What Is Mesothelioma? Lung Cancer From Asbestos
Mesothelioma is a form of lung cancer that is almost always caused by asbestos exposure and is most commonly found in the outer lining of the lungs called the mesothelium. A majority of the people who develop mesothelioma contract this cancer through breathing in asbestos fibers or being exposed to asbestos dust while on the job. In cases where mesothelioma is found in a person with no previous occupational exposure, it is summized that the exposure may have stemmed from asbestos fibers found on the clothes of someone in their home who worked in an area where asbestos dust was found.
There are a number of reasons that make diagnosing mesothelioma in its early stages extremely difficult. The symptoms of mesothelioma can have a latency period of anywhere between 20 to 50 years after the initial asbestos contact, which means by the time the symptoms begin to show, the cancer is already within its advanced stages. Once symptoms are present, diagnosis is still not a speedy process. There are a number of diseases that mirror the symptoms that are found in mesothelioma patients and because of this mesothelioma is often the last stop – usually without prior mention from the patient about the possibility of previous asbestos exposure.
The success of treatment for mesothelioma is dependent on the stage in which the cancer is found. As it is found that most mesothelioma is not discovered until the advanced stages, mesothelioma treatment is often referred to as “unsuccessful.” Studies show that when found within either stage I or II, treatment for mesothelioma – usually with a combination of radiation and chemotherapy – is successful in extending the patient’s life for five years at a rate of 74.6% (Wikipedia). There are also alternative forms of therapy that can be used in conjunction with conventional treatments, that have been shown on occasion to decrease the size of mesothelioma found in a patient.
Asbestos was used for many years in a wide array of household and industrial products because of its multiple types and uses. It is fireproof, and can also be used as an insulator, thus allowing it to become very popular during the Industrial Revolution. It is unknown whether or not people were aware of the dangers of asbestos fibers at that time, but by the 1900’s the risk of asbestos was becoming more obvious. People who lived in mining towns would develop lung problems, and general studies showed that asbestos workers died at a young age. Asbestos, in an undisturbed state, seems to pose no threat. However, as soon as it becomes damaged or friable, the fibers are able to be ingested, thus potentially leading to these or other health problems. Although some companies were aware of this danger, they continued to work with products containing asbestos with no regard to their employees. These blatant injustices are the reason for the popularity of mesothelioma in the field of litigation.
Written by Michelle Griffin
The Asbestos Cancer and Mesothelioma Support Center at Asbestos.Net
www.asbestos.net
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Calls For Compulsory Flu Jabs For NHS Staff
The Royal College of General Practitioners has called for hospital doctors, GPs, nurses, carers and other staff to have compulsory flu jabs. It is reported that Department of Health figures show fewer than one in seven frontline NHS staff had a flu jab last year! Such low levels of vaccination among staff were identified by the Health Protection Agency as a significant factor in the flu outbreak which affected a number of hospitals at the end of last year.
Dr George Kassianos of the Royal College of General Practitioners
said: “The only way to boost the effectiveness of the flu vaccine is to immunise the people who are delivering the care. You are placing patients’ at risk if you give them the flu.”
Protecting yourself and those you care for
This is a most concerning state of affairs – particularly for older people more likely to be receiving medical treatment or attending appointments. Quite clearly, it’s wise to take precautions to protect yourself or those you are caring for from the risk of flu infection – and the potentially dangerous consequences that might follow.
It’s comforting, therefore, to know that, in addition to a flu jab, many self-help measures can be taken – to avoid infection, to build up natural immunity and to obtain effective natural relief. Care
Directions presents a comprehensive guide to Colds & Flu Protection.
