Phase 1 Clinical Trial News
phase 1 clinical trial
VANCOUVER, BRITISH COLUMBIA--(Marketwire - July 2, 2009) - Tekmira Pharmaceuticals Corporation (TSX:TKM) announced today that it has initiated a Phase 1 human clinical trial for ApoB SNALP. ApoB SNALP, Tekmira's lead RNAi therapeutic product ...
Read moreTekmira Pharmaceuticals Initiates ApoB SNALP Phase 1 Clinical Trial - Phramalive.com
LOS ANGELES--( BUSINESS WIRE )-- CytRx Corporation (NASDAQ:CYTR) , a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, has filed a report with the U.S. Food and Drug Administrations (FDA ...
Read moreCytRx Files Report with the FDA in Response to the Partial Clinical ... - Businesswire.com
London, July 1 : A clinical trial is being launched in three African countries of a drug that could eliminate onchocerciasis, or river blindness, one of the leading infectious causes of blindness across Africa. The drug, moxidectin, is being ...
Read moreNew drug for speeding up elimination of river blindness across Africa ... - Top News India
(RTTNews) - Schering-Plough Corp. (SGP: News ) announced results from the Phase III ENGAGE clinical trial demonstrating that a single injection of corifollitropin alfa, first in the class of sustained follicle stimulants, achieved similar efficacy to ...
Read moreSchering-Plough Reveals Results From Phase III ENGAGE Clinical Trial ... - RTT News
(RTTNews) - Wednesday, Sucampo Pharma Americas, Inc., a unit of Sucampo Pharmaceuticals, Inc. (SCMP: News ) announced the results of its phase 2 clinical trial of orally administered cobiprostone for the prevention of gastric ulcers and other ...
Read moreSucampo Reveals Top-Line Results Of Phase 2 Clinical Trial Of ... - RTT News
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that GlaxoSmithKline (GSK) has signed multi-year, multi-million dollar contracts covering Licensing and Study Support ...
Read morePhase Forward Customer GlaxoSmithKline Signs Multi-Year Agreements - PR Inside
Best practices for conducting effective and safe clinical trials. Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range ...
Read moreResearch and Markets: Clinical Trials Handbook: Best Practices for ... - Earthtimes
Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), today reported top-line results from its phase 2 clinical trial of orally administered cobiprostone for the prevention of gastric ulcers and ...
Read moreSucampo Reports Top-Line Results Of Phase 2 Clinical Trial Of ... - Medical News Today
Preliminary interim efficacy analysis showed no clinically relevant benefit for patients Brussels (Belgium), 30 June 2009 at 10:30 pm CEST - press release, regulated information - UCB and Biogen Idec announced today the discontinuation of the Phase ...
Read moreUCB and Biogen Idec discontinue Phase II clinical trial of CDP323 - Market Wire
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that it will receive a milestone payment from Centocor Ortho Biotech Inc. (formerly known as: Centocor, Inc.) in connection with the initiation of a Phase 1 clinical trial using ...
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Resolved Question: Boy-cotters of Israeli products, would you boycott this ?
A revolutionary vaccine against all types of influenza is scheduled to enter phase 1 clinical trials in humans in the next few days. The vaccine, and Israeli development, is intended to provide universal multi-season/multi-strain protection against most human influenza virus strains, as well as the Avian flu, for a period of five years. This would enable a long-term planning of vaccine production and prevent shortages in national reserves. http://www.ynetnews.com/articles/0,7340,L-3710391,00.html moreResolved Question: is there a need to follow good clinical practices (GCP) guidelines for phase 1 studies in a clinical trial?
moreResolved Question: what is the depedent variable, depedent variable, and controlled variable in this article?
