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Product roundup from Datamonitor

Published on 29/05/07 at 10:49am

ADHD drug as effective in boys as girls, says Shire

UK pharmaceutical company Shire has said that results from a study for its attention-deficit disorder patch Daytrana show that it has significant efficacy in reducing the symptoms of ADHD in both male and female children aged six to 12 years.

In the study, investigators randomised 270 children to receive Daytrana, Johnson & Johnson's extended-release ADHD drug Oros methylphenidate, or placebo. The 96 children in the Daytrana group reported a significant mean reduction of 56.5% in their ADHD Rating Scale-IV (total scores from the study start to end, the study's primary endpoint).

The 58 boys that received Daytrana averaged a significant 56% total score reduction, while the 38 girls averaged a significant 57.4% reduction.

"Few clinical studies have examined gender differences in the response to ADHD treatments. Our study documented that Daytrana offered a favorable safety profile and was an effective ADHD treatment in both boys and girls," said Robert Findling, lead investigator and professor of psychiatry at Case Western Reserve University. "The study provides a platform to open a dialogue about gender and ADHD."

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Vion suspends phase III leukemia drug trial

Vion Pharmaceuticals is suspending enrolment and further patient treatment in its phase III clinical study of Cloretazine for patients with relapsed adult myelogenous leukemia, or AML, pending a detailed review of all of the data from the trial.

This decision was based on the recommendation of the trial's independent data safety monitoring board (DSMB) after a planned interim analysis.

The phase III trial is a double-blind, placebo-controlled, randomised evaluation of an experimental treatment consisting of Ara-C plus Cloretazine versus a control arm regimen of Ara-C and placebo.

The trial is designed to accrue patients in first relapse AML whose first complete remission (CR) was more than three months but less than24 months in duration.

The DSMB's review of clinical data from the first 210 treated patients resulted in a recommendation that enrolment and further treatment of patients on study be suspended. The DSMB's recommendation was based on its evaluation that any advantage in complete remission could be compromised by the observed on-study mortality to date.

The study will remain blinded while a complete medical review is conducted.

Alan Kessman, CEO, commented, "We will provide an update on the status of the analysis as soon more information is available."

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Critical Therapeutics to develop asthma drug with CyDex

US biopharmaceutical company Critical Therapeutics has reportedly entered into an agreement with CyDex to develop an injectable version of its Zileuton treatment for asthma.

The licence and supply agreement, which came into effect on March 16, 2007, will see the companies collaborate on the development and marketing of injectable Zileuton, Reuters said.

While CyDex has global and exclusive authorisation to develop and market the treatment in combination with, or formulated by its branded Captisol drug-enablement technology, Critical Therapeutics has global and non-exclusive licence to the scientific data relating to the technology, the publication revealed.

Critical Therapeutics is reported to have paid CyDex an initial licence fee of $50,000 and has agreed to give the company total payments of up to $2.9 million.

According to Reuters, the news caused Critical Therapeutics shares to rise 3% in morning trade on the Nasdaq, to $2.40.

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Huya and Chipscreen start cancer drug clinical trials

Huya Bioscience and Chinese firm Chipscreen Biosciences have initiated a phase I clinical trial in China for the investigational cancer compound chidamide.

San Diego-based Huya holds exclusive rights to the compound worldwide outside of China, while Chipscreen maintains rights in China. The phase I clinical trial is designed to assess the safety, tolerability and pharmacokinetics of the compound, the companies said.

Huya said that it will assist Chipscreen with development of chidamide in China and also intends to commence clinical trials of the drug in the US and Europe.

Mireille Gingras Huya's president and CEO said: "The initiation of phase I trials is a significant achievement for us. It represents both an important development milestone for this promising cancer compound and illustrates the benefits of Chinese and American Biotech companies working together to efficiently carry out drug development."

Chidamide is a histone deacetylase inhibitor, part of a new class of cancer drugs that induce selective regulation of gene expression in cancer cells.

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VGX Pharmaceuticals flu candidates trigger protective immune responses

VGX Pharmaceuticals' novel pandemic influenza vaccine candidates triggered protective immune responses in preclinical challenge studies, according to data presented at the Third International Conference on DNA Vaccines in Malaga, Spain.

VGX scientists created four synthetic consensus DNA vaccines to protect against a lethal Vietnamese H5N1strain of avian influenza in mice. One of the vaccines resulted in complete protection of mice from death and illness while two others had 60-80% protective effects. All the vaccines were delivered using VGX's proprietary CELLECTRA DNA Delivery Device. CELLECTRA is a novel adaptive electroporation device developed by VGX. The avian flu data was presented by Dr Ruxandra Draghia-Akli, VGX vice president, Immune Therapeutics Research.

Separately at the opening plenary session, Professor David Weiner of the University of Pennsylvania, conference chairman and a co-founder of VGX, presented new data showing extensive T-cell mediated immune responses to VGX's HIV vaccine candidates delivered with CELLECTRA in non-human primates.

The data revealed that the monkeys immunised with VGX vaccines displayed HIV-specific T-cell responses as much as 10-20 fold greater than those reported in the literature using other vaccine modalities.

VGX plans to conduct further preclinical studies for both the HIV and avian flu vaccines, including the IND-enabling toxicology studies in 2007.

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