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Ceravix Receives Commendatory Advice From FDA Advisory Committee

admin — Fri, 11 Sep 2009 01:16:20 +0000

Ceravix Receives Commendatory Advice From FDA Advisory Committee

GlaxoSmithKline recently advised the public that the US FDA’s Vaccines and Related Biological Products Advisory Committee voted that Ceravix, the company’s cervical cancer vaccine, presented data that substantiates the efficacy and safety of the treatment.

With regards to the prevention of cervical pre-cancers and cervical cancer relevant to human papillomavirus (HPV) types 16 and 18, Ceravix proved to be both extremely impactful and satisfactory endured in girls and young women. In addition, the committee conversed on data which presented Ceravix’s efficacy while in contact with other cancer-causing viruses.

GlaxoSmithKline’s Vice President and Director of North American Vaccine Development, Barbara Howe, MD exclaims that their recent favorable FDA recommendations marks and “important step in cancer prevention for the millions of girls and young women at risk for cervical cancer … if approved, Ceravix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in US women each year.”

The FDA will review the committee’s commendatory advice during its concluding evaluation of the Biologics License Application for the candidate vaccine. If accepted, the FDA will finalize prescribing information.

General side effects displayed during clinical trials of the Ceravix vaccine were pain, swelling and redness, fatigue, headache, muscle ache and joint pain, gastrointestinal symptoms and fever. Major side effects were mainly similar between the groups who received Ceravix and the control groups.

March of 2009, marks the date when GSK presented their Phase III pivotal study concluding data, a trial study that was the biggest efficacy trial of a cervical cancer vaccine. The data included information harvested from clinical trials hosted in more than 30 countries which utilized 30,000 Ceravix participants, revealing an ethnically and racially varied female population. The study also covered a rigorous safety assessment applicable to girls and young women between the ages of 10-25.

New Anti-T-Cell Globulin Treatment May Minimize Graft-Versus-Host Disease

admin — Wed, 19 Aug 2009 18:47:08 +0000

A recent study proclaims that patients who require a blood stem-cell transplant may be able to lessen the risk of graft-versus-host disease (GVHD – transplanted materials attack the body), thanks to ant-T-cell globulin treatment.

GVHD effects roughly 60 percent of those who have underwent blood stem cell transplants from the bone marrow or peripheral blood of unrelated donors (commonly referred to as hematopoietic cell transplantation). GVHD is a situation where the immune cells / T-cells from the donor recognizes the recipient’s tissues as unfamiliar and attack. Studies have propose antibodies that remove T-cells could avert the attack.

The recent study comprised of 201 adults who had blood cancer and had planned for a unrelated donor’s transplant. One group was treated to fend off GVHD prophylaxis, whereas the others were treated with standard therapy and anti-T-cell globulin.

After 100 days, roughly 34 percent of the people undergoing the standard treatment succumbed to GVHD or died, contrasted with 21 percent of the patients in the ATG-F group.

The phase 3 trial states that the general occurrence of acute GVHD was minimized in the ATG-F group (12 percent) than those who received the standard therapy (24 percent). The study also discovered that the two-year collective occurrence of chronic GVHD and extensive chronic GVHD in the ATG-F group was roughly 31 percent and 12 percent, contrasted with 59 and 43 percent for the standard therapy group.

The study also found that the ATG-F group did not have increased rates for relapse, deaths not related to relapse or deaths from infection, then the standard treatment.

Dr. Finke of Universitatsklinkum Feiburg in Germany stated in a news release that their study is the first “randomized clinical trial to show that ATG-F can reduce severe acute and clinically relevant chronic GVHD without compromising disease-free survival or overall survival … the use of ATG-F is safe for patients who are going to receive transplantation from matched unrelated donors.”

DSG’s EDC Enables Human Genome to Achieve Benlysta Drug Objectives

admin — Mon, 17 Aug 2009 20:43:05 +0000

After Benlysta achieved the primary endpoint in Bliss – 52, Human Genome Sciences, is pleased report that the first two pivotal Phase 3 trials involving patients with serologically active systematic lupus erythematous has been completed. The results have began to prove that Benlysta may in fact possess the potential to become the first approved systematic lupus treatment in decades.

Currently, DSG sustains the HGS study trial through data capture and support management as a result of its eCaseLink EDC software. The trial study involves roughly 400 electronic case report forms per subject, DSG then supplies critical data report tools, originating from study stipulations, thereby permitting HGS data management personnel to effectively observe and assure data quality.

HGS operated DSG’s exclusive Dashboard within eCaseLink, which quickly locates outstanding items that require attention during the global database lockdown. Furthermore, the software permitted HGS to blend in a licensed Clinical Trial Management System, as well as a third – party Interactive Voice Response System alongside eCaseLink, thereby establishing an expedient swap of analytical information.