“Gene Therapy For Blindness Improves Vision, Safety Study Indicates” ScienceDaily (Sep. 9, 2008) — All three people who received gene therapy at the University of Florida to treat a rare, incurable form of blindness have regained some of their vision, according to a paper published online today in Human Gene Therapy. The patients — one woman and two men ranging from 21 to 24 years old with a type of hereditary blindness called Leber congenital amaurosis type 2 — volunteered to test the safety of an experimental gene-transfer technique in a phase 1 clinical research study conducted by UF and the University of Pennsylvania with support from the National Eye Institute of the National Institutes of Health. In this form of LCA disease, photoreceptor cells cannot respond to light because a gene called RPE65 does not properly produce a protein necessary for healthy vision. In the study, researchers used an adeno-associated virus — an apparently harmless virus that already exists in most people — to deliver RPE65 to a small area of the retina. Not only were there no ill effects other than routine postsurgical soreness, the subjects said the vision in their treated eyes was slightly improved in dim lighting conditions. "The patients report seeing brighter areas and perhaps some images, but basically the message is that this is treatment is fully safe," said William W. Hauswirth, Ph.D., a professor of ophthalmology and member of UF's Powell Gene Therapy Center and the UF Genetics Institute. "One thing we did not do is suppress the patients' immune systems, which was done in two other LCA clinical trials that were under way," said Hauswirth, who began studying the adeno-associated virus as a vehicle to deliver genes into living animals more than 30 years ago. "Theoretically, the idea was that it might be necessary to suppress the immune system because we are using a vector that might activate the body's defenses and cause a harmful response. However, immune suppression itself carries a risk of infections and other problems. Clearly we have shown there is no need to do that in this case." Samuel G. Jacobson, M.D., Ph.D., a professor of ophthalmology with the Scheie Eye Institute at the University of Pennsylvania, is the study's principal investigator. "This groundbreaking gene therapy trial builds on 15 years of research sponsored by the National Eye Institute of NIH," said Paul A. Sieving, M.D., Ph.D., director of the NEI. "The study has partially restored vision in three young adults, and it demonstrates that gene therapy can be effective in treating human vision disease. Many human diseases are inherited in families and result from mutations in single genes. These genetic conditions are particularly suited to potential treatment by gene therapy. This trial to treat vision loss from the condition of Leber congenital amaurosis is an important demonstration of proof of principle and shows that we are on the right track. We can now invest in further work to refine, and ultimately to expand, genetic treatment approaches." Results published today focus on the health of the entire retina, not just the tiny portion that received the gene therapy. A detailed examination of the therapy's effectiveness in the treated portion of the eye will appear in an upcoming issue of the Proceedings of the National Academy of Sciences. Two other recent LCA clinical trial reports appeared recently in The New England Journal of Medicine. "The safety study itself is a milestone, but when we see a benefit to the subject — that is a truly a welcome bonus," said Barry J. Byrne, M.D., Ph.D., a professor of molecular genetics and microbiology and director of UF's Powell Gene Therapy Center, which manufactured the viral vectors used in the study. "Improvements in someone's medical condition are ultimately what we are after." LCA2 affects about 2,000 people in the United States and is one of several incurable forms of blindness collectively known as retinitis pigmentosa, which in turn affects about 200,000 Americans. Children with LCA2 experience major visual disability that can lead to total vision loss in adulthood. Although vision loss is severe, the structure of the retina — including its connection to the brain — can remain relatively intact for decades before the photoreceptor cells degenerate. Study researchers from the University of Pennsylvania also include Artur V. Cideciyan, Ph.D., Tomas S. Aleman, M.D., Sharon B. Schwartz, Ph.D., and Lili Wang, Ph.D. Shalesh Kaushal, M.D., Ph.D., Thomas J. Conlon, Ph.D., and Sanford L. Boye, M.S., from UF, and former UF Pediatrics Department Chairman Terence Flotte, M.D., now with the University of Massachusetts Medical School, also contributed to the research study. Byrne, Hauswirth and UF have interest in a company that explores the use of therapies using the adeno-associated virus. UF, Penn and Cornell University hold a patent on gene therapy technology. moreResolved Question: What were the conclusions of the study in this article?
