By Andrea: http://nursingoncologyjob.com
Recently, Cellceutix Corp. (CTIX) made an exciting announcement on their trial cancer drug: Kevetrin. Kevetrin in early studies, has demonstrated significant delay of Tumor growth in drug resistant cancer:
Cellceutix Corporation (CTIX) today announced that it has completed its second and final species toxicity study under the conditions prescribed by United States Food and Drug Administration (FDA) Good Laboratory Practices regulations. This is the last safety study required for an Investigational New Drug (IND) filing. In the study, animals were administered five doses of Kevetrin™ weekly over a 29 day period. Three groups of 14 animals were administered 5 mg/kg, 25 mg/kg and 60 mg/kg respectively while a fourth group acted as controls. There was a 14 day recovery period after the dosing. Parameters measured were hematology, clinical chemistries, weight change, food consumption, survival, urinalysis, ophthalmic examination and histopathology. This study, as well as the earlier toxicity and safety pharmacology studies, were performed by Toxikon, in Bedford, Massachusetts.
"This is the last safety study we had to complete prior to IND filing and we are extremely pleased with the results," said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Having now seen the data from all the required studies, I am very excited about the future of this compound in development for cancers that are resistant to standard therapies."
"This is an extraordinary milestone for a young company like ours," said George Evans, CEO of Cellceutix. "We would like to acknowledge our partner for these studies, Toxikon Corporation, who provided us with high quality work and excellent customer service. We believe we are now well on our way to an IND filing later this year or early next."
"We are proud to have led these important toxicology studies and help Cellceutix achieve its goal of getting Kevetrin to human trials and, ultimately, to market," said Dr. Laxman Desai, president and CEO of Toxikon, adding that "Toxikon is equipped to meet the industry's anticancer and antiviral drug discovery demands."
About Cellceutix
Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, and KM-391, which it is developing for the treatment of autism.
For more cancer updates, visit: http://www.astopnews.blogspot.com
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Showing posts with label breast cancer. Show all posts
Showing posts with label breast cancer. Show all posts
Sunday, October 31, 2010
Sunday, October 24, 2010
Genentech: Avastin Breast Cancer Drug
By Andrea: http://nursingoncologyjob.com
Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),recently announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin® (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment. In accordance with FDA guidelines, the agency has extended the review period for the sBLAs by an additional 90 days. The company now anticipates FDA action on the sBLAs by December 17, 2010.
At this time, Avastin remains under accelerated approval in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer. The FDA is currently reviewing two sBLAs that Genentech submitted in November 2009 for Avastin in combination with taxane-based, anthracycline-based and capecitabine chemotherapies based on the results of the AVADO and RIBBON1 studies. Data from AVADO and RIBBON1 were submitted as part of Genentech's effort to convert the accelerated approval to a full approval.
"We are pleased by the FDA's decision to review additional information on Avastin and are committed to working closely with the agency during this extended review period," said Hal Barron, M.D., executive vice president, Product Development and chief medical officer.
Today's announcement does not impact Avastin's availability for its approved uses for other cancer types in the U.S. or approved uses, including breast cancer, in other countries. Doctors with questions about the use of Avastin for advanced breast cancer can call Genentech's Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage or doctors with questions about reimbursement can call Genentech's Access Solutions Group at (866) 4 ACCESS.
In February 2008, FDA granted accelerated approval for Avastin in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. The approval was based on an improvement in progression-free survival (PFS). Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. There are no data available showing that Avastin improves disease-related symptoms or survival in advanced HER2-negative breast cancer.
About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF (vascular endothelial growth factor) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.
Avastin is approved for first- and second-line treatment of metastatic colorectal cancer (mCRC) in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa.
For more stock updates, visit: http://daytradingstockblog.blogspot.com
Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),recently announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin® (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment. In accordance with FDA guidelines, the agency has extended the review period for the sBLAs by an additional 90 days. The company now anticipates FDA action on the sBLAs by December 17, 2010.