Read it now
here.
http://www.caredirections.co.uk
New Survey Reveals UK Lags Behind Europe In Awareness Of One Of The World’s Most Common Cancers: Head And Neck Cancer
Results from a European-wide survey1 investigating public awareness of head and neck cancer have been announced at the International Conference on Innovative Approaches in Head & Neck Oncology (ICHNO). The results revealed that despite there being more than 7,800 new cases each year2 and 2,496 deaths per year in the UK3 – resulting from two main forms of the disease – 89% of UK survey respondents were not aware of the term ‘head and neck cancer’.1
The ‘About Face’ survey*, commissioned by Merck Serono and the European Head and Neck Cancer Society (EHNS), uncovered “worryingly low awareness of symptoms and risk factors” for head and neck cancer, according to UK patient groups, Mouth Cancer Foundation and Let’s Face It: “The new survey reveals that more needs to be done if we are to treat this disease earlier and reduce morbidity. We have used the term ‘mouth cancer’ to refer to these cancers in our public awareness campaigns in the UK. So while only one in ten has heard of the term ‘head and neck’ cancer, only one in four has not heard of mouth cancer4. But more needs to be done to improve risk and symptom awareness,” said Dr Vinod Joshi of Mouth Cancer Foundation.
These views were echoed by Christine Piff of Let’s Face It, “These findings are concerning and highlight that much more needs to be done to educate the general public about head and neck cancer, to avoid delays in presentation, diagnosis and treatment.”
Head and neck cancers include those affecting the mouth, tongue, lips, salivary glands, pharynx, larynx and sinuses and other sites of the head and neck.5
In the survey, very few UK respondents (14%)1 recognised infection with the human Papillomavirus (HPV)** as a risk factor for head and neck cancer, studies indicating presence of the virus in 26-34% of cases of the cancer.6,7 Only 41% correctly cited (prolonged) sun exposure and only 52% cited alcohol as risk factors.1,8
Not all bad news for the UK
The survey did point to an encouraging finding for the UK public compared with the other six countries in the research: Identification of smoking as a risk factor for head and neck cancer was achieved by 86% of UK respondents, which was in line with other countries, but only 43% said they actually knew a heavy smoker, compared with 77% in Spain and 78% in Italy.1
In line with the fall in the overall prevalence of cigarette smoking9 and the positive impact of anti-smoking measures3, these results suggest that the UK is ahead of its neighbours in terms of progress on smoking – which is estimated to increase the risk of developing head and neck cancer ten-fold.10
“Although the new survey confirms that almost nine out of ten in the UK1 know smoking is a major risk factor8, it is worrying that only one in two are aware1 that alcohol is a risk factor of head and neck cancer8 and that only one in seven are aware1 that HPV is a risk factor8. If prevention is to be successful, awareness of all these risk factors needs to be much higher,” added Dr Vinod Joshi of the Mouth Cancer Foundation.
In terms of symptom recognition, a few of the more obvious symptoms were recognised by UK respondents, with the highest being a lump in the neck identified by 78%. Other symptoms were identified by significantly smaller proportions of people. Jaw swelling, earache and a persistent blocked nose, were identified by only 45%, 22% and 19% respectively.1,11
* The ‘About Face’ survey was conducted across seven European countries: France, Germany, Italy, Netherlands, Spain, Sweden and the UK with 7,520 responses collected (1002 from the UK). The data and analysis was conducted by TNS Healthcare.1
** Human Papillomavirus (HPV) is the name for a common group of viruses. There are over 100 different types of HPV which affect the skin and the mucosa (the moist membranes that line parts of the body, such as the insides the mouth, throat, cervix and anus). Some types of HPV are known to increase the risk of developing particular types of cancer and are known as high-risk HPVs. Over 10 different types of high-risk HPV can be passed from one person to another. HPV is spread through skin contact, often during sex.2
References
1. ‘About Face’ Head and Neck Cancer Awareness EU Omnibus Survey, TNS Healthcare September 2008
2. Cancerbackup and MacMillan Cancer Support Website Cancerbackup and MacMillan Cancer Support Website (last accessed Feb 2009)
3. Cancer Research UK Website CancerStats http://info.cancerresearchuk.org/cancerstats/types/larynx/?a=5441 and http://info.cancerresearchuk.org/cancerstats/types/oral/?a=54412 and http://info.cancerresearchuk.org/news/archive/pressreleases/2009/february/experts-predict-drop-lung-cancer (last accessed Feb 2009)
4. Mouth Cancer Awareness Action Week 2008 Press Pack (last accessed Feb 2009)
5. National Institute for Health and Clinical Excellence (NICE). Healthcare Services for Head and Neck Cancer: Understanding NICE Guidance – Information for the Public. 2004
