Titan Pharmaceuticals, Inc. (OTC Bulletin Board: TTNP) today announced that data from its previously completed and announced Phase 3 randomized, placebo-controlled clinical trial of Probuphine were published in the Journal of the American Medical Association (JAMA). The article highlights data from the 163-patient trial, which showed that patients receiving Titan's Probuphine implant had significantly less illicit opioid use, experienced fewer symptoms of withdrawal and craving, stayed in treatment longer and had greater overall improvement when compared to placebo patients over the course of the 24-week study.
Probuphine is an innovative, subcutaneous implant formulation designed using Titan's proprietary ProNeura™ technology to deliver a steady, round-the-clock low dose of the marketed drug buprenorphine over six months following a single treatment.
"The introduction of buprenorphine into clinical practice is arguably the most significant improvement in the treatment of opioid addiction in the last decade; however, physicians excited with the clinical success of buprenorphine are also rightfully concerned about medication adherence and diversion - and potential for abuse - of the sublingual formulations of buprenorphine," said Walter Ling, M.D., Professor of Psychiatry and Director, Integrated Substance Abuse Programs at the David Geffen School of Medicine at UCLA and the paper's lead author. "Probuphine does away with these concerns by eliminating the need for take home doses. Additionally, by providing a sustained blood level of active medication, Probuphine helps diminish the daily fluctuation of the medication effects—and potentially side effects-- and reduces the total exposure of buprenorphine over time."
The publication, "Buprenorphine Implants for Opioid Dependence: A Randomized Controlled Trial" will appear in the October 13, 2010 issue of JAMA and details key trial results:
* Patients receiving Probuphine had a mean percentage of urine samples that tested negative for illicit opioids across the full 24 weeks of 36.6 percent; those in the placebo group had a mean of 22.4 percent (p=0.01)
* Nearly 66 percent of patients receiving Probuphine completed the study vs. the 31 percent who received placebo implants (p<0.001)
* Probuphine patients experienced fewer clinician-rated (p<0.001) and patient-rated (p=0.004) withdrawal symptoms
* Probuphine patients reported lower ratings of craving (p<0.001)
* Probuphine patients had a greater change on clinician global ratings of severity of opioid dependence (p<0.001)
* Probuphine patients demonstrated a greater change on the clinician global ratings of improvement (p<0.001)
* Minor implant site reactions were the most common adverse events and were consistent across the Probuphine and placebo groups
Titan is currently conducting a confirmatory Phase 3 clinical trial of Probuphine for the treatment of opioid addiction. Patient enrollment in that trial is now complete and results are expected in the second quarter of 2011, approximately three months ahead of the original schedule. This study is part of Titan's registration-directed program intended to obtain marketing approval of Probuphine for the treatment of opioid addiction in the U.S. and Europe.
"We believe that Probuphine represents a significant step forward in the safe and effective treatment of opioid addiction," said Dr. Katherine L. Beebe, Senior Vice President, Clinical Development and Medical Affairs and a co-author of the publication. "Probuphine was designed as an innovative implant formulation so that it could reduce the risk of diversion and abuse. With only one treatment, Probuphine provides a round-the-clock, effective low dose of buprenorphine over six months, which should significantly improve compliance. These improvements could change the way opioid addiction is treated and dramatically impact patients' lives."
The World Health Organization estimates that 2.8 million individuals in the U.S. and Europe are addicted to illicit opiates such as heroin, and more than 2.0 million individuals in the U.S. alone are addicted to prescription opioid medications. It is estimated that about 20 percent of this population are currently receiving pharmacological treatment.
About Probuphine
Probuphine is designed to deliver six months of continuous round-the-clock, long-term therapeutic levels of the drug buprenorphine following a single subcutaneous treatment. Buprenorphine, an approved agent for the treatment of opioid addiction, is currently available mainly in the form of a sublingual tablet formulation. The safety and effectiveness of treatment with Probuphine has been initially established in the three Phase 3 studies conducted to date, specifically, a 163 patient placebo controlled study which demonstrated clinically meaningful and statistically significant treatment with Probuphine over a 24 week period, an open label 24 week retreatment study in 62 patients who had successfully completed six months of treatment in the controlled study, and a relative bioavailability study in 9 patients treated with Suboxone® and then switched to Probuphine treatment for 60 days.
Probuphine was developed using ProNeura, Titan's continuous drug delivery system that consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting product is a solid matrix that is placed subcutaneously, normally in the upper arm in a simple office procedure, and is removed in a similar manner at the end of the treatment period. The drug substance is released slowly, at continuous levels, through the process of diffusion. This results in a constant rate of release similar to intravenous administration.
