Results tagged “clinical trial” from Allergy

BERKELEY — Biopharmaceutical company Dynavax Technologies Corp. announced Friday it is discontinuing two clinical trials for its ragweed allergy treatment.

The Berkeley-based company said it will explore developing a different path for trials for the treatment, called Tolamba.

It announced Jan. 8 that trials for the drug were inconclusive, sending shares of the company's stock that day down 30 percent to just below $6.

"It's not the death knell for the allergy program," said Shari Annes, a Dynavax spokeswoman. "It was an inconclusive trial, not a failed drug."

The prescription antihistamine Astelin(R) (azelastine HCl) Nasal Spray(R) relieved the major symptoms of pollen allergy, including sneezing, runny nose and congestion, within 15 minutes of application compared to placebo and maintained efficacy at all time points for 8 hours in a randomized, single dose, double-blind, placebo- controlled study, MedPointe Pharmaceuticals announced today.

In addition, a group of patients treated with intranasal Nasonex(R) (mometasone furoate monohydrate) did not show symptom improvement compared to placebo during the eight hour study period. Data from the 450-patient study, conducted in a controlled environmental exposure unit (EEU), were presented at the 2007 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Diego, California.

February 16, 2007 — In children with intermittent asthma, a short course of montelukast resulted in reduction in acute healthcare resources, asthma symptoms, and days lost from school and from work for parents, according to the results of a multicenter, randomized, double-blind, controlled trial reported in the February 15 issue of the American Journal of Respiratory & Critical Care Medicine.

"In children, intermittent asthma is the most common pattern and is responsible for the majority of exacerbations," write Colin F. Robertson, MD, of the Royal Children's Hospital in Melbourne, Australia, and colleagues. "Montelukast has a rapid onset of action and may be effective if used intermittently."

BERKELEY, Calif., Jan. 8 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX ) announced today that the analysis of interim one-year data from its two-year DARTT ragweed allergy trial indicated that no meaningful ragweed-specific allergic disease was observed in the study population, making it impossible to measure the therapeutic effect of TOLAMBA treatment. In all three arms of the study, including the placebo arm, minimal change from baseline was observed in the main efficacy measure of the study, the total nasal symptom score (TNSS). The company indicated that in the placebo and treated groups, the change from baseline TNSS was very low; not clinically significant; and substantially lower than what has been observed in prior trials.

"In effect, we saw three patient groups with no measurable disease during the ragweed season. This result was unexpected, though these challenges are well known to occur in allergy drug development. Due to the fact that no clinically significant disease was seen in the study population, it was impossible to measure the effect of our intervention," noted Dino Dina, MD, president and chief executive officer. Dina continued, "We are working closely with our consultants and investigators to review the data in detail and determine the future of the program."

A tiny heater that warms the lungs and airways is being used to treat asthma. The device, which is inserted through the nose or mouth, gives ten-second blasts of mild heat to the muscles to stop them contracting.

Research shows that the beneficial effects of three sessions of the device, now on trial at five hospitals in the UK, can last for more than two years.

Asthma is a major and increasing health problem, with 5.2 million people in the UK currently receiving treatment, including 1.1 million children.

Two Swedish firms have joined together to make an investigational protein-based allergy drug for Phase III trials.

Contract manufacturer Biovitrum has been asked to undertake process development and clinical trial manufacturing of the biologic drug (RES 08) by its developers, Resistentia.

 

According to Marcus Bosson, CEO of Resistentia, Biovitrum was chosen due to its “vast experience with process development for Phase III biological clinical materials.”

 

PHILADELPHIA -- Adding the long-acting beta₂-agonist Serevent (salmeterol) to an inhaled corticosteroid reduces the rate of asthma exacerbations and asthma-related hospitalizations, said researchers here. This was covered in New Options in COPD Therapy post.

Servent in combination with Flovent (fluticasone) was associated in the recent SMART (Salmeterol Multi-center Asthma Research Trial) study with severe asthma exacerbations, and an increased risk of life-threatening adverse events and respiratory deaths among African Americans, in particular. Those findings led the FDA to require a "black box" warning on long-acting beta₂ agonists.

