Latest news from Datamonitor
pharmafile | July 23, 2007 | News story | Research and Development, Sales and Marketing |Â Â Â
Affiris begins clinical testing of Alzheimer's vaccine
Affiris' Alzheimer's vaccine Affitope has now entered the clinical phase of its development and is being tested on humans for the first time.
Up to 24 Alzheimer's patients at the "mild to moderate" disease stage are to be vaccinated, with the aim of this initial phase I trial being to demonstrate the vaccine's safety and its suitability for human use.
The patients will be vaccinated four times over a period of three months, and the safety and suitability of the vaccine will be analysed over six months.
This development means that the 8.5 million euros venture capital finance agreement the company concluded with Munich-based MIG-Fonds in April 2006 has reached a key milestone on schedule.
Affiris says it has developed the Alzheimer's vaccine from patented Affitope technology, which is based on mimotopes and allows customised vaccines to be manufactured cost-effectively.
Related links:
Alzheimer's Disease – Diagnosis, Disease Modification and Prevention Key to Growing Market
Antares and Jazz to jointly develop CNS treatment
US-based Antares Pharma has signed a worldwide product development and license agreement with Jazz Pharmaceuticals, completing a feasibility agreement that was initiated between the companies in December 2005.
The product candidate underlying the agreement is being developed to treat a significant CNS disorder and is based on Antares' proprietary ATD (Advanced Transdermal Delivery) drug delivery platform, which is dedicated to the development of gels that offer a cosmetically superior option to patches.
Approved products from the same class of compounds represented worldwide sales of more than $2 billion in 2006, and are projected to achieve sales of at least $3.1 billion in 2010, Antares said.
Jazz Pharmaceuticals will pay Antares upfront and product development milestone payments in addition to payments for any future development activities. Antares will also receive royalties on product sales upon commercialisation. According to Antares, total milestone and minimum royalty payments could add up to $16.5 million or more over the life of the agreement.
Jazz Pharmaceuticals is responsible for the development and commercialisation of the product candidate, and will cover the costs of clinical trials, regulatory filings, and all manufacturing and marketing associated with the product candidate.
Jack Stover, president and CEO of Antares, said: "Moving forward with Jazz Pharmaceuticals is another significant validation of the quality, versatility and commercial potential of our ATD delivery system. We are extremely pleased with our progress in a key therapeutic area of CNS and believe it will help patients in an important and meaningful way."
Related links:
Antares Pharma Inc: LSA company report
Jazz Pharmaceuticals: LSA company report
The CNS Market Outlook to 2011
Innovations in CNS: Novel therapeutics and future R&D strategies
Arena initiates Phase I trial of thrombosis treatment
Arena Pharmaceuticals has initiated dosing in a phase I clinical trial evaluating APD791, its orally administered, internally discovered drug candidate intended for the treatment of arterial thrombo-embolic diseases.
This Phase I trial is planned to enrol up to 72 healthy adult volunteers and is primarily intended to evaluate the safety and tolerability of single ascending doses of APD791. In addition, the trial will also evaluate the pharmacokinetics and pharmacodynamics of APD791.
The trial is a randomised, placebo-controlled, double-blind, single-ascending dose trial in healthy male and female volunteers between the ages of 19 and 45 years old. It will include up to eight cohorts of nine volunteers each. In each cohort, three volunteers will be assigned to receive placebo and six volunteers will be assigned to receive APD791 in an ascending dose fashion.
In addition to evaluating APD791's safety and tolerability profile, the trial will also evaluate the pharmacokinetics and pharmacodynamics of single oral doses of APD791. Pharmacodynamics will be evaluated by measuring ex vivo inhibition of platelet aggregation.
A second phase I trial is planned to start after the first trial is completed. The second trial is primarily intended to evaluate the safety and tolerability of multiple ascending doses of APD791.
Related links:
Arena Pharmaceuticals: LSA company report
Pipline Insight: Antithrombotics – Reaching the untreated prophylaxis market
Cougar Biotechnology gets FDA backing for cancer drug trial
Cougar Biotechnology says its investigational new drug application for its multiple myeloma drug has been approved by the FDA.
This will allow Cougar to conduct a phase I clinical trial of CB3304, an orally active inhibitor of microtubule dynamics, for the treatment of relapsed or refractory multiple myeloma in the US.
Cougar expects to conduct the phase I clinical trial at a number of clinical sites, including Weill Cornell Medical College and Columbia Presbyterian Medical Center. CB3304 is an orally active alkaloid derived from opium. Preclinical studies demonstrate that CB3304 alters microtubule dynamics, blocks cell division (mitosis) and causes apoptosis (programmed cell death).
Alan Auerbach, CEO and president of Cougar biotechnology, commented: "This represents the second drug in Cougar's pipeline to advance into clinical trials and also represents a key corporate objective for the company this year."
Related links:
Cougar Biotechnology Inc: LSA company report
Stakeholder Opinions: Gynecological Cancers – Niche opportunities in advanced disease
Commercial Insight: Top 20 Cancer Therapy Brands – Sales of targeted therapies
MedImmune advances potential treatment for lupus
Maryland, US-based drug maker MedImmune has started dosing patients in a multi-dose, phase Ib clinical trial of MEDI-545, its monoclonal antibody targeting interferon-alpha. The study is designed to evaluate the safety and tolerability of multiple doses of MEDI-545 in patients with systemic lupus erythematosus, a chronic inflammatory disease.
In a press release, MedImmune said that the trial is the third clinical study of the antibody currently underway. MEDI-545 is also being evaluated in a single-dose phase I trial in lupus patients and a phase I study in patients with psoriasis.
The phase Ib trial will build on preliminary data from the ongoing phase I study in lupus patients. Early results from the single-dose trial show an acceptable safety profile and tolerability of MEDI-545.
In addition to advancing MEDI-545 as a potential treatment for lupus, MedImmune has recently expanded the anti-interferon-alpha programme to include other potential disease areas. As well as the phase I trial in patients with psoriasis that was initiated earlier in 2007, MedImmune plans to begin a trial in idiopathic inflammatory myopathies later this year.
"This multi-dose study marks an important milestone in MedImmune's efforts to develop innovative treatments for inflammatory diseases such as lupus," said Barbara White, vice president, clinical development, inflammatory disease at MedImmune.
Related links:
Medimmune Inc: LSA company report
Systemic Lupus Erythematosus: The Wait For Lupus-Specific Treatments
Stakeholder Opinions: Systemic Lupus Erythematosus – On the Verge of a Breakthrough