Wednesday 13 October 2010
FDA Funds Pediatric Trial Testing Genetically Reprogrammed HSV to Treat Cancer
A clinical trial testing a genetically reprogrammed herpes simplex virus as treatment for deadly forms of childhood cancer has received a U.S. Food and Drug Administration grant to support the research.
The Phase I trial at Cincinnati Children's Hospital Medical Center currently focuses on testing the safety of the agent HSV1716 in patients. The study includes young patients with solid tumors such as rhabdomyosarcoma or Ewing's sarcoma. These cancers have limited treatment options and survival rates under 30 percent when the cancers recur and spread to other parts of the body.
Survival curves for stubborn, metastatic childhood cancers have leveled off in the last decade, underscoring the need for new therapeutic approaches, says Timothy Cripe, M.D., Ph.D., principal investigator on the trial and a physician/researcher in division of Hematology/Oncology at Cincinnati Children's.
"We've exhausted our ability to improve cure rates with existing conventional therapies, and we need new solutions," he said. "This is why we are testing HSV. It's a potent virus that has been manipulated genetically with the intent of making it safe for the patient. When you're trying to fight fire with fire you need something that is strong."
The $600,000 grant from FDA is part of a program encouraging clinical development of "orphan drugs" as new treatments for rare diseases or conditions. The HSV1716 virus being tested in this trial was developed by Crusade Laboratories of Glasgow, Scotland.
HSV1716 is similar to other viruses now under development by Dr. Cripe and colleagues at Cincinnati Children's in that certain genes are removed so the virus does not infect healthy dormant cells or cause the disease in the recipient. Instead, the genetic manipulation is designed to prompt the virus to target, infect and degrade only rapidly dividing cancer cells.
Genetic information also can be added to HSV that programs the virus to attack cancer cells in other ways – such as activating certain types of chemotherapies in a one-two punch or destroying blood vessels that feed tumors. Research in mouse models of human cancer by Cripe's laboratory has shown oncolytic HSV agents to be effective at shrinking a variety of modeled tumor types, suggesting a possible approach for treating human disease.
"Our goal in the current HSV1716 trial is to light a fire to the cancer so that the virus replicates and spreads to the cancer cells," Dr. Cripe explained. "We have to take this one step at a time, and the initial phase of the trial focuses on making sure the virus doesn't cause adverse side effects. It has been tested in Europe in adults with brain cancer, squamous cell carcinoma and melanoma and shown in those trials to be safe."
HSV1716 has also been tested extensively for safety in animal models at Cincinnati Children's Hospital by Dr. Cripe and in Europe prior to it being tested in people.
The Phase I trial will include up to 18 patients and is expected to last three years. The optimum safe dosing for this virus is unknown, so the study will sequentially increase dosing levels in small groups of patients and observe for side effects as the trial proceeds. This earliest phase tests the lowest dose on older children and young adults with solid tumor cancers who have limited or no standard therapy options available.
The researchers plan to add younger patients with earlier stages of cancer as the trial proceeds. They will not be able to determine if the safety trial is successful until all patients have received treatment and the results analyzed. As with all clinical trials of new anticancer therapies in patients, many factors can influence the risk for severe side effects and anticancer activity. Even though HSV1716 may cause tumor shrinkage in mouse models of pediatric cancer, it may not have antitumor effect in patients.
Initial funding for the trial came from a private foundation, Solving Kids Cancer, of New York. Preclinical research that helped lead to the trial was supported by the American Cancer Society, the National Cancer Institute, the Cincinnati Children's Hospital Medical Center Translational Research Initiative and local foundations, including CancerFree Kids, teeoffagainstcancer.org, the Katie Linz Foundation, The Sarah Zepernick Foundation, the TeamConnor Cancer Foundation and money donated in memory of Katie McKenna Cappel and Zachary Heringer.
For more information about the HSV1716 pediatric trial, please visit:
http://www.cincinnatichildrens.org/svc/alpha/c/cancer-blood/cancer/sarcoma/hsv1716-pf.htm
To view a video slideshow about the trial, visit: http://www.youtube.com/watch?v=XLPzrRLuZoY
About Cincinnati Children's
Cincinnati Children's Hospital Medical Center is one of just eight children's hospitals named to the Honor Roll in U.S. News and World Report's 2010-11 Best Children's Hospitals. It is ranked #1 for digestive disorders and highly ranked for its expertise in pulmonology, cancer, neonatology, heart and heart surgery, neurology and neurosurgery, diabetes and endocrinology, orthopedics, kidney disorders and urology. Cincinnati Children's is one of the top two recipients of pediatric research grants from the National Institutes of Health. It is internationally recognized for quality and transformation work by Leapfrog, The Joint Commission, the Institute for Healthcare Improvement, the federal Agency for Healthcare Research and Quality, and by hospitals and health organizations it works with globally. Additional information can be found at www.cincinnatichildrens.org.
