can be extremely helpful for people with arthritis who also have a co-existing knee problem such as a meniscal tear or a loose piece of cartilage that is causing the majority of their symptoms.”
In the study reported in the NEJM, investigators randomized 92 individuals to arthroscopic surgery and 86 to non-operative treatment for osteoarthritis of the knee. The non-operative treatments included one physical therapy session per week for twelve weeks with a home physical therapy program, patient education, and the step-wise use of acetaminophen, non-steroidal anti-inflammatory drugs, glucosamine and an injection of hyaluronic acid. The study did not identify any benefit in the group that received surgery.
Dr. Marx points out, however, that the study excluded patients who were believed to have a large meniscal tear based on clinical examination, or, in a small number of cases, identified through magnetic resonance imaging. “This study excluded people who the doctor thought needed arthroscopy for a meniscal tear. The doctor thought they would do well with surgery,” said Dr. Marx. “So, the only ones who are included are the ones who are not good candidates for the surgery because their symptoms were due only to arthritis and arthroscopy is not generally effective in that scenario.”
In other words, although the study showed a lack of efficacy of arthroscopy, it can be very useful in patients who may have osteoarthritis, but also another knee injury, such as a symptomatic meniscal tear. There are subtleties involved in clinical decision-making, commented Dr. Marx. Patients who are young, have mild osteoarthritis, a history of injury and clear meniscal pathology would be a good candidate for surgery and, in fact, would be unlikely to heal without the surgery. In contrast, patients who have symptoms that are only due to osteoarthritis are unlikely to benefit from arthroscopy.
Arthroscopic surgery is performed by orthopedic surgeons in many joints, most commonly the knee. The advantage of arthroscopy over traditional open surgery is that the joint does not have to be opened up fully. Instead, only two or three small incisions are made.
Dr. Marx, a member of the Sports Medicine and Shoulder Service at Hospital for Special Surgery, is also an associate professor of orthopedic surgery and associate professor of public health at Weill Cornell Medical College.
About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked No. 1 in orthopedics, No. 4 in rheumatology by U.S. News & World Report (2008), and has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center. In 2008 and 2007, HSS was a recipient of the HealthGrades Joint Replacement Excellence Award. A member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College, HSS provides orthopedic and rheumatologic patient care at NewYork-Presbyterian Hospital at New York Weill Cornell Medical Center. All Hospital for Special Surgery medical staff are on the faculty of Weill Cornell Medical College. The hospital’s research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at http://www.hss.edu.
Hospital for Special Surgery
535 E 70th St.
New York, NY 10021
United States
http://www.hss.edu/index.htm
Other news:
A new test for the detection of Chlamydia trachomatis has received CE Mark certification, allowing it to be sold for clinical use in the UK. Unlike previous tests, the Roche test is designed with a dual target approach to help future proof it, by ensuring reliability of results even when mutations occur in the bacteria’s cryptic plasmid DNA. According to the National Chlamydia Screening Programme, Chlamydia trachomatis is the most commonly reported sexually transmitted disease in the UK. Although it often causes no symptoms, Chlamydia can, if left untreated, lead to complications such as pelvic inflammatory disease or infertility in women.
“Unexpected mutations in the DNA of an infectious agent such as Chlamydia can disrupt laboratory testing and, by extension, proper treatment of patients,” said Karim Tabiti, International Business Leader for HPV and CT/NG at Roche Molecular Diagnostics. “Because it is impossible to predict when these mutations will occur, we have designed this test to detect all Chlamydia strains that may carry a deletion in the cryptic plasmid, including the variant originally detected in Sweden in 2006.”
Chlamydia trachomatis is found in 1 in 10 people under the age of 25 who are tested in the UK. The infection is often referred to as a “silent” sexually transmitted disease because approximately three quarters of infected women have no symptoms. Once detected, Chlamydia trachomatis can easily be treated with antibiotics. If left untreated, health risks can include chronic pelvic pain, pelvic inflammatory disease, potentially fatal ectopic pregnancy, increased risk of HIV infection if exposed, and infertility.
The highly sensitive and reliable COBAS® TaqMan® CT Test v2.0 simultaneously detects two targets within the C. trachomatis cryptic plasmid and genome target DNA. The COBAS® TaqMan® CT Test v2.0 offers real-time PCR testing on the automated COBAS® TaqMan® 48 Analyzer. This automated platform can produce up to 48 tests per run and provide results in only 2.5 hours after sample preparation. Amplification and detection in a closed system combined with Roche’s proprietary AmpErase enzyme and internal controls for each test help prevent cross contamination. This enhances test results integrity and quality control in laboratories.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and sales by the Diagnostics Division totalled 9.3 billion Swiss francs. Roche Diabetes Care posted 2007 sales of 3.2 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at http://www.roche.com
Roche
The Cincinnati Enquirer on Sunday examined a dispute over funding to establish a local Office of Minority Health. In March, City Manager Milton Dohoney recommended that the Cincinnati City Council approve an ordinance that would have allowed the City of Cincinnati Health Department to apply for and accept a $69,023 grant from HHS to establish the center. He said the city would supply $17,489 in matching funds.
