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InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... 1b MAD study of ITMN-191 in combination with low dose ritonavir in HCV patients in the third quarter; ... twice-daily ITMN-191 co-administered with a low dose of ritonavir in combination with standard dose Pegasys(R) (peginterferon alfa-2a) and Copegus(R) ...

Purdue Pharmaceutical Products L.P. and Transcept Pharmaceuticals, Inc. Sign Exclusive Agreement to Commercialize Intermezzo(R) in the United States

... to sleep. Intermezzo ((R)) is a sublingual low dose formulation of zolpidem, the active agent most ... approximately one-quarter to one-third of the dose of active drug contained in currently marketed ... ((R)), by combining the reduced zolpidem dose with administration only on those nights when a ...

Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients

... current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, ... ANA598 and fifteen receiving placebo at each dose level. The study will be conducted at a number ...

Anadys Pharmaceuticals Reports Second Quarter 2009 Financial Results and Program Highlights

... current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, ... ANA598 and fifteen receiving placebo at each dose level. The study will be conducted at a number ...

Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients With Endometriosis

... month six was the impact of the elagolix 250 mg dose on bone mineral density (BMD) as measured by dual ... to this study we anticipated that the 250 mg dose would provide exposure such that we would start ... bone safety profile, the 150 mg once daily dose appears to be the optimal choice for upcoming ...

Sunesis Reports Financial Results for the Second Quarter 2009

... Evaluation of VorEloxin in AmL) is a Phase 2 dose regimen optimization study of single agent ... AML were enrolled and treated with a voreloxin dose of 80 mg/m2 or higher. Five of 14 of these ... also failed prior treatment with Doxil(R). Three dose cohorts of voreloxin have been studied, 48 mg/m2 ...

Santaris Pharma - Interim Report for the Period 1 January to 30 June 2009

... targeting hepatitis C finalized a single dose First/In/Man study with encouraging results and a multiple ascending dose study in healthy volunteers is scheduled to ... of the year. An IND regarding a Phase I multiple dose clinical study with SPC3649 in healthy volunteers ...

New Drug Application for Exenatide Once Weekly Accepted for Review by FDA

... patients with type 2 diabetes with just one dose per week." About Diabetes Diabetes ... side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced ... of food eaten, and body weight. No changes in dose are needed for these side effects. These are not ...

New Report Just Published: World Prostate Cancer Therapeutics Market Report

... Hormone Therapy II-32 LHRH Analogs II-33 dose of LHRH Agonists for Advance Prostate Carcinoma ... Drawbacks of Brachytherapy II-38 High dose Rate (HDR) Brachytherapy II-39 External Beam ... Androgen Deprivation Therapy (ADT) II-44 High dose Radiation (HDR) Monotherapy II-45 Drawbacks ...

Schering-Plough Announces Phase II and III Data for Corifollitropin Alfa

... to that achieved in patients receiving a daily dose of 200 IU rFSH (follitropin beta) for seven days ... oocyte and embryo quality compared to a daily dose of 200 IU rFSH given for one week.(2) Further ... that in patients weighing 60 kg or less, a single dose of 100 mcg corifollitropin alfa resulted in ...

Sanofi Pasteur Responds to Nation's Need for Hib Vaccine With Increased Supply

... - The CDC Reinstates Booster dose of Hib Vaccine - SWIFTWATER, Pa., June 25 ... recommendation that children receive a booster dose of Haemophilus influenzae type b (Hib) vaccine ... approach to immunize children whose booster dose was previously deferred at their next regularly ...

Glenmark's Novel Molecule for Diabetes, Melogliptin to Enter Phase III Trials

... of 0.75% in patients receiving 50mg twice daily dose (p<0001) and 0.60 % in patients receiving 100 mg once daily dose (p<.0001). In a subgroup of patients ... 100mg once daily dose and 50mg twice daily dose respectively, which compares favorably ...

Advanced Life Sciences' Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study

... a 100% survival rate against an inhaled lethal dose of anthrax. All of the animals in the study that received 16 mg/kg once-a-day (the human equivalent dose of 300 mg) of Restanza within 24 hours after ... Restanza was 100% protective against a lethal dose of inhaled anthrax as compared to the standard of ...

Data Presented at Society of Nuclear Medicine 2009 Annual Meeting Supports Potential of Peregrine's Cotara(R) for the Treatment of Brain Cancer

... Cotara is currently being tested in this Phase I dose response and dosimetry trial and in a Phase II ... the tumor received more than 300 times the dose of radiation compared to these normal organs. ... very encouraging," said Dr. Shen. "With a mean dose ratio showing 300-fold greater delivery of ...