The Phase I trial at Cincinnati Children's Hospital Medical Center currently focuses on testing the safety of the agent HSV1716 in patients. The study includes young patients with solid tumors such as rhabdomyosarcoma or Ewing's sarcoma. These cancers have limited treatment options and survival rates under 30 percent when the cancers recur and spread to other parts of the body.
Survival curves for stubborn, metastatic childhood cancers have leveled off in the last decade, underscoring the need for new therapeutic approaches, says Timothy Cripe, M.D., Ph.D., principal investigator on the trial and a physician/researcher in division of Hematology/Oncology at Cincinnati Children's.
"We've exhausted our ability to improve cure rates with existing conventional therapies, and we need new solutions," he said. "This is why we are testing HSV. It's a potent virus that has been manipulated genetically with the intent of making it safe for the patient. When you're trying to fight fire with fire you need something that is strong."
The $600,000 grant from FDA is part of a program encouraging clinical development of "orphan drugs" as new treatments for rare diseases or conditions. The HSV1716 virus being tested in this trial was developed by Crusade Laboratories of Glasgow, Scotland.
HSV1716 is similar to other viruses now under development by Dr. Cripe and colleagues at Cincinnati Children's in that certain genes are removed so the virus does not infect healthy dormant cells or cause the disease in the recipient. Instead, the genetic manipulation is designed to prompt the virus to target, infect and degrade only rapidly dividing cancer cells.
Genetic information also can be added to HSV that programs the virus to attack cancer cells in other ways – such as activating certain types of chemotherapies in a one-two punch or destroying blood vessels that feed tumors. Research in mouse models of human cancer by Cripe's laboratory has shown oncolytic HSV agents to be effective at shrinking a variety of modeled tumor types, suggesting a possible approach for treating human disease.
"Our goal in the current HSV1716 trial is to light a fire to the cancer so that the virus replicates and spreads to the cancer cells," Dr. Cripe explained. "We have to take this one step at a time, and the initial phase of the trial focuses on making sure the virus doesn't cause adverse side effects. It has been tested in Europe in adults with brain cancer, squamous cell carcinoma and melanoma and shown in those trials to be safe."
HSV1716 has also been tested extensively for safety in animal models at Cincinnati Children's Hospital by Dr. Cripe and in Europe prior to it being tested in people.
The Phase I trial will include up to 18 patients and is expected to last three years. The optimum safe dosing for this virus is unknown, so the study will sequentially increase dosing levels in small groups of patients and observe for side effects as the trial proceeds. This earliest phase tests the lowest dose on older children and young adults with solid tumor cancers who have limited or no standard therapy options available.
The researchers plan to add younger patients with earlier stages of cancer as the trial proceeds. They will not be able to determine if the safety trial is successful until all patients have received treatment and the results analyzed. As with all clinical trials of new anticancer therapies in patients, many factors can influence the risk for severe side effects and anticancer activity. Even though HSV1716 may cause tumor shrinkage in mouse models of pediatric cancer, it may not have antitumor effect in patients.
Initial funding for the trial came from a private foundation, Solving Kids Cancer, of New York. Preclinical research that helped lead to the trial was supported by the American Cancer Society, the National Cancer Institute, the Cincinnati Children's Hospital Medical Center Translational Research Initiative and local foundations, including CancerFree Kids, teeoffagainstcancer.org, the Katie Linz Foundation, The Sarah Zepernick Foundation, the TeamConnor Cancer Foundation and money donated in memory of Katie McKenna Cappel and Zachary Heringer.
For more information about the HSV1716 pediatric trial, please visit:
http://www.cincinnatichildrens.org/svc/alpha/c/cancer-blood/cancer/sarcoma/hsv1716-pf.htm
To view a video slideshow about the trial, visit: http://www.youtube.com/watch?v=XLPzrRLuZoY
About Cincinnati Children's
Cincinnati Children's Hospital Medical Center is one of just eight children's hospitals named to the Honor Roll in U.S. News and World Report's 2010-11 Best Children's Hospitals. It is ranked #1 for digestive disorders and highly ranked for its expertise in pulmonology, cancer, neonatology, heart and heart surgery, neurology and neurosurgery, diabetes and endocrinology, orthopedics, kidney disorders and urology. Cincinnati Children's is one of the top two recipients of pediatric research grants from the National Institutes of Health. It is internationally recognized for quality and transformation work by Leapfrog, The Joint Commission, the Institute for Healthcare Improvement, the federal Agency for Healthcare Research and Quality, and by hospitals and health organizations it works with globally. Additional information can be found at www.cincinnatichildrens.org.
