I just got a look here since David posted a day or so ago, I see the UP GOES UP'ER...can we say lets hear it for that little marine spoonge anymore? I saw a neat Discovery Channel show last 2 weeks about Meds from Marine Spoonges many many varrieties and only 2 % have been ...looked at so far. But that was when we were talking real molecu;res was it not? Not derived or copied I guess:
also NASDS were in the news about SARS last week. Some PROTESE INHIBITORS used for STDs may help ...tell them to try our SPOONGE!
Chucka
Inflazyme begins enrolment for phase 2a asthma trial
2003-05-12 16:49 ET - News Release
Mr. Ian McBeath reports
INFLAZYME ANNOUNCES INITIATION OF PHASE 2A ASTHMA TRIAL IN THE UNITED STATES WITH IPL512,602
Inflazyme Pharmaceuticals has commenced patient enrolment for the phase 2a asthma trial with IPL512,602, an oral, second-generation LSAID (leukocyte selective anti-inflammatory drug), being developed in collaboration with Aventis Pharma.
Ian McBeath, president and chief executive officer of Inflazyme, said, "We are very pleased to reach this important milestone in the development of IPL512,602 and look forward to working closely with our partner Aventis in the execution and completion of this important study."
About the study
The study is a 12-week, randomized, double-blind, parallel group trial comparing the safety, tolerability and efficacy of a daily oral dose of IPL512,602 to placebo in patients with mild to moderate persistent asthma.
The study will be undertaken in more than 20 centres across the United States and will enroll between 160 and 180 patients. The study is expected to take about 12 to 15 months to complete. Inflazyme remains responsible for the regulatory aspects of the study and chairs the partnership's joint steering committee. Aventis is responsible for conducting and financing the study.
The primary objective is to assess the effects of an oral dose of IPL512,602, administered once daily for 12 weeks, on lung function and clinical symptoms of asthma in patients with mild to moderate persistent asthma. A secondary objective will be to determine the safety and tolerability of IPL512,602 over the 12-week dosing period.
There are three periods to the trial. The first period is a screening visit, where eligibility is established and baseline lung function determined. The second period begins with the randomization of eligible subjects to either active drug (IPL512,602 tablets) or matched placebo, and will include several visits over a 12-week period. At each visit, lung function will be tested (FEV1 measurements) and patient diary and safety information will be collected. A subset of subjects will have assessments of airway hyper-responsiveness (PC20 using methacholine) and pharmacokinetics. The third period is a follow-up phase of two weeks to monitor further safety parameters.
Given a successful outcome of this study, Aventis may make a milestone payment of $10-million (U.S.) to Inflazyme and license this compound for commercialization. Inflazyme may continue to receive further milestones through to commercialization and double-digit royalties on sales.
Details of Inflazyme and the LSAIDs
Inflazyme is a Vancouver-based biopharmaceutical company focused on developing new therapies for the treatment of inflammation and other related diseases. Inflazyme's lead technologies are a range of novel, small-molecule LSAIDs that are being developed for a variety of inflammatory diseases. The company is developing three distinct series of LSAIDs -- the IPL5, IPL12 and IPL99 series. To date three LSAID molecules, from the IPL5 series, have entered human clinical trials.
In November, 2002, Aventis agreed to take over all program costs for the development of IPL512,602. At the same time the partnership was expanded by the addition of a new LSAID molecule, from Inflazyme's IPL12 series, as a second potential respiratory product, on terms identical to those for IPL512,602.
Inflazyme has other LSAIDs in clinical and preclinical development for other inflammatory diseases that are not included in the Aventis partnership.
Inflazyme has also developed a number of inhibitors of the enzyme phosphodiesterase 4 (PDE4). A lead molecule in this series, IPL455,903, was recently partnered with Helicon Therapeutics Inc. as a potential new treatment for disorders of memory associated with stroke and Alzheimer's disease. Other PDE4 molecules remain in development by Inflazyme.
About asthma
Asthma is a chronic inflammatory disease affecting the lungs. Patients with asthma experience wheezing, shortness of breath and a dry cough. An estimated 5,000 deaths in the United States are attributable to asthma each year. According to recent published studies, asthma affects an estimated 5 to 7 per cent of the population in North America and up to 10 per cent of children, and is one of the fastest-growing diseases. In 2001, the worldwide market for the treatment of asthma exceeded $12-billion (U.S.).
WARNING: The company relies upon litigation protection for "forward-looking" statements. |
