A self help and counseling guide on quit smoking guide from NCI, National Cancer Institute aimed at African American Smokers.
MEDDESKTOP: A Self-Help Intervention for African American Smokers
Cancer is not just one disease. It is a group of more than 100 different and distinctive diseases. Bringing together data, related to cancer, in an organized manner, is the task of ONCOWIKIA.
Monday, January 31, 2011
Monday, January 24, 2011
Novartis Acquires Genoptix For Cash And Gains Hematolgy and Oncology Diagnostic Service Enahancements To It's Healthcare Offerings.
Novartis, a privately held company, announced about its agreement to acquire Genoptix, Inc. (NASDAQ: GXDX) in all cash offer of USD 25.00 per share for all outstanding shares of common stock of Genoptix, (Genoptix shares gained +5.10 dollars to a share value of $24.86 this morning, and as of this writing, it is still climbing.)The acquisition will enhanced Novartis's capability to improve health outcomes for patients by advancing the ability to define and monitor individualized treatment programs.as Genoptix laboratory service offerings provide strategic fit with the current portfolio of companion diagnostic programs within Novartis Molecular Diagnostics unit.
Press Release
Press Release
Basel, January 24, 2011 - Novartis announced today that it has entered into a definitive agreement for the acquisition of Genoptix, Inc. (NASDAQ: GXDX), a specialized laboratory providing personalized diagnostic services to community-based hematologists and oncologists. The acquisition will enhance Novartis's tools and services that aim to improve health outcomes for patients by advancing the ability to define and monitor individualized treatment programs.
Under the terms of the agreement, Novartis will commence a tender offer for all outstanding shares of common stock of Genoptix at USD 25.00 per share in cash. This represents a total equity value of USD 470 million and an enterprise value of USD 330 million. The Novartis offer represents a premium of 39% over Genoptix's unaffected share price of USD 17.98 on December 13, 2010. It also implies a 27% premium over the closing price of USD 19.76 on January 21, 2011.
"The acquisition of the Genoptix medical laboratory will serve as a strong foundation for our individualized treatment programs," said Joseph Jimenez, CEO of Novartis. "Genoptix is an innovative company with a talented team of people who share our commitment to transforming the way medicine is practiced. By integrating Genoptix within Novartis, we can greatly enhance the value we add to patients, clinicians, payors and society."
Founded in 1999 and based in Carlsbad, California, Genoptix is a publicly traded, profitable laboratory that specializes in diagnosing cancers in bone marrow, blood and lymph nodes. In 2009, Genoptix had sales of USD 184 million, and for the first nine months of 2010, its reported revenue totaled USD 148 million.
Genoptix employs approximately 500 people and will become part of Novartis Molecular Diagnostics (MDx), a unit within the Novartis Pharmaceuticals Division. The acquisition will support and expedite the development of companion diagnostic programs, especially in oncology.
Novartis plans to maintain the existing operations and continue delivering Genoptix's portfolio of personalized diagnostics services to community-based hematologists/oncologists across the US.
The Genoptix Board of Directors has unanimously approved the transaction and agreed to recommend that Genoptix stockholders tender their shares. The transaction is conditional upon the tender of at least a majority of the shares of Genoptix in the tender offer, receipt of regulatory approvals and other customary closing conditions. The transaction is expected to close within the first half of 2011.
Thursday, January 20, 2011
Genetic Diversity In Leukemic Cells Advancing Cancer Discovered
Cancer scientists led by Dr. John Dick at the Ontario Cancer Institute (OCI) and collaborators at St Jude Children's Research Hospital (Memphis) have found that defective genes and the individual leukemia cells that carry them are organized in a more complex way than previously thought.
The findings, published today in Nature (DOI:10.1038/nature09733), challenge the conventional scientific view that cancer progresses as a linear series of genetic events and that all the cells in a tumour share the same genetic abnormalities and the same growth properties.
"Our results show this is not the case and open the way to discover how genetic abnormalities transform normal cells into leukemic cells and the steps that have to happen to make the leukemic cells increasingly abnormal and aggressive, how leukemic cells at different steps of genetic evolution (or progression) respond to therapy, or contribute to relapse,"? says Dr. Dick, Senior Scientist at OCI's Campbell Family Institute for Cancer Research, the research arm of Princess Margaret Hospital, and the McEwen Centre for Regenerative Medicine at University Health Network. Dr. Dick is also a Professor in the Department of Molecular Genetics, University of Toronto, and Director of the Cancer Stem Cell Program at the Ontario Institute for Cancer Research.
The research team found that the leukemia cells taken from patients with acute lymphoblastic leukemia (ALL) are actually composed of multiple families of genetically distinct leukemia cells. They looked at how these families developed and retraced the ALL "family tree" back to its origins. They discovered that the so-called black sheep "“ the cells that propagate the disease and potentially survive therapy "“ persist through generations, and even branch off and evolve to form genetically distinct cancer families. Some of these genetic families dominate, making it appear that the leukemia cells only have one set of genetic abnormalities while other families are very rare, explaining why they had never been seen before.
The study results provide data linking genetic events in ALL taken from patients when first diagnosed to their future clinical survival. In the lab, the researchers reproduced human ALL in mice transplanted with patient leukemia samples. Sometimes the dominant genetic family would grow in the mice while in other mice the rarer families would grow.
"By looking at the genetic signatures of the leukemia cells in the different mice we were able to figure out their genetic ancestry and the evolutionary trajectory that that particular leukemia took. We found that if a particular gene family was mutated, the tumours were aggressive when grown in the mice. The patients with the corresponding tumours had poorer survival showing that the human-mouse transplant system could be very useful in predicting patient outcome."
This insight into genetic diversity has positive implications for cancer treatment, says Dr. Dick. "Understanding the complexity of cellular relationships and the existence of distinct genetic families of leukemia cells will shed light on why some cells of the cancer are not killed by the therapy and eventually regrow resulting in disease relapse, and help accelerate the development of tailored therapies to wipe out all the unwanted branches in the genetic tree."
Research collaborator Dr. Charles Mullighan, a hematologist at St. Jude Children's Research Hospital, adds: "Overall, the study proved that many leukemias comprise multiple sub populations with different genetic alterations, and that these genetic alterations may evolve over time. The main clinical implication is that we now need to extend this work to identify genetic changes at low levels at diagnosis that confer a high risk of treatment failure and relapse and find ways of targeting them."
The current research builds from earlier findings published in 2007 when the Dick team developed a method to convert normal human blood cells into "human" leukemia stem cells. The converted cells, when transplanted into special mice that permit the growth of human cells, can replicate the entire disease process from the very moment it begins.
In 1994, Dr. Dick identified the first cancer stem cell in leukemia, following on the original discovery in 1961 of the blood stem cell by renowned OCI scientists, Drs. Ernest McCulloch and James Till -- a discovery that formed the basis of all current stem cell research. Dr. Dick, who holds the Canada Research Chair in Stem Cell Biology, has published other findings showing that colon cancer arises from stem cells specific to the tumour.
The research published today was financially supported by grants and fellowships from the Canadian Institutes for Health Research, the Pew Charitable Trusts, The Stem Cell Network of Canadian National Centres of Excellence, the Canadian Cancer Society, Genome Canada through the Ontario Genomics Institute, Ontario Institute for Cancer Research, the Leukemia and Lymphoma Society, a Canada Research Chair, the American and Lebanese Syrian Associated Charities of St. Jude Children's Research Hospital, and the Ontario Ministry of Health and Long Term Care.
Campbell Family Institute
The findings, published today in Nature (DOI:10.1038/nature09733), challenge the conventional scientific view that cancer progresses as a linear series of genetic events and that all the cells in a tumour share the same genetic abnormalities and the same growth properties.
"Our results show this is not the case and open the way to discover how genetic abnormalities transform normal cells into leukemic cells and the steps that have to happen to make the leukemic cells increasingly abnormal and aggressive, how leukemic cells at different steps of genetic evolution (or progression) respond to therapy, or contribute to relapse,"? says Dr. Dick, Senior Scientist at OCI's Campbell Family Institute for Cancer Research, the research arm of Princess Margaret Hospital, and the McEwen Centre for Regenerative Medicine at University Health Network. Dr. Dick is also a Professor in the Department of Molecular Genetics, University of Toronto, and Director of the Cancer Stem Cell Program at the Ontario Institute for Cancer Research.
The research team found that the leukemia cells taken from patients with acute lymphoblastic leukemia (ALL) are actually composed of multiple families of genetically distinct leukemia cells. They looked at how these families developed and retraced the ALL "family tree" back to its origins. They discovered that the so-called black sheep "“ the cells that propagate the disease and potentially survive therapy "“ persist through generations, and even branch off and evolve to form genetically distinct cancer families. Some of these genetic families dominate, making it appear that the leukemia cells only have one set of genetic abnormalities while other families are very rare, explaining why they had never been seen before.
The study results provide data linking genetic events in ALL taken from patients when first diagnosed to their future clinical survival. In the lab, the researchers reproduced human ALL in mice transplanted with patient leukemia samples. Sometimes the dominant genetic family would grow in the mice while in other mice the rarer families would grow.
"By looking at the genetic signatures of the leukemia cells in the different mice we were able to figure out their genetic ancestry and the evolutionary trajectory that that particular leukemia took. We found that if a particular gene family was mutated, the tumours were aggressive when grown in the mice. The patients with the corresponding tumours had poorer survival showing that the human-mouse transplant system could be very useful in predicting patient outcome."
This insight into genetic diversity has positive implications for cancer treatment, says Dr. Dick. "Understanding the complexity of cellular relationships and the existence of distinct genetic families of leukemia cells will shed light on why some cells of the cancer are not killed by the therapy and eventually regrow resulting in disease relapse, and help accelerate the development of tailored therapies to wipe out all the unwanted branches in the genetic tree."
Research collaborator Dr. Charles Mullighan, a hematologist at St. Jude Children's Research Hospital, adds: "Overall, the study proved that many leukemias comprise multiple sub populations with different genetic alterations, and that these genetic alterations may evolve over time. The main clinical implication is that we now need to extend this work to identify genetic changes at low levels at diagnosis that confer a high risk of treatment failure and relapse and find ways of targeting them."
The current research builds from earlier findings published in 2007 when the Dick team developed a method to convert normal human blood cells into "human" leukemia stem cells. The converted cells, when transplanted into special mice that permit the growth of human cells, can replicate the entire disease process from the very moment it begins.
In 1994, Dr. Dick identified the first cancer stem cell in leukemia, following on the original discovery in 1961 of the blood stem cell by renowned OCI scientists, Drs. Ernest McCulloch and James Till -- a discovery that formed the basis of all current stem cell research. Dr. Dick, who holds the Canada Research Chair in Stem Cell Biology, has published other findings showing that colon cancer arises from stem cells specific to the tumour.
The research published today was financially supported by grants and fellowships from the Canadian Institutes for Health Research, the Pew Charitable Trusts, The Stem Cell Network of Canadian National Centres of Excellence, the Canadian Cancer Society, Genome Canada through the Ontario Genomics Institute, Ontario Institute for Cancer Research, the Leukemia and Lymphoma Society, a Canada Research Chair, the American and Lebanese Syrian Associated Charities of St. Jude Children's Research Hospital, and the Ontario Ministry of Health and Long Term Care.
Campbell Family Institute
Wednesday, January 19, 2011
Breast Cancer Clinical Trials And Quality Of Life (QOL) A Quality And Value Assesment
Even though the incorporation of Quality of Life (QOL) in clinical studies of cancer treatment trials began more than 30 years ago, it was reported that only 60 such trials included QOL in the study, before the year 2000. But it is changing, a research team led by Julie Lemieux, MD, from the Université Laval in Québec City, Quebec, Canada.found that during the period of 2001-2009, this number jumped to 190. The report is an extension to the study carried out by the same group previously. Dr. Patricia Ganz, the editor of the editorial accompanying the report says that these researchers are extending our understanding of how QOL and treatment trials interact;
The authors provide the following recommendations based on their updated review findings:
Full Text of the article at the JNCI, The Journal Of The National Cancer Institute
how measurement of QOL outcomes adds value to randomized clinical trials in breast cancer. During the past decade, an impressive number of trials were published (n = 190) that added to those previously reported on (n = 66), reflecting the increasing interest in the inclusion of QOL and patient-reported outcomes in clinical trials, as well as the high volume of treatment and behavioral intervention research focused on patients with breast cancerThe authors also found limitations to these studies even thought he incorporation of QOL is increasing in the Cancer treatment clinical trials. The inconsistencies lies in the quality statical methods, description of statistical power and/or sample size calculation for the QOL outcomes, documentation of missing data, and reporting of the clinical significance of the QOL findings.
The authors provide the following recommendations based on their updated review findings:
1) QOL should be included as a secondary endpoint in adjuvant therapy trials only when the treatment expectation is equivalence or noninferiority, for example, when treatment decisions will be based on differences in patient outcomes between study arms or when the trial focuses on a vulnerable population (eg, elderly women) or is testing substantially different modalities (eg, endocrine vs chemotherapy) or a new treatment for which descriptive information is needed;
2) QOL assessments should be included in metastatic breast cancer treatment trials only when a minimal survival difference is expected or the treatments have substantial differences in toxicity or descriptive information about a new treatment is needed;
3) QOL-specific sample size calculations should be performed and QOL should be measured only in the subset of the study population that was defined by these calculations;
4) when QOL is not the primary trial endpoint, the results should ideally appear in a companion article published at the same time as the medical outcomes article, so that a complete appraisal of the risks and benefits of the intervention can be evaluated (. Quality-of-life measurement in randomized clinical trials in breast cancer: an updated systematic review (2001-2009). J Natl Cancer Inst. 2010;103(3):xxx-xxx.).
- Lemieux J,
- Goodwin PJ,
- Bordeleau LJ,
- Lauzier S,
- Theberge V
Full Text of the article at the JNCI, The Journal Of The National Cancer Institute
Monday, January 10, 2011
Abstral (Fentanyl) Transmucosal Tablets Approved By FDA For Alleviating Breakthrough Pain In Adult Cancer Patients.
FDA, Food and Drug Administration has approved Abstral (fentanyl) transmucosal tablets for alleviating breakthrough pain in adult cancer patients. Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use.
Transmucosal drugs are absorbed through soft surfaces in the mouth like Cheeks, Gums, Tongue, and also nasal passages and throat.
Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product.
The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.
FDA PRESS RELEASE
“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.
Transmucosal drugs are absorbed through soft surfaces in the mouth like Cheeks, Gums, Tongue, and also nasal passages and throat.
Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product.
The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.
FDA PRESS RELEASE
For Immediate Release: Jan 7, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves opioid analgesic to help cancer patients manage pain
Enrollment in REMS program required for health care professionals
The U.S. Food and Drug Administration today approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed.
“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” said John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.
Abstral is indicated for the management of breakthrough pain in patients with cancer, ages 18 years and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Breakthrough pain is pain that comes on suddenly for short periods of time and is not alleviated by a patient’s normal pain management plan. These patients are considered opioid tolerant because of their current opioid medication use. Only health care professionals skilled in the use of Schedule II opioids to treat pain should prescribe this drug product.
Abstral is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product. FDA has standardized key components of the REMS program to facilitate the adoption of a single shared system. These components include the REMS document, the Patient-Prescriber Agreement, and the enrollment form. These components can be used by all sponsors of immediate release transmucosal fentanyl products to develop individual REMS programs such as the program approved for Abstral. FDA has also directed the sponsors of this class of products to work together on a single shared system to implement the REMS.
“This approval is also a significant step toward reducing the burden on the health care system of implementing REMS programs,” added Dr. Jenkins. “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS.”
The safety of Abstral was evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months.
Common adverse reactions include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.
Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of Abstral to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
Abstral is manufactured by ProStraken Inc., based in Bedminster, N.J.
Labels:
Abstral,
FDA,
fentanyl,
Medwatch,
opioid,
opioid tollerance,
ProStraken Inc,
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transmucosal tablets
Saturday, January 8, 2011
Library of Congress, A portal To Knowledge, Gets A New Home Page.
Library of Congress, LOC, has got a new home page. I think it is very functional and as always providing needed information that we always rely on.
On most of our upcoming projects we rely on LOC information and resources for data that we can rely on.
On most of our upcoming projects we rely on LOC information and resources for data that we can rely on.
Follow the link after the jump to enjoy the new Library Of Congress Home Page, A portal To Knowledge.
Library Of Congress Via LOC Blog1 ) The Library’s current “header,” containing the Library’s logo, the Ask a Librarian, Digital Collections, and Library Catalogs buttons, and the main Search field, will be maintained. This might change someday when a revised information architecture is put into place.2 ) The top of the left column contains a rotating “carousel” of five graphics for events, information, or other featured content. The carousel changes automatically every five seconds, or users can click on the circular buttons to navigate or pause, and then click links to the specific content.3 ) Below the rotating carousel is a set of links to content about the Library. These links include: The Library’s Mission, The History of the Library, Awards and Honors, Jobs and Fellowships, FAQs, Support the Library, and More about the Library. In addition, there are sections below that for news and events, visitor information, and information about exhibitions.4 ) At the top of the middle column, which describes “what we have,” is a set of selected collection highlights. They are arranged by format, topic, or a user’s self-identified audience, such as librarians or teachers.5 ) A shaded box for researchers highlights links to our catalogs and finding aids.6 ) This section features videos about items in the Library’s collections and clips from concerts and events. It uses use the Library’s new Flash-based video player, which includes closed captions and full-screen viewing capabilities.7 ) The Explore and Discover section at the bottom of the middle column allows the Library to feature frequently updated informational and educational content. This section initially includes links for Today in History, Places in the News, the Wise Guide, MyLoc.gov, Read.gov, and the Gateway to Knowledge website.8 ) In the right column are the aforementioned, more prominent links to legislative information (THOMAS) and the functions of the U.S. Copyright Office, which is part of the Library of Congress.9) The area below that has links to major Library programs and collaborative initiatives, listed in alphabetical order.10) Rounding out the right column, the Services area contains a list of services the Library provides to the public or to the nation, also listed in alphabetical order.Finally, the bottom of the page, spanning all three columns, is the “global footer,” which will begin appearing across all the main web pages. It has links to the Library’s social media sites (Facebook, Twitter, YouTube, etc.), links to subscribe to RSS or email lists, and other useful information.
Labels:
Library of Congress,
LOC,
portal To Knowledge
Wednesday, January 5, 2011
New Class Of Drug Might Improve Herceptin (trastuzumab) Capability In Treating Aggressive Form Of Breast Cancer
The Breakthrough Breast Cancer-funded team at the University of Oxford showed that combining Herceptin with pan-HER inhibitors kills cancer cells much more effectively than Herceptin on its own. The drug combination does this by knocking out the activity of HER2 and, crucially, its related proteins, too. These results were then confirmed in mouse models.
Dr Anthony Kong, the Breakthrough Breast Cancer clinician scientist who led the study, said: “It was incredible to see how much more potent Herceptin becomes when combined with a new type of drug. We think this could have a big impact in improving survival rates for patients with HER2 positive breast cancer. “We are hoping to set up a clinical trial in the near future to test this treatment combination in patients.”
Source
pan-HER
Dr Anthony Kong, the Breakthrough Breast Cancer clinician scientist who led the study, said: “It was incredible to see how much more potent Herceptin becomes when combined with a new type of drug. We think this could have a big impact in improving survival rates for patients with HER2 positive breast cancer. “We are hoping to set up a clinical trial in the near future to test this treatment combination in patients.”
Source
pan-HER
SAN DIEGO, Dec. 20, 2010 /PRNewswire/ -- Ambit Biosciences (Ambit), today announced that it has initiated separate Phase I trials for two products AC430, a selective Janus Kinase 2 (JAK2) inhibitor, and AC480, a pan-HER inhibitor.
The Phase I trial for AC430 is a two part, placebo-controlled, single ascending, and multiple ascending dose trial in healthy volunteers. AC430 will be administered orally once-daily and doses escalated until a maximum tolerated or maximum feasible dose is established. In addition to evaluating the safety, tolerability, and pharmacokinetics of AC430, the study will also assess cytokine signal transduction.
The Phase I trial for AC480 is a multi-center, dose escalation study with AC480 administered by intravenous infusion on days one and two of a 21 day cycle, either alone or in combination with docetaxel. The trial will assess safety, pharmacokinetics and anti-tumor activity of AC480 in patients with advanced solid tumors.
"The initiations of these studies are important milestones," said Alan Lewis, President and CEO Ambit Biosciences. "AC430 has demonstrated convincing efficacy in pre-clinical models of autoimmune and inflammatory diseases, and AC480 IV was developed to assess whether pulsatile doses of a pan-HER inhibitor administered in combination with a taxane such as docetaxal would produce synergistic anti-tumor activity."
About AC430
AC430 was specifically developed to be a best-in-class JAK2 inhibitor. In preclinical studies, AC430 has exhibited potency against JAK2 in cell-based models that is at least equivalent, and in most cases superior to, competing JAK2 inhibitors, and also has excellent oral pharmacokinetic properties. In preclinical oncology and autoimmune models, AC430 is well tolerated and has significant efficacy at oral doses as low as 10 mg/kg/day. JAK2 has been implicated as a target for therapy in both oncology and autoimmune disease.
About AC480
AC480 is a small molecule kinase inhibitor that selectively inhibits the HER family of receptors, HER1, HER2, HER3 and HER4. Excessive HER signaling has been associated with the development of a wide variety of types of solid tumors, including those found in lung, breast, head and neck and brain cancers. Currently marketed HER inhibitors inhibit only one or two of the HER family members and a pan-HER inhibitor that inhibits all of the HER receptors may be effective in more cancer types. Published data with oral HER inhibitors administered in combination with taxanes, such as docetaxel, demonstrate activity in clinical studies and these clinical data are supported by preclinical data demonstrating that combining HER inhibitors with taxanes produces synergistic anti-tumor activity. An intravenous formulation of a pan-HER inhibitor such AC480 enables high pulsatile doses to be administered in combination with taxanes.
About Ambit Biosciences
Ambit Biosciences Corporation is a biotechnology company engaged in discovering, developing and commercializing targeted small molecule therapeutics for the treatment of cancer.
Ambit contacts:
Labels:
breast cancer,
Herceptin,
pan-HER,
trastuzumab
Tuesday, January 4, 2011
The Oceans May Help Us To Cure Cancer.
A future cancer medicine from the ocean
Professor Stein Ove Døskeland and his group of colleagues at the Department of Biomedicine, University of Bergen, is in the process of testing a new cancer medicine derived from bacteria found in seawater.
University of Bergen
Monday, January 3, 2011
The National Cancer Institute Revamps Clinical Trials To Bring Enhanced Efficiencies To Oncological Sciences
The National Cancer Institute (NCI) has announced major changes to be made in the long-established Clinical Trials Cooperative Group Program that conducts many of the nationwide trials of new cancer therapies. In a major transformation, NCI intends to consolidate the nine groups that currently conduct trials in adult cancer patients into four state-of-the-art entities that will design and perform improved trials of cancer therapies. These changes are designed to provide greater benefits for cancer patients and more information for researchers. These moves come in response to an NCI-requested April 2010 report from the Institute of Medicine (IOM), which called for a series of changes to the cooperative groups program, including restructuring.
“Clinical trials are at the heart of cancer care and treatment, and NCI is dedicated to making sure they are as effective as they can be, In the last decade, our knowledge of genetic and epigenetic changes that drive the initiation and progression of cancers has increased exponentially. Consequently we must assess and improve the methods by which NCI evaluates new therapies that take advantage of our new understanding of many kinds of cancers.” ” said Harold E. Varmus, M.D., NCI director.
The April IOM report noted that the current trials system is inefficient, cumbersome, underfunded, and overly complex. The report recommended consolidating existing adult cooperative groups into a smaller number of groups that could function in a more closely integrated manner.
The NCI Cooperative Group program, founded over 50 years ago, involves more than 3,100 institutions and 14,000 investigators, and the program enrolls over 25,000 patients in clinical trials each year. Four pediatric groups were consolidated into one group a number of years ago, and that sole pediatric group will not be consolidated with other groups.
“The practice of oncology has changed significantly with the development of molecular oncology, therefore we need a modern system with modern trials that will maximally utilize the molecular characteristics of a patient’s tumor and guide us to the best possible treatment for that patient, This evolution in our understanding of cancer will lead to an evolution in the design and implementation of clinical trials.” said James H. Doroshow, M.D., director, NCI Division of Cancer Treatment and Diagnosis.
For the past several decades, clinical cancer trials have used one or a combination of drugs or other treatment modalities, such as surgery or radiation, in comparison to the prevailing standard of care to see if the new treatment was superior. Recently, some trials have begun to depend on the genetic profiling of tumors. For example, one ongoing NCI-sponsored breast cancer study, called TAILORx, is examining whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to more appropriate and effective treatments.
These types of studies necessitate the screening of large numbers of patients in order to find subsets of patients with tumors that demonstrate changes in specific genetic pathways. These trials therefore require acquisition and distribution of many tumor specimens, DNA sequencing, and the matching of genetic information with treatment options. The increased complexity of these trials provides a rationale for modernization and simplification of the current cooperative group structure.
Consolidation is intended to improve the efficiencies of operations centers, data management centers, and tumor banks, and the changes will take into consideration an assessment of all currently active cooperative groups. The current groups will also be given opportunities to comment on the proposed changes and to explore specific aspects of the reorganization plans in consultation with NCI leadership.
While consolidation of specific groups proceeds, other generalized efficiencies are already being planned, such as shortening the time required to initiate new clinical trials. Historically, when a new study was proposed, the concept had to be submitted for approval in a process that took as long as several years. Furthermore, if this review was not completed within two years after concept approval, a trial was very unlikely to reach its ultimate recruitment goals, in part because the scientific questions underpinning the concept could be overtaken by new developments.
On Jan. 1, 2011, NCI will impose new deadlines, formulated by its Operational Efficiency Working Group, which will reduce by half the time to initiate new clinical studies and will terminate studies not begun within two years of concept approval.
NCI has also been working to increase efficiency in several other ways, including:
- Decreasing the average time for final sign-off and approval on protocols for national trials by its centralized institutional review board from 150 days in 2007, to 42 days in 2010
- Prioritizing a revamped review process, which will include advocates and professionals at cancer centers, with new emphasis on disease-specific and modality-specific oversight, such as imaging or cancer control
- Modernizing information technology so that a single system can collect standardized clinical trial data, such as patient information and outcomes
###
A list of the current 10 U.S.-based NCI Cooperative Groups can be found athttp://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group
Drosophila, Fruit Flies May Help Us In Delaying Cancer Progression.
blood cancer occurs when there is an out-of-control response to a chronic inflammation |
But not all insect larvae sit still while this process takes place. For instance, in Drosophila, fruit flies, the larvae activate humoral immunity mechanism that encapsulate and choke off parasitic egg.
A research by a team lead by Dr.Shubha Govind, at the City Collage Of New York recognizes parallels between how this immune system fights the wasp egg and the way blood cancer develops.
“There are fundamental similarities in the processes, the response to wasp infection is similar to acute inflammation while the cancer is akin to chronic inflammation in mammals, where regulation of the response to an infection also goes out of control.” explains Dr. Govind. “There is strong evidence that the fundamental mechanism of regulation uncovered in flies also works in humans,” she notes. “Because of the molecular similarities between flies and mammals, it may be possible to use flies to test drugs for potential anti-inflammatory effects in human disease.” While such drugs would not cure cancer, they could control inflammation and, perhaps, delay cancer progression.
The findings are published on Plos Pathogens.
PLoS Pathogens via City College Of New York
Saturday, January 1, 2011
OncoWikia Wishes A Happy and Cancer Free New Year For All!
Thank you everyone and I wish you all to be happy in excellent health and be cancer free. This year we will be focusing on Oncology (Cancer) related matters first as we expand the horizon with OncoWikia, OncoSemantic and oncomeme .
May all you be awesome this year. Thank you for your support.
May all you be awesome this year. Thank you for your support.
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OncoMeme,
OncoSemantic,
Oncowikia
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