Lupus Research Institute Highly Encouraged by Benlysta(TM) Trial Results

... trial of Benlysta(TM) (belimumab) for people with systemic lupus. "We are very hopeful that we now ... of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical ... biological agent' developed specifically for systemic lupus that has the potential to obtain FDA ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the ... approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, President and ... under the current agreement. About systemic Lupus Erythematosus ...

Data Demonstrated ACTEMRA(R) (tocilizumab) Significantly Inhibited Progression of Structural Joint Damage in Rheumatoid Arthritis Patients

... both inflammation of the joints and certain systemic effects of RA. The extensive clinical development ... Rheumatoid Arthritis RA is a progressive, systemic autoimmune disease characterized by inflammation ... that leads to loss of function. In addition, the systemic symptoms of RA include fatigue, decreased ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... HCC patients who progressed after various systemic therapies or who were no longer candidates for ... interruption or discontinuation. Patients with systemic invasive fungal infections should not receive ... to be reversible with the administration of systemic steroids, circulatory support measures, and ...

Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients

... both inflammation of the joints and certain systemic effects of RA. The extensive clinical development ... Rheumatoid Arthritis RA is a progressive, systemic autoimmune disease characterized by inflammation ... that leads to loss of function. In addition, the systemic symptoms of RA include fatigue, decreased ...

Arcion Therapeutics' Topical Pain Candidate, ARC-4558, Significantly Reduces Pain Caused by Diabetic Neuropathy

... received 23% less gel in order to avoid higher systemic dosing. Consistent with this, clonidine blood ... applying the drug topically to the area of pain, systemic exposure is minimized, and hence, systemic side effects appear to be minimal. Moreover, ...

AndroScience Corporation Announces Phase 2a Study Results on ASC-J9(TM) for the Treatment of Acne

... cream is topically administered and exhibits low systemic absorption, limiting systemic side effect risks and allowing for the treatment ... motor disease caused by AR mutation) utilizing systemic based approaches. AndroScience Corporation ...

Studies Show Combination Laser Therapy Effective At Clearing Acne, Reducing Oil Production

... with varying degrees of success - with topical, systemic and hormonal medications," said Dr. ... either treated with conventional therapy (such as systemic or topical medications) or with laser energy but ... tries to clear the condition using topical or systemic medications, including isotretinoin. However, she ...

Emerging Therapies Could Help Ease The Chronic Symptoms of Atopic Dermatitis For Adults and Children

... for more potent anti-inflammatory agents." systemic Therapies For a significant subset of atopic dermatitis patients of all ages, systemic therapy is necessary to control their condition. While systemic therapies for atopic dermatitis pose safety ...

Rosetta Genomics Reports First Ever In-Vivo Efficacy Data for a Systemic MicroRNA Therapeutic for Liver Cancer

... today the first ever in-vivo efficacy data for a systemic microRNA-based cancer therapeutic. ... oral anti-cancer drug currently approved for systemic therapy for HCC, extends survival by ... of mice, in order to evaluate the efficacy of systemic microRNA-based treatment in these ...

ESBATech's Antibody Fragment Enters Phase I/IIa Clinical Development in Osteoarthritis with the Potential for Disease-Modifying Activity

... hand, based on the local delivery and the short systemic half life, systemic exposure of ESBA105 is very low as compared to ... rather local disease. Therefore, systemic suppression of TNF alpha, as achieved by marketed ...

RHEI Pharmaceuticals Announces the Initiation of the Final Clinical Study for Approval of Tibozole in China

... RHEI Pharmaceuticals. "Although very effective, systemic drugs can have systemic side effects and drug interactions in certain ... system, will be a welcome alternative when systemic absorption could create issues in patients." ...

Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)

... both inflammation of the joints and certain systemic effects of RA. The extensive clinical ... Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation ... that leads to loss of function. In addition, the systemic symptoms of RA include fatigue, decreased ...

Topical Treatment for Cold Sores Achieves Efficacy of Oral Drugs; Represents Paradigm Shift in the Treatment of Skin Infections

... of lesions as effectively as the leading oral systemic drugs but without safety or toxicity concerns. ... attain equivalent efficacy rates to oral systemic drugs, according to the NanoBio scientists. ... treatments are widely considered inferior to oral systemic treatments because they fail to penetrate to the ...

