Enzyme in Medical Technology

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... Phase III studies of velaglucerase alfa, its enzyme replacement therapy in development for ... proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid ... Gaucher Disease results from a specific enzyme deficiency in the body, caused by a genetic ...

Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease

... (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the ... proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid ... Gaucher Disease results from a specific enzyme deficiency in the body, caused by a genetic ...

Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease

... a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the ... proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid ... Gaucher Disease results from a specific enzyme deficiency in the body, caused by a genetic ...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

... enroll approximately 60 subjects who are naive to enzyme replacement therapy (ERT) or who have not ... and females with Fabry disease as compared to enzyme replacement therapy (ERT). The Agency agrees ... resulted in increased levels of the target enzyme (a-Gal A), as measured in white blood cells and ...

Celladon Provides MYDICAR(R) Program Update of First-In-Human Trial for Advanced Heart Failure at American Society of Gene Therapy Annual Meeting

... and biological effects of restoring SERCA2a enzyme activity in heart muscle cells. The enzyme levels are decreased in late stages of heart ... of the heart to contract properly. Replacing the enzyme may restore function and reverse heart failure. ...

Celladon Corporation Announces Presentation of First-in-Human Gene Transfer to Treat Heart Failure at the 12th Annual Meeting of the American Society of Gene Therapy

... Safety Profile and Biological Effects of SERCA2a enzyme Replacement SAN DIEGO, May 26 /PRNewswire/ ... that results from its genetically targeted enzyme replacement therapy for advanced heart failure, ... of heart failure is the depletion of SERCA2a enzyme in heart muscle cells, which results in abnormal ...

Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia

... either D-3263, finasteride (an inhibitor of the enzyme 5-alpha-reductase) or a combination of the two ... is a known inhibitor of 5-alpha reductase, the enzyme that converts testosterone to DHT, D-3263 is not an inhibitor of this enzyme suggesting that the two agents may act by ...

BioMarin Initiates Phase 1/2 Clinical Trial for GALNS for Morquio A Syndrome

... has developed and manufactures two FDA-approved enzyme replacement therapies, one for the treatment of ... conditions caused by the underlying enzyme deficiency. The incidence estimates for MPS ... and planned pre-clinical trials related to the enzyme replacement therapy for MPS IVA; the content and ...

Myeloperoxidase Research Expands

... its capacity for stable Human Myeloperoxidase enzyme for clinical diagnostic, pharmaceutical ... worldwide research continues with this important enzyme that Lee Biosolutions produces. Three ... and Myeloperoxidase isoform C. MPO C is a popular enzyme among the community of protein structural ...

Enobia Initiates Infantile Enzyme Replacement Trial for Rare Bone Disease

... was dosed. Enobia is investigating enzyme Replacement Therapy (ERT) with ENB-0040 for the ... there is no approved treatment. "Our enzyme replacement therapy program for hypophosphatasia ... and a patented peptide used to target the enzyme to bone. The preclinical studies of ENB-0040 in ...

New Insight Into the Controls on a Go-To Enzyme

... new insights into regulation of one of the body's enzyme workhorses called calpains. As the ... flowing into the cell. This process induces the enzyme to snip apart many target proteins, as part of ... regulatory machinery. However, such a critical enzyme needs ultra-precise control, which is the job of ...

Celladon Announces Presentation of Clinical Data From First-in-Human MYDICAR(R) Trial for Advanced Heart Failure at American Heart Association Scientific Sessions

... treated with MYDICAR(R), a genetically-targeted enzyme replacement therapy for advanced heart ... and biological effects of restoring SERCA2a enzyme activity in heart muscle cells. The enzyme levels are decreased in late stages of ...

Parasites That Live Inside Cells Use Loophole to Thwart Immune System

... play in activating the macrophages to make an enzyme called arginase. The arginase enzyme occurs naturally in macrophages, but is normally ... a new pathway by which a pathogen can induce an enzyme that is normally not present in those macrophages ...

Enobia Pharma Appoints Industry Veterans with Commercial and Manufacturing Expertise to Expand Senior Management Team

... commercialization and planning for Myozyme(R), an enzyme replacement therapy for ultra-orphan Pompe ... and a patented peptide used to target the enzyme to bone. Preclinical studies of ENB-0040 in the ... there is no currently approved drug therapy. enzyme Replacement Therapy for the treatment of ...