6. McKaig RG et al. Human papillomavirus and head and neck cancer: epidemiology and molecular biology. Head Neck 1998 May;20(3):250-65 http://www.ncbi.nlm.nih.gov/pubmed/9570632 (last accessed Feb 2009)
7. Kramer AR et al, Human papillomavirus types in head and neck squamous cell carcinomas worldwide: a systematic review. Cancer Epidemiol Biomarkers Prev 2005;14(2):467-75
8. American Society for Clinical Oncology (last accessed Feb 2009)
9. National Statistics Online (last accessed Feb 2009)
10. University of York Centre for Reviews and Dissemination. Management of head and neck cancers. Eff Health Care 2004; 8(5)
11. National Cancer Institute Factsheet (last accessed Feb 2008)
About EHNS
The EHNS was convened in early 2006 and its aim is to promote exchange of knowledge in all aspects of head and neck neoplastic disease (or cancer) and to promote the highest standards of research, education and training, disease prevention and patient care across Europe. The EHNS consists of a multi-disciplinary body bringing together clinicians, other healthcare professionals, scientists and patient organizations involved in any aspect of head and neck oncology. The society consists of individuals, national and multi-national societies and associated study groups oriented towards head and neck cancer research, training and treatment throughout Europe.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.
Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Saizen® and Serostim®).
With an annual R&D investment of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases. http://www.merckserono.com/
About Merck
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website.
Merck is a global pharmaceutical and chemical company with total revenues of € 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,800 employees in 59 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
Merck
Latest Approaches To HIV Infection Management A Focus On HIV/TB And HIV/hepatitis Co-infections
Fondation Mérieux organizes its 15th Cent Gardes Symposium in New Delhi – India on March 3-6, 2009.
The conference will be opened by Alain Mérieux, chairman of Fondation Mérieux and Professor Albert Osterhaus (Erasmus Hospital – Rotterdam). Keynote addresses will be given by Professor Françoise Barré-Sinoussi, 2008 Nobel Prize in Medicine.
This conference aims at reviewing the HIV situation in India and other Asian countries in light of the strong prevalence of viral hepatitis and tuberculosis.
As co-infection with HIV and hepatitis viruses or TB strongly affects the epidemiology, diagnosis, patho-biology, and treatment of each disease, the objective of this meeting is to understand the impact of the co-infection on the prevention, detection and management of the three diseases.
More than 100 scientists, clinicians, public health actors in the fields of HIV, hepatitis and tuberculosis, from all the continents – will share their knowledge and experience in order to define the most adapted strategies to mitigate the spread and the impact of the co-infections in the Indian and Asian continent.
The following major issues will be addressed:
- The epidemiological situation in Asia,
- The immunopathology and natural history of dual infections,
- Immunization (strategies of TB and HBV vaccination in HIV infected patients),
- Disease diagnosis and patient monitoring,
- Therapeutic strategies in case of co-infections.
This conference aims at promoting comprehensive care and treatment for co-infected patients, by decompartmentalizing the different diseases approaches and considering the impact of various social, economic and public health organizational factors.
This symposium falls within the framework of « The Cent Gardes » international conferences created by Dr. Charles Mérieux in 1986, during the period when the HIV infection was surfacing. Past symposiums have allowed the foremost specialists throughout the world to present their work to the international scientific community, in particular in the field of vaccine approaches for this pathology. After Beijing in 2005, this is the second time for Fondation Mérieux to organize « The Cent Gardes » international conference outside France, which shows its commitment in promoting scientific exchange and collaboration between developed and emerging countries in the fight against HIV/AIDS.
About
Founded in 1967 by Dr. Charles Mérieux, Fondation Mérieux is an independent foundation with official charitable status.
Its mission is to fight infectious diseases affecting underprivileged countries by making diagnosis and prevention solutions available to them with sustainable development in mind.
It has four main areas of action: applied research, training and exchange of knowledge, enhancing of clinical biology and healthcare infrastructure, and assistance to patients and their families. Les Cent Gardes Symposium is a perfect example of the Fondation’ international actions to disseminate scientific information and innovation.
