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

Exposure to levels of radon gas typically found in 90 percent of American homes appears to reduce the risk of developing lung cancer by as much as 60 percent, according to a study published in the March 2008 issue of the journal Health Physics. The finding differs significantly from the results of previous case-control studies of the effects of low-level radon exposure, which have detected a slightly elevated lung cancer risk (but without statistical significance) or no risk at all.

The study, undertaken jointly by researchers at Worcester Polytechnic Institute (WPI), Fallon Clinic, and Fallon Community Health Plan, is the first to observe a statistically significant hormetic effect of low-level radon exposure. Toxins and other environmental stressors (including radiation) that have a beneficial effect at very low doses are said to exhibit hormesis (scientists believe that the low doses of toxins may stimulate repair mechanisms in cells). Home exposure to radon, a naturally occurring radioactive decay product of radium, has been thought to be the second leading cause of lung cancer, after cigarette smoking. Chemically inert, it can percolate out of the ground into basements.

The study was initiated and managed by Donald F. Nelson, now professor emeritus of physics at WPI, during the 1990s, a time when concern over the link between residential radon exposure and lung cancer was growing. Nelson says the aim was to try to establish what level of radon exposure actually correlated with significant lung cancer risk and to establish a safety zone for home radon levels. “We were certainly not looking for a hormetic effect,” says co-author Joel H. Popkin of Fallon Clinic and St. Vincent Hospital in Worcester. “Indeed, we were stunned when the data pointed to that conclusion in such a strong way.”

In the study, the exposure of 200 individuals with confirmed cases of primary lung cancer to radon was compared to the exposure of 397 carefully matched, randomly selected control subjects. All subjects were 40 years old or older and had lived in their homes for at least 10 years. All of the cases and controls were residents of Worcester County in Massachusetts and were enrolled in the same health maintenance organization, Fallon Community Health Plan.

The results were statistically adjusted for factors known to be correlated with lung cancer risk, including smoking, occupational exposure to carcinogens, and level of education. The adjusted results show that the odds ratios of developing lung cancer fall below one (the no effect level) at radon exposure levels within the range measured in about 90 percent of homes across the United States (0-150 Becquerel per cubic meter of air, or about 0-4 picoCuries per liter). The Environmental Protection Agency (EPA) recommends that homeowners take remediation actions when household radon exposure levels rise above 4 picoCuries per liter, based on the belief that radon exposure presents a linearly increasing lung cancer risk (a view not supported by the new study in the low-dose region).

In a statistical analysis led by Richard E. Thompson, associate scientist in the department of biostatistics at the Johns Hopkins University Bloomberg School of Public Health, two mathematical techniques were used to compute the odds ratios of developing lung cancer. They each showed a statistically significant lowered lung cancer risk - a reduction of as much as 60 percent–over portions of the 0-150 Becquerel per cubic meter range. The results of the current study do not fall within the “linear, no threshold” (LNT) model commonly used to analyze radon’s cancer risk (in fact, the current study calls into question the validity of that model). The model starts with cancer risks documented for exposure to high levels of radon (for example, by uranium miners) and extrapolates a considerable distance to risks at low levels (for example, for homeowners). In that model, the odds ratios of developing cancer rise linearly from one, beginning at a radon level of zero. The model has been used by the EPA to derive its estimate that 21,000 cancer deaths annually can be attributed to radon exposure, and also accounts for the common belief that there is no safe level of radon exposure.

Donald Nelson says the differences in the outcomes of this and previous studies may be attributable to key elements of the new study’s design. For example, he noted, care was taken to place radon monitors (for yearlong measurements) in areas of the home where the subjects spent the most wakeful time. Monitors were also place in the subjects’ present and former bedrooms and on any other home level where they spent as little as one hour per week. The subjects’ exposures were then obtained by weighting the measurements according to the time typically spent near each detector. The results were further adjusted to account for how subjects’ home use changed with changing lifestyle (for example, transitioning from full-time employment to retirement). “Our analysis shows this to be an important improvement over exposure measures used by almost all other studies,” he said.

“It is important to note,” Nelson added, “that these new results do not dispute the lung cancer risk associated with higher levels of radon exposure experienced by uranium miners. Nevertheless, the results represent a dramatic departure from previous results and beliefs. Of course, a single epidemiological study is seldom regarded as definitive, so our results point to the need for new studies using our techniques.”