St. Jude Study Gives New Insights Into How Cells Accessorize Their Proteins

... Researchers have determined how an enzyme that stitches all-important molecular adjustments ... molecular leap to cullin-RING from the previous enzyme in the cadre that manages the attachment process. ... attaches to cullin-RING, it activates the enzyme to attach ubiquitin to its target protein. In ...

TRANSCEND(TM) Trial Results Presented at European Society of Cardiology Congress and Published in The Lancet

... patients intolerant to angiotensin-converting enzyme inhibitors: a randomized controlled trial. The ... angioedema associated with angiotensin-converting enzyme inhibitor therapy. A review of the literature and ... effectiveness of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers ...

Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting With FDA for Amigal in Fabry Disease

... acts by selectively binding to the misfolded enzyme responsible for Fabry disease, alpha-GAL. After ... folding, processing, and trafficking of the enzyme from the endoplasmic reticulum to its final ... pharmacological chaperone is displaced, and the enzyme can perform its normal, biological ...

Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models

... treatment with chemotherapy and pegylated enzyme produces significantly enhanced survival ... chemotherapy alone - - Pegylated enzyme well tolerated - SAN DIEGO, July 22 ... animal efficacy data for its pegylated-rHuPH20 enzyme (PEGPH20) at the American Association for Cancer ...

New Study Shows BENICAR(R) (olmesartan medoxomil) Reverses Blood Vessel Damage Independent of Blood Pressure Lowering

... system, such as angiotensin-converting enzyme inhibitors or ARBs, have ... of Angiotensin Receptor Antagonism and Converting enzyme Inhibition. Circulation 1999;100;2267-75 4. ... 7. Mulvany MJ. Effects of angiotensin-converting enzyme inhibition on vascular remodeling of ...

Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy

... the acquisition of arylsulfatase -A (ASA) an enzyme Replacement Therapy (ERT) in Phase 1-2 clinical ... damage. MLD is caused by a deficiency in the enzyme ASA which causes an excess concentration of ... disease caused by a deficiency of the lysosomal enzyme arylsulfatase A (ASA) which results in an ...

JAK2 Inhibitor Shows Potent Activity in Cells From MPD Patients

... mutation which causes over-activation of the enzyme JAK2. Cytopia is developing selective and potent inhibitors of the JAK2 enzyme to block excessive activity. Cytopia has ... that Cytopia's compounds block the mutant JAK2 enzyme and thereby inhibit, in the case of PV, ...

One Shot of Gene Therapy Spreads Through Brain in Animal Study

... disease, physicians can supply the missing enzyme to patients and successfully relieve disease ... and most other lysosomal storage diseases, enzyme replacement, when available, is not ... brain, where the gene produced the enzyme. The enzyme then cleaned up the storage lesions to the point ...

Pharmasset Commences Dosing in Phase 3 Registration Studies of Clevudine for HBV

... ability to suppress HBV DNA and normalize liver enzyme levels after 48 weeks of treatment," stated Dr. ... undetectable serum HBV DNA and normalized liver enzyme (ALT) levels following 48 weeks of monotherapy. ... had seriously elevated liver enzyme levels. Otherwise, there was no meaningful ...

Sarasota's Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes

... who are known to have deficiencies of this enzyme in their muscles," said Dr. Farese. "The findings ... that are responsible for the production of this enzyme could eventually cause obesity and the ... how human diabetics acquire a deficiency of this enzyme in their muscles; however, this mouse ...

AMT Intends to Incorporate Additional Data to its Marketing Authorization Dossier for Glybera(R)

... LPLD. Because of a defective gene, LPLD patients do not produce an enzyme that normally breaks down fats in the blood. These patients have extremely ... therapy, which inserts into muscle tissue a healthy gene that restores the enzyme (lipoprotein lipase) activity required to process fat. The advantage of ...

Enobia Pharma Receives FDA Orphan Drug Designation for Hypophosphatasia Product Candidate ENB-0040

... immunoglobulin Fc domain and a patented anionic peptide used to target the enzyme to bone. Preclinical studies of ENB-0040 in the "knockout" mouse model of ... bone disorders for which there is no currently approved drug therapy. enzyme Replacement Therapy for the treatment of hypophosphatasia is the Company's ...