At this time, Avastin remains under accelerated approval in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer. The FDA is currently reviewing two sBLAs that Genentech submitted in November 2009 for Avastin in combination with taxane-based, anthracycline-based and capecitabine chemotherapies based on the results of the AVADO and RIBBON1 studies. Data from AVADO and RIBBON1 were submitted as part of Genentech's effort to convert the accelerated approval to a full approval.
"We are pleased by the FDA's decision to review additional information on Avastin and are committed to working closely with the agency during this extended review period," said Hal Barron, M.D., executive vice president, Product Development and chief medical officer.
Today's announcement does not impact Avastin's availability for its approved uses for other cancer types in the U.S. or approved uses, including breast cancer, in other countries. Doctors with questions about the use of Avastin for advanced breast cancer can call Genentech's Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage or doctors with questions about reimbursement can call Genentech's Access Solutions Group at (866) 4 ACCESS.
In February 2008, FDA granted accelerated approval for Avastin in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. The approval was based on an improvement in progression-free survival (PFS). Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. There are no data available showing that Avastin improves disease-related symptoms or survival in advanced HER2-negative breast cancer.
About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF (vascular endothelial growth factor) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.
Avastin is approved for first- and second-line treatment of metastatic colorectal cancer (mCRC) in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa.
For more stock updates, visit: http://daytradingstockblog.blogspot.com
Saturday, October 16, 2010
Hologic Inc: Selenia Dimensions 3-D to help Increase Early Detection of Breast Cancer
By Andrea: http://nursingoncologyjob.com
Hologic, Inc. (HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced that the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) today unanimously voted that Hologic's Pre‐Market Approval (PMA) demonstrated both the effectiveness and safety of the Company's Selenia Dimensions three‐dimensional (3‐D) digital mammography tomosynthesis system, "Selenia Dimensions 3‐D." In addition, the Panel voted in favor that the benefits of this new technology outweigh the risks.
Following today's FDA Panel meeting, which was held in Gaithersburg, Maryland, Hologic will work with the FDA on next steps for approval of its 3‐D digital mammography system. While the Panel's favorable vote is advisory in nature, the FDA will consider it in its final review of Hologic's PMA application for the Selenia Dimensions tomosynthesis system.
"Our Selenia Dimensions 3‐D technology marks tremendous progress in the early diagnosis of breast cancer," said Jay A. Stein, Co‐Founder and Chief Technical Officer. "The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions. I speak for all of Hologic in voicing great satisfaction that the FDA Panel has weighed in so positively in favor of this valuable new tool in the battle to limit breast cancer mortality."
Hologic's Selenia Dimensions 3‐D digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a two -dimensional (2‐D) image, breast tomosynthesis produces a three‐dimensional image. We believe our multicenter clinical study has demonstrated that compared to 2‐D digital mammography alone, 3‐D digital tomosynthesis used in combination with 2‐D digital mammography has the potential to reduce recall rates and improve cancer detection.
Hologic's Selenia Dimensions 3‐D digital mammography tomosynthesis system is presently commercially available outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional only system that can be upgraded to do breast tomosynthesis (3‐D) imaging when and if the product is approved by the FDA.
"We are extremely pleased with the outcome of today's FDA Panel meeting," said Rob Cascella, President and Chief Executive Officer. "Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2‐D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. Our Selenia Dimensions platform represents the next phase in breast cancer detection ‐ fast, high‐quality 2‐D and 3‐D digital tomosynthesis imaging of the breast. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologists to help save more women's lives."
Hologic, Inc. (HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced that the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) today unanimously voted that Hologic's Pre‐Market Approval (PMA) demonstrated both the effectiveness and safety of the Company's Selenia Dimensions three‐dimensional (3‐D) digital mammography tomosynthesis system, "Selenia Dimensions 3‐D." In addition, the Panel voted in favor that the benefits of this new technology outweigh the risks.