With the support of Fondation Christophe et Rodolphe Mérieux, under the auspices of Institut de France, it develops a network of laboratory outposts in the field, at the heart of infected areas. Current field sites are located in Mali, Cambodia, Laos, Haiti, China and Madagascar.
Fondation Mérieux
Restricting Access To Patient Records Will Damage Patient Care, Say Top Researchers
Moves to restrict researchers’ access to patient record data will undermine patient care, say top researchers in an article published by the medical journal Pulse. Heads of some of the UK’s top research organizations warn that over-protectiveness over the safety of public data will result in UK patients not having access to clinical trials treatments.
The UK government has dropped a key pledge to grant researchers the right in the NHS constitution to access identifiable medical records without needing to get patient consent – this was after an uproar among General Practitioners (GPs).
In order to select clinical trial participants, the researchers say it is essential to be able to access patient data without having to seek consent first. The researchers suggest safe havens be set up so they might access anonymous patient data.
Sir Mark Walport, director of the Wellcome Trust – said the NHS Constitution was “going in the right direction” but Government was dithering over allowing access to anonymous patient data. “It is becoming harder and harder to do research that was previously easy to do. If you actually explain to patients about how their data is going to be used, then they are happy for it to be used.”
Sir Mark says the argument is being distorted by concern over high profile data leaks from government agencies “None of these were related to medical research – not one,” he said.
Professor Peter Weissberg, Medical Director, British Heart Foundation, said patients could gain access to “gold standard” treatment in clinical trials, but this was being jeopardized by Government moves to curb access to medical records.
Weissberg added “We run the risk of unpicking everything that we have done before, and we may not be able to do landmark studies such as the Heart Protection Study in this country.”
Click here to view article online.
About PulseToday
PulseToday is the GP’s website in the UK providing general practice news, clinical education and practice information to GPs and primary care staff.
You can register on this site to get access to further information by visiting:
www.pulsetoday.co.uk/subscribemenu.asp
Written by – Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Bionovo Announces Publication Of Positive Phase 2 Trial Results For Menerba(TM)
Bionovo, Inc. (Nasdaq: BNVI) announced the online publication of a peer-reviewed article in the journal, Menopause, reporting Menerba(TM) (formerly MF101) is well tolerated, safe and effective for the treatment of vasomotor symptoms (hot flashes and night sweats) associated with menopause.
The Phase 2 clinical trial was designed to evaluate the safety and efficacy of two doses of Menerba versus placebo. The trial was conducted under the direction of Dr. Deborah Grady, an international key opinion leader, from the University of California, San Francisco. The trial was a randomized, double-blinded, placebo-controlled study that enrolled 217 healthy postmenopausal women reporting severe hot flashes, and was conducted at 6 clinical sites in the U.S. Participants were randomized to drug or identical placebo for 12 weeks.
After 12 weeks of treatment, there was a statistically significant decrease in frequency of all hot flashes in the higher dose of Menerba (p=0.04). There was also a very clear dose response trend in multiple efficacy analyses. When compared to placebo, women in the Menerba high dose group were 2.3 times more likely to have at least a 50% reduction in hot flashes after 12 weeks of treatment (OR 2.3, p=0.03).
The study further elucidated that Menerba reduced the number of times women were awakened from sleep due to hot flashes, also known as “night awakenings” or “night sweats.” The median percent reduction in night time awakenings from hot flashes for women randomized to the higher dose of Menerba was 67%, and this reduction was statistically superior compared to placebo (p=0.05).
Menerba was extremely well tolerated with 98% of participants completing the trial and 91% taking at least 75% of assigned doses. The only statistically significant side effect was transient loose stools (12% on Menerba versus 3% on placebo; p=0.03).
Safety analyses showed no cases of endometrial hyperplasia or uterine cancer during the trial. There were no differences in incidents of vaginal bleeding between the placebo group and the two treatment groups of Menerba. Likewise, there was no increase in blood estradiol levels. This finding further supports that Menerba will not lead to an increased risk for breast or uterine cancers.
This Phase 2 trial of Menerba provided evidence that treatment with Menerba is effective for the treatment of hot flashes in postmenopausal women and the drug is very well tolerated without any significant side effects.