New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease

... of Prevenar at 2, 3 and 4 months with a booster dose of Prevenar 13 or Prevenar at 12 months. ... after the infant series and after the booster dose showed that a high percentage of infants ... 13 at age 12 to <24 months; and 3) a single dose of Prevenar 13 at age 24 to <72 months. Each ...

Clinical Pharmacology Study With AZILECT(R) (Rasagiline Tablets) Demonstrated It Does Not Increase Tyramine Sensitivity

... for Inhibiting MAO-B at Maximum Approved dose KANSAS CITY, Mo., June 9 /PRNewswire/ -- ... of tyramine sensitivity at the maximum approved dose of 1 mg. The presentation was made during the ... which measures the ratio of tyramine pressor dose before (baseline) and after MAO inhibitor ...

Proteolix Presents Clinical Data from Two Clinical Studies of Carfilzomib in Multiple Myeloma at the 14th Congress of the European Hematology Association

... safety and to establish a maximum-tolerated dose of carfilzomib in combination with lenalidomide ... have been reported. A maximum-tolerated dose has not yet been established and dose-escalation ... at doses well below the maximum-tolerated dose for either lenalidomide or carfilzomib alone. ...

Keryx Biopharmaceuticals Reports Positive Phase 2 Study Results of Zerenex (Ferric Citrate) for the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients

... enrollment and immediately switched to a starting dose of 4.5 grams per day of Zerenex (ferric citrate). ... enrollment and immediately switched to a starting dose of 6.0 grams per day of Zerenex (ferric citrate). ... (ferric citrate); The average daily dose of PhosLo(R) (calcium acetate) was 6.9 grams per ...

Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientific Sessions

... patients receive the benefits of an optimized dose of exenatide immediately upon initiation of ... patients to inject themselves." The phase 1b dose ranging study was conducted at multiple centers ... thiazolidinediones. The study included four dose arms to which patients were randomized to receive ...

Celator(R) Pharmaceuticals Presents Data on the Activity of CPX-351 Against Leukemia at the European Hematology Association Congress

... recovery). Some of these remissions occurred at dose levels as low as one-third to one-half of the maximum tolerated dose (MTD; established in this study as 101 u/m(2)). ... and accumulation of the drugs over the three dose induction course (infusions on Days 1, 3, 5). ...

Anadys Pharmaceuticals, Inc. Announces Strategic Restructuring to Focus Operations on Continuing the Advancement of ANA598

... after treatment is ended. The proposed dose levels in this study are 200 mg and 400 mg, each ... to initiate dosing of patients in the 400 mg dose group will be determined after assessing 28 day data from the 200 mg dose group. Anadys intends to enroll 90 patients in ...

Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

... (>=2). The median prior doxorubicin equivalent dose was approximately 300 mg/m2, the dose that is associated with six cycles of CHOP ... comparator arm. The median doxorubicin equivalent dose at the end of therapy was 513 mg/m2 (with a range ...

Peregrine Pharmaceuticals Presents Promising Data From Its Phase II Bavituximab Breast Cancer Trial at 2009 ASCO Annual Meeting

... side effects. These did not require dose modification or treatment discontinuation. ... PK profile and that a maximum tolerated dose was not reached even at the highest planned dose level. The majority of adverse events reported ...

Mersana Reports Preliminary Phase 1 Results of XMT-1001 in Patients with Advanced Solid Tumors

... Study The Phase 1 trial is an open label, dose escalation study of XMT-1001 administered as an ... the study are to determine the maximum tolerated dose (MTD) as well as to assess safety and pharmacokinetics. The maximum tolerated dose is not yet defined and accrual to the study ...

FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

... two groups. One group received their optimal dose of VYVANSE the first week and placebo the second ... received placebo the first week and their optimal dose of VYVANSE the second week. The primary ... or equal to 10 percent and twice placebo) in the dose optimization phase for patients taking VYVANSE ...

Valeant Pharmaceuticals Reports Encouraging Final Results With Taribavirin Phase IIb Study

... ribavirin arm; supporting the premise that higher dose weight-based taribavirin may be as effective as ... a high relapse rate and, except for the lowest dose with taribavirin, relapse rates are also ... "We are very pleased with the results from this dose finding study which confirms that taribavirin ...

OncoGenex Pharmaceuticals Announces OGX-427 Treatment Demonstrates Safety, Evidence of Declines in Circulating Tumor Cells and Reductions in Tumor Markers in a Phase 1 Cancer Trial

... a single agent up to 1000 mg. A maximum tolerated dose was not identified up to and including the 1000-mg dose of OGX-427 monotherapy. Subsequently, as defined by the protocol, an 800-mg dose of OGX-427 in combination with docetaxel was ...

