As the lifespan of laboratory mice goes, Dr Vincent Tuohy’s have won the lottery. But only those who were injected with his groundbreaking breast cancer vaccine. none of these tiny research creatures, bred to make them prone to the disease, went on to develop it. all of the others did.
For nearly a decade, the Irish immunologist has been convinced that the secret to ridding the human body of its most insidious killer lies not in treating tumours but preventing them from ever taking hold in the first place.
In the way that childhood vaccination programmes have proven to be the most successful intervention in medical history, wiping out diseases like polio, mumps and measles, he became certain that deadly tumours could be eliminated in the same way.
Cancer is an overgrowth of the body’s own cells, so making a vaccination that would tell the body to stop this process is exceptionally complex because it can result in the destruction of healthy tissue and cause more harm than excellent.
A further complication with breast cancer is that tumour cells are strikingly similar to benign ones and it can be hard to distinguish between them.
But from his lab at the Cleveland Clinic, Ohio, Dr Tuohy laid the scientific groundwork for this first-of-its-kind vaccine by targeting a protein called alpha-lactalbumin, which is found in most breast cancer cells.
His team created a vaccine containing an antigen against the protein, causing the immune system to attack it. In their research, the vaccine even proved successful in shrinking existing tumours. however, although this vital protein is not found on normal breast cells, it is present in women who are lactating. As such, the vaccine would only be suitable for women who are not going to breast feed in the future.
This week, many in the normally cautious world of science hailed the vaccine as “monumental”, claiming it had the potential to eradicate breast cancer for excellent.
Breast cancer, which is the most common form of the disease after skin cancer, accounts for nearly a third of all cancers in women in Ireland and is responsible for at least 640 deaths every year.
Up to now, only two cancer-prevention vaccines have been approved for use, one against cervical cancer and the other against liver cancer. however, these vaccines target viruses — namely the human papillomavirus (HPV) and Hepatitis B (HBV). this is the first time that a vaccine has been developed that will target cancer formation itself.
“Tumours are like drunks in a bar,” says Dr Tuohy, “turning up and saying and doing things they shouldn’t. once they take root, they are very hard to eliminate and trying to treat cancer has been terribly disappointing. Preventing it in the first place would be much simpler.
“If you can isolate the proteins that are acting up in the body, you can do that. we reckon that breast cancer is a completely preventable disease in the same way that polio is completely preventable.
“We have a wonderful vaccination programme for children that protects us from polio, measles and 17 different diseases — but it stops at age 13. There’s nothing fancy about what we’ve done. We’re vaccinating against something that isn’t there — unless you already have a tumour — so it shouldn’t harm you and it should kill the tumours.”
The next step for Dr Tuohy and his team is to get funding so that the vaccine can go into human trials, a process which could begin next year. however, it will be at least a decade before the vaccine itself is approved for use in the general public.
The cancer research community in Ireland has welcomed the development as impressive.
“This is a big milestone in the war against cancer and certainly one of the biggest breakthroughs we’ve had,” says Professor William Gallagher of the UCD School of Biomolecular and Biomedical Science.
“And the study was published in Nature Medicine, a journal you don’t really get into unless you are going to have a big impact. The beauty of it is that you could shut off the need for treatment if you can prevent the disease from coming all together.
“But cancer cells are just modified versions of our own cells, so if you try to immunise against your own cells you have to be very careful,” says Prof Williams, whose research focus is breast and skin cancer.
“The other problem with a disease like breast cancer is that it can be germinating for over 20 years and has often already spread before you can find it in mammography.
“Cancer is very clever. The ability of tumour cells to spread kills 90pc of people with the disease. Tumours even send out signals from their primary location to preferred second sites they have chosen for re-homing. It’s a bit like going off to a holiday home and preparing it in advance. The tumour releases proteins, sent through the bloodstream, to the bone marrow, liver or brain, for example, and tells them to make an environment there where it can grow.”
The idea that a cure for cancer might be just around the corner has been tempered by another important fact: just because the new vaccine works in mice does not mean it will be effective in humans.
The most experimented-on creature in this history of humanity share over 90pc of their genes with humans and their main biological body systems work in the same way as ours — but a mouse can never produce all the answers.
Trial researchers in labs often give doses to mice that are much higher than a doctor could safely use on a patient. To make a drug suitable for human use means managing the side effects, a process that can take years to tackle.
But, that should not take away from the value of mice to some of the world’s most significant medical advances, including the discovery of penicillin, the role of vitamins and understanding how genes work.
As women’s hopes were raised by the prospect of a new weapon in the battle against their most common form of cancer, it was also an important week for men’s health, following research that shows a new vaccine for prostate cancer is safe and has few side effects.
In April, the US Food and Drug Administration approved the vaccine, Provenge, for use in men with advanced prostate cancer who have failed hormone treatments.
Unlike the breast cancer vaccine, it is a therapeutic, not preventive, treatment made from the patient’s own white blood cells. these cells are removed from the patient and treated with the drug; they are then placed back into the system. They then trigger an immune response which in turn kills cancer cells and leaves normal ones unharmed.