“I am very encouraged and pleased by the findings of this clinical trial,” said Deborah Grady, M.D., Associate Dean for Clinical and Translational Science, Professor of Medicine and Director of the University of California, San Francisco (UCSF) Women’s Health Clinical Research Center. “The combination of a trend to better efficacy with the higher dose of Menerba and a very strong safety profile of a drug that was extremely well tolerated by menopausal women is exciting news. These early positive clinical results are encouraging for discovering a safer therapy for hot flashes.”
“Menerba is an estrogen receptor beta selective drug,” said Jan Ake Gustafsson, M.D., the discoverer of estrogen receptor beta, from Houston University and a member of the National Academy of Sciences. “The results from Menerba’s first Phase 2 clinical trial support the role of estrogen receptor beta as a novel target for treating menopausal symptoms.”
“Large clinical trials, such as the HERS and the WHI, elucidated serious safety concerns associated with hormone therapy. These results have led to a dramatic drop in the use of estrogens,” said Isaac Cohen, chairman and CEO of Bionovo, Inc. “For this reason, it is important to develop safer alternatives for treating menopausal symptoms currently affecting 30 million women in the US. Our results indicate Menerba is effective and safe for the treatment of hot flashes and we are eager to move forward with the development of this drug. Clearly, Menerba has the potential to help millions and reach blockbuster sales soon after market launch.”
Bionovo, Inc.
Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women’s health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, “BNVI”. For more information about Bionovo and its programs, visit:http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as “believes,” “expects,” or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Bionovo, Inc.
http://www.bionovo.com
Nektar Announces Positive Results From Phase 2 Study Of Oral NKTR-118 In Patients With Opioid-Induced Constipation (OIC)
Nektar Therapeutics (Nasdaq: NKTR) announced positive topline results from a Phase 2 double-blind, randomized, placebo-controlled study of NKTR-118 in patients with opioid-induced constipation (OIC). NKTR-118, a peripheral opioid antagonist, is an oral once-a-day investigational drug to treat OIC, the most common and debilitating manifestation of opioid-bowel dysfunction (OBD). The Phase 2 study of NKTR-118 is terminating early on the basis of overwhelming evidence of efficacy at two different dose levels of 25 mg once daily and 50 mg once daily. The study achieved a clinically meaningful and highly statistically significant, dose-dependent increase in spontaneous bowel movements (SBMs) from baseline after the first week of NKTR-118 treatment with the 25 mg dose and the 50 mg dose versus placebo (p
“These data show that NKTR-118 taken orally once-daily at the 25 mg and 50 mg dose levels dramatically increased bowel movements within the first week of treatment for patients with OIC,” said Lynn R. Webster, M.D., Medical Director, Lifetree Clinical Research and Pain Clinic, member of the board of directors of the American Academy of Pain Management and lead clinical investigator for the Phase 2 Study of NKTR-118. “Further, these effects were sustained over the entire 28-day treatment period without opiate withdrawal or reversal of analgesia. There are no oral therapies to date that have demonstrated as much promise as NKTR-118 to help this heterogeneous population of patients.”
Oral NKTR-118 combines Nektar’s advanced small molecule polymer conjugate technology platform with naloxol, a derivative of the opioid-antagonist drug, naloxone. Nektar’s technology has been shown to increase oral bioavailability and reduce penetration across the blood-brain barrier, an important potential advance for many other small molecule therapies.
“NKTR-118 demonstrates that our advanced polymer conjugate technology can potentially create new small molecule drugs with optimal physicochemical and pharmacological properties,” said Howard W. Robin, President and CEO of Nektar. “Nektar is well- recognized as the industry leader in large molecule PEGylation. This validation of our platform with small molecules is a major achievement for Nektar and sets the stage for the future growth of our pipeline.”
About the Phase 2 Study for NKTR-118
The Phase 2 study for NKTR-118, in 208 pain patients experiencing OIC, was an international, multicenter, randomized, double-blind, dose-escalation, placebo-controlled trial.
The primary endpoint of the study was a change in SBMs from a two-week baseline period during which the patient had to demonstrate significant constipation in the absence of laxatives, to the change in SBMs at the end of the first week of randomized study drug. Patients in the study were being treated for moderate to severe pain with 30 to 1,000 morphine equivalent units. Under the study protocol, patients were randomly assigned to placebo or one of three different dose cohorts (5 mg, 25 mg, and 50 mg given as a single daily oral dose) for a treatment period of four weeks. In addition to measures of SBMs, patients also recorded daily use of opiates and pain NRS scores.