The ordinance stated that the center “would be a natural partner for collaboration with other interested government, community, professional and academic entities working on the problem of differential health status [and] outcomes based on race, ethnicity and other factors.” The City Council rejected the grant because members said “it only would have created a new bureaucracy and required matching money,” the Enquirer reports. Council members also said that the not-for profit Center for Closing the Health Gap in Greater Cincinnati has the same mission as a potential minority health office and receives $150,000 annually from the city. The center focuses on obesity and related conditions, such as diabetes and heart disease, in the black community.
Christopher Smitherman, president of the local branch of the National Association for the Advancement of Colored People, called the council’s rejection of the grant “immoral,” adding that the initial grant could have led to $200,000 in additional funds over two years. Council member Laketa Cole, however, said there was no guarantee that the city would have received the additional $200,000.
U.S. Rep. Steve Chabot (R) has asked HHS for additional information on the grant and has asked the state, which received the funding, not to give the grant money to any other city until that information has been received.
Council member Chris Bortz said that some city officials were investigating whether the city could accept the grant and give it to the Center for Closing the Health Gap in Greater Cincinnati. Smitherman said he opposes such a plan (Prendergast, Cincinnati Enquirer, 9/21).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
CuraGen Corporation
(Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on
oncology, today announced that it has completed the enrollment of patients
into its Phase II trial evaluating CR011-vcMMAE for the treatment of
advanced melanoma. CuraGen also announced that Phase II results from
this trial will be presented during an oral session at the 23rd Annual
Meeting of the International Society for Biological Therapy of Cancer
(iSBTc), being held October 31 — November 2, 2008, in San Diego, CA. The
trial will be presented by Dr. Patrick Hwu, Co-Principal Investigator and
Professor and Chairman of the Department of Melanoma Medical Oncology at
The University of Texas, M.D. Anderson Cancer Center.
“We are very pleased with the clinical progress achieved with
CR011-vcMMAE. Completing enrollment in this melanoma study ahead of
schedule highlights the external support for this novel antibody-drug
conjugate from our investigators,” commented Dr. Timothy Shannon, President
and Chief Executive Officer of CuraGen. “We expect that treatment of
patients will still be ongoing in this Phase II trial at the time of iSBTc,
and therefore look forward to presenting the first data from all treated
patients in November, and anticipate that final results from the study will
be available during the first half of 2009.”
A total of 36 patients were enrolled in this Phase II open-label,
multi-center trial evaluating the efficacy and safety of CR011-vcMMAE 1.88
mg/kg administered intravenously once every three weeks in patients with
unresectable Stage III or Stage IV melanoma. Eligible patients had
progressive disease at trial entry and may have received one prior
cytotoxic regimen and any number of prior immunotherapies. Clinical
efficacy endpoints include objective response rate, progression free rate,
time to response and duration of response.
CuraGen is also continuing the Phase I portion of the trial evaluating
the use of a weekly as well as a two out of every three week regimen of
CR011-vcMMAE to explore the optimal dose and schedule of administration.
Results from these more frequent dosing schedules are expected to be
available in the first half of 2009.
In addition, CR011-vcMMAE is being studied in an ongoing Phase II trial
in patients with metastatic breast cancer who have received previous
chemotherapy. It is anticipated that preliminary results from the breast
cancer trial will be presented in the first half of 2009.
CR011-vcMMAE targets glycoprotein NMB (GPNMB), which is overexpressed
in a variety of cancers including melanoma, breast cancer and brain tumors.
CR011-vcMMAE is an antibody-drug conjugate comprised of a fully-human
monoclonal antibody against GPNMB linked to a potent tubulin destabilizing
agent, monomethyl auristatin E (MMAE). The enzyme-sensitive linker, which
was licensed from Seattle Genetics, is designed to be stable in the
bloodstream and to release MMAE inside tumor cells, resulting in cancer
cell death.
About Melanoma
According to the American Cancer Society, it is expected that
approximately 60,000 new cases of melanoma will be diagnosed, including
nearly 11,000 patients diagnosed with Stage III or Stage IV disease, and an
estimated 8,000 people in the U.S. will die of the disease during 2008. The
prognosis for patients with advanced melanoma is poor, and studies have
shown that the median survival is less than nine months.