Nelson also noted that the study revealed a dramatic correlation between level of education and lung cancer risk. Subjects who had at least some college education were found to have only 30 percent of the lung cancer risk of those with less than a high school education. “While education has been found to be an important correlated variable in many health studies,” he said, “this is a particularly striking and statistically significant result, one found after smoking, job exposures, and radon were statistically adjusted for.”

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About Worcester Polytechnic Institute

Founded in 1865 in Worcester, Mass., WPI was one of the nation’s first engineering and technology universities. WPI’s 18 academic departments offer more than 50 undergraduate and graduate degree programs in science, engineering, technology, management, the social sciences, and the humanities and arts, leading to the BA, BS, MS, ME, MBA and PhD. WPI’s world-class faculty work with students in a number of cutting-edge research areas, leading to breakthroughs and innovations in such fields as biotechnology, fuel cells, and information security, materials processing, and nanotechnology. Students also have the opportunity to make a difference to communities and organizations around the world through the university’s innovative Global Perspective Program. There are more than 20 WPI project centers throughout North America and Central America, Africa, Australia, Asia, and Europe.

About Fallon Community Health Plan

Founded in 1977, Fallon Community Health Plan provides health care services designed to meet the unique and changing needs of all we serve. FCHP is the only health plan in Massachusetts that is both an insurer and provider of care. Our product portfolio includes a variety of group and individual health plan options (HMO, POS, PPO, Medicaid and Medicare Advantage plans) featuring flexible and innovative benefit designs. We administer fully-insured and self-insured funding arrangements with customized services for employers. Our uniquely developed provider networks offer high-quality, cost-effective, coordinated care and give our members access to doctors and hospitals throughout Massachusetts. We also offer a broad spectrum of services and programs to ensure our members, at every stage of life, remain as healthy and productive as possible. FCHP is a provider of care through its Summit ElderCare®program, an advanced and completely integrated program that offers seniors and their caregivers an alternative to nursing home placement. Our continued commitment to deliver high-quality health care and exceptional customer service has earned FCHP consistent ratings as one of the nation’s top health plans, and in 2007, placed our Medicare and Medicaid health plans as the best in the nation. FCHP is the only health plan in Massachusetts to have been awarded “Excellent” Accreditation by the National Committee for Quality Assurance for our HMO, Medicare Advantage and Medicaid products. For more information, please visit http://www.fchp.org/.

About Fallon Clinic

Fallon Clinic, a non-profit organization, is the largest independent multi-specialty group practice in Central Massachusetts. Fallon Clinic physicians and health care professionals offer a comprehensive array of primary care and specialty services, supported with cutting-edge technologies and service-oriented processes. Founded in 1929 by a team of physicians from Mayo Clinic led by Dr. John Fallon, Fallon Clinic continues to grow and thrive. Based in Worcester, Fallon Clinic has over 1,700 employees and nearly 260 physicians who see more than a million patients a year at 26 locations. Fallon Clinic admits to all major hospitals in central Massachusetts and the surrounding area and accepts a broad range of insurance coverage, including plans from all major Massachusetts payers. More information about Fallon Clinic can be found by visiting http://www.fallonclinic.org/.

Source: Michael Dorsey
Worcester Polytechnic Institute

A small RNA molecule, known as let-7 microRNA (miRNA), substantially reduced cancer growth in multiple mouse models of lung cancer, according to work by researchers at Yale University and Asuragen, Inc., published in the journal Cell Cycle.

Cancer afflicts 1.5 million people a year in the United States alone, and lung cancer is the most common and deadly form of cancer worldwide. This study indicates a direct role for a miRNA in cancer progression and introduces a new paradigm of using miRNAs as effective therapeutic agents to treat human cancer.

“We believe this is the first report of a miRNA being used to a beneficial effect on any cancer, let alone lung cancers, the deadliest of all cancers worldwide,” said senior author Frank Slack, associate professor of molecular, cellular and developmental biology at Yale.

Slack’s research group initially discovered the let-7 miRNA in C. elegans, a tiny worm used as a model system for studying how organisms develop, grow and age. They went on to show that in humans, let-7 negatively regulates a well-known determinant of human lung cancers, the RAS oncogene.

In collaboration with scientists at Asuragen, the Slack lab has studied the tumor suppressor activity of this small RNA. Their work revealed that let-7 is commonly present at substantially reduced levels in lung tumors - and that reduced levels of let-7 likely contribute to the development of the tumors. These discoveries focused public attention and research efforts to understand the potential use of naturally occurring microRNAs like let-7 to combat cancer.

This new work demonstrates that let-7 inhibits the growth of lung cancer cells in culture and in lung tumors in mice. They also showed that let-7 can be applied as an intranasal drug to reduce tumor formation in a RAS mouse model lung cancer.

“We believe that our studies provide the first direct evidence in mammals, that let-7 functions as a tumor suppressor gene,” said Slack. “Because multiple cell lines and mouse models of lung cancer were used, it appears that therapeutic application of let-7 may provide benefits to a broad group of lung cancer patients.”

“This has been a very productive industry-academic collaboration between Yale and Asuragen scientists” commented Matt Winkler CEO of Asuragen. “This work provides further evidence of the importance of miRNAs in the development of cancer and provides additional support for miRNA replacement therapy as an important component of effective cancer treatment regimens of the future.”

Other authors on the paper were Aurora Esquela-Kerscher, Phong Trang and Joanne Weidhaas at Yale; Jason Wiggins, Lubna Patrawala, David Brown and Andreas Bader at Asuragen, Inc.; Angie Cheng and Lance Ford at Ambion, Inc. The work was funded by a grant from the State of Connecticut Department of Public Health and fellowships from the National Institutes of Health.

Citation: Cell Cycle (March 15, 2008).

http://www.yale.edu

Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced that preliminary data from a Phase 1 trial of an oral formulation of picoplatin in patients with solid tumors will be presented at the 2008 American Association for Cancer Research meeting to be held from April 12-16 in San Diego, CA. In addition, preclinical data of picoplatin overcoming platinum resistant small cell lung cancer cells in platinum resistant cell lines will also be presented at a separate poster presentation.

Details are as follows:

— A Phase 1 randomized crossover picoplatin bioavailability pharmacokinetics and pharmacodynamics study.

Abstract #209, Session ID: Clinical Research 1; Yee L, Sharma S, Breitz H, Karlin D, Phillips A, Houston S, Saleh M. General Poster Session Sunday April 13, 8:00 AM PT.

— Picoplatin overcomes resistance in small cell lung cancer cell lines treated with other platinum-based chemotherapeutics.

Abstract #713, Session ID: Experimental Molecular Therapeutics 3; Parham C, Shocron E, McMahon G, Patel N. General Poster Session Sunday April 13, 8:00 AM PT.

Picoplatin is the Company’s lead product candidate under investigation in three clinical trials.

About Picoplatin

Picoplatin is a chemotherapeutic agent that has an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumors. Picoplatin has been evaluated in more than 750 patients and has anti-tumor activity in multiple indications with less severe kidney or nerve toxicity than is commonly observed with other platinum chemotherapy drugs.

Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registrational trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and is evaluating overall survival as the primary endpoint. The Company also is evaluating intravenous picoplatin in two ongoing Phase 2 clinical trials for the treatment of hormone refractory prostate cancer (HRPC) and metastatic Colorectal Cancer (mCRC). Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors. Picoplatin has not been approved by regulatory authority for use in humans.

About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. For additional information please visit http://www.poniard.com.

This release contains forward-looking statements, including statements regarding the Company’s business objectives and strategic goals, drug development plans, results of clinical trials and the potential safety and efficacy of its products in development. The Company’s actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the Company’s research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of required regulatory approvals; the market’s acceptance of the Company’s proposed products; the Company’s anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company’s ability to preserve and protect intellectual property rights; the Company’s dependence on third-party manufacturers and suppliers; the Company’s lack of sales and marketing experience; the Company’s ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company’s current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2007. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.

(C) 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved.

Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.

Poniard Pharmaceuticals, Inc.
http://www.poniard.com

A new report from the Society for Cardiothoracic Surgery in Great Britain & Ireland (published by Dendrite Clinical Systems), has for the first time recorded the variations in activity and surgical approaches between thoracic surgical units in the United Kingdom and Ireland. Presented at the recent Annual Meeting of the Society for Cardiothoracic Surgery in Great Britain & Ireland (Edinburgh, Scotland), ‘The First National Thoracic Database Report 2008′, is the first stage in an attempt to report clinically audited data for thoracic surgery affecting all the organs within the chest (lung and oesophagus), with the exception of the heart.

“This First National Thoracic Database Report is the first time data from the National Thoracic Registry has been put together in a comprehensive report,” commented UK Thoracic Surgical Audit Lead, Mr Richard Page, Consultant Thoracic Surgeon & Associate Medical Director at the Cardiothoracic Centre, Liverpool. “The report puts into context how our approach to thoracic surgery has evolved over the years, and demonstrates that the results of thoracic surgery in the UK have improved over time and compare very favourably with international standards. I believe it is of great educational value.”

The purpose of the ‘The First National Thoracic Database Report 2008′ is not only to report the number/type of procedures, but also to highlight the differing approaches to thoracic surgery between individual hospitals. The report includes:

– Data from over 340,000 individual patient records;

– Detailed information on the surgical management of lung cancer; and

– Activity from at least 95% (data from 36 of 40 centres) of thoracic surgical activity from the United Kingdom and the Republic of Ireland.

This comprehensive, 88-page report provides an overview from 25 years of national activity (1980-2007), detailing unit specific activity for a three-year period (2002-2007) and provides procedural activity in the following areas:

– Open and minimally invasive surgery (video assisted thoracic surgery [VATS]);

– Lung resection with details on activity for primary lung cancer;

– Pneumothorax surgery; and

– Oesophagogastric (upper GI) surgery with details on activity for primary oesophagogastric cancer.

Importantly, the report highlights several different approaches to treating thoracic disease, which clearly reflects the differing philosophical approaches to some complex and difficult diseases. For instance, the Registry highlights a clear trend to a reduction in the proportion of pneumonectomies, implying recognition of the dangers associated with the procedure and a better selection of surgical patients.

“One of the most important messages from my point of view is that over the years we have got much better at selecting our patients for lung cancer surgery. For instance twenty-five years ago when a patient was taken to theatre for a lung cancer operation there was a one in four chance that the cancer could not be removed - that would seem horrendous by today’s standards. This dramatic reduction in the “open and close” rate for lung cancer operations, implies a better understanding of the place of surgery for lung cancer, especially with more accurate pre-operative staging since the introduction of computed tomography in the late 1980’s,” added Mr Page.

The report also shows the variations and changes in practice over the years (the majority of procedures for oesophageal cancer are now performed by upper GI surgeons), as well as how technological developments have changed practice. For example, video assisted thoracic surgery procedures, as a proportion of the total workload, increased from approximately 6% in 1981 to nearly 30% in 2004-2007.

The information contained within the report forms the basis of effective clinical governance and will serve to improve the outcomes for patients, as well as assist in the planning and implementation of future thoracic surgical services. “By reporting procedure type/s and the locations where in the surgery is carried out, it is hoped this first national audit will lead to better organisation of services,” Mr Page commented. “For example, there are more thoracic procedures performed in some parts of the country than others, for whatever reason, and that is a very powerful argument for extra resources. I hope the report highlights that need.”

The first report contains no patient-specific details and is therefore not designed to compare and measure surgical outcomes between hospitals, but rather variations in surgical activity. However, the Society has agreed a minimum dataset to allow for a report on such issues within the United Kingdom and Ireland for thoracic surgical practice.

“The dataset we have agreed has been established for some four or five years and is easy to understand and uncomplicated. If you make it too complicated one runs the risk of not getting the reports in at all and if you make it too simple the data is not very useful, so it is about striking a balance. It concentrates on the surgical management of lung cancer. Of course there is a temptation to expand the dataset and to look in detail at more diseases, but at first it is best to establish the process so people understand what we want and further down the road there may well be a case for expanding the dataset. In this first report we have shown what can be done and over time we hope to develop a more comprehensive report,” Mr Page concluded.

Dr Peter Walton, Managing Director of Dendrite Clinical Systems, commented, “We are delighted to publish ‘The First National Thoracic Surgery Report’, which we believe will be of tremendous educational value to both the Society, its members and other healthcare professionals involved in thoracic surgical services. I would like to thank the SCTS for their support and in particular, Mr Page, for the enthusiasm, dedication and determination he has shown in producing the report. I would also like to pay tribute to all the contributors for their endeavours, without whom this report would not have been possible. We look forward to working with the SCTS in the future and publishing additional reports that will provide even greater insights into thoracic surgery in the UK and Ireland.”

The highlights of the report were presented at the recent Annual Meeting of the Society for Cardiothoracic Surgery in Great Britain & Ireland, in Edinburgh, Scotland, held 9th-11th March 2008.

Click here for a copy of the report

Dendrite Clinical Systems Ltd

Dendrite Clinical Systems Ltd is a specialist supplier of clinical databases, analysis software and consultancy services for the international healthcare sector. With over 15 years experience, the company has a unique and proven track record of delivery based on a deep understanding of professional users needs in an increasingly dynamic health care environment. Working closely with hospitals, national and international societies and associations, and industry partners, we have developed and launched numerous web-based databases and registries, which assist in establishing clear standards for clinical care. Dendrite’s client base extends across >250 hospitals and >50 national and international databases, across 32 different countries. Our prestigious list of clients includes the European Association for Cardio-Thoracic Surgeons, the British Association of Endocrine and Thyroid Surgeons, the European and American Venous Forums, and the European Society for Vascular Surgery.

http://www.e-dendrite.com

BioNumerik Pharmaceuticals, Inc. (”BioNumerik”) and ASKA Pharmaceutical Co., Ltd. (”ASKA”) announced the results of a Phase III clinical trial of Tavocept(TM) in patients with advanced non-small cell lung cancer. Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik.

The multicenter, double-blind, randomized, placebo controlled Phase III clinical trial was conducted by ASKA in Japan through the joint venture, KI Pharmaceuticals, Inc., with BioNumerik. The trial included 182 patients with advanced non-small cell lung cancer who received the chemotherapy drugs paclitaxel and cisplatin as first-line therapy every three weeks. Half of all patients in the trial received Tavocept along with their chemotherapy, while the other half received a placebo and chemotherapy. The primary trial endpoint was to evaluate Tavocept’s potential for preventing and reducing the severity of sporadic and cumulative nerve damage, or neuropathy, experienced by patients receiving paclitaxel and cisplatin chemotherapy.

The trial results indicate that the number of patients reporting either severe sporadic or cumulative neuropathy was approximately 50% lower in the Tavocept arm of the trial compared to the placebo arm. While this outcome represents a strong trend in favor of Tavocept (p = 0.1565), the results are not statistically significant (p
A surprising and medically important observation from the trial was an observed increase in the median survival time for patients receiving Tavocept as compared to those receiving placebo. The median survival time observed for patients receiving Tavocept was approximately 40 days longer than for patients receiving placebo. For patients with adenocarcinoma, the most frequently occurring type of lung cancer, the median survival time was increased by approximately 138 days for patients receiving Tavocept as compared to those receiving placebo.

Frederick H. Hausheer, M.D., Chairman & Chief Executive Officer of BioNumerik, and Chairman of KI Pharmaceuticals, Inc. stated: “We are encouraged by the observed evidence of Tavocept’s potential to protect against sporadic (i.e. intermittent) and cumulative chemotherapy-induced neuropathy. The observed survival benefit in this patient population along with significant reductions in renal toxicity, vomiting and anemia further support our belief in this drug’s therapeutic potential. We observed that a substantial proportion of the patients from the trial are still alive and we will continue to monitor the survival of these patients. We believe that this Phase III trial outcome is an important step towards the validation of our approach to cancer drug discovery and development.”

Hashime Kanazawa, Ph.D., Executive Director of ASKA, and President of KI Pharmaceuticals, Inc. stated: “We are pleased with this result, particularly the multiple statistically significant findings that were observed. This data will be the basis for further studies, which we intend to pursue expeditiously. We are currently in the process of reviewing a number of additional Tavocept clinical trial designs.”

Additional observations from the trial included a statistically significant reduction in cisplatin-induced kidney damage (nephropathy) and a statistically significant reduction in chemotherapy-induced vomiting for patients receiving Tavocept in comparison to those receiving placebo. There were also substantially fewer instances of physician chemotherapy dose reductions, treatment delays or discontinuance of chemotherapy treatment due to neuropathy in the Tavocept arm of the study, compared to the placebo arm. Patient quality of life questionnaire scores were more favorable in the Tavocept arm of the study.

The trial results also included substantial evidence of the potential ability of Tavocept to maintain or stimulate hematological function in the body, as well as the potential to mitigate or prevent chemotherapy-induced anemia and to maintain or stimulate erythropoietin function or synthesis. Erythropoiesis is the process by which red blood cells are produced, and involves the release of a hormone called erythropoietin that stimulates the red bone marrow to begin red blood cell production.

In commenting on the observations from the trial, Ross C. Donehower, M.D., Director of Medical Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Professor of Oncology and Medicine at the Johns Hopkins University School of Medicine; and a member of BioNumerik’s Scientific Advisory Board stated: “This is the culmination of years of hard work and commitment on the part of BioNumerik leadership and employees, as well as the investigators and AKSA Pharmaceutical Co. It has the potential to improve cancer therapy and decrease toxicity in a meaningful way. It is a very exciting result.”

Michael C. Perry, M.D., M.A.C.P., Professor of Hematology and Medical Oncology, Nellie B. Smith Chair Emeritus, Ellis Fischel Cancer Center, University of Missouri-Columbia; and a member of BioNumerik’s Scientific Advisory Board, stated: “Multi-center randomized, double-blind, placebo- controlled phase III trials such as this one are usually regarded as the ‘gold standard’ for proving the efficacy of drugs in oncology. In this study of patients with advanced non-small cell lung cancer, the standard chemotherapy regime of paclitaxel and cisplatin was combined with Tavocept or placebo to evaluate Tavocept’s potential for reducing troublesome peripheral neuropathy. There was an approximately 50% decrease in severe sporadic or cumulative neuropathy, not statistically significant, probably due to the study’s size. Other side effects such as kidney damage and chemotherapy-induced vomiting were also less in Tavocept treated patients. Unexpectedly, there also was a longer median survival for patients receiving Tavocept, especially for patients with the adenocarcinoma subtype, the most common type of lung cancer in the United States. The findings of increased efficacy combined with decreased toxicity are very encouraging, but these results will require verification in other studies.”

Previous Phase III clinical trials for Tavocept measured neuropathy only in terms of cumulative neuropathy and they were inconclusive. BioNumerik and ASKA believe the results from this trial demonstrate that chemotherapy-induced neuropathy is both sporadic and cumulative; a hypothesis that this trial tested prospectively in a multicenter, double-blind, placebo controlled setting.

BioNumerik has granted KI Pharmaceuticals, Inc. the exclusive right to develop, market, distribute and sell Tavocept in Japan. BioNumerik holds exclusive rights to Tavocept for territories outside of Japan.

About Adenocarcinoma:

Adenocarcinoma is a type of cancer that can occur in cells that are in organs such as the lung, colon, prostate and breast. Adenocarcinoma is the most common type of lung cancer, making up approximately 30%-50% of all cases.

About BioNumerik:

BioNumerik Pharmaceuticals, Inc., based in San Antonio, Texas, is focused on the discovery, development and commercialization of novel drugs for the treatment of cancer and cancer supportive care. BioNumerik currently has two drug candidates, Karenitecin(R) and Tavocept(TM), in late-stage clinical development. BioNumerik has eight additional drug discovery research programs, and has generated a patent portfolio of more than 450 patents and pending patent applications worldwide.

About ASKA:

ASKA, located in Tokyo, Japan, is a research and development (R&D) oriented company, which contributes to the society by developing and providing innovative pharmaceutical products with concentrating its management resources to the specific therapeutic areas. Additional information about ASKA is available through its corporate website, http://www.aska-pharma.co.jp/english/index.html. ASKA and BioNumerik have formed KI Pharmaceuticals, Inc., located in Tokyo, Japan, as a joint venture aimed at developing a broad portfolio of new compounds to distribute and market in Japan.

BioNumerik Pharmaceuticals, Inc.
http://www.bionumerik.com

National Lung Cancer Partnership, in partnership with the LUNGevity Foundation, is pleased to announce the winners of their third annual research grant competition.

The research grants, each $100,000, were created to advance research in basic lung cancer biology, risk assessment, prevention, detection, and response to treatment. “With the support of Genentech and our very generous donors, we’re able to offer researchers critical funding when choosing to investigate this deadly disease,” said Regina Vidaver, executive director of National Lung Cancer Partnership.

Hildegard Schuller, M.D., Ph.D., of the University of Tennessee is the recipient of a research grant for advancing the understanding of sex differences in lung cancer. Dr. Schuller’s research will evaluate the relationship between estrogen and the nicotine-derived carcinogen, NNK, in lung tumor formation. She hypothesizes that estrogen and NNK cause more DNA damage in lung cells than NNK alone.

“Understanding the basic mechanisms of estrogen’s influence in lung carcinogenesis should provide new targets for early diagnosis, prevention, and therapy,” said Dr. Schuller.

The second grant recipient is Albert Baldwin, Ph.D. of the Lineberger Cancer Center at the University of North Carolina at Chapel Hill. Dr. Baldwin will study molecules involved in the regulation of normal cell growth. When mutated, some of these molecules can cause normal cells to begin growing out of control, and can lead to cancer. In addition, he will investigate drugs that can block steps governing uncontrolled cell growth, with the goal of blocking lung tumor initiation and growth.

“Our goal is to increase the understanding of the development of lung cancer and to improve lung cancer treatment,” said Dr. Baldwin. “We are hopeful that the studies will lead to new therapeutic options for a large number of lung cancer patients.”

Lung cancer research is severely under-funded at the federal level in proportion to the death toll from this disease. The research grant program was created to drive research that will increase understanding of lung cancer and support scientists who choose to pursue lung cancer research, even in the face of a poor funding climate.

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National Lung Cancer Partnership is the only national lung cancer organization founded by physicians and researchers and focused on understanding how the disease affects women differently than men. The 501(c) (3) organization was founded in 2001.

The LUNGevity Foundation is the only organization in the U.S. dedicated exclusively to funding lung cancer research. The 501(c) (3) organization was founded in 2000 by seven Chicago-area lung cancer survivors to increase funding for lung cancer research.

Source: Sara Conley
National Lung Cancer Partnership

National Lung Cancer Partnership is pleased to announce that Adam Marcus, Ph.D., of the Winship Cancer Institute at Emory University is the winner of the organization’s 2007 Career Development Award.

The Career Development Award, in the amount of $80,000, provides two years of protected time for newly independent investigators to develop their careers in lung cancer research. “With the support of the Lilly Foundation and our very generous donors, we’re able to offer lung cancer researchers this critical period of time to further their investigation of this deadly disease,” said Regina Vidaver, executive director of National Lung Cancer Partnership.

The award will support Dr. Marcus’ research into how lung cancer cells are able to invade surrounding tissues. He will focus on the how mutations of the LKB1 cellular protein cause lung cancer cells to move into other tissues and how these cell mutations can affect the sensitivity of lung cancer cells to chemotherapy drugs.

“By understanding how LKB1 contributes to lung cancer invasion, our research could potentially impact the development of novel diagnostic and prognostic approaches to control lung cancer malignancy,” said Dr. Marcus.

Lung cancer research is severely under-funded at the federal level in proportion to the death toll from this disease. National Lung Cancer Partnership grants support scientists who choose to pursue lung cancer research, even in the face of a poor funding climate.

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National Lung Cancer Partnership is the only national lung cancer organization founded by physicians and researchers and focused on understanding how the disease affects women differently than men. The 501(c) (3) organization was founded in 2001.

Source: Sara Conley
National Lung Cancer Partnership

According to a study published by BMJ, smokers whowere told their lung age were significantly more likely to quit thanthose who did not receive the information.

Usually, when patients go to the doctor to have their lungs checked,they receive complex lung data. The idea of a lung age was developed tohelp patients better understand these data and to demonstrate thatsmoking has a premature aging effect on the lungs. Lung age can bethought of as the age of the average healthy person with similar lungfunction to the individual.

There is no current evidence indicating that telling people their lungage increases their propensity to quit, and so researcher Gary Parkesand colleagues decided to test this idea. Their working hypothesis isthat telling smokers their lung age would lead to quitting and theknowledge would be especially effective in patients with the most lungdamage.

A sample of 561 current smokers - older than 35 years of age and fromfive general practices in Hertfordshire - participated in the study.The researchers initially collected information onage, smoking history, and medical conditions.

A spirometer was used to test lung function before the researchersrandomly assigned the participants to two groups. Spirometers recordthe volume and rate at which a patient exhales air from the lungs.

After the spirometer reading, the intervention group received moredetailed results about lung age and a diagram that explained howsmoking ages the lungs. They were also told that the rate of lungdeterioration could be reduced if they quit smoking. The control groupreceived the raw data results of the spirometer and no furtherexplanation -just a number for forced expiratory volume in one second(FEV1).