Secondary endpoints included reversal of analgesia as measured by a change in pain NRS or increase in opiate use during the 28-day treatment period. NKTR-118 did not result in an increase in pain and was not associated with an increase in opiate use at any time during the 28-day treatment period at any dose. NKTR-118 was also not associated with opiate withdrawal as assessed by a change in the Clinical Opiate Withdrawal Scale. The most frequent side effects observed in the study that led to discontinuation of medication were diarrhea, nausea and abdominal cramping. These side effects were most frequent in the 50 mg dose group.
Final patients in the 50 mg dose cohort are completing treatment. Final results from the Phase 2 study are expected to be presented at scientific and medical conferences in 2009. The results of the Phase 2 study will enable Nektar to evaluate the drug in Phase 3 pivotal trials in order to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA).
About NKTR-118
Oral NKTR-118 combines Nektar’s advanced small molecule polymer conjugate technology platform with naloxol, a derivative of the opioid-antagonist drug, naloxone. Nektar’s technology has been shown to increase oral bioavailability and reduce penetration of oral NKTR-118 across the blood-brain barrier, an important potential advance for this and possibly many other small molecule therapies.
The antagonist NKTR-118 targets mu-opioid receptors within the enteric nervous system, which mediate OBD, a symptom complex resulting from opioid use that encompasses constipation, bloating, abdominal cramping, and gastroesophageal reflux. Constipation is the hallmark of this syndrome and is generally its most prominent component. In patients who take opiates chronically for pain management, anywhere from 45-90% of patients will develop debilitating constipation associated with other symptoms of opiate-induced bowel dysfunction as a result of the opiate binding to the mu-opioid receptor in the gut(1).
According to IMS Health, about 230 million prescriptions were written for opioids in 2007 in the United States alone. Currently, there are no oral drugs approved that are indicated to treat OIC. OBD and OIC can significantly impact quality of life and increase healthcare utilization.
1. Panchal SJ, Muller-Schwefe P, Wurzelmann JI. Opioid-induced bowel
dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract.
2007;61(7):1181-1187.
About Nektar
Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar’s technology and drug development expertise have enabled nine approved products for partners, which include leading biopharmaceutical companies. Nektar is also developing a robust pipeline of its own potentially high-value therapeutics that addresses unmet medical needs by leveraging and expanding its technology platforms to improve and enable molecules.
This press release contains forward-looking statements that reflect the company’s current views regarding the potential of the company’s technology platforms and the potential of NKTR-118 and the results of the Phase 2 study for that drug candidate. These forward-looking statements involve risks and uncertainties, including but not limited to: (i) NKTR-118 is in mid-stage clinical development and the risk of failure remains high and failure can unexpectedly occur at any stage prior to regulatory approval due to efficacy, safety or other factors; (ii) the timing or success of the commencement or end of clinical trials and commercial launch of new drugs may be delayed or unsuccessful due to regulatory delays, clinical trial design, slower than anticipated patient enrollment, drug manufacturing challenges, changing standards of care, clinical outcomes, or delay or failure in obtaining regulatory approval in one or more important markets; (iii) the company’s patent applications for its proprietary or partner product candidates may not issue, patents that have issued may not be enforceable, or intellectual property licenses from third parties may be required in the future; (iv) the outcome of any existing or future intellectual property or other litigation related to the company’s proprietary product candidates; and (v) the preliminary Phase 2 results for NKTR-118 described in this press release remain subject to completion of final data gathering and analysis and therefore this data remains subject to change. Other important risks and uncertainties are detailed in the company’s reports and other filings with the Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K.
Actual results could differ materially from the forward-looking statements contained in this press release. The company undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise. For more information on Nektar Therapeutics, please visit http://www.nektar.com.
