Posts Tagged ‘Therapeutics’

Chemoprevention Gene Therapy Technique May Lead to Pancreatic Cancer Treatment

Chemoprevention Gene Therapy Technique May Lead to Pancreatic Cancer Treatment

Chemoprevention Gene Therapy Technique May Lead to Pancreatic Cancer Treatment

Researchers at the Virginia Commonwealth University Massey Cancer Center and the VCU Institute of Molecular Medicine have published findings that implicate a new chemoprevention gene therapy (CGT) for preventing and treating pancreatic cancer, one of the most lethal and treatment-resistant forms of cancer.

In the July issue of Molecular Cancer Therapeutics, the researchers showed that combining a dietary agent with a gene-delivered cytokine effectively eliminates human pancreatic cancer cells in mice displaying sensitivity to these highly aggressive and lethal cancer cells.

Cytokines are a category of proteins that are secreted into the circulation and can affect cancer cells at distant sites in the body, including metatases. The cytokine used in this study was melanoma differentiation associated gene-7/interleukin-24, known as mda-7/IL-24.

The dietary agent, perillyl alcohol (POH), was combined with mda-7/IL-24, which is already used in other cancer treatments. POH is found in a variety of plants, including citrus plants, and has been well-tolerated by patients who have received it in clinical studies.

The results indicated that the CGT approach not only prevented pancreatic cancer growth and progression, but it also effectively killed established tumors, thereby displaying profound chemopreventive and therapeutic activity.

Paul B. Fisher, Ph.D., was principal investigator of the study, which was supported by the National Institutes of Health and the Samuel Waxman Cancer Foundation. Fisher, who recently joined VCU from Columbia University, is professor and interim chair of VCU’s department of human and molecular genetics; holds the Thelma Newmeyer Corman chair in cancer research at Massey; and is director of the VCU Institute of Molecular Medicine.

“Our hypothesis was that certain non-toxic dietary agents that had the ability to promote reactive oxygen species (ROS) would break down pancreatic cancer cell resistance to therapy following administration of mda-7/IL-24 and be safe for human use,” said Fisher. “We are very excited at the prospect of this chemoprevention gene therapy as a means of both preventing and treating pancreatic cancer, and it has significant potential to move rapidly into human clinical trials.”

Pancreatic cancer has a five-year survival rate of less than 5 percent, and currently there is no effective chemotherapy or radiation therapy for it. About 37,000 new cases are diagnosed in the United States each year.

To read an abstract of the study, visit http://mct.aacrjournals.org/cgi/content/abstract/7/7/2042.

About the VCU Massey Cancer Center

VCU Massey Cancer Center is one of only 66 National Cancer Institute-designated institutions in the country that leads and shapes America’s cancer research efforts. Working with all kinds of cancers, the Center conducts basic, translational and clinical cancer research, provides state-of-the-art treatments and clinical trials, and promotes cancer prevention and education. Since 1974, Massey has served as an internationally recognized center of excellence. It offers a wide range of clinical trials throughout Virginia, oftentimes the most trials in the state, and serves patients in Richmond and in four satellite locations. Its 1,000 researchers, clinicians and staff members are dedicated to improving the quality of human life by developing and delivering effective means to prevent, control and ultimately to cure cancer. Visit Massey online at www.massey.vcu.edu or call 877-4-MASSEY for more information.

About VCU and the VCU Medical Center

Virginia Commonwealth University is a major, urban public research university with national and international rankings in sponsored research. Located in downtown Richmond, VCU enrolls more than 31,000 students in 222 degree and certificate programs in the arts, sciences and humanities. Sixty-six of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 13 schools and one college. MCV Hospitals and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the nation’s leading academic medical centers. For more, see www.vcu.edu.

Researchers at the Virginia Commonwealth University might have come upon a method that will effectively address pancreatic cancer, one of the most pernicious diseases having no real treatment options.