DSM and LibraGen Sign Agreement to Co-Develop Transaminases for Production of Chiral Amines

... at DSM Pharmaceutical Products. "In addition, by combining LibarGen's enzyme discovery and DSM's manufacturing capabilities the development timelines from enzyme discovery and screening to final product delivery to our customers will ...

Enobia Pharma Initiates Clinical Testing of Enzyme Replacement Therapy to Treat Hypophosphatasia

... alkaline phosphatase (TNSALP), and a patented peptide used to target the enzyme to bone. Preclinical studies of ENB-0040 in the "knockout" mouse model of ... bone disorders for which there is no currently approved drug therapy. enzyme Replacement Therapy for the treatment of hypophosphatasia is the Company's ...

AMT Prepares for Submission of Marketing Authorization Dossier for AMT-011 (Glybera(R))

... and diabetes. Because of a defective gene HPL-patients do not produce an enzyme that normally breaks down fats in the blood. Currently, there is no ... into muscle tissue after which the body starts to make the missing enzyme again. The advantage of this therapy is its potential to cure a disease ...

Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil

... company, announced that ELAPRASE(R) (idursulfase), a human enzyme replacement therapy for the treatment of Hunter syndrome, has been ... business unit of Shire focused on genetic diseases, is the first and only enzyme replacement therapy approved for people suffering from Hunter syndrome. ...

Halozyme Therapeutics Presents Pre-Clinical Studies of Systemic Delivery of Pegylated rHuPH20 Enyzme in Prostate Cancer Models at American Association for Cancer Research Conference

... (AACR) conference. Halozyme is investigating its Pegylated-rHuPH20 enzyme (PEGrHuPH20) as a candidate for the systemic treatment of tumors rich in ... of the PEGrHuPH20 enzyme. The dose dependent effects of systemic enzyme treatment were evaluated by a combination of direct micropressure ...

Lilly Launches Its First Phase III Trial for Treatment of Alzheimer's Disease

... associated with Alzheimer's disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer's ... (1-877-285-4559). About LY450139 LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creating a shorter, sticky protein called amyloid ...

FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008

... ARI-2243 has an extremely high affinity (Ki of 27 picomolar) for the DPP-4 enzyme and drug dissociation from the enzyme is very slow. Such kinetics confer potency and long activity. During OGTT ...

Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial

... the maximum approved or tolerated dose of either an Angiotensin Converting enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). This randomized, ... dose of an angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEi). The study is designed for subjects to be on drug for six ...

REMICADE-Treated Patients Experienced Rapid and Substantial Improvement in Psoriasis in Critical Regions of Body

... in the REMICADE group compared with the placebo group were elevated liver enzyme tests. There were more serious AEs (6 percent), including one fatal ... in the REMICADE group compared with the placebo group were elevated liver enzyme tests. Serious AEs occurred at rates of 2 percent in the placebo group, 3 ...

Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex

... is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. Hyaluronidase should not be ... Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated. Furosemide, the benzodiazepines, and phenytoin are ...

Lexicon Files Investigational New Drug Application for LX2931 as a Potential Treatment for Rheumatoid Arthritis

... United States. LX2931 was developed at Lexicon as an inhibitor of a key enzyme in the sphingolipid pathway, which controls lymphocyte circulation and ... gene knockout program, Genome5000(TM). Knockout mice lacking this enzyme had a significantly decreased number of circulating lymphocytes and were ...

Amicus Therapeutics Announces Positive Results From Two Phase 1 Clinical Studies of AT2220 for Pompe Disease

... to selectively bind to and stabilize acid a-glucosidase (GAA), the enzyme deficient in Pompe disease. This deficiency leads to lysosomal ... symptoms of Pompe disease. AT2220 facilitates proper trafficking of the enzyme to the lysosomes, the compartments in the cell where it is needed to break ...

Diamyd Updates Gene Therapy Program and Outlines Plans for Phase I Clinical Trial for Treatment of Cancer Pain

... For example, while GABA that is produced with the help of the GAD enzyme dampens spinal cord injury pain very well, enkephalin seems particularly ... autoimmune diabetes, is the active substance in Diamyd. GAD65 is also an enzyme that converts the excitatory neurotransmitter glutamate to the inhibitory ...

Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet

... the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to ... essential amino acid found in most protein-containing foods. If the active enzyme is not present in sufficient quantities, Phe accumulates to abnormally ...