“Gene Therapy For Blindness Improves Vision, Safety Study Indicates ScienceDaily” (Sep. 9, 2008) — All three people who received gene therapy at the University of Florida to treat a rare, incurable form of blindness have regained some of their vision, according to a paper published online today in Human Gene Therapy. The patients — one woman and two men ranging from 21 to 24 years old with a type of hereditary blindness called Leber congenital amaurosis type 2 — volunteered to test the safety of an experimental gene-transfer technique in a phase 1 clinical research study conducted by UF and the University of Pennsylvania with support from the National Eye Institute of the National Institutes of Health. In this form of LCA disease, photoreceptor cells cannot respond to light because a gene called RPE65 does not properly produce a protein necessary for healthy vision. In the study, researchers used an adeno-associated virus — an apparently harmless virus that already exists in most people — to deliver RPE65 to a small area of the retina. Not only were there no ill effects other than routine postsurgical soreness, the subjects said the vision in their treated eyes was slightly improved in dim lighting conditions. "The patients report seeing brighter areas and perhaps some images, but basically the message is that this is treatment is fully safe," said William W. Hauswirth, Ph.D., a professor of ophthalmology and member of UF's Powell Gene Therapy Center and the UF Genetics Institute. "One thing we did not do is suppress the patients' immune systems, which was done in two other LCA clinical trials that were under way," said Hauswirth, who began studying the adeno-associated virus as a vehicle to deliver genes into living animals more than 30 years ago. "Theoretically, the idea was that it might be necessary to suppress the immune system because we are using a vector that might activate the body's defenses and cause a harmful response. However, immune suppression itself carries a risk of infections and other problems. Clearly we have shown there is no need to do that in this case." Samuel G. Jacobson, M.D., Ph.D., a professor of ophthalmology with the Scheie Eye Institute at the University of Pennsylvania, is the study's principal investigator. "This groundbreaking gene therapy trial builds on 15 years of research sponsored by the National Eye Institute of NIH," said Paul A. Sieving, M.D., Ph.D., director of the NEI. "The study has partially restored vision in three young adults, and it demonstrates that gene therapy can be effective in treating human vision disease. Many human diseases are inherited in families and result from mutations in single genes. These genetic conditions are particularly suited to potential treatment by gene therapy. This trial to treat vision loss from the condition of Leber congenital amaurosis is an important demonstration of proof of principle and shows that we are on the right track. We can now invest in further work to refine, and ultimately to expand, genetic treatment approaches." Results published today focus on the health of the entire retina, not just the tiny portion that received the gene therapy. A detailed examination of the therapy's effectiveness in the treated portion of the eye will appear in an upcoming issue of the Proceedings of the National Academy of Sciences. Two other recent LCA clinical trial reports appeared recently in The New England Journal of Medicine. "The safety study itself is a milestone, but when we see a benefit to the subject — that is a truly a welcome bonus," said Barry J. Byrne, M.D., Ph.D., a professor of molecular genetics and microbiology and director of UF's Powell Gene Therapy Center, which manufactured the viral vectors used in the study. "Improvements in someone's medical condition are ultimately what we are after." LCA2 affects about 2,000 people in the United States and is one of several incurable forms of blindness collectively known as retinitis pigmentosa, which in turn affects about 200,000 Americans. Children with LCA2 experience major visual disability that can lead to total vision loss in adulthood. Although vision loss is severe, the structure of the retina — including its connection to the brain — can remain relatively intact for decades before the photoreceptor cells degenerate. Study researchers from the University of Pennsylvania also include Artur V. Cideciyan, Ph.D., Tomas S. Aleman, M.D., Sharon B. Schwartz, Ph.D., and Lili Wang, Ph.D. Shalesh Kaushal, M.D., Ph.D., Thomas J. Conlon, Ph.D., and Sanford L. Boye, M.S., from UF, and former UF Pediatrics Department Chairman Terence Flotte, M.D., now with the University of Massachusetts Medical School, also contributed to the research study. Byrne, Hauswirth and UF have interest in a company that explores the use of therapies using the adeno-associated virus. UF, Penn and Cornell University hold a patent on gene therapy technology. moreResolved Question: what is the Independent Variable, the Dependent Variable, and the Controlled Variable in this article ?