Both the intervention and the control groups were encouraged to quitsmoking and were offered referral to local NHS services designed tohelp people quit. In addition, the researchers told both groups thatthey would receive another lung function assessment after 12 monthstime.

Upon follow-up, 98% of participants received breath and saliva tests.Results showed that 13.6% of patients in the intervention group and6.4% of patients in the control group had successfully quit smoking.That is, patients who were told their lung age 12 months priorwere about twice as likely to have quit smoking than those who were notgiven that piece of information.

Contrary to their original hypothesis, the researchers found in boththe intervention and control groups, people with worsespirometric lung age results were no more likely to have quit thanthose with normal lung age results. This is rather unexpected, and itindicates that simply knowing what one’s lung age is helps a smokerquit, regardless of the actual lung age. Additional research isnecessary in order to shed light on the psychological reasons behindthis finding.

Since smoking cessation rates can be increased if primary carephysicians provide spirometry and lung age information topatients, the authors suggest that it may be wise to screensmokers over 35 years of age in order to reduce smoking and improveearly diagnosis of chronic lung disease. Parkes and colleagues alsoacknowledge that a formal economic evaluation should be conducted toestimate the cost effectiveness of this new and simple intervention.

An editorial in the same journal adds that the best way to communicatethe lung age results of spirometry is with a graphic display.

Effect on smoking quit rate of telling patients their lungage: the Step2quit randomised controlled trial
Gary Parkes, Trisha Greenhalgh, Mark Griffin, and Richard Dent
BMJ(March 2008). 336:598-600.
doi:10.1136/bmj.39503.582396.25
ClickHere to View Article

Written by: Peter M Crosta
Copyright: Medical News Today

Lung Cancer Alliance (LCA) called the new screening guidelines announced by the National Comprehensive Cancer Network (NCCN) “a positive step in the right direction that will encourage those at high risk for lung cancer to fully investigate their option of getting a CT scan.”

LCA President Laurie Fenton Ambrose said that lung cancer will continue to kill more people each year than all the other major cancers combined until more at risk people realize the urgency of being diagnosed early.

Currently only 16% of lung cancer patients are being diagnosed at an early and curable stage.

To date only CT scanners can detect lung cancers early - a fact that no one disputes - but the statistical debate goes on.

Fenton Ambrose pointed out that similar statistical debates held up mammograms for years until Congress stepped in. Debates still rage over mammograms for women under the age of 50 and PSA testing for prostate cancer in men.

The debate carried into the NCCN meeting earlier this month and the panel reviewing lung cancer was unable to reach a consensus on routine CT scans. However, NCCN issued a compromise statement recommending that people at high risk for lung cancer should participate in a clinical trial on CT screening or go to a center with expertise in all areas of lung cancer diagnosis and treatment to discuss the potential risks and benefits of a screening CT.

“This is exactly what we have been saying for the past two years,” said Fenton-Ambrose, “and we are pleased that NCCN takes this position as well.”

The only national CT trial still accepting participants is the International Lung Cancer Early Action Program (I-ELCAP).

That program, which was launched in 1992, has scanned over 30,000 people at high risk for lung cancer in 26 states and 8 foreign countries. The results of its first 13 years were published in the New England Journal of Medicine in 2007 and showed that CT scanning could detect lung cancer at its earliest stages, and those treated promptly had 10-year survival rates of 92%.

Currently, without screening, the national 5-year survival rate for lung cancer is 15%.

In 2002, the National Cancer Institute began a trial comparing CT scans to chest x-rays and stopped recruitment two years later. Those patients will be followed until 2009 but results are not expected to be published until 2012.

“Another 850,000 people will die of lung cancer by that time. We cannot continue to ignore the rapid advances in imaging that can offer those at high risk the chance of an early diagnosis when the disease is still curable,” she said.

Lung Cancer Alliance (http://www.LungCancerAlliance.org) is the only national non-profit organization dedicated exclusively to patient support and advocacy for those living with or at risk for lung cancer. Lung Cancer Alliance is committed to leading the movement to reverse decades of stigma and neglect by empowering those with or at risk for the disease, elevating awareness and changing health policy.

Lung Cancer Alliance
http://www.lungcanceralliance.org