Study Demonstrates Pine Bark Naturally Improves Tinnitus
More than 50 million Americans will experience some degree of tinnitus in their lifetime, according to the American Tinnitus Association. Tinnitus is a hearing condition that causes the constant misperception of sound, including hissing, ringing and rushing noises. A study recently published in Panminerva Medica reveals that Pycnogenol® (pic-noj-en-all), an antioxidant plant extract derived from the bark of the French maritime pine tree, is effective in relieving tinnitus symptoms by improving blood flow in the inner ear.
"Impaired blood flow to the ear is a common cause for tinnitus, a disturbing and very debilitating condition that can considerably impact overall health and quality of life," said Dr. Gianni Belcaro, a lead researcher on the study along with his team from Irvine3 Vascular labs, Chieti-Pescara University. "With few options available for treatment, this study gave us the opportunity to explore a natural solution to tinnitus symptoms and its causes."
In a study conducted by the Chieti-Pescara University in Italy, 82 patients between the ages of 35 and 55 with mild-to-moderate tinnitus in only one ear, while the other remains unaffected, were studied throughout a four-week period. Tinnitus in all subjects was a result of restricted blood supply to the inner ear, as measured by high resolution ultrasonography imaging of their cochlear blood flow. Patients were assigned to one of three groups: A, B and control. Group A consisted of 24 patients who were administered 150 mg/day of Pycnogenol®, group B consisted of 34 patients who were administered 100 mg/day of Pycnogenol®, and the control group consisted of 24 patients who received no Pycnogenol®. None of the patients had previously used medication for their tinnitus symptoms.
At the beginning of the study, patients' average initial systolic and diastolic blood flow velocities were 14.3 and 4.22 cm/sec in the low dose Pycnogenol® group and 13.2 and 3.2 cm/sec in the high dose Pycnogenol® group, indicative of insufficient blood perfusion of the ear in both groups. The study found that after four weeks of treatment with Pycnogenol®, inner ear systolic and diastolic blood flow velocities in the affected ear rose to an average of 21.2 and 8.23 cm/sec in the low dose group and to 24.3 and 12.5 cm/sec in the high dose group. Not only are these results significant for the improvement of inner ear blood micro-circulation and, consequently reduction of tinnitus symptoms, but they also indicate the potentially dose-related effect of Pycnogenol® on the condition.
The study also examined in detail the effects of Pycnogenol® on the symptoms of tinnitus. Using a Subjective Tinnitus Scale (STS) at the inception of the study, subjects were instructed to rate their symptoms from "zero" (low intensity of symptoms) to "fifteen" (constant and severe symptoms). The initial STS average value was approximately 8.8 among patients in the Pycnogenol® group and 7.9 in the control group. After four weeks, STS scores reduced to 5.2 in the low dose group and 3.3 in the high dose group, demonstrating a dramatic reduction of the disturbing background noise in the effected ear. There were no significant changes within the control group.
"The study clearly indicates Pycnogenol®'s ability to improve vascular function and restore cochlear blood perfusion, which in turn relieves the severity of tinnitus symptoms" said Dr. Belcaro. "The results provide further evidence of the supplement's natural efficacy for a variety of vascular health symptoms."
This study further corroborates Pycnogenol®'s prominence for improvement of vascular function which spans from the large arteries and veins to the tiniest micro-vessels.
Pycnogenol® is a proprietary, patented pine bark extract and the research findings detailed here and in other published journals may not be applied to other pine bark extracts on the market.
About Pycnogenol®
Pycnogenol® is a natural plant extract originating from the bark of the maritime pine that grows along the coast of southwest France and is found to contain a unique combination of procyanidins, bioflavonoids and organic acids, which offer extensive natural health benefits. The extract has been widely studied for the past 40 years and has more than 230 published studies and review articles ensuring safety and efficacy as an ingredient. Today, Pycnogenol® is available in more than 700 dietary supplements, multi-vitamins and health products worldwide. For more information, visit www.Pycnogenol.com.
About Natural Health Science, Inc.
Natural Health Science Inc. (NHS), based in Hoboken, New Jersey, is the North American distributor for Pycnogenol® (pic-noj-en-all) brand French maritime pine bark extract on behalf of Horphag Research. Pycnogenol® is a registered trademark of Horphag Research Ltd., Guernsey, and its applications are protected by U.S. patents #5,720,956 / #6,372,266 and other international patents. Horphag Research Ltd. Is the recipient of the 2008 Frost & Sullivan North American Health Ingredients Excellence in Research Award. NHS has the exclusive rights to market and sell Pycnogenol® in North America and benefits from more than 40 years of scientific research assuring the safety and efficacy of Pycnogenol® as a dietary supplement. For more information about Pycnogenol® visit our Web site at www.Pycnogenol.com.