Study Results Show Epratuzumab Provided Clinically Meaningful Reduced Disease Activity in Patients With Lupus

... in patients with active moderate and severe systemic lupus erythematosus (SLE). These findings ... antibody under investigation for the treatment of systemic lupus erythematosus (SLE). CD22 is a ... Inc., Morris Plains, NJ, USA. About systemic lupus erythematosus (SLE) ...

Early Data Show Potential for Imatinib Mesylate Tablets to Treat Life-Threatening Form of Pulmonary Artery Disease

... rearrangements; adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-KIT ... to be reversible with the administration of systemic steroids, circulatory support measures, and temporarily withholding Gleevec. MDS/MPD disease and systemic mastocytosis may be associated with high ...

Phosphagenics Announces Initiation of Phase 1 Clinical Trial in Humans for Its Transdermal Lidocaine

... the dermal bioavailability and will measure the systemic exposure of lidocaine in one of the leading ... with rapid pain relief, while not increasing systemic exposure, and we are excited to continue moving ... centre bioavailability trial of dermal and systemic pharmacokinetics in 12 healthy adult volunteers ...

Continuous Treatment With Abbott's HUMIRA(R) Achieves Superior Long-Term Efficacy for Psoriasis Patients Compared to Interrupting Treatment

... Diagnosis of Psoriatic Arthritis or Recent systemic Therapy PARIS, Sept. 18 /PRNewswire-FirstCall/ ... (PsA), or if he or she has a recent history of systemic therapy, including biologic treatments. At ... with a medical history of PsA * Prior systemic treatment o 78 percent of patients with ...

Human Genome Sciences Completes Enrollment in Second Phase 3 LymphoStat-B(R) Trial

... (belimumab) in patients with active systemic lupus erythematosus (SLE). Belimumab is being ... help control autoimmune disease activity. About systemic Lupus Erythematosus systemic lupus erythematosus (SLE) is a chronic, ...

U.S. NCI Starts Enrolment in Phase 2 Systemic Melanoma Clinical Trial with REOLYSIN(R)

... trial for patients with metastatic melanoma using systemic administration of REOLYSIN(R), Oncolytics' ... and overall survival. Patients will receive systemic administration of REOLYSIN(R) at a dose of ... expectations related to the U.S. NCI Phase 2 systemic administration clinical trial for patients with ...

The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer

... - Nexavar is First Approved systemic Therapy to Treat the Disease - WAYNE, N.J. and ... remained a treatment challenge, due to a lack of systemic therapies to extend life and limited opportunity ... New York. "This landmark study reflects a new systemic standard of care using Nexavar in the first-line ...

Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytren's Contracture

... Pharmacokinetic Study Demonstrates Lack of systemic Exposure of XIAFLEX Serious Adverse Events ... ("PK") Study that demonstrate the lack of systemic exposure of XIAFLEX in patients treated for ... events were consistent with previous trials. No systemic allergic reactions were noted. In data from the ...

Data Show FLECTOR(R) Patch Yields Significant Pain Reduction for Acute Strains, Sprains and Contusions

... for Clinicians Concerned About systemic Exposure When Using an Oral NSAID TAMPA, Fla., ... presented Thursday, May 8, demonstrate that the systemic exposure to diclofenac, or amount of active drug ... delivery of FLECTOR(R) Patch results in minimal systemic absorption of diclofenac, one of the best selling ...

Phosphagenics Reports Positive Pre-clinical Results for Targeted Delivery of Lidocaine

... increased efficacy while restricting systemic exposure. A phase 1 human clinical trial is ... a single topical application, while restricting systemic exposure. Lidocaine concentrations were ... did not lead to a significant increase in systemic exposure. The average plasma lidocaine ...

ESBATech's Lead Antibody Fragment Enters Clinical Development for Ophthalmic Indications

... approach has a very low risk of provoking systemic adverse effects." ESBATech is the first and ... targeted sites, in combination with extremely low systemic load, in order to achieve low risk of systemic drug reactions using topical and local ...

Raptor Pharmaceuticals Corp. Initiates Phase IIa Clinical Study for Convivia(TM)

... oral formulation of 4-MP designed to reduce peak systemic acetaldehyde levels in ALDH2 deficient persons ... Convivia(TM) is designed to reduce peak systemic acetaldehyde levels in ALDH2 deficient persons ... the ability of Convivia(TM) to reduce peak systemic acetaldehyde levels in ALDH2 deficient persons ...