“Gene Therapy For Blindness Improves Vision, Safety Study Indicates ScienceDaily” (Sep. 9, 2008) — All three people who received gene therapy at the University of Florida to treat a rare, incurable form of blindness have regained some of their vision, according to a paper published online today in Human Gene Therapy. The patients — one woman and two men ranging from 21 to 24 years old with a type of hereditary blindness called Leber congenital amaurosis type 2 — volunteered to test the safety of an experimental gene-transfer technique in a phase 1 clinical research study conducted by UF and the University of Pennsylvania with support from the National Eye Institute of the National Institutes of Health. In this form of LCA disease, photoreceptor cells cannot respond to light because a gene called RPE65 does not properly produce a protein necessary for healthy vision. In the study, researchers used an adeno-associated virus — an apparently harmless virus that already exists in most people — to deliver RPE65 to a small area of the retina. Not only were there no ill effects other than routine postsurgical soreness, the subjects said the vision in their treated eyes was slightly improved in dim lighting conditions. "The patients report seeing brighter areas and perhaps some images, but basically the message is that this is treatment is fully safe," said William W. Hauswirth, Ph.D., a professor of ophthalmology and member of UF's Powell Gene Therapy Center and the UF Genetics Institute. "One thing we did not do is suppress the patients' immune systems, which was done in two other LCA clinical trials that were under way," said Hauswirth, who began studying the adeno-associated virus as a vehicle to deliver genes into living animals more than 30 years ago. "Theoretically, the idea was that it might be necessary to suppress the immune system because we are using a vector that might activate the body's defenses and cause a harmful response. However, immune suppression itself carries a risk of infections and other problems. Clearly we have shown there is no need to do that in this case." Samuel G. Jacobson, M.D., Ph.D., a professor of ophthalmology with the Scheie Eye Institute at the University of Pennsylvania, is the study's principal investigator. "This groundbreaking gene therapy trial builds on 15 years of research sponsored by the National Eye Institute of NIH," said Paul A. Sieving, M.D., Ph.D., director of the NEI. "The study has partially restored vision in three young adults, and it demonstrates that gene therapy can be effective in treating human vision disease. Many human diseases are inherited in families and result from mutations in single genes. These genetic conditions are particularly suited to potential treatment by gene therapy. This trial to treat vision loss from the condition of Leber congenital amaurosis is an important demonstration of proof of principle and shows that we are on the right track. We can now invest in further work to refine, and ultimately to expand, genetic treatment approaches." Results published today focus on the health of the entire retina, not just the tiny portion that received the gene therapy. A detailed examination of the therapy's effectiveness in the treated portion of the eye will appear in an upcoming issue of the Proceedings of the National Academy of Sciences. Two other recent LCA clinical trial reports appeared recently in The New England Journal of Medicine. "The safety study itself is a milestone, but when we see a benefit to the subject — that is a truly a welcome bonus," said Barry J. Byrne, M.D., Ph.D., a professor of molecular genetics and microbiology and director of UF's Powell Gene Therapy Center, which manufactured the viral vectors used in the study. "Improvements in someone's medical condition are ultimately what we are after." LCA2 affects about 2,000 people in the United States and is one of several incurable forms of blindness collectively known as retinitis pigmentosa, which in turn affects about 200,000 Americans. Children with LCA2 experience major visual disability that can lead to total vision loss in adulthood. Although vision loss is severe, the structure of the retina — including its connection to the brain — can remain relatively intact for decades before the photoreceptor cells degenerate. Study researchers from the University of Pennsylvania also include Artur V. Cideciyan, Ph.D., Tomas S. Aleman, M.D., Sharon B. Schwartz, Ph.D., and Lili Wang, Ph.D. Shalesh Kaushal, M.D., Ph.D., Thomas J. Conlon, Ph.D., and Sanford L. Boye, M.S., from UF, and former UF Pediatrics Department Chairman Terence Flotte, M.D., now with the University of Massachusetts Medical School, also contributed to the research study. Byrne, Hauswirth and UF have interest in a company that explores the use of therapies using the adeno-associated virus. UF, Penn and Cornell University hold a patent on gene therapy technology. moreResolved Question: Do screenings for clinical trials test for cannabis?