In the July issue of Molecular Cancer Therapeutics, the researchers showed that combining a dietary agent with a gene-delivered cytokine effectively eliminates human pancreatic cancer cells in mice displaying sensitivity to these highly aggressive and lethal cancer cells.

Cytokines are a category of proteins that are secreted into the circulation and can affect cancer cells at distant sites in the body, including metatases. The cytokine used in this study was melanoma differentiation associated gene-7/interleukin-24, known as mda-7/IL-24.

The dietary agent, perillyl alcohol (POH), was combined with mda-7/IL-24, which is already used in other cancer treatments. POH is found in a variety of plants, including citrus plants, and has been well-tolerated by patients who have received it in clinical studies.

The results indicated that the CGT approach not only prevented pancreatic cancer growth and progression, but it also effectively killed established tumors, thereby displaying profound chemopreventive and therapeutic activity.

Source : http://www.news.vcu.edu/news/VCU_Massey_Cancer_Center_and_VCU_Institute_of_Molecular_Medicine

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Neovasc Tiara Transcatheter Mitral Valve in Pre-Clinical Trials; Reducer Stent Proving Itself for Refractory Angina

Neovasc Tiara Transcatheter Mitral Valve in Pre-Clinical Trials; Reducer Stent Proving Itself for Refractory Angina

Neovasc Tiara Transcatheter Mitral Valve in Pre-Clinical Trials; Reducer Stent Proving Itself for Refractory Angina

Tiara is a novel transcatheter device that will enable the treatment of mitral regurgitation (MR), a condition that is often severe and can lead to heart failure and death.

Neovasc is in the pre-clinical stage of developing the Tiara for the treatment of severe MR, a condition that affects approximately four million patients in the U.S. alone. Currently, conventional surgical treatments are only appropriate for about 20% of these patients, leaving the majority of patients untreated.

The Tiara device is delivered through the apex of the heart to replace the mitral valve while preserving the integrity of the surrounding structures of the heart. Due to the complexity of the mitral valve anatomy, development of transcatheter treatments for mitral regurgitation has significantly lacked in comparison to aortic valve replacement devices.

Challenges to treatment of the mitral valve include:

Complex geometry of the mitral apparatus

Conformational changes of the mitral apparatus throughout the cardiac cycle

Maintaining continuity with the sub valvular structures

Native D shape of the mitral valve

Proximity to the aortic valve and potential for LVOT obstruction

Large size of the mitral valve – larger crossing profile

High closing pressures

Left ventricular remodelling

British Columbia-based Neovasc is developing a new transcatheter mitral valve with which they aim to overcome some of the challenges of existing prostheses. The new Tiara device is already going through animal trials and the company has announced positive results regarding ease of implantation, confidence of fixation, and overall positive hemodynamics at this week’s Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

The Tiara was developed to address the specific anatomy of the mitral valve rather than being a modified aortic valve. It is made to continuously conform to its surroundings with every heartbeat, preserving the natural shape of the valve.

From the company press release:

They reported that during these acute animal studies, the Tiara valves were implanted successfully in 81% of the test animals, with total procedure times ranging from 17 to 26 minutes. In the successful implantations, angiographic and echo imaging demonstrated excellent function of the Tiara device, with no obstruction of the left ventricular outflow tract, no pericardial effusion, no encroachment on the aortic valve,no transvalvular gradients and most importantly, no significant paravalvular leak. Researchers also reported early results from the first long-term animal implantations of the Tiara device, including echocardiogram images of Tiara valves obtained

approximately three months after implant, which demonstrated continuing good function and integrity of the valve. These chronic animal studies are ongoing.

Additionally, Neovasc reported clinical results on its Reducer implant for treating refractory angina. The Reducer actually restricts the outflow of coronary blood, effectively increasing perfusion pressure.