"Impaired blood flow to the ear is a common cause for tinnitus, a disturbing and very debilitating condition that can considerably impact overall health and quality of life," said Dr. Gianni Belcaro, a lead researcher on the study along with his team from Irvine3 Vascular labs, Chieti-Pescara University. "With few options available for treatment, this study gave us the opportunity to explore a natural solution to tinnitus symptoms and its causes."
In a study conducted by the Chieti-Pescara University in Italy, 82 patients between the ages of 35 and 55 with mild-to-moderate tinnitus in only one ear, while the other remains unaffected, were studied throughout a four-week period. Tinnitus in all subjects was a result of restricted blood supply to the inner ear, as measured by high resolution ultrasonography imaging of their cochlear blood flow. Patients were assigned to one of three groups: A, B and control. Group A consisted of 24 patients who were administered 150 mg/day of Pycnogenol®, group B consisted of 34 patients who were administered 100 mg/day of Pycnogenol®, and the control group consisted of 24 patients who received no Pycnogenol®. None of the patients had previously used medication for their tinnitus symptoms.
At the beginning of the study, patients' average initial systolic and diastolic blood flow velocities were 14.3 and 4.22 cm/sec in the low dose Pycnogenol® group and 13.2 and 3.2 cm/sec in the high dose Pycnogenol® group, indicative of insufficient blood perfusion of the ear in both groups. The study found that after four weeks of treatment with Pycnogenol®, inner ear systolic and diastolic blood flow velocities in the affected ear rose to an average of 21.2 and 8.23 cm/sec in the low dose group and to 24.3 and 12.5 cm/sec in the high dose group. Not only are these results significant for the improvement of inner ear blood micro-circulation and, consequently reduction of tinnitus symptoms, but they also indicate the potentially dose-related effect of Pycnogenol® on the condition.
The study also examined in detail the effects of Pycnogenol® on the symptoms of tinnitus. Using a Subjective Tinnitus Scale (STS) at the inception of the study, subjects were instructed to rate their symptoms from "zero" (low intensity of symptoms) to "fifteen" (constant and severe symptoms). The initial STS average value was approximately 8.8 among patients in the Pycnogenol® group and 7.9 in the control group. After four weeks, STS scores reduced to 5.2 in the low dose group and 3.3 in the high dose group, demonstrating a dramatic reduction of the disturbing background noise in the effected ear. There were no significant changes within the control group.
"The study clearly indicates Pycnogenol®'s ability to improve vascular function and restore cochlear blood perfusion, which in turn relieves the severity of tinnitus symptoms" said Dr. Belcaro. "The results provide further evidence of the supplement's natural efficacy for a variety of vascular health symptoms."
This study further corroborates Pycnogenol®'s prominence for improvement of vascular function which spans from the large arteries and veins to the tiniest micro-vessels.
Pycnogenol® is a proprietary, patented pine bark extract and the research findings detailed here and in other published journals may not be applied to other pine bark extracts on the market.
About Pycnogenol®
Pycnogenol® is a natural plant extract originating from the bark of the maritime pine that grows along the coast of southwest France and is found to contain a unique combination of procyanidins, bioflavonoids and organic acids, which offer extensive natural health benefits. The extract has been widely studied for the past 40 years and has more than 230 published studies and review articles ensuring safety and efficacy as an ingredient. Today, Pycnogenol® is available in more than 700 dietary supplements, multi-vitamins and health products worldwide. For more information, visit www.Pycnogenol.com.
About Natural Health Science, Inc.
Natural Health Science Inc. (NHS), based in Hoboken, New Jersey, is the North American distributor for Pycnogenol® (pic-noj-en-all) brand French maritime pine bark extract on behalf of Horphag Research. Pycnogenol® is a registered trademark of Horphag Research Ltd., Guernsey, and its applications are protected by U.S. patents #5,720,956 / #6,372,266 and other international patents. Horphag Research Ltd. Is the recipient of the 2008 Frost & Sullivan North American Health Ingredients Excellence in Research Award. NHS has the exclusive rights to market and sell Pycnogenol® in North America and benefits from more than 40 years of scientific research assuring the safety and efficacy of Pycnogenol® as a dietary supplement. For more information about Pycnogenol® visit our Web site at www.Pycnogenol.com.
QIAGEN and Abbott Enter Into Agreement on Molecular Tests for HIV, HCV and HPV
QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) and Abbott (ABT: NYSE) today announced that they have entered into an agreement that significantly strengthens both companies' testing menus for automated in-vitro diagnostic applications in the United States and Canada. Financial terms were not disclosed.