In trials, some patients with the disease who had been given a very limited time saw their lives extended by two to three years.
For those at the coalface of cancer research, the dream of learning a magic bullet against the disease has long been abandoned.
But there is a growing sense of optimism that while medicine may not be able to wipe out this most complex of diseases forever, small, incremental steps like this will ensure that more and more people lead long healthy lives, keeping it at bay.
Why yet another cancer 'miracle' really is a cause for hope this time
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Despite the seriousness of the disease, many victims do not show any lung cancer symptoms until the cancer has grown or spread to other parts of the body. The most apparent lung cancer symptoms do not usually appear until the illness reaches the more advanced stages, and even then there are few lung cancer symptoms that are specific to lung cancer only.
An unexplained cough that just won’t go away is the most common sign of lung cancer. In people who have a persistent cough, or smoker’s cough, lung cancer may show up as a change in the cough. Lung cancer symptoms get worse and become simpler to identify as the disease worsens, but the earliest stages are often undetectable.
Nearly one-fourth of lung cancers are learned by accident because there are no obvious symptoms. In these cases, lung cancer appears as a small mass and is usually learned during a routine chest x-ray or CT scan.
The majority of lung cancer symptoms begin when the cancerous mass, or tumor, gets huge enough to begin interfering with normal lung function. at this point, the lung cancer has grown within the lungs, and the lung cancer symptoms normally reported include:
• coughing up mucus tinged with blood
• coughing up blood
• shortness of breath
When the lung cancer spreads to parts of the body further outside the lungs, other lung cancer symptoms begin to appear, including:
• shooting pain in the shoulder that spreads down the arm, called Pancoast’s Syndrome
• becoming hoarse due to paralysis in the vocal chords
• difficulty swallowing if the cancer should spread to the esophagus.
If the tumor is large enough to obstruct the air passage into the lung, it may cause part of the lung to collapse or produce recurring bouts of pneumonia, bronchitis or other respiratory infections.
There are a few lung cancer symptoms that seem to be completely unrelated to the lungs, yet they still occur. these include:
• unexplained fever
• unusual changes in fingertip shape
• swollen glands, or lymph nodes, in the lower neck and upper chest.
Since many of these lung cancer symptoms are fairly innocuous on their own, they are often not identified as being associated with lung cancer. that is why lung cancer is not usually diagnosed until it has reached a more advanced stage.
Once the lung cancer has reached stage 4 and spread into parts of the body that are located further from the lungs, there are more signs but they can also seem unrelated. If the cancer moves into the bones, patients may experience terrible pain in the areas of the bone where the cancer has taken hold. When lung cancer reaches the brain, the cancer often causes blurred vision, headaches, seizure and stroke-like symptoms.
Lung Cancer Facts – Information on lung cancer symptoms and
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I wonder why diaphoresis can be the symptom of lung cancer.]]>
PRINCETON, N.J., May 21, 2010 (BUSINESS WIRE) —-Results to be Presented at 46th Annual Meeting of the American Society of Clinical Oncology
Bristol-Myers Squibb Company /quotes/comstock/13*!bmy/quotes/nls/bmy (BMY 22.96, -0.13, -0.56%) today announced positive results from a randomized Phase 2 study evaluating ipilimumab in combination with standard chemotherapy in previously untreated patients with advanced non-small cell lung cancer (NSCLC). The study, known as 041, met the predefined criteria for significant improvement (p-value of <0.1) in immune-related progression –free survival (irPFS), the primary endpoint, over chemotherapy alone. an additional analysis of progression-free survival (PFS), assessed using traditional mWHO criteria(1), also reached statistical significance in one of the two dosing schedules that combined ipilimumab with standard chemotherapy. (Abstract #7531)
“Results from this Phase 2 study are very encouraging and support further investigation of ipilimumab in NSCLC in large scale Phase 3 trials,” said Dr. Thomas J. Lynch, Jr., director of Yale Cancer Center and physician-in-chief of the Smilow Cancer Hospital at Yale-New Haven. “As with melanoma, ipilimumab brings an innovative approach to lung cancer, which is very hard to treat. These results add to our understanding of the potential of immuno-oncology in the treatment of cancer.”
Ipilimumab is a T-cell potentiator that specifically blocks the inhibitory signal of CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. Suppression of CTLA-4 can augment the immune system’s T-cell response in fighting disease.
The 041 study evaluated two distinct regimens of ipilimumab in combination with a chemotherapy regimen that is commonly used to treat advanced NSCLC in the first-line setting compared to the same chemotherapy regimen given alone. The ipilimumab arms improved irPFS by approximately one month compared to the chemotherapy-only arm. Immune-related adverse events reported in the study included gastrointestinal, skin, liver, or endocrine systems.
Plotting for a Phase 3 study of ipilimumab in the treatment of NSCLC is under way. Ipilimumab is an investigational compound and not currently approved for use by health authorities.