Neovasc Reducer Neovasc Tiara Transcatheter Mitral Valve in Pre Clinical Trials; Reducer Stent Proving Itself for Refractory Angina (VIDEO)From Neovasc:

The Neovasc researchers reported on the experience of the first 11 patients who were implanted with the Reducer and followed for six months or more as part of the REDUCE-1 and REDUCE-2 Registries. No complications or cardiac adverse events were recorded in these patients. Clinical parameters including the patients’ angina scores and their daily consumption of nitroglycerin were diminished significantly six months after Reducer implantation. Additionally, exercise stress test parameters improved, and functional imaging of myocardial perfusion showed that blood flow in the heart improved significantly. Measures of left ventricular ejection fraction, considered a key indicator of cardiac function, alsoimproved after Reducer implantation.

Source : http://www.neovasc.com/products/neovasc-tiara/

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Guided Therapeutics seeks premarket approval from FDA for LuViva Advanced Cervical Scan

Guided Therapeutics seeks premarket approval from FDA for LuViva Advanced Cervical Scan

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it met with the Food and Drug Administration (FDA) on July 20, 2012. The company believes the meeting was very positive and plans to work with FDA to finalize the path forward to gain premarket approval (PMA) for the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.

The preliminary plan calls for the company to file a PMA amendment using existing clinical data to address the agency’s questions stemming from its January 20, 2012 “not approvable” letter. The company maintained at the meeting with the FDA that the new data analysis to be included in the amended PMA demonstrates the clinical benefit of LuViva in light of new cervical cancer screening guidelines adopted earlier this year.

“We are pleased with both the tenor and substance of the meeting with FDA and believe we have a good plan to move the PMA process forward through what we hope will be a quick review and approval for LuViva,” said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics. “We believe that once approved, LuViva will have a very positive impact on the U.S. healthcare system by improving the standard of care for the early detection of cervical disease, and providing women and doctors the first test with instant results.”

LuViva has been under FDA PMA review since September 23, 2010. The company received a “not approvable” letter for the product on January 20, 2012. In May, 2012 the company requested a meeting with the agency, and suggested a path for possible approval to which the FDA was receptive. After a PMA amendment is submitted, the FDA has 180 days during which it can respond.

In addition to the recently announced CE Mark, LuViva has marketing approval from Health Canada. Guided Therapeutics was awarded ISO 13485 certification in January, 2011. The company continues to anticipate a launch in international markets later in 2012.

Source : http://www.news-medical.net/news/20120726/Guided-Therapeutics-seeks-premarket-approval-from-FDA-for-LuViva-Advanced-Cervical-Scan.aspx

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Guided Therapeutics’ LuViva Cleared for Early Detection of Cervical Disease

Guided Therapeutics’ LuViva Cleared for Early Detection of Cervical Disease

Guided Therapeutics’ LuViva Cleared for Early Detection of Cervical Disease

NORCROSS, Ga.–(BUSINESS WIRE)–Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has received notification that CE Mark approval has been granted for LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.

“We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

The CE Mark is required to sell products in the 27 nations that comprise the European Union (EU). There are about 146 million women who are targeted by existing or planned cervical cancer screening programs in EU member states, according to the European Cancer Observatory.

“The notification of CE Mark for LuViva is a significant milestone for the company and allows us to begin our European launch later this year, as planned,” said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. “We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

“Notification of the CE Mark and previously announced Health Canada approval for LuViva further validates the product and our ability to manufacture to the highest standards. We expect the CE Mark award will generate more demand for the product and open opportunities in markets outside the EU as well. In addition to the more than 20 countries already covered by distribution agreements, we plan to expand our network to additional countries in Europe, Latin America and Asia and having the CE Mark should accelerate those efforts,” Dr. Faupel added.

Today’s CE Mark notification is the first of two expected for LuViva. A second CE Mark application is expected to be filed later this year to comply with updated European medical device standards and to include design improvements. The company also must continue to pass annual ISO audits of its quality system in order to maintain the CE Mark on its products. The company has passed two consecutive ISO audits, the last being in January of 2012.

In addition to the CE Mark, LuViva has marketing approval from Health Canada and remains under U.S. Food and Drug Administration premarket approval review. Guided Therapeutics was awarded ISO 13485 certification in January, 2011.

