PROLOR Biotech Inc., a company developing next generation biobetter therapeutic proteins, announced initiation of a Phase 2 clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in children with growth hormone deficiency.
The pediatric trial follows successful completion of a Phase 2 trial of hGH-CTP in growth hormone deficient adults, which demonstrated that hGH-CTP was safe and well tolerated with the potential to reduce the required dosing frequency of human growth hormone from the current standard of one injection per day to a single weekly injection. A subsequent pilot study suggested that bi-monthly dosing of hGH-CTP may also be feasible.
Growth hormone deficiency (GHD) in children occurs when the pituitary gland fails to secrete adequate amounts of growth hormone. Growth hormone replacement therapy may enable a GHD child to reach a normal height, but the therapy requires daily injections and may require a total of more than 3,000 injections before the child reaches the age of 18.
“Obtaining regulatory clearance for a clinical trial in children is a challenge for any drug developer. We believe that our receipt of regulatory clearance for the initiation of our Phase 2 study in growth hormone deficient children is another indicator of the quality of our hGH-CTP program,” said Dr. Abraham Havron, CEO of PROLOR.
Dr. Havron continued, “Our Phase 2 pediatric study is designed to provide information about the effectiveness and safety of a range of doses of hGH-CTP for a single weekly injection regimen in pediatric patients. We look forward to advancing our comprehensive clinical program for hGH-CTP in 2012, including this Phase 2 pediatric trial and an anticipated Phase 2I trial in growth hormone deficient adults that is targeted for later this year.”
The pediatric hGH-CTP Phase 2 trial is a randomized, open-label, dose-finding study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected weekly in children with growth hormone deficiency. The trial will compare the 12-month growth velocity of children receiving certain doses of hGH-CTP, injected once weekly, or commercial hGH injected daily, which is the current standard of care. The trial is expected to take place at up to 35 sites in 12 countries.
Date: March 20, 2012
Source: PROLOR Biotech Inc.
martes, 27 de marzo de 2012
Cardium Starts Phase 3 Generx Study
Cardium Therapeutics announced the initiation of the ASPIRE Phase 3 registration study to evaluate the therapeutic effects of Cardium's lead product candidate, Generx (Ad5FGF-4) in patients with myocardial ischemia (insufficient blood flow in the heart due to coronary artery disease).
The ASPIRE study is a 100-patient, randomized and controlled multi-center study being conducted at up to six leading cardiology centers in the Russian Federation. The study is designed to further evaluate the safety and effectiveness of Cardium's Generx DNA-based angiogenic product candidate, which has already been tested in clinical studies involving 650 patients at more than one hundred medical centers in the U.S., Europe and elsewhere. The therapeutic efficacy of Generx will be quantitatively assessed using rest and stress SPECT imaging (Single-Photon Emission Computed Tomography) to sensitively measure improvements in microvascular cardiac perfusion following a one-time, non-surgical, catheter-based administration of Generx. The Cedars-Sinai Medical Center Nuclear Cardiology Core Laboratory in Los Angeles, California, will serve as the central core lab for the ASPIRE study and will be responsible for the analysis of SPECT myocardial imaging data electronically transmitted from the Russian medical centers participating in the ASPIRE study. Advanced Biosciences Research, an affiliate of bioRASI which is a global clinical research organization, is Cardium's Russian sponsor and development partner and is responsible for the ASPIRE program management and regulatory compliance.
Generx is a disease-modifying regenerative medicine biologic that is being developed to offer a one-time, non-surgical option for the treatment of myocardial ischemia in patients with stable angina due to coronary artery disease, who might otherwise require surgical and mechanical interventions, such as coronary artery by-pass surgery or balloon angioplasty and stents. Similar to surgical/mechanical revascularization approaches, the goal of Cardium's Generx product candidate is to improve blood flow to the heart muscle – but to do so non-surgically, following a single administration from a standard cardiac infusion catheter.