Following today's FDA Panel meeting, which was held in Gaithersburg, Maryland, Hologic will work with the FDA on next steps for approval of its 3‐D digital mammography system. While the Panel's favorable vote is advisory in nature, the FDA will consider it in its final review of Hologic's PMA application for the Selenia Dimensions tomosynthesis system.
"Our Selenia Dimensions 3‐D technology marks tremendous progress in the early diagnosis of breast cancer," said Jay A. Stein, Co‐Founder and Chief Technical Officer. "The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions. I speak for all of Hologic in voicing great satisfaction that the FDA Panel has weighed in so positively in favor of this valuable new tool in the battle to limit breast cancer mortality."
Hologic's Selenia Dimensions 3‐D digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a two -dimensional (2‐D) image, breast tomosynthesis produces a three‐dimensional image. We believe our multicenter clinical study has demonstrated that compared to 2‐D digital mammography alone, 3‐D digital tomosynthesis used in combination with 2‐D digital mammography has the potential to reduce recall rates and improve cancer detection.
Hologic's Selenia Dimensions 3‐D digital mammography tomosynthesis system is presently commercially available outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional only system that can be upgraded to do breast tomosynthesis (3‐D) imaging when and if the product is approved by the FDA.
"We are extremely pleased with the outcome of today's FDA Panel meeting," said Rob Cascella, President and Chief Executive Officer. "Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2‐D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. Our Selenia Dimensions platform represents the next phase in breast cancer detection ‐ fast, high‐quality 2‐D and 3‐D digital tomosynthesis imaging of the breast. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologists to help save more women's lives."
Breast Cancer Awareness Month: Events
By Andrea: http://nursingoncologyjob.com
Today from 9:30am-6pm the staff and teachers at Quiltique will be auctioning off their “blinged” bras to raise money for the Susan G. Komen Foundation.
The idea started with a post on the BERNINA Blog. They invited their blog’s readers to “Bling their Bra” in October, to celebrate Breast Cancer Awareness Month. Quiltique, a local Henderson quilt shop took the idea one step further. They asked their staff and teachers to create over-the-top lingerie creations to auction, with the auction proceeds going to the Susan G. Komen Foundation. The staff and teachers went wild, creating one-of-a-kind originals, some of which would turn the head of even the most seasoned Las Vegas Stripper.
Though the staff has taken a whimsical approach, the goal is clear – to raise money to fight breast cancer, a disease that has affected far too many mothers, daughters, sisters, aunts, grandmothers, cousins… and dear friends.
For customers interested in a treat for the stomach as well as the eyes, the staff has baked up culinary sensations to sell at their bake sale, also on October 16th, which will also benefit Susan G. Komen.
Quiltique is a boutique quilt shop in Henderson, Nevada that has been family owned and operated since 2003. It is located at 213 N. Stephanie, on the corner of Stephanie and American Pacific.
Today from 9:30am-6pm the staff and teachers at Quiltique will be auctioning off their “blinged” bras to raise money for the Susan G. Komen Foundation.
The idea started with a post on the BERNINA Blog. They invited their blog’s readers to “Bling their Bra” in October, to celebrate Breast Cancer Awareness Month. Quiltique, a local Henderson quilt shop took the idea one step further. They asked their staff and teachers to create over-the-top lingerie creations to auction, with the auction proceeds going to the Susan G. Komen Foundation. The staff and teachers went wild, creating one-of-a-kind originals, some of which would turn the head of even the most seasoned Las Vegas Stripper.
Though the staff has taken a whimsical approach, the goal is clear – to raise money to fight breast cancer, a disease that has affected far too many mothers, daughters, sisters, aunts, grandmothers, cousins… and dear friends.
For customers interested in a treat for the stomach as well as the eyes, the staff has baked up culinary sensations to sell at their bake sale, also on October 16th, which will also benefit Susan G. Komen.
Quiltique is a boutique quilt shop in Henderson, Nevada that has been family owned and operated since 2003. It is located at 213 N. Stephanie, on the corner of Stephanie and American Pacific.
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