About CuraGen
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stage
biopharmaceutical company developing diverse approaches for the treatment
of cancer. CuraGen Corporation is headquartered in Branford, Connecticut.
For additional information please visit http://www.curagen.com.
Forward Looking Statements
Statements in this press release regarding management’s future
expectations, beliefs, intentions, goals, strategies, plans or prospects,
including statements relating to the clinical progress of our development
programs, the timing and expected results of our clinical programs, and the
development and marketability of planned drugs, may constitute
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be identified
by terminology such as “anticipate,” “believe,” “could,” “could increase
the likelihood,” “estimate,” “expect,” “intend,” “is planned,” “may,”
“should,” “will,” “will enable,” “would be expected,” “look forward,” “may
provide,” “would” or similar terms, variations of such terms or the
negative of those terms. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors including the risk that any
one or more of CuraGen’s drug development programs will not proceed as
planned for technical, scientific or commercial reasons or due to patient
enrollment issues or based on new information from nonclinical or clinical
studies or from other sources, the success of competing products and
technologies, CuraGen’s stage of development as a biopharmaceutical
company, government regulation and healthcare reform, technological
uncertainty and product development risks, product liability exposure,
uncertainty of additional funding, CuraGen’s history of incurring losses
and the uncertainty of achieving profitability, reliance on research
collaborations and strategic alliances, competition, patent infringement
claims against CuraGen’s products, processes and technologies, CuraGen’s
ability to protect its patents and proprietary rights and uncertainties
relating to commercialization rights, as well as those risks, uncertainties
and factors referred to in CuraGen’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2008, filed with the Securities and Exchange
Commission under the section “Risk Factors,” as well as other documents
that may be filed by CuraGen from time to time with the Securities and
Exchange Commission. As a result of such risks, uncertainties and factors,
CuraGen’s actual results may differ materially from any future results,
performance or achievements discussed in or implied by the forward-looking
statements contained herein. CuraGen is providing the information in this
press release as of this date and assumes no obligations to update the
information included in this press release or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
CuraGen Corporation
http://www.curagen.com
Other news:
The use of antipsychotic medications in children keeps stirring up controversy.
A study funded by the National Institute of Mental Health has found that newer drugs for schizophrenia Lillys Zyprexa and J&Js Risperdal are no more effective than an older, cheaper drug and are more likely to cause some harmful side effects, the New York Times reports this morning. The finding calls into question the relative risks of the newer drugs, which had been generally assumed to be safer than older medicines, and could lead to a change in prescribing, according to the NYT.
The study, being published by the American Journal of Psychiatry, involved 119 young people aged 8 to 19 who got either Zyprexa, Risperdal or molindone, an older generic. After eight weeks, 34% of kids on Zyprexa, 46% on Risperdal and 50% on molindone showed significant improvement.
By then, however, so many had stopped taking their drug that it wasnt clear those differences were significant, NYT explains. Meanwhile, kids on Zyprexa gained an average of 13 pounds, and those on Risperdal gained an average of nine, while those taking molindone gained less than a pound. The kids on Zyprexa and Risperdal also showed more problems with cholesterol and insulin levels that could be warning signs for diabetes.
Linmarie Sikich, the studys lead researcher at the University of North Carolina, told the Times that the guidelines for treating schizophrenia need to be revised, so that some of the milder, traditional or older medications are considered first-line treatments in some cases.
Spokesmen for Lilly and J&J told the Times that their drugs werent approved to treat schizophrenia in children and that there was a need for new therapies, given the small number of options for kids. (Risperdal, which is now generic itself, did get an FDA nod for treatment of some conditions kids last year.)
The Times points out that prescription rates for the newer meds, called atypical antipsychotics, have skyrocketed in recent years. And a piece by the NYT last year showed that docs in Minnesota who got more drug-company funding also tended to prescribe the drugs more to kids.
Risperdal photo via Wikimedia Commons
Other news:
On Tuesday, October 7,
watch surgeons from University Hospitals Case Medical Center perform
a nipple sparing mastectomy with complete reconstruction.
This breast-preserving procedure provides patients undergoing
mastectomy with an excellent cosmetic outcome. Julian Kim, MD, FACS,
and Hooman Soltanian, MD, will be available during this interactive
panel discussion to answer any viewer questions.
Dr. Kim relates, “This is a procedure that has been tried by a
handful of surgeons over the past six or seven years, but it is a
highly specialized procedure that results in a very nice cosmetic
outcome because the breast retains its natural shape and appearance.”
To view a preview for this program and learn more visit OR-Live.
Video-Link Available
OR-Live
Other news: