Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced that approximately 90 percent of CyberKnife centers worldwide are now treating lung cancer with the CyberKnife® Robotic Radiosurgery System*. The number of lung cancer patients is growing significantly as well, with more than 5,000 individuals receiving CyberKnife treatments to date.
Lung cancer deaths are predicted to increase dramatically, according to a recent report from the World Health Organization (WHO). Lung cancer is expected to become more prominent in the underdeveloped world as a result of an anticipated rise in the use of tobacco products, which is the primary cause of approximately 80 percent of all lung cancer. The WHO “Report On The Global Tobacco Epidemic” projects that lung cancer incidence will increase from 18 million cases in the 20th century to 180 million cases in the 21st century worldwide. The majority of lung cancer cases are expected to be concentrated in 10 countries: China (30 percent of all cases), India (10 percent), Indonesia, Russia, the United States, Japan, Brazil, Bangladesh, Germany and Turkey.
“CyberKnife represents an important advance in the treatment of lung cancer. The CyberKnife System’s unparalleled accuracy allows me to offer an effective, non-invasive treatment option for patients with early-stage lung cancer who are not good candidates for surgery,” Richard Whyte, M.D., professor of cardiothoracic surgery at Stanford University Medical Center.
In many cases, patients with lung cancer also suffer from other medical conditions that could preclude them from eligibility for surgery to remove the tumors. The CyberKnife System gives doctors a new tool for attacking lung cancer without surgery. Combined with Accuray’s Synchrony® Respiratory Tracking System and Xsight® Lung Tracking System, the CyberKnife System enables physicians to deliver radiation accurately, even while the patient breathes normally, and reduces the risk of damaging surrounding healthy tissues and critical structures. Because no actual surgery is needed, the CyberKnife is often a viable alternative for patients previously considered medically inoperable, and can be done on an outpatient basis.
“The CyberKnife System is giving new hope to lung cancer patients who may not have had any other options in the past,” said Eric P. Lindquist, senior vice president and chief marketing officer at Accuray. “The CyberKnife System is well positioned to meet the growing need for lung cancer treatments as diagnoses of the disease are expected to increase exponentially around the world in the coming years.”
CyberKnife centers in 12 countries are now treating lung cancer patients. The only country where the CyberKnife System is installed but not being used to treat lung cancer is Japan, where current regulatory approvals for the System are limited to treatments involving the head and neck. * This statistic excludes Systems in Japan, where whole-body radiosurgery is not yet approved by regulatory authorities.
About the CyberKnife® Robotic Radiosurgery System
The CyberKnife Robotic Radiosurgery System is the world’s only robotic radiosurgery system designed to treat tumors anywhere in the body non-invasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment. This enables the CyberKnife System to deliver high-dose radiation with pinpoint precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames.
About Accuray
Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a non-surgical treatment option for those diagnosed with cancer. Accuray develops and markets the CyberKnife Robotic Radiosurgery System, which extends the benefits of radiosurgery to include extracranial tumors, including those in the spine, lung, prostate, liver and pancreas. To date, the CyberKnife System has been used to treat more than 40,000 patients worldwide and currently more than 125 systems have been installed in leading hospitals in the Americas, Europe and Asia. For more information, please visit http://www.accuray.com.
Safe Harbor Statement
The foregoing may contain certain forward-looking statements that involve risks and uncertainties, including uncertainties associated with the medical device industry. Except for the historical information contained herein, the matters set forth in this press release as to procedure growth, market acceptance, clinical studies, regulatory review and approval, and commercialization of products are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. You should not put undue reliance on any forward-looking statements.
Important factors that could cause actual performance and results to differ materially from the forward-looking statements we make include: procedure growth, market acceptance of products; competing products, the combination of our products with complementary technology; and other risks detailed from time to time under the heading “Risk Factors” in our report on Form 10-K for the 2007 fiscal year, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission.. The Company’s actual results of operations may differ significantly from those contemplated by such forward-looking statements as a result of these and other factors. We assume no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws.
Accuray Incorporated
Pro-Pharmaceuticals, Inc. (Amex: PRW), announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of DAVANAT® in combination with chemotherapy and biologic to treat a breast cancer patient. The Company currently has two ongoing Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.
The American Cancer Society estimates that approximately 180,000 new cases of breast cancer will be diagnosed in the United States this year and approximately 45,000 deaths will occur.
Pre-clinical studies showed that DAVANAT®, in combination with chemotherapy, significantly reduced tumor growth in mice implanted with metastatic human breast cancer. Results from similar pre-clinical studies designed to optimize formulations of DAVANAT® in combination with Avastin® and 5-FU also lowered toxicity as indicated by the weight gain of the mice in the study. Avastin® recently has been approved for treating breast cancer in combination with chemotherapy.
“Our goal is to improve the clinical benefit for patients being treated with chemotherapy by extending their lives and improving their quality of life,” said Theodore Zucconi, President, Pro-Pharmaceuticals. “We are pleased that the FDA has approved the use of DAVANAT® to treat a breast cancer patient. Our clinical and pre-clinical data support the fact that DAVANAT® extends survival with fewer side effects when used with chemotherapies and biologics. The need to improve drug therapies, particularly anti-cancer agents is significant and represents a large market opportunity. This is the third cancer indication for which we have received a compassionate use IND approval.”
As recently reported, data from a Phase II trial for end-stage colorectal cancer patients showed DAVANAT® extended median survival by 6.7 months with significantly reduced levels of toxicity. Additionally, the data showed no apparent change from the baseline measurements in clinical blood test parameters including platelets and white blood cell counts. Reduced toxicity data indicates improved quality of life. The data for the 20 patients revealed that three patients survived more than one year, two patients survived more than two years and one patient is still alive.
About DAVANAT® and Galectins
DAVANAT®, the Company’s lead product candidate, is a targeted therapeutic compound composed of a complex carbohydrate polymer. DAVANAT®’s mechanism of action is targeting lectins on the tumor cell surface. DAVANAT® targets specific lectins like Gal 1 and Gal 3 that are implicated in cancer development and metastasis. Galectins have been reported to be expressed on breast cancer cells and are implicated in cell development and play important roles tumor cell survival, angiogenesis and tumor metastasis.
Pro-Pharmaceuticals, Inc.
Pro-Pharmaceuticals is engaged in the discovery, development and commercialization of first-in-class, targeted therapeutic compounds for advanced treatment of cancer, liver, microbial and inflammatory diseases. The initial focus is the development of a new generation of anti-cancer treatments using carbohydrate polymers to increase survival and improve the quality of life for cancer patients. DAVANAT®, the lead pipeline candidate, is a proprietary new chemical entity that is currently in Phase II trials for first-line treatment of colorectal and biliary cancer. The Company’s technology also is being used to treat diseases such as liver and kidney fibrosis. The Company is headquartered in Newton, Mass. Additional information is available at www.pro-pharmaceuticals.com.
Forward Looking Statements
Any statements in this news release about future expectations, plans and prospects for the Company, including without limitation statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements as defined in the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in such statements. We caution investors that actual results or business conditions may differ materially from those projected or suggested in forward-looking statements. More information about those risks and uncertainties is contained the Company’s most recent quarterly or annual report and in the Company’s other reports filed with the Securities and Exchange Commission. The forward-looking statements represent the Company’s views as of the date of this news release and should not be relied upon to represent the Company’s views as of a subsequent date. While the Company anticipates that subsequent events may cause the Company’s views to change, the Company disclaims any obligation to update such forward-looking statements.
Pro-Pharmaceuticals, Inc.
Sir Bobby Robson, who used to be manager of the England football team, has launched the Sir Bobby Robson Cancer Trial and Research Centre, a charitable foundation aimed at combating cancer. Sir Bobby, who was first diagnosed with cancer in 1991, said his aim is to raise ￡500,000 (about $1 million).
The new research centre is being built at the Freeman Hospital, Newcastle (England). It will concentrate on early cancer detection and treatment, as well as carrying out clinical trials on new medications. It will have dedicated research facilities, as well as a 12 bed unit.
“I have had cancer five times now but I have had a wonderful life and I feel lucky to be alive. I owe my life to the people who have cared for me and treated me during the last 15 years in which I have had the disease. I think I might be remembered for what I did in football. But the legacy I would like to leave behind is what I tried to do to help people with cancer live longer,” Sir Bobby said.
Football celebrities were present at the launch, including Bob Wilson (ex-Arsenal goalkeeper), Des Lynham and Jim Rosenthal (TV presenters).
Sir Bobby Robson and Cancer
– Sir Bobby Robson was diagnosed with cancer in 1991. He has been diagnosed with cancer five separate times during his life and has undergone several operations.
– During the 1995-1996 football season he had to miss work as manager of Porto for some months when he developed malignant melanoma.
– In 2007 he was operated on for a brain tumor - he suffered some swelling in the brain, and according to Sky Sports News, experienced some loss of feeling in his left side. In October 2007 doctors said he was cancer-free.
– On May 7th 2007 Robson announced that he had been diagnosed with cancer (for the 5th time).
Apart from being manager of the England team, he was also manager of Fulham, Ipswich Town, PSV Einghoven, Sporting Clube de Portugal, F.C. Porto, FC Barcelona, and Newcastle United.
– Freeman Hospital
– Donate Now!!
– Sir Bobby Robson’s Biography - www.officialplayersites.com
Written by - Christian Nordqvist
Copyright: Medical News Today
The use of sentinel lymph node biopsy (SLNB) during breast cancer surgery increased substantially from 1998 through 2007, according to an article published online March 25 in the Journal of the National Cancer Institute. However, non-white women, older women, and those living in poorer areas of the U.S. were less likely to receive SLNB than their counterparts who are white, younger, or from more affluent areas, respectively.
A key prognostic factor for breast cancer is whether or not the disease has spread beyond the breast tissue into neighboring lymph nodes. To look for such invasion, surgeons can remove many lymph nodes in a procedure called axillary lymph node dissection (ALND) or only a few in the SLNB procedure. In 1998, clinical care guidelines changed, allowing surgeons to use SLNB for certain patients. SLNB is associated with easier recovery and fewer long-term problems for patients than ALND.
In the current study, Amy Y. Chen, M.D., of Emory University and the American Cancer Society in Atlanta and colleagues examined patient data from a national hospital-based cancer registry to determine how frequently SLNB had been used between 1998 and 2007. They also looked at whether patient-related factors or the type of treatment facility affected a woman’s chance of receiving SLNB over ALND.
The researchers identified 490,899 women in the National Cancer Database who underwent breast cancer surgery during the study period and had a stage of disease for which SLNB would be appropriate. The proportion of these patients who underwent SLNB increased from 26.8 percent to 65.5 percent during the study period. However, not all women were equally likely to undergo SLNB. Non-white women, women aged 72 years or older, and those who lived in zip code areas that had a lower proportion of high school graduates or lower median incomes were less likely than women who were white, younger, or from more educated or affluent regions to undergo SLNB. Disparities between these groups persisted from 1998 through 2007. For example, in 1998, 29 percent of white women received SLNB, compared with 26 percent among African American women and 35 percent among Hispanic women. In 2007, these rates rose to 70 percent, 64 percent, and 67 percent, respectively.
The clinical guidelines recommend that SLNB only be performed in facilities that have teams experienced with the procedure. While the use of SLNB increased over time in all types of hospitals, data were not available to assess whether disparities in access to SLNB were related to lack of experience with the procedure in facilities that were treating poorer women.
“The disparities that were related to receipt of SLNB in this study are particularly important in light of the clinical advantages associated with this technique. Better outcomes have been reported for patients receiving SLNB than for patients receiving ALND,” the authors write.
In an accompanying editorial, Stephen B. Edge, M.D., of Roswell Park Cancer Institute in Buffalo, N.Y., describes the history of sentinel lymph node biopsy and its rapid acceptance among breast cancer surgeons. The incorporation of the technique preceded outcome data from large randomized trials. In this instance, such enthusiasm appears to have been well placed, he writes, but a more cautious approach with new interventions should be observed in general.
Despite the eagerness of surgeons to use the technique, not all patients have equal access to the less invasive approach. “Given America’s track record of disparate care, I suppose we should not be surprised that racial and ethnic minorities were disproportionately deprived of another medical advance. However, this observation is profoundly disappointing and sobering. It is yet another call for us to redouble efforts to identify and correct the root causes of disparities,” Edge writes.
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Citation:
* Article: Chen AY, Halpern MT, Schrag NM, Stewart A, Leitch M, Ward E. Disparities and Trends in Sentinel Lymph Node Biopsy Among Early-Stage Breast Cancer Patients (1998 - 2007). J Natl Cancer Inst 2008; 100:462-474
* Editorial: Edge SB. Early Adoption and Disturbing Disparities in Sentinel Node Biopsy in Breast Cancer. J Natl Cancer Inst 2008; 100:449-450
The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Visit the Journal online at http://jnci.oxfordjournals.org/.
Source: Liz Savage
Journal of the National Cancer Institute
It is well established that Id1, a gene normally produced only in embryonic development, is reactivated in many ’solid’ cancers, or carcinomas.
In the case of breast cancer, the Id1 gene is active only in the more aggressive and metastatic varieties of cancer. Typically those cancers do not possess the oestrogen receptor, and for that reason cannot be treated with Tamoxifen (a drug that interferes with the action of oestrogen), the most effective breast cancer treatment available.
The outcomes for women with breast cancers producing Id1 are therefore much worse than for women with other forms of breast cancer.
Findings by Dr Alex Swarbrick, a scientist at Sydney’s Garvan Institute of Medical Research, in collaboration with Professor J. Michael Bishop, Nobel Prize winner and Chancellor of the University of California San Francisco (UCSF), may provide hope for such women in the future. Their article, published online this week in the international journal Proceedings of the National Academy of Sciences, USA (PNAS), shows that Id1 drives some breast cancers.
Dr Swarbrick initiated the Id1 project three years ago while working as a post doctoral researcher in the laboratory of Professor Bishop He conducted much of the experimental work for the project at UCSF, then analysed the data and tissue samples at Garvan. “We happened to ask the right questions about the right gene,” he said. “Up to that point, no-one else had asked whether or not Id1 actually contributed to the origin and behaviour of breast cancer”.
“By artificially activating the Id1 protein in mouse mammary glands, we demonstrated that Id1 indeed contributes to cancer - and that mammary cancers with high levels of Id1 become very aggressive and highly metastatic.”
“We also showed that if we genetically switch off the Id1 gene in an established tumour, those mice live much longer than mice with continual Id1 expression in their tumour. In fact about 40% of them were cured and the tumours just shrank away.”
“One of our most surprising findings was that although the tumours went away, the cells making up the tumour didn’t die, as you’d expect.”
Instead, the vanishing tumours underwent ’senescence’ a tumour suppressive mechanism that scientists are only just beginning to understand. The word is derived from the Latin ’senescere’, to grow old. For cells, it means they permanently lose the ability to divide.
Swarbrick believes that as well as trying to kill aggressive breast cancers, it may also be effective to drive them into senescence, to put them to sleep. “You induce a terminal sleep, and then the immune system just gobbles them up.”
“Many cancers mutate the genes involved in cell death, so it’s hard to kill them. Our results suggest that in the future if we can therapeutically target the genes controlling senescence, such as Id1, we can force these tumours to senesce.”
ABOUT GARVAN
The Garvan Institute of Medical Research was founded in 1963. Initially a research department of St Vincent’s Hospital in Sydney, it is now one of Australia’s largest medical research institutions with approximately 400 scientists, students and support staff. Garvan’s main research programs are: Cancer, Diabetes & Obesity, Arthritis & Immunology, Osteoporosis, and Neuroscience. The Garvan’s mission is to make significant contributions to medical science that will change the directions of science and medicine and have major impacts on human health. The outcome of Garvan’s discoveries is the development of better methods of diagnosis, treatment, and ultimately, prevention of disease.
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
Sydney
NSW 2010
Australia
http://www.garvan.org.au
Why are some cancers more aggressive than others? This was the question explored by a number of doctors and Inserm research scientists at the Institut Curie when they studied the biological profile of a form of breast cancer.
The results were astounding: tumour aggressiveness seems to be determined from the very first tumour cells and the biological diversity observed in invasive cancers already exists in localised forms.
These results could make it possible to define subpopulations of localised cancers and adapt the treatment according to the associated risks.
But with this work published in the Clinical Cancer Research issue of 1st April, the question remains of the origin of tumour cell aggressiveness: if it does not arise from biological modifications formerly acquired by tumour cells, how is the invasive capacity triggered off?
There is not one breast cancer: there are many sorts, and treatment differs according to the state of evolution, location and cells from which it is propagated (see inset on “breast cancers”).
15% to 20% of them are in situ canicular breast tumours: this localised cancer develops to the detriment of the epithelial cells of the galactophoric ducts, which convey the milk produced by the mammary gland. If it is not diagnosed in time, an in situ canicular breast carcinoma can invade the neighbouring tissues. Invasive canicular cancers represent 80% of all cases of invasive breast cancer.
Dr Anne Vincent-Salomon(1), a doctor/researcher at the Institut Curie working under Dr Olivier Delattre(2), Director of the “Genetics and biology of cancers” Inserm 830 Unit at the Institut Curie, has studied the biological profile of in situ canicular breast cancers. This work would not have been possible without the collaboration of the surgeons, anatomopathologists and radiotherapists of the Institut Curie Breast Cancer Unit headed by Dr Brigitte Sigal, nor without the help of biologists and biocomputer scientists from the Inserm/Institut Curie “Genetics and biology of cancers ” Unit.
Drs Anne Vincent-Salomon and Olivier Delattre analysed the phenotype and genetic profile of 57 in situ canicular breast tumours, together with the gene expression the transcriptome(3) of 26 of these tumours. Now, these profiles at the localised stage are very similar to those observed with invasive in situ canicular breast cancers. Diversity, and in particular the invasive power of breast cancers, thus exists in the early stages.
Cancers characterised, for example, by a mutation of the TP53 gene or overexpression of HER2 receptors possess this alteration right from the first phases of their development. The classification basal-like, luminal or ERBB2 (see inset on “breast cancers”) adopted to define invasive breast cancers and their treatment more clearly could thus be used with localised forms as well.Another conclusion drawn from the work: since they are present from the very beginning of development, TP53 mutations or expression modifications in HER2 receptors are not those that trigger off the invasion of the cancers. Likewise for the alterations in the development genes that appear right at the start of the tumour’s evolution. So how does a tumour acquire an aggressive character? If it does not arise from successive genetic modifications within tumour cells, could it be that a tumour’s evolution depends on the genetic context in which it takes place?
Are there genetic specificities peculiar to the patient that influence the evolution of tumours? Maybe not everything is contained in the tumour cells alone
References
(1) Dr Anne Vincent-Salomon is an anatomopathologist in the Tumour Biology Department at the Institut Curie. She undertook this work during her thesis carried out notably by means of an Inserm INTERFACE contract enabling her to devote her time to research while another doctor replaced her.
(2) Dr Olivier Delattre is the Inserm Research Director at the Institut Curie.
(3) The transcriptome is all the ARN messengers, the molecules serving as matrix for the synthesis of proteins from the expression of part of the genome of a cell tissue or type of cell.
INSTITUT CURIE
26, rue d’Ulm
75005 Paris Cedex 05
http://www.curie.fr
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, announced that the Korean FDA (KFDA) has granted marketing approval for ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol® in the approved indication. ABRAXANE is now approved for marketing in 34 countries.
As previously announced, Abraxis granted an exclusive license to Green Cross Corporation for the commercialization of ABRAXANE in Korea. Green Cross made an upfront payment and will pay a royalty on net sales of ABRAXANE in Korea as well as milestone payments. In a separate agreement, Green Cross has granted an exclusive license to Abraxis for the future commercialization of the following biosimilars in the U.S. and Canada: erythropoetin, pegylated G-CSF (granulocyte-colony stimulating factor), Interferon-Alpha, recombinant Factor VIII, and etanercept. Interferon Alpha has been launched in Korea by Green Cross. Green Cross filed for regulatory approval with the KFDA for recombinant Factor VIII in the second quarter of 2008 and Green Cross has completed Phase III studies for erythropoetin. Pegylated GCSF and etanercept are in early stages of development. Once approval has been received, Abraxis will pay Green Cross a milestone on each product in addition to royalties on net sales.
Green Cross currently expects to launch ABRAXANE in Korea in the first quarter of 2009 following pricing approval. Green Cross plans to establish a dedicated sales force for ABRAXANE and implement various marketing campaigns to support a successful launch. Abraxis has two additional global partnerships for the commercialization of ABRAXANE with Taiho Pharmaceuticals in Japan and Biocon Limited in India.
“The approval for ABRAXANE in Korea provides an effective new treatment option to physicians and patients in Korea in the fight against metastatic breast cancer. We look forward to expanding the global market presence of ABRAXANE,” said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience.
“This approval represents an exciting new direction for Green Cross’s oncology business and we are very pleased to bring this unique and efficacious drug to cancer patients in Korea,” said B.G. Rhee, Ph.D., executive vice president of Green Cross.
In Korea, there are approximately 20,000 cases of metastatic breast cancer. The Korean oncology market for 2007 is estimated at US$533 million of which the chemotherapy market and its taxanes component are estimated at US$400 million and US$77 million, respectively, per IMS.
In addition to the approval in Korea, ABRAXANE is approved for marketing in the U.S. and is currently co-promoted in collaboration with AstraZeneca Pharmaceuticals LP. ABRAXANE is the fastest growing taxane in the U.S.
ABRAXANE was approved in Canada in 2007 for the treatment of metastatic breast cancer including first-line disease. ABRAXANE was approved in India in November 2007 for the second-line treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Most recently, ABRAXANE was approved in the European Union in January 2008 for the treatment of metastatic breast cancer. ABRAXANE is currently under active review in Australia, Russia and China by their respective regulatory agencies.
About ABRAXANE
ABRAXANE, the first in a new class of protein-bound nanoparticle drugs utilizing the company’s proprietary nanoparticle albumin-bound (nab™) technology, is currently in various stages of development for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck.
The U.S. Food and Drug Administration (FDA) approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in 2007 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.
ABRAXANE uses albumin, a human protein, to deliver the active ingredient paclitaxel. Unlike some other chemotherapy treatments, ABRAXANE does not contain chemical solvents, which eliminates the need for pre-medication with steroids or antihistamines often needed to prevent the toxic side effects associated with solvents. ABRAXANE is administered in 30 minutes as compared to three hours for solvent-based paclitaxel.
The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. For the full prescribing information for ABRAXANE, please visit http://www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca Pharmaceuticals LP.
About Green Cross
Green Cross, a leader in the Korean biotechnology and pharmaceutical industries, is a fully integrated, internationally recognized biotechnology company dedicated to the research, development and marketing of products such as vaccines and biopharmaceuticals. Green Cross has successfully developed vaccines for Hepatitis B (Hepavax), Epidemic Hemorrhagic Fever (Hantavax) and chicken pox. The company manufactures the only seasonal influenza vaccine in Korea and is developing an avian influenza vaccine as well as recombinant Factor VIII and IX for hemophilia, and recombinant PTH for severe osteoporosis. In oncology, Green Cross is developing Greenstatin (anti-angiogenic peptide) and modified PEG-G-CSF for neutropenia.
http://www.greencross.com
About Abraxis BioScience
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-based nanoparticle chemotherapeutic compound (ABRAXANE®) which is based on the company’s proprietary tumor targeting technology known as the nab™ platform. The first FDA approved product to use this nab platform, ABRAXANE®, was launched in 2007 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq Global Market under the symbol ABII. For more information about the company and its products, please visit http://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 launch of ABRAXANE in Korea. 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 market launch of ABRAXANE in Korea, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in Abraxis BioScience’s Form 10-K for the year ended December 31, 2007 and other filings 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.
Taxol® is a registered trademark of Bristol-Myers Squibb Company.
Abraxis BioScience
Siemens has announced the creation of an Ultrasound and Women’s Health division to promote and support its products and services within the UK healthcare marketplace.
Mammography and ultrasound are playing an increasingly important role in the detection and diagnosis of breast disease. Breast cancer is the most common cancer in women in the UK*, however, thanks to increased awareness and extending screening services, early detection and diagnosis has boosted survival rates.
The creation of the new dedicated team follows comprehensive customer research and is in response to the evolving breast care environment. “The introduction of new applications and techniques such as elastography, silicon transducers and tomosynthesis has called for detailed and specialist advice in the marketplace,” said Andrew Pattison, Director of Diagnostic Ultrasound & Women’s Health at Siemens.
“Furthermore, with the Government’s commitment to extending screening services for women and greater awareness of symptoms by patients, this sector of the health service is facing increasing pressure. Our team of professionals will deliver a high level of consultancy, working with clinical teams at hospitals to explain how the latest technologies can deliver tangible benefits to improve patient outcomes.”
To meet the changing needs of the marketplace, Siemens has recently launched new products that will fall into the Women’s Health team remit. The range of ACUSON ultrasound solutions has been bolstered with the launch of the S2000, a clinically advanced acoustic system and Siemens’ first new generation Full-Field Digital Mammography system, the MAMMOMAT Inspiration, has also been introduced.
The MAMMOMAT Inspiration has been developed with the input of healthcare professionals to meet the requirements of staff and patients. The result is an advanced mammography unit that improves workflow and adapts to meet the needs of the patient. A simple upgrade to the system ensures a seamless transition to the functionality of stereotactic biopsy and to 3D imaging using tomosynthesis. Screening, diagnosis and tomosynthesis will therefore be based on a single digital platform for the first time.
The MAMMOMAT Inspiration uses new breast compression technologies for enhanced patient comfort as well as MoodLight feature to promote relaxation during examination. Patient throughput and image resolution of the whole breast, for advanced and detailed diagnosis, is improved via the isocentric rotation of the X-ray tube. The system also provides advantages in high throughput screening environments that demand speed as it offers 27 seconds between exposure times and 18 seconds between exposure and display of high resolution digital images. This means that 15 patients can be examined per hour.
The latest system in the ultrasound range is the ACUSON S2000. This next generation solution is ready for silicon transducer ultrasound technology, the first development in probe technology in over 40 years. The S2000 debuts innovative Acoustic Radiation Forced Impulse (ARFI) to expand strain imaging capabilities. It also offers many new applications for Radiology however improved 4D imaging and automated fetal measurements also makes the S2000 ideal for obstetrics and gynaecological procedures.
Further information on the Siemens Ultrasound and Women’s Health team and product portfolio is available at http://www.siemens.co.uk/medical.
Note:
* Source: BBC.co.uk, Women’s Health pages.
Siemens Healthcare is one of the world’s largest suppliers to the healthcare industry. The company is a renowned medical solutions provider with core competence and innovative strength in diagnostic and therapeutic technologies as well as in knowledge engineering, including information technology and system integration. With its laboratory diagnostics acquisitions, Siemens Healthcare is the first fully integrated diagnostics company, bringing together imaging and lab diagnostics, therapy and healthcare information technology solutions, supplemented by consulting and support services. Siemens Healthcare delivers solutions across the entire continuum of care - from prevention and early detection, to diagnosis, therapy and care. The company employs more than 49,000 people worldwide and operates in 130 countries. In the fiscal year 2007 (Sept. 30), Siemens Healthcare reported sales of €9.85 billion, orders of €10.27 billion and group profit of €1.32 billion.
Siemens Healthcare
Evidence is growing from animal and human studies that genistein, a potent chemical found in soy, protects against development of breast cancer - but only if consumed during puberty, says a Georgetown University Medical Center researcher in the British Journal of Cancer published online. The challenge now, she says, is for scientists to understand precisely why soy appears to provide a shield against the most common cancer in women.
“Timing seems to be vitally important in use of this bioactive food, and if we can figure out why that is so, then we may be able to help prevent breast cancer in the widest sense possible,” says the researcher, Leena Hilakivi-Clarke, Ph.D., a professor of oncology at the Lombardi Comprehensive Cancer Center at Georgetown.
Although there are a number of tantalizing theories to explain the connection, “at the present time no convincing explanation can be offered as to why the breast cancer-risk reducing effect of genistein might be strongest during childhood and early adolescence,” she says.
Hilakivi-Clarke is a senior author of a review article published in the journal that sums up the state of knowledge concerning the role of early life genistein exposures in modifying breast cancer risk. She has long studied the link between soy use and breast cancer, as have her three co-authors, all Finnish researchers.
There have only been three human studies that tracked soy use during puberty and later breast cancer development, and two of them focused on Asian females, who eat soy in their traditional diet. But these studies suggest soy offers a very strong protective effect - a 50 percent or more reduction in the risk of breast cancer - when soy is eaten during childhood and adolescence.
The strongest evidence for genistein’s protective effect comes from studies in mice and rats, Hilakivi-Clarke says. For example, numerous studies in rats show that the data regarding prepubertal exposure to genistein are very consistent in showing a reduction in mammary cancer risk, she says. Exposure to soy in fetal development or in adult life does not have the same protective effect.
Further examination of experimental versus control rats demonstrated that use of genistein in puberty cut the number of so-called “terminal end buds” in the breast. These are the structures that lead to growth of the mammary epithelium, which are the cells lining milk ducts, etc., and it is in these epithelial cells that breast cancer originates. But Hilakivi-Clarke says it is not clear if a mere reduction in the number of these structures could reduce cancer risk, or why.
Other studies suggest that genistein controls expression of genes in terminal end buds that regulate cell growth, repair and death. For example, the chemical could be controlling the ability of stem cells, found on these buds, to reproduce themselves or to differentiate into more specialized cells. “There is evidence that suggests that the more stem cells there are on these structures, the greater the risk of breast cancer development,” she says. This evidence supports the theory that breast cancer arises from stem cells that have lost growth control.
Other associated research has found that the genes that genistein appears to activate in developing mammary glands are well known — BRCA1, p53, and PTEN tumor suppressors, Hilakivi-Clarke says. These genes repair genetic damage and control cell survival and death, and they may also help control stem cell reproduction, she says, and genistein apparently “up-regulates” these genes, boosting production of their beneficial proteins.
What is perhaps most intriguing, she says, is that the same process that protects the breast from excess growth during pregnancy seems to be at work during puberty. “In pregnancy, BRCA1 is also up-regulated, perhaps in order to control the fate of stem cells, allowing them to make more cells for milk production, for example, but not more of themselves.”
So Hilakivi-Clarke favors the notion that genistein is acting as a breast cancer protective just as an early first pregnancy in women is known to protect against later development of the cancer:
“If malignancies occur in breast stem cells, then it is better that many of these cells are differentiated earlier rather than later. Pregnancy hormones do that, so the shorter time there is between puberty and pregnancy, the greater that protection may be,” she says. “Genistein may also help control the fate of stem cells in the same way.”
“We think this is the mechanism by which genistein works, but we really don’t know and we need to find out,” Hilakivi-Clarke says. “The findings will matter.”
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Preparation of the review was supported by grants from the National Cancer Institute (NCI), the National Institute of Environmental Health Sciences (NIEHS), and the Academy of Finland. Co-authors include Anni Warri, Ph.D., Niina Saarinen, Ph.D., and Sari Makela, M.D., Ph.D., from the University of Turku in Finland.
About Lombardi Comprehensive Cancer Center
The Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center and Georgetown University Hospital, seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Lombardi is one of only 39 comprehensive cancer centers in the nation, as designated by the National Cancer Institute, and the only one in the Washington, DC, area. For more information, go to http://lombardi.georgetown.edu/.
About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO), home to 60 percent of the university’s sponsored research funding.
Source: Karen Mallet
Georgetown University Medical Center
Another piece of the puzzle that is breast cancer has been found by University of Queensland researchers.
Dr Melissa Brown, from UQ’s School of Molecular and Microbial Sciences, and her team have discovered how a particular gene associated with breast cancer behaves, which may lead to better testing for the debilitating disease.
Dr Brown and Dr Juliet French at UQ, together with their colleagues at The University of Oxford, studied the BRCA1 gene and found that it exists in a looped formation.
“Our studies suggest that BRCA1 looks a bit like a bow when the gene is switched off, and that part of this ‘bow’ disappears when the gene is switched on,” Dr Brown said.
“Interestingly, the shape of the bow changes in different breast cancer cells, raising the possibility that this gene looping may contribute to the cancer process.”
She said ongoing studies would identify the specific DNA sequences and DNA binding molecules involved in BRCA1 gene looping.
“The status of these sequences in a larger cohort of breast cancer patients will also be determined,” she said.
“This information may lead to more sensitive pre-symptomatic testing for breast cancer and the identification of new therapeutic targets.”
The research was recently published in the scientific journal Proceedings of the National Academy of Sciences.
The University of Queensland, Brisbane Australia