Under the terms of the agreements, QIAGEN will receive kits for a PCR-based molecular assay for HIV-1 viral load testing in the U.S. and Canada which will be commercialized under QIAGEN's brand. This test will enable healthcare professionals to measure the viral load of HIV infections in patients. It is expected that the new HIV-1 test will be available by 2012, thereby adding to QIAGEN's pipeline of U.S. regulatory submissions which is expected to also include a quantitative HBV (Hepatitis B) test. In addition, Abbott will provide a quantitative HCV (Hepatitis C) test which will be optimized and labeled for use on QIAGEN's QIAsymphony RGQ instrument and marketed under the Abbott brand in the U.S. and Canada. Subject to regulatory approval, this test may be available by the end of 2012.
QIAGEN will supply Abbott with certain key products required for a PCR-based HPV (human papillomavirus) test in the U.S. and Canada. This test will run on Abbott's m2000 lab automation system which features throughput up to 96 samples per run. QIAGEN itself will continue to address the HPV screening market with its prevention platform QIAensemble which is designed to process up to 2,000 samples per shift. Technologies which are the basis of QIAGEN's current and next-generation HPV screening assays are not subject to the transaction.
Tests for HIV and HCV are currently among the most widely used commercial applications in molecular diagnostics, with U.S. markets estimated to be in the range of US$ 180 and 140 million in annual sales, respectively. Laboratories with molecular diagnostic capabilities usually include these frequently performed assays in their testing menus. QIAGEN and Abbott believe that these agreements significantly strengthen the value of their respective automation platforms and will reinforce their leadership in infectious disease testing. QIAGEN's QIAsymphony RGQ system was launched last month with a broad portfolio of assays, including HIV, HBV and HCV tests, and is registered for clinical use in European markets.
"The agreement is a good strategic fit," said QIAGEN's CEO Peer Schatz. "It has the potential to significantly accelerate our dissemination strategy for the QIAsymphony RGQ by expanding our molecular diagnostic menu offering in the United States with important testing options. It also allows us to commercialize previously unused intellectual property around a PCR design for HPV assays by converting it into revenue and by targeting it into a clearly defined sub-segment of the market. And, finally, it enables both parties to address the different market segments for HPV and thereby promises to further drive market adoption of this important testing method in North America."
"We're pleased to provide QIAGEN access to our leading technology, and believe the addition of a PCR-based HPV test to our m2000 menu will benefit many more women who may be infected with the virus and at risk of developing cervical cancer," said Stafford O'Kelly, head of Abbott's molecular diagnostics business.
QIAGEN's portfolio already includes a broad menu of assays including FDA approved assays for HPV (digene HPV) and chlamydia as well as CE-labeled tests for the detection of HIV, HCV, hepatitis B virus (HBV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes-simplex virus (HSV), Influenza, multiple bacteria and respiratory viruses, personalized healthcare assays such as KRAS, EGFR, as well as many other target diseases. In addition, QIAGEN has a broad pipeline of additional and novel assays for its QIAsymphony and QIAensemble platforms for launch in the U.S., Europe and in many other countries in 2011 through 2013.
Abbott offers a broad menu of tests on its m2000 system outside the United States including tests for HIV viral load, hepatitis B and C viral load, hepatitis C genotyping, chlamydia, gonorrhea, human papillomavirus, cytomegalovirus, Epstein-Barr virus, and methylated septin 9 (mS9) for colorectal cancer. Tests approved in the United States include those for HIV, HBV, chlamydia and gonorrhea.
About QIAGEN
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs more than 3,500 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
QIAGEN Safe Harbour Statement
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
Under the terms of the agreements, QIAGEN will receive kits for a PCR-based molecular assay for HIV-1 viral load testing in the U.S. and Canada which will be commercialized under QIAGEN's brand. This test will enable healthcare professionals to measure the viral load of HIV infections in patients. It is expected that the new HIV-1 test will be available by 2012, thereby adding to QIAGEN's pipeline of U.S. regulatory submissions which is expected to also include a quantitative HBV (Hepatitis B) test. In addition, Abbott will provide a quantitative HCV (Hepatitis C) test which will be optimized and labeled for use on QIAGEN's QIAsymphony RGQ instrument and marketed under the Abbott brand in the U.S. and Canada. Subject to regulatory approval, this test may be available by the end of 2012.
QIAGEN will supply Abbott with certain key products required for a PCR-based HPV (human papillomavirus) test in the U.S. and Canada. This test will run on Abbott's m2000 lab automation system which features throughput up to 96 samples per run. QIAGEN itself will continue to address the HPV screening market with its prevention platform QIAensemble which is designed to process up to 2,000 samples per shift. Technologies which are the basis of QIAGEN's current and next-generation HPV screening assays are not subject to the transaction.
Tests for HIV and HCV are currently among the most widely used commercial applications in molecular diagnostics, with U.S. markets estimated to be in the range of US$ 180 and 140 million in annual sales, respectively. Laboratories with molecular diagnostic capabilities usually include these frequently performed assays in their testing menus. QIAGEN and Abbott believe that these agreements significantly strengthen the value of their respective automation platforms and will reinforce their leadership in infectious disease testing. QIAGEN's QIAsymphony RGQ system was launched last month with a broad portfolio of assays, including HIV, HBV and HCV tests, and is registered for clinical use in European markets.
"The agreement is a good strategic fit," said QIAGEN's CEO Peer Schatz. "It has the potential to significantly accelerate our dissemination strategy for the QIAsymphony RGQ by expanding our molecular diagnostic menu offering in the United States with important testing options. It also allows us to commercialize previously unused intellectual property around a PCR design for HPV assays by converting it into revenue and by targeting it into a clearly defined sub-segment of the market. And, finally, it enables both parties to address the different market segments for HPV and thereby promises to further drive market adoption of this important testing method in North America."
"We're pleased to provide QIAGEN access to our leading technology, and believe the addition of a PCR-based HPV test to our m2000 menu will benefit many more women who may be infected with the virus and at risk of developing cervical cancer," said Stafford O'Kelly, head of Abbott's molecular diagnostics business.
QIAGEN's portfolio already includes a broad menu of assays including FDA approved assays for HPV (digene HPV) and chlamydia as well as CE-labeled tests for the detection of HIV, HCV, hepatitis B virus (HBV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes-simplex virus (HSV), Influenza, multiple bacteria and respiratory viruses, personalized healthcare assays such as KRAS, EGFR, as well as many other target diseases. In addition, QIAGEN has a broad pipeline of additional and novel assays for its QIAsymphony and QIAensemble platforms for launch in the U.S., Europe and in many other countries in 2011 through 2013.
Abbott offers a broad menu of tests on its m2000 system outside the United States including tests for HIV viral load, hepatitis B and C viral load, hepatitis C genotyping, chlamydia, gonorrhea, human papillomavirus, cytomegalovirus, Epstein-Barr virus, and methylated septin 9 (mS9) for colorectal cancer. Tests approved in the United States include those for HIV, HBV, chlamydia and gonorrhea.
About QIAGEN
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs more than 3,500 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
QIAGEN Safe Harbour Statement
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).
Beta-Pro Expands Operations to Meet Demands for Human Cells in Hepatocyte Drug Discovery Market
Beta-Pro LLC, announced today that it has expanded its operations to accommodate increasing demands from pharmaceutical drug discovery and research institutes in the $2 billion hepatocyte market. The human cellular sciences company now manages extensive laboratory facilities in the University of Virginia Research Park in Charlottesville, Virginia.
"Beta-Pro has already established a foothold in the human pancreatic islet cell market and has consistently been able to supply diabetes researchers and transplant centers with high-quality, clinical and transplantable human islets and other pancreatic biomaterials," said Beta-Pro Principle Scientific Advisor and Professor of Surgery at the University of Virginia, Kenneth L. Brayman, M.D., Ph.D. "Based on our success we are now broadening the focus of our cellular services to include liver biology and the needs of pharmaceutical companies in testing drugs in human hepatocyte-cell cultures."
Beta-Pro partners with leading pharmaceutical companies and research organizations including: Pfizer, Eli Lilly, Genentech, Merck, Genomics Institute of the Novartis Research Foundation (GNF), and The Broad Institute in Cambridge, Massachusetts. Beta-Pro's new laboratory is designated as a good laboratory practice (GLP) facility and is now fully operational. The company has moved its snap-frozen cell bank to the new location and will use the facility to focus on hepatocytes and other human cell applications, including drug discovery services and toxicology screening using human cells.
About Beta-Pro
Beta-Pro isolates and distributes human pancreatic islet cells, acinar tissue, hepatocytes, adipose-derived stem cells, mesenchymal stem cells, and other biomaterials from surplus organs not placed for whole organ transplant in GMP and GLP facilities. The company also offers custom drug discovery and toxicology testing services using human cells for potential pharmacological applications. Beta-Pro charges and recovers fees for the costs for organ procurement, processing, preservation, quality control, storage, handling, and delivery of islets, other biomaterials, and biological data. For more information, call (434) 973-9456 begin_of_the_skype_highlighting (434) 973-9456 end_of_the_skype_highlighting or visit www.betaprolabs.com.