"The ASPIRE trial represents a major milestone for Cardium and is the fifth clinical study under Generx's clinical development program that when completed will have enrolled more than 750 patients at over 100 medical centers throughout the U.S., Canada, South America, Western Europe and Russia. With positive safety and efficacy data from this single registration study, a Generx clinical dossier would become eligible for submission for marketing and sales in the Russian Federation, and would also be expected to support submissions seeking approval for marketing and sales of Generx in certain other countries of the Commonwealth of Independent States, comprising former republics under the Soviet Union," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.
The ASPIRE study is also specifically designed to provide additional clinical evidence regarding the safety and effectiveness of Generx that would be useful for optimizing and broadening commercial development pathways in other industrialized countries such as Brazil, India, Europe and the United States.
Date: March 20, 2012
Source: Cardium Therapeutics
The ASPIRE study is a 100-patient, randomized and controlled multi-center study being conducted at up to six leading cardiology centers in the Russian Federation. The study is designed to further evaluate the safety and effectiveness of Cardium's Generx DNA-based angiogenic product candidate, which has already been tested in clinical studies involving 650 patients at more than one hundred medical centers in the U.S., Europe and elsewhere. The therapeutic efficacy of Generx will be quantitatively assessed using rest and stress SPECT imaging (Single-Photon Emission Computed Tomography) to sensitively measure improvements in microvascular cardiac perfusion following a one-time, non-surgical, catheter-based administration of Generx. The Cedars-Sinai Medical Center Nuclear Cardiology Core Laboratory in Los Angeles, California, will serve as the central core lab for the ASPIRE study and will be responsible for the analysis of SPECT myocardial imaging data electronically transmitted from the Russian medical centers participating in the ASPIRE study. Advanced Biosciences Research, an affiliate of bioRASI which is a global clinical research organization, is Cardium's Russian sponsor and development partner and is responsible for the ASPIRE program management and regulatory compliance.
Generx is a disease-modifying regenerative medicine biologic that is being developed to offer a one-time, non-surgical option for the treatment of myocardial ischemia in patients with stable angina due to coronary artery disease, who might otherwise require surgical and mechanical interventions, such as coronary artery by-pass surgery or balloon angioplasty and stents. Similar to surgical/mechanical revascularization approaches, the goal of Cardium's Generx product candidate is to improve blood flow to the heart muscle – but to do so non-surgically, following a single administration from a standard cardiac infusion catheter.
"The ASPIRE trial represents a major milestone for Cardium and is the fifth clinical study under Generx's clinical development program that when completed will have enrolled more than 750 patients at over 100 medical centers throughout the U.S., Canada, South America, Western Europe and Russia. With positive safety and efficacy data from this single registration study, a Generx clinical dossier would become eligible for submission for marketing and sales in the Russian Federation, and would also be expected to support submissions seeking approval for marketing and sales of Generx in certain other countries of the Commonwealth of Independent States, comprising former republics under the Soviet Union," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.
The ASPIRE study is also specifically designed to provide additional clinical evidence regarding the safety and effectiveness of Generx that would be useful for optimizing and broadening commercial development pathways in other industrialized countries such as Brazil, India, Europe and the United States.
Date: March 20, 2012
Source: Cardium Therapeutics
Merck Ponders Next Step for Vorapaxar
CHICAGO (AP) - Officials at drugmaker Merck & Co. say they will take more time to decide what to do about an experimental blood thinner that gave disappointing results in a second big study.
The study was aimed at preventing repeat heart attacks and strokes in people who had already suffered one or were in danger of one because of hardened arteries in their legs.
The drug, vorapaxar, lowered the risk of those problems but also raised the risk of major bleeding, including dangerous bleeding in the head, which largely canceled out the drug's benefit.
Results of the study were discussed Saturday at an American College of Cardiology conference in Chicago and published by the New England Journal of Medicine.
Merck had hoped vorapaxar would become a new, first-of-its-kind blood thinner.