Nektar Therapeutics
http://www.nektar.com
TissueGene Announces Regulatory Allowance To Initiate Phase IIa Study Of TG-C In South Korea For Osteoarthritis Of The Knee
TissueGene, Inc. announced that its South Korean licensing partner Kolon Life Science, Inc. (KLS) has received regulatory allowance from the Korea Food and Drug Administration (KFDA) to initiate a Phase IIa clinical trial of TissueGene-C (TG-C) in patients with severe osteoarthritis of the knee. TG-C has been developed for the localized delivery of allogeneic human cells expressing TGF-beta1 in order to induce the regeneration of cartilage.
In Asia, TissueGene has licensed intellectual property rights to KLS, a subsidiary of Kolon, for the clinical development and commercialization of TissueGene’s lead product candidates TG-C and TG-B, developed for the regeneration of cartilage and bone, respectively. Under the terms of the agreement, TissueGene has received an undisclosed up-front payment and will receive on-going royalty payments based upon future sales. TissueGene is currently completing Phase I clinical trials in the U.S. and continues to work closely with KLS in order to coordinate their regulatory efforts and efficiently conduct parallel clinical trials for TG-C in both the U.S. and Korea.
The Phase IIa clinical trial is designed as a randomized, multi-center study in order to evaluate the safety and efficacy of TG-C in patients with Grade IV Degenerative Joint Disease (DJD) of the knee, who have been unresponsive to existing therapies. The patients will receive an intra-articular injection to the damaged joint area at one of two dose levels of TG-C. The primary endpoint of the trial will be evidence of symptomatic improvement and the secondary endpoint will be evidence of cartilage regeneration through MRI evaluation.
“The launch of this Phase II study represents a critical step in the development of a commercially and clinically viable mechanism to initiate regeneration of cartilage for patients suffering from osteoarthritis,” stated Dr. Kwan Hee Lee, President and CEO of TissueGene. “And I believe our success thus far can be attributed primarily to the strategic alliance between TissueGene, Kolon and KLS. By bridging our domestic and international resources, this business model has not only enabled for rapid preclinical and clinical development, but has allowed for innovative cost control mechanisms and significant long-term growth opportunities.”
About TissueGene, Inc.
TissueGene, Inc. is a Maryland-based biopharmaceutical company with a strong global vision focused on developing a proprietary and innovative suite of regenerative orthopedic therapeutic products. Founded in 1999, the Company’s primary pipeline is focused on the treatment and regeneration of damaged cartilage, bones, disc and nerves. The Company’s core technology employs a form of cell-mediated gene therapy to deliver well-known therapeutic proteins to localized areas of damaged tissue. The sustained expression of such proteins, along with the cellular matrix it is delivered in, initiates rapid and permanent repair of injured tissue without the need for invasive surgical procedures. The Company has successfully demonstrated the growth of cartilage, bone, nerve and tendons in animals. For more information, please visit http://www.TissueGene.com.
About Kolon Life Science, Inc.
Kolon Life Science, Inc. (KLS), a subsidiary company of Kolon, is a leading biochemical company in Korea focused on research and discovery in the life sciences. In 2006, Kolon established KLS by merging TissueGene Asia Co., Ltd with their existing active pharmaceutical ingredients (APIs) and specialty chemicals business. For more information, please visit http://www.kolonls.co.kr.
TissueGene, Inc.
http://www.tissuegene.com
Pitt Study Finds Children Of Bipolar Parents Have Increased Risk Of Psychiatric Disorders
Children and teens of parents with bipolar disorder have an increased risk of early-onset bipolar disorder, mood disorders and anxiety disorders, according to a study by University of Pittsburgh School of Medicine researchers published in the March issue of Archives of General Psychiatry, one of the JAMA/Archives journals.
An estimated one in 100 children and teens worldwide has bipolar disorder. Identifying the condition early may improve long-term outcomes, potentially preventing high psychosocial and medical costs. Researchers from the Pittsburgh Bipolar Offspring Study suggest that having family members with bipolar disorder is the best predictor of whether their children will go on to develop the condition.
“A bipolar diagnosis at a young age deprives children of the opportunity to experience normal emotional, cognitive and social development, and this is why there is an urgent need to identify, diagnose and treat these patients early on,” said Boris Birmaher, M.D., director of the Child and Adolescent Anxiety Program and co-director of the Child and Adolescent Bipolar Services at Western Psychiatric Institute and Clinic of UPMC, endowed chair in Early Onset Bipolar Disease and professor of psychiatry at the University of Pittsburgh School of Medicine.