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

... enzyme (PEGrHuPH20) as a candidate for the systemic treatment of tumors rich in hyaluronan (HA) ... microenvironment of prostate tumors following systemic administration of its PEGrHuPH20 pre-clinical ... enzyme. The dose dependent effects of systemic enzyme treatment were evaluated by a combination ...

Study Shows Intradigm's RNAi Nanoplex Technology To Be Effective Systemic siRNA Delivery Platform for the Treatment of Various Cancer Models

... Corporation, a leading developer of targeted, systemic RNA interference (RNAi) therapeutics, today ... known as PolyTran(TM). PolyTran enables safe systemic delivery of the siRNAs. Additionally, this ... company dedicated to the development of targeted, systemic RNA interference (RNAi) therapeutics for the ...

MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate

... Lower systemic drug exposure observed compared to currently ... Unit Dose Budesonide (UDB) demonstrated lower systemic drug exposure when compared to the currently ... our Phase 3 clinical program resulted in lower systemic drug exposure compared to the currently marketed ...

NanoBio Corporation Completes Interim Analysis of Phase 2 Clinical Trial in Onychomycosis

... formulation without significant skin irritation, systemic absorption, or other safety concerns. "NB-002 ... absorbed," Baker said. "The absence of systemic absorption provides a significant advance ... by the disease do not receive treatment. systemic treatments represent well over 80 percent of the ...

NanoBio Corporation Successfully Completes Phase 2b Study in Herpes Labialis

... adverse events, significant skin irritation or systemic blood absorption. In contrast, leading oral systemic treatments for herpes labialis carry label ... that NB-001 achieves the efficacy of leading systemic treatments without presenting safety, ...

MacroChem Announces Presentation of Pexiganan Phase 3 Study Results for Topical Treatment of Diabetic Foot Infection

... presentation of a poster entitled "Topical versus systemic Antimicrobial Therapy for Treating Infected ... topical therapy available as an alternative to systemic treatment focuses attention on the wound and, in ... uses a new antimicrobial, while avoiding adverse systemic effects and the promotion of antibiotic ...

Phosphagenics Initiates U.S. Clinical Trials for Its Topical Retinoic Acid

... liver damage when substantial amounts enter the systemic circulation. Irritation, though, is the most ... acid, reduce irritation and dryness and limit systemic circulation would significantly increase ... as limit the delivery of retinoic acid into the systemic circulation, which is important because of its ...

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

... of 12 and who were candidates for phototherapy or systemic therapy. Patients received either REMICADE 5 ... of 12 and who were candidates for phototherapy or systemic therapy. Patients were randomized to ... psoralen plus ultraviolet light A (PUVA) or systemic therapy for psoriasis. Trial participants were ...

NanoBio Corporation Presents Preclinical and Interim Clinical Data on Topical Treatments for Herpes Labialis and Onychomycosis at AAD 2008

... and antifungal effects without safety concerns or systemic absorption. Interim findings in subjects with ... an excellent safety profile with no systemic absorption coupled with an ability to kill the ... concerns. Pharmacokinetic studies show no systemic absorption, a factor that enhances the safety ...

Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic Foot Ulcers

... drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold. ... antibiotics are often associated with systemic side effects and widespread use can lead ... will investigate the product as an adjunct to systemic therapy for treating moderately infected ulcers ...

Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans

... announced today that it has commenced systemic dosing in humans of its proprietary ... is the first human clinical trial involving the systemic delivery of siRNA. The Phase I clinical trial is ... noteworthy as it represents the first documented systemic dosing of siRNA in humans. While the science of ...

Nexavar First FDA-Approved Drug Therapy for Liver Cancer

... Only systemic Therapy Proven to Significantly Improve Overall ... an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown ... will likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer, and is ...

New Research Shows Masimo Perfusion Index (PI) Effective in the Noninvasive Detection of Congenital Heart Defects (CHD) in Newborns

... defects (CHD) in newborns with duct-dependent systemic circulation. Even when routine neonatal ... fails mainly in children with duct-dependent systemic circulation. Granelli and Ostman-Smith conducted ... heart defects that have duct-dependent systemic circulation. As a result, researchers concluded ...

Human Genome Sciences Reports Positive Data from Long-Term Treatment with LymphoStat-B(R) in Patients with Active Systemic Lupus Erythematosus

... with standard of care in patients with active systemic lupus erythematosus (SLE). The results will be ... commercialized under the agreement. About systemic Lupus Erythematosus systemic lupus erythematosus (SLE) is a chronic, ...