BioMarck Pharmaceuticals, Ltd., a research company involved in the treatment of respiratory diseases, announced that it has completed enrollment in the middle dose group of its ongoing Phase 2 clinical trial and that an independent safety monitoring committee recently reviewed the safety results from the middle dose group of the study. Based on this review, the monitoring committee recommended that BioMarck continue enrollment in the study, known as the BREATH 1 study (BIO-11006: Respiratory Effectiveness of A Targeted Therapeutic).
Following this positive review, BioMarck had planned to escalate to the last dose group in the study (i.e., the high dose group). However, based on results of studies of BIO-11006 in mouse models, discussions with pulmonary experts, and feedback from potential partners, BioMarck has amended the BREATH 1 protocol to include two-dose groups that will receive BIO-11006 Inhalation Solution twice per day. This change in study protocol will add an additional 10 total patients to the study; each twice-per-day dose group will consist of 32 patients (24 BIO-11006 patients and eight placebo patients). The original protocol would have enrolled 54 more patients; 36 would have received 250 mg of BIO-11006 once per day, and 18 would have received placebo. BioMarck estimates that it will now complete enrollment in the BREATH 1 study in Q1 or Q2 2010.
BioMarck Chairman and Chief Executive Officer Allen F. Gant stated, “The completion of the middle dose group and review of the safety data achieves another important development milestone and is a positive step in our mission to treat COPD and other respiratory diseases associated with the over-secretion of mucus and pulmonary inflammation. I am also confident that the changes we have implemented into the BREATH 1 study serve to strengthen the study and maximize the chances of demonstrating the benefits of BIO-11006 Inhalation Solution.”
BIO-11006 Inhalation Solution inhibits the function of the MARCKS protein (myristoylated alanine-rich C kinase substrate), which has been shown to be a vital component for secretion of mucus and inflammatory mediators. These two inhibitory aspects of BIO-11006 Inhalation Solution have been demonstrated in several different animal models of airway disease.
Excessive secretion of mucus and inflammation are a common and distinguishing feature of COPD/chronic bronchitis, and studies conducted in the last several decades demonstrate the contribution of excessive mucus to the restriction of airflow in the lungs. However, there are no drugs that specifically inhibit excessive mucus secretion in the lungs; development of BIO-11006 Inhalation Solution may fill this therapeutic gap.
COPD, or chronic obstructive pulmonary disease, is generally defined by a limitation of airflow in the lungs. This limited airflow may result from repetitive lung injury and inappropriate injury repair in lung. The airways of the lungs are normally covered by mucus that protects the airways from dehydration, pathogens, chemicals, inflammation, reactive oxygen species, and particulate irritants. However, in response to repetitive irritant exposure from cigarette smoke, for example, excessive secretion of mucus and inflammation occurs.
It is expected that more than 50 million individuals worldwide will suffer from COPD by 2010. In the United States alone, COPD affects at least 12 million patients and causes 120,000 deaths per year, making it the fourth leading cause of death.
About BioMarck Pharmaceuticals
BioMarck Pharmaceuticals, Ltd. is a privately owned biopharmaceutical company dedicated to the discovery and development of new drugs for the treatment of pulmonary diseases and disorders associated with the over-secretion of mucus and pulmonary inflammation. In developing its lead compound, BIO-11006 Inhalation Solution, BioMarck has chosen chronic obstructive pulmonary disease (specifically chronic bronchitis) as its first target, but other diseases including asthma and cystic fibrosis are later disease targets. Conduct of the BREATH 1 study is supported in part by an SBIR Award (Number R44HL073591) from the National Heart, Lung, and Blood Institute. BioMarck licensed its technology on a worldwide exclusive basis from North Carolina State University. For more information on BioMarck, please visit its Web site at www.biomarck.com. The content of this release is solely the responsibility of BioMarck and does not necessarily represent the official views of the National Heart, Lung, And Blood Institute or the National Institutes of Health.
Company Contact
Simon Fitall
sfitall@biomarck.com
This press release might contain forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "might," "could," "will," "would," "expect," "plan," "believe," "estimate," "predict," "plan," "intend," "goal," or the negative of such terms or other similar expressions. Forward-looking statements reflect our current expectations and views about future events as of the time we published these documents. The forward-looking statements involve known and unknown risks, uncertainties and other factors that might cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. Given these risks and uncertainties, you should not place undue reliance on any such forward-looking statements. In addition, the information in this press release is believed to be accurate as of the date hereof, but should not necessarily be relied upon to reflect management's current views at any future date.
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