I recently got a job being tested for a phase 1 clinical trial for a lot of money. I told them I have not taken any recreational drugs in the last few months which in retrospect is not exactly true. Are they likely to test for cannabis in my screening moreResolved Question: Did you know Russians outlive Americans with Chemo?
NOV-002, the lead compound acts as a chemoprotectant and an immunomodulator. It is marketed in Russia by PharmaBAM under the trade name Glutoxim®, and has been administered to over 5,000 patients, demonstrating clinical efficacy and excellent safety. The U.S.-based Phase 1/2 clinical trial of NOV-002 for non-small cell lung cancer (NSCLC) has been completed, with positive results. During an End-of-Phase 2 meeting, the FDA agreed that advancing NOV-002 into a pivotal Phase 3 trial in advanced NSCLC, in combination with first-line chemotherapy, is warranted. In May 2006, Novelos finalized a Special Protocol Assessment (SPA) with the FDA for a single pivotal trial, obtained Fast Track designation in August 2006, and this Phase 3 trial commenced in November 2006. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is in addition being developed for acute radiation injury. Novelos' pipeline of drugs is based on oxidized glutathione, a natural metabolite that is part of the glutathione pathway. This pathway is the primary determinant of intracellular redox (oxidation/reduction) potential and, as such, plays a key role in cell protection (e.g. detoxification) and in regulation of cell signaling pathways (e.g. leading to cytokine production). Novelos’ lead products are believed to act, in part, via post-translational modification (glutathionylation) of critical regulatory proteins that mediate processes including immune function, cell proliferation and tumor progression (in combination with chemotherapy). They may also sensitize tumor cells to certain chemotherapeutic drugs by modifying drug detoxification processes. NOV-205, a second compound acts as a hepatoprotective agent with immunomodulating and antiinflammatory properties. Russian clinical studies in hepatitis B and C patients showed that after treatment with NOV-205, viral load was undetectable in a high proportion of patients and serum biochemical markers of liver damage were significantly decreased. Novelos' IND for NOV-205 as mono-therapy for chronic hepatitis C has been accepted by the FDA, and a U.S. Phase 1b trial in patients who previously failed treatment with pegylated interferon plus ribavirin is ongoing. moreResolved Question: Clinical Trial Investigational Review Boards (IRBs)?
Is it "customary" that the investigators for a Phase III trial of an experimental therapeutic drug NOT SHARE trial data with insiders at the phrama company conducting the trial-- other than, say, a monthly update? More specifically, is it realistic this would have been the case for the IRB overseeing the late-stage trials for Pfizer's torcetrapib which was abruptly terminated (within 3 hours) of receipt bu Pfizer scientists of a monthly IRB update showing a mortality of 82 deaths of those taking the drug versus 51 taking a combination therapy.....with 7,500 patients in each arm of the trial (15,000 total)? I can't believe that Pfizer insiders weren't receiving more than a monthly update an a trial to approve a drug which was expected to be the largest-seller ever and on which they had invested $1 billion? Mary's answer below is instructive but factually incorrect. The FDA issued a paper in March 2006 providing "Guidance" to clinical trial sponsors on the establishment and monitoring of Clinical Trial Data Monitoring Committees. The paper provided "guidance" and is NOT mandatory. Moreover, it suggests that IRBs can in fact have access to blinded trial results and communicate with trial sponsors. Therefore, I'll modify my question: why would a monitoring committee (appointed by Pfizer) not have highlighted the mortality rates of one arm of the torcetrapib trial in its month-earlier call to Pfizer as the company has suggested? I'm cynical....can anybody confirm my cynicism? Good insights Mary and iwannamkaegoodchanges. I'll defer disagreement over the interpretation of the Guidelines-- sponsors have much more flexible than either of you acknowledge. However, let me put a question to you both? Couldn't a participant "leak" to representatives of the sponsor information regarding the unblinded data? Note: I'm not an insider like you, but I know more than you might think-- in particular, how big pharma doesn't always play by the rules and can cite instances of such. moreMore Phase 1 Clinical Trial Results