Saphris Sublingual Tabs Receives FDA Endorsement

admin — Mon, 17 Aug 2009 20:38:51 +0000

The US FDA has approved Saphris sublingual tablets for the acute therapy of schizophrenic adults, as well as the acute therapy of manic or mixed bipolar I disorder, with or without adult psychotic attributes. Saphris is endorsed for first-line therapy, and is the first prescription drug to receive primary consent for both of these symptoms concurrently.

Shering-Plough, the research company behind Saphris are overly “pleased with the U.S. approval of Saphris, which represents an important new choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment.” Schering – Plough Research Institute, executive vice president and president Thomas P. Koestler, PhD went on to express their excitement with Saphris’ addition to their “product portfolio, and represents the first U.S. approval resulting from Organon/Schering – Plough combination.”

The FDA endorses Saphris, issues from a New Drug Application that contains efficacy data from their clinical study program which encompassed roughly 3,000 schizophrenic and mania trial patients. Saphris’ new drug application was also reinforced by safety data issued from 4,500 people, some of which were treated for over two years. The FDA’s endorsement stems from acute schizophrenia trials, where Saphris showed noteworthy statistical efficacy when compared with placebo and acute bipolar l disorder studies, in which, Saphris proved statistically, an immense lowering of bipolar symptoms versus that of the placebo trials.

Top-Line Results From Zelrix Phase III, Clinical Trials

admin — Thu, 13 Aug 2009 15:56:09 +0000

Pharmaceutical company NuPathe Inc., who specializes in the generation of revolutionary products to treat neurological and psychiatric diseases, publicizes top-line results from the Phase III Zelrix clinical trial. Zelrix is a clinically developed transdermal patch used for the treatment of acute migraines. The double-blind, placebo-controlled trial occurred in a multi-center, nonspecific, parallel group. The effectiveness and bearability of the migraine treatment was contrasted against placebo treatments in 530 adults.

Jane Hollingsworth, chief executive officer of NuPathe explains “Zelrix was designed to overcome key barriers to successful treatment of migraine; treatment-altering nausea, treatment-limiting side effects and inconsistent drug absorption.” Zelrix’s migraine patch utilizes the company’s exclusive iontophoretic transdermal technology, SmartRelief with a common prescribed treatment for migraines, sumatriptan.

Two hours post application, patients who administered the Zelrix patch showed notable advancements on all five of the key effectiveness end points, compared with those patients who administered the placebo patch. The endpoints include: pain free (pain symptom score = 0), pain relief, nausea free, photophobia free and phonophobia free.

Zelrix caused low triptan-specific side effects. The most common side effects were mild and transient itching, pain and tingling at the application site.

International Experts Issue Lantus Statement

admin — Tue, 11 Aug 2009 16:38:43 +0000

Sanofi-aventis recently publicized the release of an Expert Statement issued by a board of multidisciplinary, internationally acclaimed experts, which follows an in-depth evaluation of the recent publications of registry analyses with Lantus in Diabetologia. Combined, the board of international experts boasts specialties in endocrinology, oncology and epidemiology, they all came to the conclusion that all four manuscripts have crucial methodological restrictions and flaws, the manuscripts display unstable and indefinite results with reference to the potential relationship between insulin glargine use and an increase risk of cancer.

Professor Riddle of Medicine, Diabetes Section Head, Division of Endocrinology/Diabetes/Clinical Nutrition at the Oregon Health Sciences University in Portland, states that with reference “to the merits of the published data, we agreed that all four published manuscripts have significant methodological limitations and shortcomings … the nature of these limitations and their potential magnitude are such that, individually or in aggregate, these studies provide inconsistent and inconclusive results which do not justify new clinical recommendations to patients.”

Following an autonomous, meticulous, in-depth analyses of the published data, all 14 experts signed-off on the the statement. This comes at a time when a mass of recent releases from global Health Authorities have began to circulate.

The experts have suggested an implementation of action on the part of the company, independent experts or professional associations, that can lead to a comprehensible, exact resolution of the situation.

Safety Concerns Cease NHLBI’s Sickle Cell, Pulmonary Hypertension Trial

admin — Tue, 11 Aug 2009 16:36:45 +0000

The National Heart, Lung and Blood Institute (NHLBI) has halted a clinical trial involving drug treatment tests for pulmonary hypertension in adults who suffer from sickle cell disease. The trial comes to a premature end after only one year of study, due to safety concerns. These concerns come after a 16 week interim review was conducted of the 33 participants. Researchers discovered that participants actively taking sildenafil (Revatio), were experiencing an increase in consequential medical problems, versus the placebo participants. The most common effect were episodes of severe pain (sickle cell crisis), which required hospitalization for the participants. No deaths has occurred during the clinical trial.

Sickle cell disease is one of the most prevalent genetic blood disorders in the U.S. Pulmonary hypertension is an immobilizing high blood pressure condition that effects the arteries, potentially leading to heart failure and death. Approximately, 30 percent of sickle cell patients are expected to develop pulmonary hypertension.

The study coined walk-PHaSST, was the first of its kind to involve a multi-center, randomized clinical trial, intent on testing the the safety and effectiveness of sildenafil for sickle cell disease patients who have also developed pulmonary hypertension.