Study Results
Immune-related PFS was 5.52 months (hazard ratio, 0.775; p=0.094), 5.68 months (hazard ratio, 0.686; p=0.026) and 4.63 months for the concurrent, phased and chemotherapy-alone groups, respectively. Progression-free survival as assessed by mWHO, a secondary endpoint, was 4.11 months (hazard ratio, 0.882; p=0.250), 5.13 months (hazard ratio, 0.691; p=0.024)) and 4.21 months for the concurrent, phased and chemotherapy-alone groups, respectively. Interim results for overall survival, also a secondary endpoint, were 11.01 months (hazard ratio, 0.962; p=0.429), 11.56 months (hazard ratio, 0.748; p=0.104) and 9.99 months for the concurrent, phased and chemotherapy-alone groups, respectively. Results for survival were based on an interim analysis and follow up continues.
Grade 3/4 adverse events (AEs) were 58%, 52% and 42% for the concurrent, phased and chemotherapy alone groups, respectively, and were reflective of previously reported events for these individual agents. The incidences of Grade 3/4 immune-related AEs were 20% and 15% for the concurrent and phased groups, respectively. Immune-related adverse events were treated with the use of supportive care and systemic steroids using established protocol-specific treatment guidelines.
About the Study
Study 041 is a multi-center, randomized, double blind, three arm trial evaluating the efficacy and safety of ipilimumab in combination with paclitaxel/carboplatin compared to paclitaxel/carboplatin alone in previously-untreated patients with Stage IIIb or IV non-small cell lung cancer (n=203). The trial enrolled patients with squamous and non-squamous cell histology. Patients were randomized to receive ipilimumab (10 mg/kg every three weeks) concurrent with the first four cycles of chemotherapy (concurrent regimen), ipilimumab (10 mg/kg every three weeks) in combination with cycles three through six of chemotherapy (phased or sequential regimen) or chemotherapy alone. Ipilimumab was administered in a maintenance schedule (10 mg/kg every 3 months) after discontinuation of chemotherapy and until progression or undue toxicity in the former two treatment arms.
About Lung Cancer
In the U.S., more than 219,000 people were diagnosed with lung cancer in 2009, which accounts for about 15 percent of all cancer diagnoses.Non-small cell lung cancer makes up 85 percent of these cases, with many being diagnosed with locally advanced or metastatic disease. Lung cancer is the leading cause of cancer-related death in men and women, with more than 159,000 deaths occurring in 2009 — accounting for about 28 percent of all cancer deaths.
About Bristol-Myers Squibb
For more information about Bristol-Myers Squibb, visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. no forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the clinical trials described in this release will support a regulatory filing for ipilimumab for an indication in non-small cell lung cancer, that ipilimumab will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2009, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
(1) Modified World Health Organization criteria (mWHO) assess response in baseline lesions and stable disease with slow steady decline in total tumor burden.
SOURCE: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company Media: Sarah Koenig, 609-252-4145 sarah.koenig@bms.com or Investors: John Elicker, 609-252-4611 john.elicker@bms.com
Copyright Business Wire 2010
Controlled Phase 2 Study of Ipilimumab Shows Clinical Activity in Advanced Non …
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Lung cancer is very perilous and prognosis for the disease is very poor. Thus no one can afford to wait to develop the disease and then treat it. According to data from the U.S. government, more than 200,000 people in the U.S. are diagnosed and more than 160,000 die from the disease each year.
Is there anything we can do in reality to prevent lung cancer?
We have already known that physical activity, diet high in fruits and vegetables, high in nutrients like vitamin C, E, or selenium may reduce the risk of lung cancer. High exposure to sunlight and or taking vitamin D supplements, getting enough sleep, avoiding stress and fatigue and environmental pollutants may also help.
A new study published in the Nov 2008 issue of Cancer Epidemiol Biomarkers Prev. showed once again that high levels of serum 25-hydroxyvitamin D [25(OH)D] level was linked with reduced risk of lung cancer.
For the prospective cohort study, Kilkkinen A and colleagues of the National Public Health Institute in Helsinki, Finland looked at data on serum vitamin D levels and cases of lung cancer for 6,937 men and women. During a maximum follow-up of 24 years, 122 cases of lung cancer were recorded.
An association between vitamin D and lung cancer risk was observed for the highest versus lowest tertile with the odds ratio 0.72. But the researchers said the link was not statistically significant.
But, the significant association was found among women and young men and women.
For women, those who had highest levels of vitamin D in their blood were 84 percent less likely to develop lung cancer. For younger participants, those with highest levels were 66 percent less likely to have the disease compared to those with the lowest levels.
The researchers concluded that “although there was no overall association between vitamin D and lung cancer risk, women and young participants with a higher level of vitamin D were observed to have a lower lung cancer risk.”
The study was not a trial, but there is a very excellent chance that the association is a causal relationship. Laboratory studies have already yielded evidence suggesting that vitamin D suppresses lung carcinogenesis.