The company-sponsored study involved more than 26,000 patients in 32 countries. All were given usual heart medicines plus aspirin, and half also received daily vorapaxar pills.
Safety monitors stopped part of the study last year after seeing higher rates of bleeding in the head among people with a history of stroke who were on the experimental drug. The study continued in the rest of the participants.
After three years, about 9 percent of those given vorapaxar had suffered a heart attack or a stroke or had died from heart-related causes versus more than 10 percent of those not given the drug. Moderate or severe bleeding occurred in about 4 percent of those on vorapaxar versus just more than 2 percent of the others, said the study's leader, Dr. David Morrow of Brigham and Women's Hospital in Boston.
Among those with a history of heart attack - two-thirds of study participants - the drug had a net benefit, though, leaving the possibility that Merck might pursue seeking federal approval to sell it for these patients.
However, several experts not connected with the study said the drug's relatively modest benefit and likely high cost would make it a tough sell even if it were allowed on the market.
"This is not a drug that I would put in my personal medicine chest," said Dr. Eduardo Marban of Cedars-Sinai Medical Center in Los Angeles.
Merck officials said they would discuss the results with more scientists before deciding next steps.
Date: March 24, 2012
Source: Associated Press
The study was aimed at preventing repeat heart attacks and strokes in people who had already suffered one or were in danger of one because of hardened arteries in their legs.
The drug, vorapaxar, lowered the risk of those problems but also raised the risk of major bleeding, including dangerous bleeding in the head, which largely canceled out the drug's benefit.
Results of the study were discussed Saturday at an American College of Cardiology conference in Chicago and published by the New England Journal of Medicine.
Merck had hoped vorapaxar would become a new, first-of-its-kind blood thinner.
The company-sponsored study involved more than 26,000 patients in 32 countries. All were given usual heart medicines plus aspirin, and half also received daily vorapaxar pills.
Safety monitors stopped part of the study last year after seeing higher rates of bleeding in the head among people with a history of stroke who were on the experimental drug. The study continued in the rest of the participants.
After three years, about 9 percent of those given vorapaxar had suffered a heart attack or a stroke or had died from heart-related causes versus more than 10 percent of those not given the drug. Moderate or severe bleeding occurred in about 4 percent of those on vorapaxar versus just more than 2 percent of the others, said the study's leader, Dr. David Morrow of Brigham and Women's Hospital in Boston.
Among those with a history of heart attack - two-thirds of study participants - the drug had a net benefit, though, leaving the possibility that Merck might pursue seeking federal approval to sell it for these patients.
However, several experts not connected with the study said the drug's relatively modest benefit and likely high cost would make it a tough sell even if it were allowed on the market.
"This is not a drug that I would put in my personal medicine chest," said Dr. Eduardo Marban of Cedars-Sinai Medical Center in Los Angeles.
Merck officials said they would discuss the results with more scientists before deciding next steps.
Date: March 24, 2012
Source: Associated Press
viernes, 23 de marzo de 2012
SanBio Enrolls Patients in Stroke Trial
SanBio Inc. announced the successful enrollment of the first dose cohort of patients in its Phase 1/2a clinical trial testing the safety and efficacy of a novel allogeneic stem cell therapy product, SB623, in patients suffering from chronic deficits resulting from previous stroke injuries. The first 6 patients, of a total of 18, have been successfully administered SB623. The trial is being conducted at Stanford University and the University of Pittsburgh. No safety concerns have been reported.
SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of chronic stroke. "This represents a major milestone in the human clinical testing of this important new approach for regenerative medicine", said Keita Mori, SanBio CEO. "We are pleased to learn that the initial dose level was well tolerated."
SB623 is being delivered to the damaged region of the brains of patients who have suffered an ischemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.
"The successful completion of the initial dose cohort is a major step in any first-in-human study", said Dr. Ernest Yankee, SanBio's Vice President of Development. "We are looking forward to initiating the next two dose cohorts and wrapping up the study. The safety findings thus far are very encouraging."