Once-daily dosing with a very long-acting beta₂-agonist (VLABA) would be a significant convenience and compliance-enhancing advantage leading to improved clinical outcomes in patients with asthma and chronic obstructive pulmonary disease (COPD). A once-daily VLABA will pave the way for a fixed-combination inhaler: with an inhaled corticosteroid in asthma and COPD and an inhaled long-acting anticholinergic for use in COPD.

Carmoterol 

Carmoterol is one such new VLABA in clinical development for asthma and COPD, and clinical data on a new metered-dose inhaler (pMDI) formulation were presented at the European Respiratory Society 16th Annual Congress. Professor Peter Barnes led off the discussion addressing the need for such a very long-acting agent. The inhaled route is preferred over the oral route when using VLABA because both routes allow excellent smooth muscle relaxation and bronchodilation, and the mast cells that are involved in bronchoconstriction are positioned close to the airway lumen and accessible to the inhaled route. Therefore, drug delivery via the inhaled route provides a much better bronchoprotective effect than the oral route. An airway that is bronchodilated continuously for 24 hours expends theoretically much less energy than airways subjected to repetitive closure when short-acting agents are used. Prof. Jean Bousquet, from France, presented information on a new, once-daily long-acting beta₂-agonist (LABA), carmoterol.

Inflazyme Pharmaceuticals has successfully completed patient recruitment in its phase IIb trial with IPL512,602 for the treatment of moderate to severe asthma.

The phase IIb trial will evaluate the efficacy and safety of once daily, oral dosing of IPL512,602 against placebo. Enrolled in the study are those patients with moderate to severe asthma who still experience significant symptoms which are not well controlled despite taking prescribed medications. IPL512,602 represents a new therapeutic approach that focuses on improving asthma control and reducing asthma symptoms.

The purpose of this study is to evaluate the effects of IPL512,602 on several measures of asthma control including asthma quality of life. Additional measures of asthma control include the incidence of night-time awakenings, need for rescue medication and asthma symptoms.

Inflazyme said that in a phase IIa study of IPL512,602 the patients who were most affected by their asthma going into the study appeared to derive the most benefit.

source - Pharmaceutical Business Review 

A daily tablet that could cure hay fever will be available within months.

The pills, which dissolve under the tongue, dramatically reduce the symptoms of the allergy which blights the lives of one in four Britons each summer.

Manufacturer, Danish drug firm ALK-Abello, believes its Grazax tablets, which can be taken at home, will even cure some sufferers.

The prescription-only pills, which are based on grass pollen, have recently been licensed for use and are expected to be on sale in the UK within three months.

Popped under the tongue once a day during the summer, they are the first tablets to tackle the underlying course of hay fever, rather than merely treat the symptoms.

Patients with symptomatic moderate asthma who were treated with anti-tumor necrosis factor alpha, an anti-inflammatory monoclonal antibody, experienced significantly fewer disease exacerbations than individuals taking a placebo.

This research appears in the first issue for October 2006 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Americans accustomed to the seasonal misery of sneezing, runny noses and itchy, watery eyes caused by ragweed pollen might one day benefit from an experimental allergy treatment that not only requires fewer injections than standard immunotherapy, but leads to a marked reduction in symptoms that persists for at least a year after therapy has stopped, according to a new study in the October 5 issue of i The New England Journal of Medicine (NEJM). The research was sponsored by the Immune Tolerance Network, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both components of the National Institutes of Health (NIH), and the Juvenile Diabetes Research Foundation International.

BALTIMORE, Oct. 5 (UPI) -- Baltimore researchers have successfully used an experimental DNA-based vaccine to protect against ragweed allergies, commonly known as hay fever.

Patients receiving the vaccine showed an average 60 percent reduction in allergy symptoms compared to those receiving a placebo, say researchers at The Johns Hopkins University School of Medicine.

The NEW ENGLAND JOURNAL OF MEDICINE (Vol. 355, October 5, 2006, No.14), today reported that a new approach to allergy therapy not only reduced the acute allergic responses of individuals with ragweed allergies but also sustained that effect for over 12 months. The novel treatment, called "AIC" in the paper, is a TLR9 agonist linked to ragweed allergen, developed by Dynavax Technologies Corporation (Nasdaq: DVAX).