Compared with the offspring of control parents, children with bipolar parents had a 14-fold increased risk of having a bipolar spectrum disorder, as well as a two-to three-fold increase of having a mood or anxiety disorder. Children in families where both parents had bipolar disorders also were more likely to develop the condition than those in families containing one parent with bipolar disorder. However, their risk for other psychiatric disorders was the same as children who had one bipolar parent.
Bipolar disorder, commonly called manic-depression, often emerges in adolescence, and is characterized by intense swings between depression, mania and periods with mixed symptoms. Bipolar spectrum disorders consist of three sub-types. Bipolar I (BP-I) is characterized by episodes of full-blown mania and major depression; bipolar II (BP-II) involves episodes of less severe mania, called hypomania, and major depression; and the third sub-type is called Bipolar Not Otherwise Specified (BP-NOS), which involves symptoms consistent with elated or irritable moods that are disruptive to daily living, plus two to three other symptoms of bipolar disorder.
In this blind study, researchers compared 388 children and teens, ages 6 to 18, of 233 parents with BP-I and BP-II to 251 offspring of 143 demographically matched control parents. Parents were assessed for psychiatric disorders, family mental health history, family environment, exposure to negative life events, and also were interviewed about their children. Children were assessed directly for bipolar disorder and other psychiatric disorders by researchers who did not know their parents’ diagnoses.
“Consistent with prior research, most parents with bipolar disorder recalled that their illness started before age 20 and about 20 percent had illness that started before age 13,” said Dr. Birmaher. “In contrast, most of their children developed their first bipolar disorder episode before age 12, suggesting the possibility that parents were more perceptive of their children’s symptoms early in life or perhaps that bipolar disorder appears earlier in new generations.”
The researchers note that these findings have important clinical implications. “Clinicians who treat adults with bipolar disorder should question them about their children’s psychopathology to offer prompt identification and early interventions for any psychiatric problems that may be affecting the children’s functioning, particularly early-onset bipolar disorder,” said Dr. Birmaher. “Further studies are needed to help determine the clinical, biological and genetic risk factors that may be modified to prevent the development of psychiatric disorders in the children of those with bipolar disorder.”
Co-authors of the Pittsburgh Bipolar Offspring Study include David Axelson, M.D., Kelly Monk, R.N., Catherine Kalas, R.N., Benjamin Goldstein, M.D., Mary Beth Hickey, B.A., Mihaela Obreja, M.S., Mary Ehmann, M.A., Satish Iyengar, Ph.D., Warl Shamseddeen, M.D., David Kupfer, M.D., and David Brent, M.D., all from WPIC and the University of Pittsburgh Department of Psychiatry.
The Pittsburgh Bipolar Offspring Study was supported in part by funding provided by the National Institute of Mental Health.
Western Psychiatric Institute and Clinic (WPIC) is considered to be one of the nation’s foremost university-based psychiatric care facilities and one of the world’s leading centers for research and treatment of mental health disorders. WPIC houses the Department of Psychiatry of the University of Pittsburgh School of Medicine and is the flagship of UPMC Behavioral Health, the psychiatric specialty division of the University of Pittsburgh Medical Center.
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Research And Markets: Lymphoma Drug Pipeline Update 2009
Research and Markets has announced the addition of the “Lymphoma Drug Pipeline Update 2009″ report to their offering.
Lymphoma is a broad term encompassing a variety of cancers of the lymphatic system. There are today more than 200 therapeutics targeting lymphoma in active development, from early preclinical to marketed drugs. In addition, the accumulated number of ceased drugs over the last three years amount to another 50 drugs.
Lymphoma Drug Pipeline Update lists all drugs and gives you a progress analysis on each one of them. Identified drugs are linked to 123 different targets. These targets are further categorized on the CD-ROM by 44 classifications of molecular function and with pathway referrals to BioCarta, KEGG and NetPath. Read more below on how the Lymphoma Drug Pipeline Update is organized.
How May Drug Pipeline Update Be of Use?
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