Date: March 20, 2012
SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of chronic stroke. "This represents a major milestone in the human clinical testing of this important new approach for regenerative medicine", said Keita Mori, SanBio CEO. "We are pleased to learn that the initial dose level was well tolerated."
SB623 is being delivered to the damaged region of the brains of patients who have suffered an ischemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.
"The successful completion of the initial dose cohort is a major step in any first-in-human study", said Dr. Ernest Yankee, SanBio's Vice President of Development. "We are looking forward to initiating the next two dose cohorts and wrapping up the study. The safety findings thus far are very encouraging."
Date: March 20, 2012
Tribute's Cambia Approved for Migraine
Nautilus Neurosciences announced that their Canadian promotional partner, Tribute Pharmaceuticals, a wholly owned subsidiary of Stellar Pharmaceuticals, was granted a Notice of Compliance (NOC) approval from Health Canada for Cambia (diclofenac potassium for oral solution) in the treatment of acute migraine with or without aura in adults. Cambia is expected to be launched in Canada during the second half of 2012. Cambia has been available to patients in the United States since May 2010.
Nautilus Neurosciences has exclusive marketing rights for Cambia in the United States and Canada, which they obtained from APR, a Swiss drug delivery and drug development company. Patents have been granted that protect the product in the United States through 2026.
"We congratulate our partners at Tribute Pharmaceuticals on the Health Canada approval and look forward to continuing to work with them on the Canadian launch of Cambia. We are excited that Cambia will be available as a treatment option for physicians and patients in Canada," said William Maichle, the CEO of Nautilus Neurosciences.
Mr. Maichle added, "[I] expect Nautilus Neurosciences to experience record growth in 2012 as Cambia continues to fill an important unmet need for patients suffering from the debilitating effects of migraine."
Date: March 22, 2012
Nautilus Neurosciences has exclusive marketing rights for Cambia in the United States and Canada, which they obtained from APR, a Swiss drug delivery and drug development company. Patents have been granted that protect the product in the United States through 2026.
"We congratulate our partners at Tribute Pharmaceuticals on the Health Canada approval and look forward to continuing to work with them on the Canadian launch of Cambia. We are excited that Cambia will be available as a treatment option for physicians and patients in Canada," said William Maichle, the CEO of Nautilus Neurosciences.
Mr. Maichle added, "[I] expect Nautilus Neurosciences to experience record growth in 2012 as Cambia continues to fill an important unmet need for patients suffering from the debilitating effects of migraine."
Date: March 22, 2012
Ulcer Drug Clears Late-stage Hurdles
CHAPEL HILL, N.C. (AP) - Pozen Inc. said its experimental ulcer treatment worked in two late-stage clinical trials.
Pozen's drug candidate PA32540 combines omeprazole, the active ingredient in heartburn drugs like Prilosec, with aspirin. The omeprazole is released as soon as the drug is taken and the aspirin is released over time. Pozen said patients who took PA32540 in the clinical trials had fewer gastric ulcers than patients who took a placebo, and the drug also met secondary goals, like reducing gastroduodenal ulcers.
There were a total of 1,049 patients in the studies. All of them were taking aspirin to prevent heart problems, and they were at risk for aspirin-related ulcers. Patients took either PA32540 or placebo once per day for six months.
Pozen said it will file for marketing approval of PA32540 in the third quarter.
Pozen's drugs include the arthritis drug Vimovo. It helped develop the migraine treatment Treximet, although it sold most of its royalty rights to the drug in 2011.
Date: March 22, 2012
Source: Associated Press
Pozen's drug candidate PA32540 combines omeprazole, the active ingredient in heartburn drugs like Prilosec, with aspirin. The omeprazole is released as soon as the drug is taken and the aspirin is released over time. Pozen said patients who took PA32540 in the clinical trials had fewer gastric ulcers than patients who took a placebo, and the drug also met secondary goals, like reducing gastroduodenal ulcers.