NHLBI Director Elizabeth Nabel M.D., reminds the public that because the walk-PHaSST medical problems were individually specific to sickle cell disease patients, these findings “should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective.”

Array Publicizes Oral Glucokinase Activator Outcomes in Type 2 Diabetes Patients

admin — Tue, 11 Aug 2009 16:33:50 +0000

Array BioPharma Inc. has recently notified the public of their Phase 1 favorable top-line clinical trial data, conducted with a group Type 2 diabetes patients and their small molecule glucokinase activator (GKA), ARRY-403. The drug has completed the final primary and secondary processes of safety, pharmacokinetics and glucose control.

ARRY-403 was assessed in a Phase 1 single ascending dose study. The study contained 41 patients who suffer from Type 2 Diabetes, they received either a placebo or 25 mg to 400 mg of single doses of ARRY-403, the group was divided into 7 dose cohorts.

The clinical trial has found that ARRY-403 was well managed at all doses, absorbed quickly, and exposure was dose-dependent. Once daily therapeutic dosing produced consistency with pharmacokinetic. As well as the activator supplied dose-dependent decrease in glucose excursions in response to a conventional meal, and decrease in 24-hour fasting blood-glucose.

Array has arranged a multiple ascending 10-day dose study of Type 2 Diabetes patients, in order to safely gauge exposure and glucose control. The company intends on publicizing the entire Phase 1 clinical trial findings in the beginning of 2010.

Baxter Completes CELVAPAN A/H1N1 Pandemic Vaccine

admin — Fri, 07 Aug 2009 16:32:44 +0000

Baxter International has recently announced that they have finished the production of their first commerical batches of CELVAPAN A/H1N1 pandemic vaccine. Currently, Baxter is discussing distribution options with national health authorities, so long as they receive appropriate permission. Baxter implemented their proprietary Vero cell production technology when developing CELVAPAN.

When the World Health Organization increased the pandemic notification level to phase 6 and announced it as an official pandemic, many health authorities began to place orders for the vaccine. As a result, Baxter plans to provide their initial CELVAPAN quantities to the health authorities who have created pandemic contracts with them.

Vero cell production technology, has met all Baxter’s expectations. The technology was able to respond to the pandemic, and in return quickly produce a vaccine within 12 weeks of receiving the A/H1N1 virus strain.

Joy Amundson, corporate vice president and president of Baxter BioScience proudly stated “we are pleased with our company’s ability to meet its expected timelines in developing and producing CELVAPAN … [it] is an encouraging validation of our science, our Vero cell vaccine technology and the teamwork at Baxter in meeting this important milestone to help address an urgent public health issue.”

In an effort to abide with all regulatory authorities, requirements, Baxter is working with regulatory authorities to ensure support and approvals of CELVAPAN are achieved. Baxter produced a mock-vaccine which consisted of several pandemic strains and tested it in five worldwide clinical trials consisting of over 1300 people. Plus, over 3,500 people have been vaccinated during their ongoing phase lll study.

US FDA Supports Antipsychotic Once-Monthly Invega Sustenna

admin — Fri, 07 Aug 2009 15:57:52 +0000

The US FDA has recently approved Invega Sustenna extended-release injectable suspension for acute and maintenance therapy of adult schizophrenia. Invega Sustenna is the first US approved once a month injectable, long-acting, atypical antipsychotic. The Janssen sector of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will be responsible for the US marketing of Invega Sustenna.

Schizophrenia is a severe brain disorder that effects roughly one percent of the world’s population. The disorder compromises a person’s capacity to think clearly, identify with others, and differentiate between fantasy and reality. Although there is no cure for Schizophrenia, symptoms and risk of relapse can generally be supervised with treatment that includes ongoing, long-term therapy and antipsychotic medications.

Studies show that 80 percent of schizophrenic patients will experience at least one relapse within five years of original diagnosis. Patients who are treated using an oral atypical antipsychotic will fail to take their medication one-third of the year. As a result, it is key for healthcare providers to assure that patients are engaging with their treatment course, to diminish the chance of relapse.

Psychiatry and Neuroscience professor and director at the University of Cincinnati College of Medicine, and a clinical investigators who worked on the Invega Sustenna trials, Henry A. Nasrallah, M.D., states that “Inconsistent compliance with medication is one of the single greatest impediments to managing the symptoms of schizophrenia and delaying relapse … the approval of once-monthly Invega Sustenna will provide healthcare professionals with a treatment option that is … a monitoring tool for uninterrupted medication compliance, which may help optimize clinical outcomes in schizophrenia.

The FDA endorsement is a result of four acute symptom control studies and a longer-term maintenance study that compared placebo to Invega Sustenna. Invega Sustenna surpassed the placebo by progressing positive and negative syndrome scale total scores, and in the longer-term maintenance study delayed time to relapse.

During clinical trials, frequent side-effects included reactions at the site of injection, somnolence/sedation, dizziness, akathisia and extrapyramidal disorder.