*RF Ablation Effective For Treating Inoperable Lung Cancer Rhode Island Hospital Study Confirms RF Ablation Effective For Treating Inoperable Lung Cancer Rhode Island Hospital Study Confirms
31 Mar 2007
A minimally invasive procedure known as radiofrequency (RF) ablation is effective for treating lung cancer in patients who are not candidates for surgery, according to a Rhode Island Hospital study published in the April issue of the journal Radiology.
Damian Dupuy, MD, director of ablation at Rhode Island Hospital and professor of diagnostic imaging at The Warren Alpert Medical School of Brown University, conducted a study of 153 patients who were treated for early-stage, inoperable lung cancer with RF ablation. The procedure involves using a specialized needle inserted through the skin to transmit high-frequency electrical currents into a tumor. The overall results of the study show RF ablation to be safe and linked it with promising long-term survival and local tumor progression outcomes when compared to the older treatment method of external beam radiation (EBT).
EBT, which has been used for decades, requires many treatments over a six-week period. This can often lead to a variety of side effects. RF ablation, however, is performed in a single day on an outpatient basis, is minimally invasive and has few side effects.
Dupuy says, "Our study has shown that this minimally invasive procedure can successfully treat patients with lung cancer who could not undergo surgery in one fairly simple treatment. The study also shows that radiofrequency ablation is equal to or more effective in terms of both survival and tumor control." With RF ablation, the Rhode Island Hospital researchers noted a two-year survival rate at 57 percent compared to 51 percent using EBT.
"With lung cancer screening for at-risk individuals on the horizon, we will be able to detect lung cancers at earlier stages. In my lifetime, I foresee image-guided radiofrequency ablation replacing many surgical procedures for the treatment of cancer as we continue to improve these minimally invasive treatment methods."
Other survival rates for stage I, non-small cell cancer treated with RF ablation were 78 percent for one year, 57 percent for two years, 36 percent for three years and 27 percent for both four and five years.
http://www.medilexicon.com/medicalnews.php?newsid=66438∞

*Lack Of A Protein In Lung Tumors May Increase Risk Of Death Lack Of A Protein In Lung Tumors May Increase Risk Of Death
29 Mar 2007
A study of human lung tumors indicates that lung cancer patients who lack a particular protein may do more poorly than those with normal levels of that same protein.
If the findings are verified in a clinical trial, the absence of the protein might be used to identify lung cancer patients who need more aggressive therapy after surgery.
The protein is the product of a gene called Olig1, which previously has not been linked with lung cancer, and it is located in a chromosome region that is often lost in the tumor cells of many lung-cancer patients.
The research examined tumors from people with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It sought to identify genes that are turned off, or silenced, by a process called aberrant DNA methylation.
The study wanted to learn if the pattern of silenced genes could distinguish between two subtypes of NSCLC, adenocarcinoma and squamous cell carcinoma.
The research identified 47 genes that together can differentiate between the two lung cancer subtypes. It also found that the silencing of the Olig1 gene - which results in the absence or low levels of its protein product - was linked to poor survival in NSCLC patients.
The study, led by researchers at the Ohio State University Comprehensive Cancer Center, is published in the March 27 issue of PLoS Medicine.
"We found that when the Olig1 protein is down-regulated or absent, the risk of death is significantly higher compared with patients who have normal levels of the protein," says first-author Romulo M. Brena, a graduate research associate in molecular genetics and in molecular virology, immunology and medical genetics.
"Even low levels of the protein were associated with better survival," he says.
The findings might have important clinical significance, says coauthor Gregory Otterson, associate professor of internal medicine and a medical oncologist who specializes in lung cancer treatment.
"This study identified a novel gene that had no known role in lung cancer development and that is silenced in a large number of patients," says Otterson, also a researcher with the Ohio State University Comprehensive Cancer Center . "The absence of the protein may have important prognostic implications."
Lung cancer is the leading cause of cancer illness and death worldwide. Every year, an estimated 1.2 million people are diagnosed with the malignancy, and 1.1 million others die from the disease. More than 85 percent of these cases are NSCLC.
Presently, a lung-cancer patient's prognosis is based on how far the disease has progressed, which is determined by staging the disease.
"There is a high correlation between survival and a patient's stage," Brena says. "But there is also wide variation in overall survival among patients who are in the same stage. Some live for only a short time, others for a longer time.
"We don't know why that is, but it is probably related to the molecular and genetic characteristics of the tumor," he says. "The presence or absence of Olig1 may be one of those characteristics."
An analysis of patient survival data indicated that patients with little or no Olig1 in their tumor cells had about a 15 percent decrease in survival.
The researchers are now trying to learn the role of the Olig1 gene and protein in lung cells and how their loss may contribute to cancer development.
http://www.medilexicon.com/medicalnews.php?newsid=66221∞

*Peregrine Pharmaceuticals Completes Patient Enrollment In Bavituximab Combination Therapy Trial In Advanced Cancer Patients Peregrine Pharmaceuticals Completes Patient Enrollment In Bavituximab Combination Therapy Trial In Advanced Cancer Patients
23 Mar 2007
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing targeted therapeutics for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that enrollment of the planned 12 evaluable patients in its Phase lb cancer trial has been completed. This trial at clinical sites in India is designed to assess the safety of bavituximab in combination with common chemotherapy agents in advanced cancer patients with metastatic disease who had failed prior therapy. Data from this study are expected to support the initiation of Phase II cancer trials later this year.
To date, the safety profile of bavituximab in combination with chemotherapy appears similar to that seen in advanced cancer patients undergoing chemotherapy treatment alone. Nine patients have completed their course of therapy and have been assessed for tumor response at the eight week scheduled MRI or CT scan. Of these, more than half of the patients achieved either disease stabilization or an objective tumor response. "Disease stabilization" is defined as less than a 20% increase in the size of the tumor up to a 30% reduction in tumor size, while "objective response" is defined as greater than a 30% reduction in tumor size. Both stable disease and objective response are considered potential signs of anti-tumor activity. Patients demonstrating either an objective tumor response or stable disease have been offered continued treatment with the combination regimen on a compassionate use basis.
"We are encouraged by the results seen to date in this first test of bavituximab in combination with common chemotherapy regimens," said Steven W. King, president and CEO of Peregrine. "Achieving stable disease and objective responses in these very ill advanced cancer patients is a promising sign, and we look forward to reporting top-line results as soon as patient follow-up and data analysis are complete. We are optimistic that these results, in combination with data from our ongoing U.S. Phase l cancer trial, will support advancing bavituximab into more extensive combination therapy cancer trials later this year."
The Phase Ib open label trial is designed to characterize the safety, tolerability and pharmacokinetics of bavituximab given in combination with standard chemotherapy regimens including docetaxel, gemcitabine and carboplatin/paclitaxel. These regimens are commonly used for treating major solid cancers, and the enrolled patients include those with breast, ovarian and lung cancers. Study patients are considered enrolled and evaluable for safety analysis after completing four of the planned eight weekly doses of bavituximab in combination with chemotherapy. The chemotherapy agent was administered for up to eight weeks on its standard prescribed administration schedule. Patients are also being evaluated for tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) parameters, receiving CT or MRI scans prior to therapy and at week eight, although this assessment is not a formal endpoint of the study.
Study participants are being followed for an additional four weeks after their last dose of bavituximab. Patients with stable or improved disease may continue with chemotherapy and bavituximab on a compassionate use basis. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.
Bavituximab is a monoclonal antibody that targets and binds to a phospholipid called phosphatidylserine, which is located on the inside of normal cells but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is currently in clinical trials in the U.S. and India for the treatment of solid tumors and in the U.S. as a treatment for chronic hepatitis C infection. Extensive preclinical data demonstrate good anti-tumor activity in a variety of tumor types, especially when bavituximab is administered in combination with chemotherapy or radiation.
http://www.medilexicon.com/medicalnews.php?newsid=65871∞

*Innovative Cancer Treatment: Destroying Tumors With Heat Innovative Cancer Treatment: Destroying Tumors With Heat
11 Mar 2007
"In radio frequency ablation, the heat is generated by a multi-pronged probe placed into the tumor tissue in a procedure monitored by ultrasound or computer tomography. You could say the tumor is 'boiled away' on the spot," explained Professor Riccardo Lencioni from the Radiology Department at the University of Pisa, Italy, at the kick-off press conference for the European Congress of Radiology (ECR) 2007, held at Austria Center Vienna from March 9 to 13 and attended by some 16,000 participants from 92 countries. "The advantage of RFA is the small diameter of the probes of about 1.2 millimeters and the attainable lesion size of several centimeters without shifting the probes. At the same time, bleeding is effectively stopped along the insertion path through the obliteration of potential sources of blood. This method prevents puncture channel metastases caused by the dispersion of cancer cells."
Heat treatment of metastases or tumors may be painful depending on their location and the organ involved. Patients are therefore sedated or given anesthesia for this procedure. "This method of local obliteration is well-suited for the early treatment of liver, kidney, lung, breast and bone tumors," noted Professor Lencioni. "Unlike radiation or chemotherapy, this procedure has the advantage that it can be repeated - if need be - because of the lack of systemic side-effects. Thermoablation monitored by appropriate imaging can be carried out during brief hospital stays of two to three days."
Option for Inoperable Lung Cancer
This method is becoming increasingly important, for example, in the treatment of lung carcinomas, especially in cases where surgery is out of the question. Many patients with lung carcinomas are poor surgical candidates because they are long-term smokers and have contracted co-existent secondary illnesses that would make surgery more riskly. For non-small-cell lung carcinomas, there is also a relatively high risk of recurrence even after tumors are removed surgically. In many cases, chemotherapy and radiation therapy do not yield satisfactory results either.
Successful in Liver Tumors - Alternative to Surgery
RF ablation has been used successfully in the treatment of early-stage liver tumors for six years. Professor Lencioni: "For tumors with a diameter of about three centimeters, sustainable tumor destruction has even been achieved with a single needle insertion. In terms of patients' response rates and survival rates, this procedure is comparable to conventional surgical procedures and offers an alternative to surgery."
For larger tumors in the liver, the success rate of RF ablation is just 50 percent, however. In about half the cases, the tumor spreads to adjoining tissue even after radio frequency treatment. The chances of a cure for large tumors of the liver increase with minimally invasive procedures undertaken directly in the blood vessels. This fact has led to a new treatment approach.
TACE: Transarterial Chemoembolization
Transarterial chemoembolization with drug-eluting microspheres ("Precision TACE") is an innovative treatment option for liver tumors. Professor Lencioni: "TACE is a well established treatment for liver cancer. It is based on the fact that up to 95 percent of the hepatocellular carcinomas are supplied by the hepatic arteries. Normal liver tissue, for its part, receives about two thirds of its blood supply through the portal vein and about one third from arterial blood. Chemoembolization causes the hepatic arteries to close up and the tumor tissue dies. Normal liver tissue is not affected."
In Precision TACE, doxorubicin-eluting particles are delivered to the tumor via the hepatic artery. Professor Lencioni: "Owing to the microspheres, the drug for inhibiting cell growth in the tumor is present in the liver tissue in a concentration a hundred times greater than in systemic intravenous chemotherapy. Side-effects such as vomiting or stomach pain are completely absent. Blockage of the arterial flow of blood also prolongs the period of action for chemotherapeutic agents."
Pilot Study with Doxorubicin
Studies on animal models have shown that the cytostatic agent doxorubicin can significantly increase the effect on liver tumors when combined with RF ablation. Tumor cells not completely destroyed by RF ablation are at least so weakened by the exposure to high heat that doxorubicin can take full effect and destroy the tumor completely. A pilot study is being done to determine whether or not these promising results are applicable to human beings.
"Twenty patients with a liver tumor larger than three centimeters in size were subjected to RF ablation followed 24 hours later by chemoembolization with doxorubicin. In 70 percent of the cases, the tumor was completely destroyed," reported Professor Lencioni. "Overall, the data from the pilot study appear to favor the combined application of RF ablation and transarterial chemoembolization to combat hepatocellular liver carcinoma. The combined method also has an excellent safety profile. The procedure has low complication rates while offering a good quality of life and shortening the hospital stay."
About the B&K KOMMUNIKATION
Press office for a number of scientific congresses, such as the Annual Meeting of the European Society of Neurology (ens)
B&K KOMMUNIKATION
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*Breath Test Detects Lung Cancer In Early Stages Breath Test Detects Lung Cancer In Early Stages
17 Feb 2007
A new breath test has been reported to detect lung cancer in its early stage. Lung cancer is the leading cause of cancer death in the United States, and doctors believe that early detection could offer sufferers their best chance for early survival.
Dr. Michael Phillips, CEO of Menssana Research, the company that developed the breath test, said, "We developed a breathalyzer that is one billion times more sensitive than those the police use to measure alcohol in the breath. It detects around 200 different chemicals in a person's breath, and some of these chemicals are markers of cancer. A breath test has great advantages over most other medical tests - it is completely safe, painless and non-invasive. All you have to do is breathe gently into a tube for two minutes. There are no potentially dangerous x-rays to worry about, and it will certainly be a lot less expensive than chest imaging."
In a study funded by the National Institutes of Health that will be published in Cancer Biomarkers, researchers studied 404 smokers and ex-smokers aged over 60. The breath test predicted lung cancer with almost the same accuracy as computerized tomography, or chest CT, the best screening test for lung cancer currently available.
Early detection is essential to save lives. Lung cancer affects over 170,000 Americans annually and more than 95% of them are dead within 5 years if the tumor has metastasized to other organs, versus only 20% if the tumor is found while it is still confined to the lung.
The breath test will not be available in the USA until approved by the Food and Drug Administration, but may be available sooner in the European Union.
Menssana Research is currently developing breath tests to detect several other diseases in their early stages, including pulmonary tuberculosis, breast cancer, and ischemic heart disease. The FDA has already approved the Heartsbreath test for heart transplant rejection. Dr. Phillips said he hopes that physicians and patients will eventually consider a breath test the way we think of a chest x-ray or blood test: as an inexpensive and convenient screening test which can detect several diseases in their earliest and most treatable stages.
Menssana Research, Inc.
http://www.menssanaresearch.com/∞
http://www.medilexicon.com/medicalnews.php?newsid=63287∞

*Avastin(reg) Is First Medicine To Extend Survival Beyond One Year In Patients With Previously Untreated Non-small Cell Lung Cancer Avastin(reg) Is First Medicine To Extend Survival Beyond One Year In Patients With Previously Untreated Non-small Cell Lung Cancer
17 Dec 2006
Avastin(reg) is the first medicine proven to help previously untreated patients suffering from the most common form of lung cancer to live longer than a year, according to a landmark US study (E4599) published in the prestigious New England Journal of Medicine.
The study showed that the median duration of survival in the Avastin plus paclitaxel and carboplatin chemotherapy group was 12.3 months compared to 10.3 months in the group treated with chemotherapy alone. Overall patients treated with Avastin plus chemotherapy had an approximate 27 percent improvement in survival compared to patients receiving chemotherapy alone.
"This is the first large, randomized clinical study in which an anti-angiogenic, combined with chemotherapy, extended survival beyond one year in patients with advanced lung cancer," said Alan B. Sandler, M.D., director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., and Study Chair for the E4599 trial. "The results of this study have changed the treatment standard of care for this devastating disease - an important step forward for patients with advanced lung cancer."
The results from the pivotal study highlight the outstanding achievements of the innovative cancer medicine Avastin in helping people with previously untreated advanced NSCLC[i]. Lung cancer is the most common form of cancer as well as the single biggest cancer killer with more than 900 lives lost to the disease every day in Europe and new treatment options are desperately needed.
The impressive data from the E4599 study formed the basis for the US approval of Avastin for treatment of advanced NSCLC which was granted by the FDA in October 2006. For the European filing[1] which was submitted on 8 August 2006, the E4599 study was supported by the preliminary data from the ongoing "Avastin in Lung" (BO17704) study.
Avastin was approved in the EU in January 2005 and in the US in February 2004 for the first-line treatment of patients with metastatic colorectal cancer. It received another approval in theUS in June 2006 as a second-line treatment for patients with metastatic colorectal cancer. The first filing for Avastin in Japan occurred in April 2006 for the treatment of metastatic colorectal cancer. More recently, Avastin was filed for the treatment of women with advanced breast cancer in the EU in July 2006.
About the pivotal E4599 study
The results of the randomised, controlled, multicenter Phase III E4599 study of 878 patients with locally advanced, metastatic or recurrent NSCLC, with histology other than predominant squamous cell, show that:
http://www.medilexicon.com/medicalnews.php?newsid=59137∞

*Pharmacyclics Announces Presentation Of Pooled Analysis Of Xcytrin(R) For Lung Cancer Brain Metastases Pharmacyclics Announces Presentation Of Pooled Analysis Of Xcytrin(R) For Lung Cancer Brain Metastases
Pharmacyclics, Inc. (Nasdaq: PCYC) today announced the presentation of pooled results from two randomized Phase 3 clinical trials, which indicate that Xcytrin(R) (motexafin gadolinium) Injection combined with whole brain radiation therapy (WBRT) significantly prolonged time to neurologic progression in non-small cell lung cancer (NSCLC) patients with brain metastases. The presentation took place at the Society for Neuro-Oncology's 11th Annual Meeting being held this week in Orlando, FL.
"These data demonstrate that Xcytrin, used in combination with whole brain radiation therapy, may significantly improve neurologic outcomes in patients with brain metastases from non-small cell lung cancer," said William R. Shapiro, M.D., chief of the Neuro-Oncology Division of Neurology at the Barrow Neurological Institute, and presenter of the pooled Phase 3 results. "These two large studies both used an innovative and clinically meaningful endpoint and reveal consistent benefit in this patient population."
The presentation, "Motexafin gadolinium (MGd) combined with whole brain radiation therapy prolongs time to neurologic progression in non-small cell lung cancer (NSCLC) patients with brain metastases: pooled analysis of two randomized Phase 3 trials," described pooled results from two Phase 3 trials evaluating the safety and efficacy of WBRT alone to WBRT plus Xcytrin in NSCLC patients with brain metastases. The primary endpoint for both trials was time to neurologic progression (TNP) as determined by a blinded events review committee. In the two trials, 805 NSCLC patients received either WBRT (N = 403) or WBRT plus Xcytrin (N = 402). The treatment arms were well balanced for all known prognostic factors.
In the pooled results analysis, the median TNP determined by a blinded events review committee was 15.4 months for patients receiving WBRT plus Xcytrin compared to 9.0 months for patients treated with WBRT alone (P = 0.016, hazard ratio = 0.73). Secondary endpoints also showed significant benefit for Xcytrin plus WBRT compared to WBRT alone: TNP as determined by investigators, P = 0.015, hazard ratio = 0.76; time to neurocognitive progression, P = 0.02, hazard ratio = 0.78. Xcytrin was well tolerated in the study. The most common drug related grade 3 and 4 adverse events were hypertension (5%) and fatigue (3%), all of which were reversible. Xcytrin did not interfere with the ability to deliver WBRT.
The data used in this pooled analysis are derived from the Phase 3 SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) trial, which enrolled 554 patients and was designed to compare the safety and efficacy of WBRT alone to WBRT plus Xcytrin in NSCLC patients with brain metastases, combined with the data from an earlier Phase 3 clinical trial in patients with metastatic cancer to the brain resulting either from lung, breast or other types of solid tumors. In that study, 401 patients were enrolled and a treatment benefit was observed in the pre-defined subset of 251 patients with NSCLC. Both Phase 3 trials enrolled patients with NSCLC meeting similar eligibility criteria and having similar baseline disease characteristics. In addition, both studies used identical treatment regimens, and similar clinical assessments were performed. As presented by Dr. Shapiro and his colleagues, the magnitude of the treatment benefit was comparable in each of the trials and in the pooled analysis of the data.
"We are moving forward with preparation of a new drug application (NDA) with the U.S. Food and Drug Administration and anticipate filing by the end of the calendar year," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics. "This pooled data from two randomized trials presented at the Society for Neuro-Oncology meeting provides the basis for the integrated efficacy data that will be contained in our NDA."
About Brain Metastases
Brain metastases occur when cancer cells spread to the brain and grow, causing major neurologic complications. Patients with brain metastases usually suffer serious deterioration of neurologic and neurocognitive function such as loss of short-term memory, compromised verbal skills and fine motor coordination, and reduction in cognitive performance. Most patients with brain metastases are treated with WBRT. In some patients, radiosurgery can be performed on a limited number of lesions in an attempt to improve local tumor control. The primary goal of radiation therapy to the brain is to reverse or prevent neurological deterioration and prevent death due to tumor progression in the brain. NSCLC is the most common form of lung cancer, and brain metastases may occur in up to half of these patients. Patients with NSCLC develop brain metastases early in the course of their disease and studies have shown that brain metastases from lung cancer may be among the most amenable to treatments.
http://www.medilexicon.com/medicalnews.php?newsid=57102∞

*Introgen's Novel Nanoparticle Tumor Suppressor NPRL2 Shows Promise In The Treatment Of Drug Resistant Cancers Introgen's Novel Nanoparticle Tumor Suppressor NPRL2 Shows Promise In The Treatment Of Drug Resistant Cancers
21 Nov 2006
Preclinical data with the NPRL2 tumor suppressor gene demonstrated that systemic treatment using NPRL2 nanoparticles in combination with cisplatin resulted in a 90 percent inhibition of tumor growth in human lung cancer cells compared to control treatments, reported Introgen Therapeutics, Inc. (Nasdaq: INGN). The NPRL2 gene, believed to be important in the genesis of multiple types of cancer, including lung cancer and renal cell cancer, is licensed to Introgen from The University of Texas M. D. Anderson Cancer Center.
This study was performed in the laboratory of Dr. Lin Ji, associate professor in the Department of Thoracic and Cardiovascular Surgery at M. D. Anderson and collaborators in the Department of Imaging Physics at M. D. Anderson and The University of Texas Southwestern Medical Center.
Preclinical studies evaluated the NPRL2 gene which demonstrated its ability to exhibit tumor suppressor activity against human lung cancer. A study published in a recent issue of the biomedical journal Cancer Research indicated that low expression of the NPRL2 gene may predict resistance to response to cisplatin chemotherapy in patients with lung cancer. The NPRL2 protein was analyzed in 40 lung cancers and low expression of NPRL2 was correlated with resistance to cisplatin, one of the mainstays of chemotherapy for lung cancer. In lung cancers that were resistant to cisplatin, re- introduction of the normal NPRL2 gene resulted in dramatic re-sensitization to cisplatin. This effect was confirmed in animal studies using human cisplatin- resistant lung tumors. A 90 percent inhibition of tumor growth was observed with systemic treatment using NPRL2 nanoparticles in combination with cisplatin, compared to control treatments. Thus, NPRL2 may serve as an important biomarker to identify and treat patients with tumors resistant to cisplatin chemotherapy.
These studies were further highlighted by The University of Texas M. D. Anderson Cancer Center in the November issue of their electronic publication Cancer Wise which may be accessed at http://www.cancerwise.org∞
. Dr. Sunil Chada, Introgen associate vice president for Clinical Research and Development stated, "The ability to use a simple biomarker assay for NPRL2 to identify patients who would not derive benefit from cisplatin represents an important advance and underscores the significance of NPRL2 in lung cancer. Development of NPRL2 gene drugs using systemic nanoparticle delivery may help patients whose tumors are resistant to cisplatin by re-sensitizing tumors to this commonly used therapy."
NPRL2 has been identified by the International Lung Cancer Chromosome 3p21.3 Tumor Suppressor Gene Consortium, including researchers from M. D. Anderson Cancer Center, The University of Texas Southwestern Medical Center, and the National Cancer Institute. The NPRL2 gene was identified within a "genomic hotspot" of cancer causing mutations at the region of the third human chromosome termed 3p21. This region is frequently deleted or mutated in early stage lung cancer. Introgen previously announced that it acquired the exclusive worldwide license for a family of at least 10 anti-cancer genes identified by the consortium including NRPL2 and FUS1. Introgen is developing INGN 401 which utilizes the FUS-1 tumor suppressor gene in a nanoparticle formulation and is now in clinical testing for the systemic treatment of metastatic non-small cell lung cancer. Additional genes within this genomic hotspot also appear to be important in control of cancer progression and may function as therapeutic genes as well as prognostic biomarkers.
Mutations in the 3p21 region of chromosome 3 are found in approximately 90 percent of small-lung cancer, more than 50 percent of non-small-lung cancer, as well as in renal, breast, pancreatic, oral and uterine cancers. Mutations in the 3p21 region of the genome are the earliest genetic abnormality currently detected in lung cancer, suggesting that one or more of these genes could act as "gatekeeper," preventing cells from becoming cancerous.
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle therapies to treat a wide range of cancers using tumor suppressors and cytokines. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility.
Introgen holds licensing agreements with M. D. Anderson Cancer Center to commercialize products based on licensed technologies, and has the option to license future technologies under sponsored research agreements. The University of Texas Board of Regents owns stock in Introgen. These arrangements are managed in accordance with M. D. Anderson's conflict of interest policies.
Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its clinical development program for treatment of cancer or other diseases with genes located in the 3p21 region of the genome, including NPRL2 and FUS-1. The actual results may differ from those described in this release due to risks and uncertainties that exist in Introgen's operations and business environment, including Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, dependence upon proprietary technology and the current competitive environment, history of operating losses and accumulated deficits, reliance on collaborative relationships, and uncertainties related to clinical trials, the safety and efficacy of Introgen's product candidates, the ability to obtain the appropriate regulatory approvals, Introgen's patent protection and market acceptance, as well as other risks detailed from time to time in Introgen's filings with the Securities and Exchange Commission including its filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising after the date hereof.
Introgen Therapeutics, Inc.
http://www.introgen.com∞
http://www.medilexicon.com/medicalnews.php?newsid=57097∞

*Jefferson Scientists Find Blood Vessel-building Protein Halts Blood Vessels From Forming In Cancer Jefferson Scientists Find Blood Vessel-building Protein Halts Blood Vessels From Forming In Cancer
19 Nov 2006
A piece of the protein cellular scaffolding involved in building blood vessels during development might have the opposite effect in tumors.
Cell biologists at Jefferson Medical College and the Kimmel Cancer Center of Thomas Jefferson University in Philadelphia have found that the protein fragment endorepellin blocks both skin and lung cancer tumors from progressing in animal models by preventing their ability to recruit new blood vessels, a process called angiogenesis. They showed that endorepellin has surprisingly powerful effects on halting a cancer tumor's ability to move about and spread.
The researchers believe that these latest findings, appearing November 15, 2006 in the Journal of the National Cancer Institute, could lead to a new type of tumor inhibitor that might be used to prevent cancer from spreading to other areas in the body.
The researchers, led by Renato Iozzo, M.D., professor of pathology, anatomy and cell biology at Jefferson Medical College of Thomas Jefferson University, used two animal models of cancer to study squamous cell carcinoma and lung carcinoma. When they injected animals with artificially created "recombinant" endorepellin, they discovered that it blocked tumor growth, metabolism and angiogenesis. They also found for the first time that endorepellin targets the tumor endothelial cells, blocking the creation of new blood vessels.
"These findings have major implications for cancer treatments for a range of solid tumors such as lung, prostate and breast," Dr. Iozzo says. "All of these tumors depend on angiogenesis, so we think this could be an effective adjuvant therapy for cancer."
Endorepellin is part of the protein perlecan, which plays fundamental roles in vascular biology as scaffolding for blood vessel formation in development. In cancer, perlecan not only regulates growth factor activity, but also is a barrier to invading cancer cells.
Anti-angiogenesis drugs were all the rage in the late 1990s, when animal studies showed two drugs seemingly "melting" tumors in mice. But disappointing human clinical trials since then have scaled back expectations, and most now see such drugs as part of a treatment milieu that includes surgery, chemotherapy and radiation. More recent study results, however, Dr. Iozzo says, have renewed interest in the drugs' potential.
Dr. Iozzo says that these results suggest that endorepellin might be used to help prevent metastatic cancer spread in patients who have had a primary tumor removed. "It could be used preventatively and for maintenance, and in combination with other drugs," he notes.
"While endorepellin prevents the formation of the original blood vessels in tumor development, I think it would be more effectively used after the tumor has formed and cells try to migrate and spread," Dr. Iozzo says. The researchers are hoping to begin clinical testing of endorepellin in the near future.
http://www.medilexicon.com/medicalnews.php?newsid=56738∞

*FDA Approves New Drug For Advanced Lung Cancer FDA Approves New Drug For Advanced Lung Cancer
16 Oct 2006
Promising results from a clinical trial led by lung cancer specialist, Alan Sandler, M.D., director of Thoracic Oncology at Vanderbilt-Ingram Cancer Center, have helped in the effort to get a new drug approved by the Food and Drug Administration to fight an advanced form of the disease.
The trial involved the drug bevacizumab, now marketed as Avastin, being tested in nearly 900 patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) who had not received any prior chemotherapy. The study was part of the Eastern Cooperative Oncology Group (ECOG), one of the largest clinical cancer research organizations in the United States, and involved over 150 other study sites across the country. The patients were randomized and half received the new drug in addition to chemotherapy; the other half of the group received chemotherapy alone, which is the standard treatment option.
Patients who received Avastin combined with chemotherapy lived, on average, about two months longer than the group who only received chemotherapy. Sandler said it might not sound like a huge improvement, but for patients with this advanced, and often deadly, form of lung cancer, it is a major advancement. ?Patients overwhelmingly want to live longer. It is important to note, these numbers represent an ?average;' some patients may not achieve any benefit while some patients may receive a survival benefit far beyond the two-month average.?
In addition, the study also showed that some patients who received the drug plus chemotherapy saw their tumors shrink or go away altogether. Sandler said the results were groundbreaking.