Tags: 25-hydroxyvitamin D, Cancer Epidemiol Biomarkers, lung cancer, Vitamin D, Vitamin D cuts lung cancer risk in young people by 70 p
This entry was posted on Monday, November 10th, 2008 at 12:07 am and is filed under Other. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
Vitamin D cuts lung cancer risk in young people by 70%
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Secondhand smoke, once considered a mere nuisance, has proved to be far more harmful. It can lead to lung cancer and heart disease, exacerbate asthma and cause pneumonia and bronchitis in babies. Now, a new study links it to another serious condition: dementia in adults.
A study published Feb. 13 in the British Medical Journal found a significant increase in the risk of dementia and other forms of cognitive impairment in people over 50 who have been exposed to high levels of secondhand smoke. (See pictures of vintage pro-smoking advertisements.)
Previous research has linked active smoking with cognitive impairment. but this is the first large-scale study to associate secondhand-smoke exposure to dementia and other neurological problems in older populations.
In the study, researchers at the University of Cambridge, Britain’s Peninsula Medical School and the Universityof Michigan tested saliva samples from nearly 5,000 non-smoking adults overthe age of 50 for cotinine a by-product of nicotine high levels of which would signal exposure to secondhand smoke. Participants in the study also provided a detailed smoking history. The researchers then used established neuropsychological tests to assess brain function and cognitive impairment.
They found that patients with high levels of cotinine were 44% more likely to show signs of cognitive impairment than those with very low levels. there was also “an exposure-response gradient” between cotinine concentration and poor mental performance: the more cotinine in a subject’s saliva, the worse that subject performed on tests measuring mental agility, memory and clear thinking. (Read “The Year in Medicine 2008: From A to Z.”)
Alzheimer’s and dementia experts think that the mediating factors between secondhand smoke and cognitive impairment could be heart disease and stroke; secondhand-smoke exposure raises the risk of heart disease and stroke, which in turn raise the risk of dementia.
“One potential mechanism could be that smoke disrupts the way in which our blood vessels carry blood to the brain,” says Sarah Day, head of public health for Britain’s Alzheimer’s Society. “A type of dementia called vascular dementia is caused by minute hemorrhages in the brain. if smoke is having an effect on the cells in the blood vessel walls, that’s a pretty good explanation as to why secondhand smoke would have an effect.” (Read “Mild Exercise May Counter Dementia.”)
Responding to the research, Alzheimer’s campaigners joined the study’s authors in calling for public-smoking bans in cities, states and countries that have so far resisted them.
A wave of recent research has linked secondhand smoke to health problems; many of these studies were made possible by the implementation of smoking bans throughout the developed world. A recent study, for example, showed that the risk of heart problems dropped in both smokers and nonsmokers following Scotland’s smoking ban in 2006. many U.S. states are still without smoking bans, but, as is almost all of the developing world. but opponents of such legislation are now fighting a losing battle, according to Dr. Iain Lang of Peninsula Medical School, a co-author of the study.
“I [reckon] this is a final nail in the coffin for those who try to suggest there is no harm involved in secondhand smoke,” he says.
In an editorial accompanying the study, Mark Eisner, an associate professor of medicine at the University of California, San Francisco, commended the study but pointed out that cotinine only remains in saliva for two to three days after exposure to smoke, which is problematic as cognitive impairment in the elderly develops over many years. He called for further study into the effects of cumulative lifetime exposure to secondhand smoke to confirm the link.
But in a strongly worded conclusion, Eisner pointed out that some of the most vital breakthroughs for human health have come from altering environmental factors and that even in an era of “groundbreaking science aimed at decoding the human genome…millions of people worldwide continue to die from passive smoking.” Calling for further antismoking legislation, he argued that in the fight against illness and premature death, “we should not forget the ‘low-tech’ intervention of clearing the air we breathe.”
See pictures of the world’s most polluted places.
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LOS ANGELES, May 06, 2010 (BUSINESS WIRE) —-Company Reports first Quarter 2010 Net Loss for Common Shareholders of $3 Million, or $0.07 per Share, with Adjusted Net Income of $9 Million, or $0.22 per Share
Abraxis BioScience, Inc. /quotes/comstock/15*!abii/quotes/nls/abii (ABII 48.15, +0.37, +0.77%) , a fully integrated biotechnology company, today reported unaudited financial results for the first quarter ended March 31, 2010.
First Quarter 2010 Highlights
Net revenue for the first quarter of 2010 was $110.8 million compared with $72.6 million for the first quarter of 2009. ABRAXANE(R) revenue for the first quarter of 2010 increased to $87.9 million compared with $70.1 million for the first quarter of 2009. other product revenue and other revenue for the first quarter of 2010 increased to $22.9 million from $2.5 million in the first quarter of last year, primarily due to increased sales of raw material products and sales from Drug Source Company, LLC, an entity in which we obtained a controlling interest during the first quarter of 2010 and whose results of operations are now required to be consolidated into our financial statements.
Yucky profit for the first quarter of 2010 was $88.2 million, or 80 percent of net revenue, compared with $63.5 million, or 87 percent of net revenue, for the first quarter of 2009. While yucky profit increased due to higher sales volumes in the United States as well as increased net selling prices globally, the decrease in yucky margin as a percentage of net revenue was caused primarily by an increase in sales of lower margin raw material products.
“Abraxis continues to achieve significant research and development, commercial and operations milestones. our recently reported data in non-small cell lung cancer and pancreatic cancer combined with our broad line up for the American Society of Clinical Oncology Annual Meeting (ASCO) lay the groundwork for fantastic progress in 2010,” said Bruce Wendel, Vice Chairman and Chief Executive Officer of Abraxis BioScience. “We anticipate our clinical activities and continued global expansion to generate additional value for shareholders.”
Research and development expense for the first quarter of 2010 was $33.4 million compared with $32.3 million for the first quarter of 2009. the increase was primarily due to a milestone payment, additional spending on Phase III clinical trials for pancreatic cancer and melanoma and other research and development projects, offset by lower spending on our Phase 3 lung cancer clinical trial.
Selling, general and administrative expenses for the first quarter of 2010 increased to $50.4 million compared to $45.1 million for the first quarter of 2009. the increase was mainly due to additional spending on sales and marketing, primarily in the European Union and China.
On a GAAP basis, net loss for common shareholders for the first quarter of 2010 was $3.0 million, or $0.07 per share, compared with net loss for common shareholders for the first quarter of 2009 of $22.9 million, or $0.57 per share.
Adjusted net income for common shareholders for the first quarter of 2010 was $8.8 million, or $0.22 per share, compared to adjusted net loss for common shareholders of $5.6 million, or $0.14 per share, for the first quarter of the prior year. Adjusted net income (loss) for common shareholders excludes amortization of intangible assets, realized loss on marketable securities and non-cash stock compensation expense.
(Reconciliation tables are provided below)
Company Highlights
– According to IntrinsiQ data for March 2010, in all lines of metastatic breast cancer (MBC), ABRAXANE use represented 31.4 percent of the taxane market. In second line + MBC, ABRAXANE was 41.6 percent. ABRAXANE continues to be a leader in the taxane market in the third line + setting of the MBC market with a 47.6 percent market share.
– In March, Abraxis announced that the Phase 3 study in non-small cell lung cancer had achieved its primary endpoint of overall response rate. Details of the study data will be presented at the upcoming meeting of the ASCO.
– Abraxis announced updated overall survival findings from a Phase I/II study that explored the potential benefit of ABRAXANE in combination with gemcitabine for the first-line treatment of advanced pancreatic cancer. These findings were discussed during a keynote address by Daniel Von Hoff, M.D. of the Translational Genomics Research Institute (TGen) at the 101st Annual Meeting of the American Association for Cancer Research (AACR). Also presented at AACR were the results of a pre-clinical study of ABRAXANE given in combination with bevacizumab, which demonstrated that the combination may have potential in the treatment of triple-negative breast cancers.
Non-GAAP Financial Measures
The company believes that its presentation of non-GAAP financial measures, such as adjusted net income (loss) for common shareholders and adjusted net income (loss) per common share, provide useful supplementary information to investors in understanding the underlying operating performance of the company and facilitates additional analysis by investors. the company also uses non-GAAP financial measures internally for operating, budgeting and financial planning purposes. the non-GAAP financial measures presented by the company may not be comparable to similarly titled measures reported by other companies. the non-GAAP financial measures are in addition to, and not a substitute for or superior to, measures of financial performance calculated in accordance with GAAP. A reconciliation of GAAP net loss to adjusted net income (loss) for common shareholders for the three months ended March 31, 2010 and 2009 is included with this news release.
About ABRAXANE(R)
ABRAXANE(R) is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience’s proprietary nab(R) technology platform. this protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. by wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma and pancreatic cancer.
The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE please visit www.abraxane.com.
About Abraxis BioScience, Inc.
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. the company’s portfolio includes the world’s first and only protein-bound nanoparticle chemotherapeutic compound (ABRAXANE(R)), which is based on the company’s proprietary tumor targeting technology known as the nab(R) platform. the first FDA approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer and is now approved in 39 countries. the company continues to expand the nabplatform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
FORWARD-LOOKING STATEMENTS
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the clinical development plot, and the timing and scope of clinical studies and trials, for ABRAXANE and the global commercialization of ABRAXANE. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the fact that results from pre-clinical studies may not be predictive of results to be obtained in other pre-clinical studies or future clinical trials; delays in commencement and completion of clinical studies or trials, including slower than anticipated patient enrollment and adverse events occurring during the clinical trials; decisions by regulatory authorities regarding whether and when to approve ABRAXANE or product candidates for various indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of ABRAXANE and other products and product candidates; unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE or product candidates; the need for additional data or clinical studies for ABRAXANE or product candidates; regulatory developments (domestic or foreign) involving the company’s manufacturing facilities; the market adoption and demand of ABRAXANE and other products, the costs associated with the ongoing launch of ABRAXANE; research and development associated with the nab(R) technology platform; the impact of pharmaceutical industry regulation; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; the ability to successfully manufacture products in a time-sensitive and cost effective manner; the acceptance and demand of new pharmaceutical products; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2009 and in other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
Abraxis BioScience, Inc. Condensed Consolidated Statements of Operations (Unaudited, in thousands, except per share amounts) Three Months ended March 31, ———————————- 2010 2009 ——- ——-Abraxane revenue $ 87,947 $ 70,093Other product revenue 18,767 525Other revenue 4,116 1,964 ——- ——-Net revenue 110,830 72,582Cost of sales 22,630 9,127 ——- ——-Yucky profit 88,200 63,455Operating expenses: Research and development 33,446 32,331 Selling, general and administrative 50,413 45,149 Amortization of intangible assets 10,088 9,950 ——- ——- Total operating expenses 93,947 87,430 ——- ——-Loss from operations (5,747 ) (23,975 )Equity in net (loss) income of unconsolidated entities (1,009 ) 1,031Interest income 565 1,146Other income (expenses) 2,687 (1,440 ) ——- ——- —Loss before income taxes (3,504 ) (23,238 )(Benefit) provision for income taxes (239 ) 63 ——- — ——-Net loss $ (3,265 ) $ (23,301 ) — ——- — — ——- —Net loss for noncontrolling interests (262 ) (380 ) ——- — ——- —Net loss for common shareholders $ (3,003 ) $ (22,921 ) === ======= === === ======= ===Basic and diluted net loss per common share $ (0.07 ) $ (0.57 ) === ======= === === ======= ===B 40,181 40,081asic and diluted weighted average common shares outstanding === ======= === === ======= ===The composition of stock-based compensation included above is asfollows: Cost of sales $ 104 $ 103 Research and development 185 1,192 Selling, general and administrative 1,391 3,119 ——- ——- Total stock-based compensation $ 1,680 $ 4,414 === ======= === =======Selected ratios as a percentage of net revenue: Yucky profit 79.6 % 87.4 % Research and development 30.2 % 44.5 % Selling, general and administrative 45.5 % 62.2 % Abraxis BioScience, Inc. GAAP Net Loss For Common Shareholders to Adjusted Net Income (Loss) for Common Shareholders and per Share Reconciliation (Unaudited, in thousands, except per share amounts)Adjusted net income (loss) for common shareholders and adjustednet income (loss) per common share are defined as net loss forcommon shareholders and net loss per common share, respectively,in each case excluding amortization of intangible assets, realizedloss on marketable securities and non-cash stock compensationexpense. We believe that our presentation of non-GAAP financialmeasures provides useful supplementary information to investors inunderstanding our underlying operating performance and facilitatesadditional analysis by investors.We also use non-GAAP financialmeasures internally for operating, budgeting and financialplanning purposes.the non-GAAP financial measures below may notbe comparable to similarly titled measures reported by othercompanies.the non-GAAP financial measures are in addition to,and not a substitute for or superior to, measures of financialperformance calculated in accordance with GAAP.Reconciliation ofnet loss and net loss per common share to adjusted net income(loss) for common shareholders and adjusted net income (loss) percommon share for each of the three months ended March 31, 2010 and2009 is below: Three Months ended March 31, —————————— 2010 2009 —— ——-Net loss for common shareholders $ (3,003 ) $ (22,921 ) Amortization of intangible assets 10,088 9,950 Realized loss on marketable securities (a) – 2,944 Stock compensation expense 1,680 4,414 —— ——-Adjusted net income (loss) for common shareholders $ 8,765 $ (5,613 ) ===== ====== = ======= =Adjusted net income (loss) per common share $ 0.22 $ (0.14 ) ===== ====== = ======= =Weighted average common diluted shares outstanding (b) 40,370 40,081 ====== =======Net loss per common share $ (0.07 ) $ (0.57 ) Amortization of intangible assets 0.25 0.25 Realized loss on marketable securities (a) – 0.07 Stock compensation expense 0.04 0.11 —— ——-Adjusted net income (loss) per common share $ 0.22 $ (0.14 ) ===== ====== = ======= =(a) Represents write-down of marketable securities whose declinein values were determined to be other than temporary.(b) the calculation of weighted average common diluted shares forthe three months ended March 31, 2010 includes 189,000 dilutiveshares, which were excluded from the calculation of net loss percommon share, because there was adjusted net income in the period. Abraxis BioScience, Inc. Condensed Consolidated Balance Sheets (In thousands) March 31, ————————————– 2010 2009 ——— ———Assets (Unaudited)Current assets: Cash and cash equivalents $ 191,439 $ 203,312 Accounts receivable, net 57,657 47,220 Related party receivable – 51 Inventories 56,215 54,209 Prepaid expenses and other current assets 31,355 40,994 Deferred income taxes 25,510 25,510 ——— ——— 362,176 371,296 Total current assetsProperty, plant and equipment, net 247,423 236,798Investments in unconsolidated entities 9,656 22,774Intangible assets, net of accumulated amortization 142,248 144,633Goodwill 253,821 241,361Other non-current assets 65,767 51,518 ——— ——— Total assets $ 1,081,091 $ 1,068,380 === ========= === =========Liabilities and equityCurrent liabilities: Accounts payable $ 22,115 $ 28,577 Accrued liabilities 94,225 88,723 Accrued litigation costs 57,635 57,635 Related party payable 1,815 334 Income taxes payable 282 142 Deferred revenue 3,158 3,138 ——— ——— Total current liabilities 179,230 178,549Deferred income taxes, non-current 31,765 29,507Long-term portion of deferred revenue 4,082 4,867Other non-current liabilities 14,983 9,192 ——— ——— Total liabilities 230,060 222,115EquityStockholders’ equity: Common stock 40 40 Additional paid-in capital 1,216,951 1,213,707 Accumulated deficit (378,808 ) (375,805 ) Accumulated other comprehensive income 3,227 5,011 ——— ——— Total stockholders’ equity 841,410 842,953Noncontrolling interest 9,621 3,312 ——— ——— Total equity 851,031 846,265 ——— ——— Total liabilities and equity $ 1,081,091 $ 1,068,380 === ========= === =========
SOURCE: Abraxis BioScience, Inc.
Investors and Media Inquiries: Abraxis BioScience, Inc. Maili Bergman Director Investor Relations & Corporate Communications 310-405-7522 investorrelations@abraxisbio.com or PondelWilkinson Inc. Rob Whetstone 310-279-5963
Copyright Business Wire 2010
Abraxis BioScience Reports First Quarter 2010 Financial Results
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Of all the types of cancer that we have become familiar with in the past few decades, lung cancer is at or near the top of the list. Breast cancer gets as much attention from media, from patients and family members as lung cancer, but lung cancer is also quite feared among the general population.
When cells grow at an uncontrolled rate in the lungs, cancer has gotten a excellent start. Lung tissue is rejuvenated or grows into normal, healthy tissue except when “abnormal” cells cause masses or lumps. this might first be experienced as reduced lung capacity but can eventually cause more serious problems. Lung cancer is often life-threatening.
In some cases, this cell growth starts in the lungs and spreads to other parts of the body through the lymph system or through blood circulation. it is vital to catch cancer spots or collections of cells early, before the condition spreads throughout the lungs or to the rest of the body.
According to the American Cancer Society 15 percent of all cancer is diagnosed as starting in the lungs. among deaths caused by cancer, 29 percent are due to lung cancer. A majority of these cases are caused by tobacco smoking or by pollution from outside sources. in fact, studies show that about 90 percent of some types of lung cancer are directly related to inhaling tobacco smoke.
One of the first symptoms of lung cancer is intense, continuous coughing. Pain can develop from this excessive activity. Lung cancer can cause severe shortness of breath, even in the early stages. The voice may become hoarse because of limited air passage when talking and from inflammation of the throat and larynx. in some cases, people cough up blood. Conditions such as pneumonia and bronchitis are more likely in those with lung cancer.
It is also possible that individuals feel abnormal fatigue, developed a fever or even lose weight in the early stages of lung cancer. General pain and swelling is also common. Doctors have to diagnose lung cancer with chest X-rays, MRI or CT scans, and sometimes even cameras inserted internally through the mouth. if possible, doctors would like to take some cells out if they are possibly cancerous, so they can examine these cells under a microscope.
Cancer is described in stages, depending on size and extent of a tumor, the degree to which it has spread through the body and whether it is developing in other major organs. Treatment options include radiation, chemotherapy and surgery. some patients may choose “alternative” methods that include dietary changes and herbal supplements. Patients may find that chemotherapy and radiation cause additional problems and may choose dietary changes, vitamins, herbal supplements etc. in fact, some medical professionals have went away from using chemical and radiation techniques because they feel them toxic. Individual treatment programs can be designed by the family members, doctors and others. Treatment options should be carefully considered, using all the information available.
What is Lung Cancer? What are its Symptoms and its Treatment …
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Phase 2 study of bafetinib for advanced prostate cancer April 07, 2010
CytRx Corporation announced plans to initiate a Phase 2 trial in the second half of 2010 to evaluate the effectiveness and safety of its drug candidate bafetinib (formerly known as INNO-406) in patients with an advanced form of prostate cancer known as metastatic hormone-refractory prostate cancer.
lung cancer (NSCLC)">Phase 2 study of ARQ 197 for treatment of non-small cell lung cancer (NSCLC) March 31, 2010
ArQule Incorporated announced results from its Phase 2 study of ARQ 197 for the treatment of patients with advanced, refractory non-small cell lung cancer (NSCLC).