The study used to support LuViva’s CE Mark application was the multi-center U.S. pivotal trial, in which 1,607 women at risk for developing cervical disease were evaluated. In this patient population, LuViva was able to detect cervical cancer up to two years earlier than the Pap test, human papillomavirus (HPV) test, colposcopy and biopsy. LuViva detected 86.3 percent of the cervical disease cases that had been missed by Pap, HPV tests and biopsy. LuViva would have reduced the number of unnecessary biopsies by about 40 percent. LuViva is initially intended as a follow-up test after a positive Pap result.

About LuViva® Advanced Cervical Scan

LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful and unnecessary testing. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.

About Guided Therapeutics

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level. The Company’s first planned product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. Guided Therapeutics has also entered into a partnership with Konica Minolta to develop a non-invasive test for Barrett’s Esophagus using the technology platform. For more information, visit: www.guidedinc.com.

The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use. LuViva, the wave logo and “Early detection, better outcomes” are registered trademarks owned by Guided Therapeutics, Inc.

Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the exchange offer, as described in the Offer to Exchange, as well as those related to: the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and subsequent quarterly reports.

NORCROSS, Ga.–(BUSINESS WIRE)–Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has received notification that CE Mark approval has been granted for LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.

“We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

The CE Mark is required to sell products in the 27 nations that comprise the European Union (EU). There are about 146 million women who are targeted by existing or planned cervical cancer screening programs in EU member states, according to the European Cancer Observatory.

“The notification of CE Mark for LuViva is a significant milestone for the company and allows us to begin our European launch later this year, as planned,” said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. “We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false positives and unnecessary biopsies, and provide significant savings to healthcare systems throughout Europe.”

“Notification of the CE Mark and previously announced Health Canada approval for LuViva further validates the product and our ability to manufacture to the highest standards. We expect the CE Mark award will generate more demand for the product and open opportunities in markets outside the EU as well. In addition to the more than 20 countries already covered by distribution agreements, we plan to expand our network to additional countries in Europe, Latin America and Asia and having the CE Mark should accelerate those efforts,” Dr. Faupel added.

Today’s CE Mark notification is the first of two expected for LuViva. A second CE Mark application is expected to be filed later this year to comply with updated European medical device standards and to include design improvements. The company also must continue to pass annual ISO audits of its quality system in order to maintain the CE Mark on its products. The company has passed two consecutive ISO audits, the last being in January of 2012.

In addition to the CE Mark, LuViva has marketing approval from Health Canada and remains under U.S. Food and Drug Administration premarket approval review. Guided Therapeutics was awarded ISO 13485 certification in January, 2011.

The study used to support LuViva’s CE Mark application was the multi-center U.S. pivotal trial, in which 1,607 women at risk for developing cervical disease were evaluated. In this patient population, LuViva was able to detect cervical cancer up to two years earlier than the Pap test, human papillomavirus (HPV) test, colposcopy and biopsy. LuViva detected 86.3 percent of the cervical disease cases that had been missed by Pap, HPV tests and biopsy. LuViva would have reduced the number of unnecessary biopsies by about 40 percent. LuViva is initially intended as a follow-up test after a positive Pap result.

About LuViva® Advanced Cervical Scan

LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful and unnecessary testing. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.

About Guided Therapeutics

Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is developing a rapid and painless testing platform for the early detection of disease based on its patented biophotonic technology that utilizes light to detect disease at the cellular level. The Company’s first planned product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. Guided Therapeutics has also entered into a partnership with Konica Minolta to develop a non-invasive test for Barrett’s Esophagus using the technology platform. For more information, visit: www.guidedinc.com.

The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use. LuViva, the wave logo and “Early detection, better outcomes” are registered trademarks owned by Guided Therapeutics, Inc.

Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the exchange offer, as described in the Offer to Exchange, as well as those related to: the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and subsequent quarterly reports.

Source : http://www.businesswire.com/news/home/20120718005191/en/Guided-Therapeutics-Notified-CE-Mark-Approval-LuViva%C2%AE

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