?This is the first time in more than 10 years that we've seen an increase in survival in patients with metastatic, non-small cell lung cancer. More specifically, bevacizumab represents the first targeted agent, that when combined with chemotherapy in the chemotherapy-na?ve setting, revealed an improvement in overall survival. We believe that this concept will ultimately translate into more patients being cured of their disease if we can get to them before it has spread,? said Sandler, who is also the medical director of Hematology and Oncology at Vanderbilt-Ingram.
Non-small cell lung cancer is the most common kind of the disease, with about 175,000 new cases diagnosed each year in the U.S. Each year, about 160,000 Americans die from the disease, which is more than the second, third, fourth and fifth most common cancers combined in the U.S.
The drug works by stopping the development of new blood vessels, which feed a tumor and allow it to grow. It is a humanized, monoclonal antibody that binds to or blocks a specific protein or pathway that is needed for blood vessel development. ?It blocks VEGF, or vascular endothelial growth factor, which appears to be extremely important in new blood vessel development,? explained Sandler.
Because Avastin is directed against a specific target, Sandler said it primarily spares normal, healthy cells in the process, and therefore, side effects are not as severe as chemotherapy. ?It is generally very well tolerated.? However, there are some unique side effects and Sandler said the most serious is bleeding from the primary lung tumor. ?There were five patients who died secondary to a pulmonary hemorrhage that was felt to be treatment-related. It is a drug that works on blood vessels, and that is something that we need to pay close attention to,? he added.
For more information about non-small cell lung cancer or treatment for the disease, log on to: http://www.vicc.org∞.
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*Modern Radiation Therapy Ups Lung Cancer Survival Modern Radiation Therapy Ups Lung Cancer Survival
01 Sep 2006
Modern three-dimensional radiation therapy has been proven to be more successful at curing lung cancer than older two-dimensional radiation therapy for some patients with early stage lung cancer, according to a new study in the September 1, 2006 edition of the International Journal of Radiation Oncology * Biology * Physics, the official journal of the American Society for Therapeutic Radiology and Oncology (ASTRO).
Non-small cell lung cancer (NSCLC) accounts for 87 percent of all lung cancers diagnosed. Currently, the best treatment for stage I NSCLC is surgery or stereotactic radiation therapy (SRT), often followed by chemotherapy if the lesion was larger than 3 cm or radiotherapy and chemotherapy if the surgical margin or hilar or mediastinal nodes were positive at the time of operation. The five-year survival outcomes are very high, with 50 to 67 percent of these patients living at least five years after diagnosis if patients had a well staged stage I NSCLC. When surgery is not an option because the patient has heart problems or other complications, treatment options include varying types of radiation therapy and chemotherapy, alone or in combination.
In this study, doctors at M.D. Anderson Cancer Center in Houston wanted to see if conventional radiation therapy worked as well as the newer three- dimensional conformal radiation therapy (also called 3D-CRT) at curing patients with early stage non-small cell lung cancer. 3D-CRT was created to improve upon older types of radiation therapy by allowing doctors to aim several radiation beams at the tumor to shape or "conform" the radiation to the lung. The idea is that tailoring each beam allows doctors to give more radiation to the tumor while keeping it away from nearby healthy tissues.
Between 1978 and 2003, 200 patients with medically inoperable stage I NSCLC were treated with radiation therapy alone. Eighty-five received 3D-CRT while 115 received conventional therapy. Thirty-six percent of patients who received 3D-CRT lived five years after diagnosis compared to 10 percent who received the conventional therapy. Their causes of deaths were more related to intercurrent disease rather than cancer. Local failure was significantly reduced by 3D-CRT compared to conventional RT.
"This study proves that three-dimensional conformal radiation therapy improves outcomes for patients with medically inoperable stage I non-small cell lung cancer," said Ritsuko Komaki, M.D. "Patients with this type of lung cancer should ask their radiation oncologist about 3D-CRT." Dr. Komaki is a radiation oncologist and professor at M.D. Anderson Cancer Center in Houston.
For more information on lung cancer, visit http://www.rtanswers.org∞. ASTRO is the largest radiation oncology society in the world, with more than 8,500 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to the advancement of the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research and disseminating research results and representing radiation oncology in a rapidly evolving socioeconomic healthcare environment.
American Society for Therapeutic Radiology and Oncology
http://www.astro.org∞
http://www.rtanswers.org∞
http://www.medilexicon.com/medicalnews.php?newsid=50955∞