Oncothyreon announces clinical data from three product candidates presented at American Society of Clinical Oncology (ASCO) Annual Meeting

... from 0.5 mg to 10 mg. The maximally tolerated dose has not yet been identified. The most common ... activity, even in the early cohorts in this dose escalation trial," said Dr. Kirkman. "We believe ... days. A randomized Phase 2 trial comparing two dose levels of PX-12 in up to 80 patients at three ...

Centocor Ortho Biotech Data to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

... failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2 ... be included in calculations of total cumulative dose Cardiac toxicity may also occur at ... platelet count), at least prior to each dose of DOXIL In patients with recurrent ...

Results From Neurotech's NT-501 Phase 2 Retinitis Pigmentosa Studies Demonstrate Consistent Biological Effect on Photoreceptors

... significant (p< 0.001 for the high dose group in each study), dose-dependent increase in ... randomized, double-masked, sham-controlled dose ranging studies designed to evaluate the safety ... each patient received either a high or low dose NT-501 implant in one eye and a sham treatment in ...

Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial

... less than or equal to 300mg/m2 of doxorubicin, a dose at which 5.6% of patients are expected to develop ... a median total cumulative doxorubicin equivalent dose of 535mg/m2, the frequency of CHF among PIX 301 ... Clinical CHF- related or unrelated to drug dose (mg/mg2 doxorubicin Doxorubicin(1) ...

Schering-Plough Announces Changes to its Global Collaboration with Novartis to Develop Combination Therapies for Asthma and COPD

... of age. In the U.S., it is available in two dose strengths, 110 mcg for children between 4 and 11 ... by any route, and reduce each patient's dose to the lowest dose that effectively controls his/her symptoms. ...

EntreMed ENMD-2076 Phase 1 Data to Be Presented at ASCO Annual Meeting

... - 6:00 p.m. Abstract No.: 3520, "An open-label, dose escalation, safety, and pharmacokinetic study of ... Abstract No.: 3562, "A single center, open-label, dose escalation, safety, and pharmacokinetic study of ... the study include defining the maximum tolerated dose (MTD) ...

Bayer and Onyx Announce Nexavar Data Presentations at 45th American Society of Clinical Oncology Annual Meeting

... Multitargeted, Metronomic, and Maximum-Tolerated dose "Chemo-Switch" Regimen Produces Enhanced Activity ... Phase 1/2 Study of Idarubicin, High dose Ara-C and Sorafenib in Patients with Acute ... side effects, temporary treatment interruption, dose modification or permanent discontinuation should ...

Lilly Set to Unveil More Than 50 Studies at ASCO 2009

... problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may ... with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the ... with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the ...

First oral uveitis drug reduces both inflammation and recurrence in potentially blinding eye disease

... a safety profile for LX211 at the 0.4 mg/kg bid dose that suggests the experimental drug would be ... Hopkins University, Baltimore, found that the dose of oral corticosteroids used commonly to keep ... 25 mg/day. This compares to a recommended chronic dose by the uveitis community of 10 mg/day or less. Of ...

PharmAthene Presents Data for SparVax(TM), a Novel Vaccine for the Prevention and Treatment of Anthrax Infection, at the 12th Annual Conference on Vaccine Research

... one of two Phase II trials evaluating different dose and dosing regimens of SparVax(TM). The objective ... of BioThrax(R) or SparVax(TM) (at one of two dose levels followed by an antigenic challenge dose, i.e., a dose to show that the initial series of doses ...

Flu vaccine given in microneedle skin patches proves effective in mice

... intramuscular hypodermic injections at the same dose in another group of mice. The researchers ... infected both groups of mice with a high dose of influenza virus. While all mice in a control ... are needed to determine the minimum vaccine dose needed for full protection. The Emory and ...

Anadys Pharmaceuticals Reports First Quarter 2009 Financial Results and Highlights

... antiviral and safety data from all three dose levels in the recently completed Phase Ib ... (Day 4) exceeding 2 log10 (>99%) at all dose levels. At 200 mg bid, the median viral load ... ANA598 and two subjects receiving placebo at each dose level (400 mg once-daily, 800 mg once-daily and ...

AEterna Zentaris Presents Phase 1 Results for AEZS-112 in Patients with Advanced Cancer and Lymphoma at AACR Annual Meeting in Denver

... 22 patients (12 men/10 women) were studied on 7 dose levels ranging from 13 to 800 mg/week. In all, 62 ... GI reactions and electrolyte loss at a dose of 200x3mg/week, no clinically relevant ... courses; - So far, a maximum tolerated dose for weekly dosing has not been defined; ...
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