EvoLife products available for cancer patients undergoing chemotherapy and radiotherapy March 31, 2010
EvoLife Laboratories has launched its product line of skin, oral, nail, hair, hygiene care for cancer patients undergoing chemotherapy and radiotherapy.
FDA grants priority review to Tasigna for newly diagnosed chronic myeloid leukemia February 19, 2010
Novartis announced that Tasigna (nilotinib) 200 mg capsules has been granted priority review by the FDA for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
FDA cancer drug approval rate reviewed in JNCI February 19, 2010
The FDA’s Office of Oncology Drug Products approved 53 new indications for the use of oncology and hematology drugs and biologics from July 2005 to the end of 2007.
Tarceva approved as maintenance therapy for advanced non-small …
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Long wait for colonoscopies
[Posted: Fri 07/05/2010 by Deborah Condon]
Nearly 1,000 patients are currently waiting more than three months for a colonoscopy – the most effective procedure for diagnosing bowel cancer, the Irish Cancer Society (ICS) has said.
It has expressed serious concern about these figures, particularly as bowel (colorectal) cancer is the second most common cause of cancer death in Ireland, after lung cancer. in 2008 there were 2,216 new cases of bowel cancer and 966 deaths from the disease.
Over 50% of patients in Ireland are diagnosed with stage 3 or 4 bowel cancer – the most advanced stage of the disease. Less than 5% of patients with stage 4 bowel cancer survive for longer than five years.
According to data provided by hospitals to the National Treatment Buy Fund (NTPF), which manages public hospital waiting lists, there are now 951 people waiting more than three months for a colonoscopy. while this represents a minor decrease of 4% since the ICS last published figures in March, it also marks an upward trend over the last six months. There are now 130 more people waiting in excess of three months for a colonoscopy since last December.
Commenting on the figures, Kathleen O’Meara of the ICS said that the society is concerned about ‘the potential impact the continued high number of people on waiting lists may have on a screening programme’.
“We warmly welcomed the Minister for Health’s announcement on bowel cancer screening which will involve the use of selected hospitals to deliver screening colonoscopies, and is due to begin in 2012. however, we believe that unless the problem of waiting lists is tackled in advance of screening being delivered, we are not sure that we can have full confidence in the ability of our hospital system to deliver screening while not impacting symptomatic services at the same time,” she clarified.
She pointed out that a year ago, Minister Mary Harney instructed the HSE to ensure that patients needing an urgent colonoscopy should not have to wait more than four weeks following referral from their GP. however since March, some hospitals have seen an increase in patients waiting more than three months for this procedure.
For example, the number of patients waiting more than three months in Beaumont Hospital in Dublin has jumped from 66 to 131. in December 2009, just nine people were waiting. while in Sligo General Hospital, there are now 99 patients waiting more than three months, compared to 74 in March and 44 in December.
Letterkenny General Hospital has seen an increase from 43 patients in March to 56 now, while Galway University Hospital has seen the number of patients waiting jump from 62 in March to 106 now.
But, the news is not all bad, with some hospitals improving their performance. For example, in Tallaght Hospital, the number of patients waiting more than three months has fallen by 24% since March, from 90 patients to 68.
Mercy University Hospital in Cork has reduced its waiting list by 32%, from 153 people to 104 people, while Limerick Regional in Dooradoyle has seen the number of people waiting more than three months fall from 134 in March to 57 now.
Since the ICS started to highlight this issue in November 2008, the number of patients waiting more than three months for a colonoscopy has dropped from 1,919 to 951, a reduction of 50%. however by comparison, in September 2009, the overall reduction stood at 72%.
“While we welcome the considerable progress hospitals have made since we first drew attention to the problem in 2008, the ICS is seriously concerned to see that the total number of people waiting has increased by over 30% in just over six months. this means that 229 more patients are now waiting for colonoscopies than there were in September 2009,” Ms O’Meara pointed out.
While some of the figures may include patients who have been called for a colonoscopy and were unable to attend or patients scheduled for a repeat colonoscopy, the increases across the majority of hospitals are ‘very worrying’, the society insisted.
“Bowel cancer is the second biggest cancer killer in Ireland, with more than half of new cases being diagnosed in stage 3 or 4, where survival rates are much lower. We urge people who have been waiting for a colonoscopy in a public hospital for more than six weeks to take action by contacting their GP to see if they can schedule the procedure as soon as possible,” said ICS nursing services manager, Joan Kelly.
If patients are waiting for longer than three months, they can contact the National Treatment Buy Fund (LoCall 1890 720 820) to discuss referral for a colonoscopy to a private hospital free of charge.
If you are concerned about bowel cancer, you can also speak in confidence with a specialist cancer nurse by calling the ICS’s National Cancer Helpline on 1800 200 700. Calls are free of charge.
Bowel cancer warning signs include a change in bowel habits that last more than a month, bleeding from the back passage, regular feelsings of trapped wind or fullness in the stomach area, feeling as though there is something left to pass even after a bowel movement, weight loss for no apparent reason or ongoing tiredness/weakness.
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