"Beta-Pro has already established a foothold in the human pancreatic islet cell market and has consistently been able to supply diabetes researchers and transplant centers with high-quality, clinical and transplantable human islets and other pancreatic biomaterials," said Beta-Pro Principle Scientific Advisor and Professor of Surgery at the University of Virginia, Kenneth L. Brayman, M.D., Ph.D. "Based on our success we are now broadening the focus of our cellular services to include liver biology and the needs of pharmaceutical companies in testing drugs in human hepatocyte-cell cultures."
Beta-Pro partners with leading pharmaceutical companies and research organizations including: Pfizer, Eli Lilly, Genentech, Merck, Genomics Institute of the Novartis Research Foundation (GNF), and The Broad Institute in Cambridge, Massachusetts. Beta-Pro's new laboratory is designated as a good laboratory practice (GLP) facility and is now fully operational. The company has moved its snap-frozen cell bank to the new location and will use the facility to focus on hepatocytes and other human cell applications, including drug discovery services and toxicology screening using human cells.
About Beta-Pro
Beta-Pro isolates and distributes human pancreatic islet cells, acinar tissue, hepatocytes, adipose-derived stem cells, mesenchymal stem cells, and other biomaterials from surplus organs not placed for whole organ transplant in GMP and GLP facilities. The company also offers custom drug discovery and toxicology testing services using human cells for potential pharmacological applications. Beta-Pro charges and recovers fees for the costs for organ procurement, processing, preservation, quality control, storage, handling, and delivery of islets, other biomaterials, and biological data. For more information, call (434) 973-9456 begin_of_the_skype_highlighting (434) 973-9456 end_of_the_skype_highlighting or visit www.betaprolabs.com.
One in 10 Children Has Mental Illness; State by State Figures; Are Candidates Addressing the Facts?
One in ten children has a mental health condition that causes significant impairment and more than half of all lifetime cases begin by age 14, the National Alliance on Mental Illness (NAMI) reported today, but only one-third get the help they need..
(Logo: http://photos.prnewswire.com/prnh/20100216/NAMILOGO)
(Logo: http://www.newscom.com/cgi-bin/prnh/20100216/NAMILOGO)
As part of an Election 2010 series, NAMI released state by state estimates of the number of children and adolescents ages 10-17, reminding editors, reporters, bloggers and others to ask candidates for public office to address the facts about mental illness in their states and communities.
See State Data Below
* One in ten children has a serious mental health condition, but only one-third receive treatment.
* Half of all lifetime cases of mental illness begin by age 14 and three-quarters begin by age 24.
* On average, eight to 10 years pass from when symptoms of mental illness begin to when they get treatment.
* Suicide is the third leading cause of death for youth ages 15-24.
During the nation's recession, mental health services for children and adolescents have faced devastating state budget cuts. Congress has some responsibility to help strengthen state mental health care systems. Federal mental health block grants have been reduced or frozen over the past 10 years.
(Logo: http://photos.prnewswire.com/prnh/20100216/NAMILOGO)
(Logo: http://www.newscom.com/cgi-bin/prnh/20100216/NAMILOGO)
As part of an Election 2010 series, NAMI released state by state estimates of the number of children and adolescents ages 10-17, reminding editors, reporters, bloggers and others to ask candidates for public office to address the facts about mental illness in their states and communities.
See State Data Below
* One in ten children has a serious mental health condition, but only one-third receive treatment.
* Half of all lifetime cases of mental illness begin by age 14 and three-quarters begin by age 24.
* On average, eight to 10 years pass from when symptoms of mental illness begin to when they get treatment.
* Suicide is the third leading cause of death for youth ages 15-24.
During the nation's recession, mental health services for children and adolescents have faced devastating state budget cuts. Congress has some responsibility to help strengthen state mental health care systems. Federal mental health block grants have been reduced or frozen over the past 10 years.
Friday 29 January 2010
Parabit Systems Successfully Installs Infant Protection Systems at Major Long Island Hospitals
Parabit Systems Inc. is pleased to announce the successful installation of Secure Cares Infant Protection Systems in three major hospitals on Long Island.
Good Samaritan Hospital is operating the full system providing protection in Pediatrics and Maternity covering four floors as well as the elevators and emergency exit doors. All installations provide the capability of ultimate protection from infant abduction and patient wandering. Parabit Systems currently has other Health Care Facilities within the New York Market
Good Samaritan Hospital is operating the full system providing protection in Pediatrics and Maternity covering four floors as well as the elevators and emergency exit doors. All installations provide the capability of ultimate protection from infant abduction and patient wandering. Parabit Systems currently has other Health Care Facilities within the New York Market
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