There were a total of 1,049 patients in the studies. All of them were taking aspirin to prevent heart problems, and they were at risk for aspirin-related ulcers. Patients took either PA32540 or placebo once per day for six months.
Pozen said it will file for marketing approval of PA32540 in the third quarter.
Pozen's drugs include the arthritis drug Vimovo. It helped develop the migraine treatment Treximet, although it sold most of its royalty rights to the drug in 2011.
Date: March 22, 2012
Source: Associated Press
jueves, 22 de marzo de 2012
First Portion of TMX-101 Study Complete
Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, has successfully completed the safety portion of a Phase 1/2 trial for TMX-101.
This three-part trial is an open-label, multicenter, dose escalation study. In the first part of the study, which has now completed, safety was tested in patients with non-muscle-invasive bladder cancer (NMIBC) who had also undergone a complete transurethral resection (TUR). TMX-101 was administered once a week for a total of six instillations into the bladder of patients after TUR. The second part of the study will be an assessment of the effective biological dose in patients with one marker lesion remaining after TUR. The third part will follow patients for one year for safety and status of the disease. No serious adverse events were reported and all related adverse events were mild to moderate in severity, with immediate resolution, and were mainly limited to the genitourinary system. Based on the results, the Dose Escalation Committee has concluded that intravesical instillation of TMX-101 is safe at doses from 0.05% up to and including 0.4% and recommended the continuation of the trial.
Johanna Holldack, CEO of Telormedix, commented, “Since 1984, no new drugs have been approved for the treatment of non-muscle invasive bladder cancer (NMIBC) .There is a high unmet clinical need for better and innovative therapies and Telormedix hopes to introduce its TMX-101, a TLR7 agonist, as a treatment for bladder cancer. Our study results so far are encouraging and we are excited that we are now able to initiate the marker lesion part of the study in order to evaluate the biological activity.”
The second part of the study will be an assessment of the effective biological dose in patients with one marker lesion remaining after TUR. Specifically, this study will examine TMX-101’s safety on Marker Lesions (MTD) focused on a dose level of 100 mg in 50 mL (0.2%) and is scheduled to start in Q1/Q2 2012. The third and final part of the study will follow patients for one year for safety and status of the disease.
Date: March 19, 2012
This three-part trial is an open-label, multicenter, dose escalation study. In the first part of the study, which has now completed, safety was tested in patients with non-muscle-invasive bladder cancer (NMIBC) who had also undergone a complete transurethral resection (TUR). TMX-101 was administered once a week for a total of six instillations into the bladder of patients after TUR. The second part of the study will be an assessment of the effective biological dose in patients with one marker lesion remaining after TUR. The third part will follow patients for one year for safety and status of the disease. No serious adverse events were reported and all related adverse events were mild to moderate in severity, with immediate resolution, and were mainly limited to the genitourinary system. Based on the results, the Dose Escalation Committee has concluded that intravesical instillation of TMX-101 is safe at doses from 0.05% up to and including 0.4% and recommended the continuation of the trial.
Johanna Holldack, CEO of Telormedix, commented, “Since 1984, no new drugs have been approved for the treatment of non-muscle invasive bladder cancer (NMIBC) .There is a high unmet clinical need for better and innovative therapies and Telormedix hopes to introduce its TMX-101, a TLR7 agonist, as a treatment for bladder cancer. Our study results so far are encouraging and we are excited that we are now able to initiate the marker lesion part of the study in order to evaluate the biological activity.”
The second part of the study will be an assessment of the effective biological dose in patients with one marker lesion remaining after TUR. Specifically, this study will examine TMX-101’s safety on Marker Lesions (MTD) focused on a dose level of 100 mg in 50 mL (0.2%) and is scheduled to start in Q1/Q2 2012. The third and final part of the study will follow patients for one year for safety and status of the disease.
Date: March 19, 2012
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