Research Triangle Park, North Carolina (PRWEB) November 14, 2012
BioMarck Pharmaceuticals announces that the US Patent & Trademark Office has granted a new US patent (#8,293,870) for the use of its proprietary peptides in COPD (chronic obstructive pulmonary disease). BioMarck’s proprietary peptides are designed to inhibit the function of the MARCKS protein. This new patent not only adds protection for the use of BioMarck’s lead compound, BIO-11006 (and a large number of its analogs) in the treatment of COPD, but also extends patent protection through 2026. An earlier composition of matter patent (#7,524,926) already protects the amino acid sequences of BioMarck’s proprietary peptides (including BIO-11006) through 2025, and also protects their use in asthma through the same date.
This announcement strengthens the hope that better treatments for COPD will be found and made available to the many millions of patients with COPD whose lives are currently being compromised and shortened by the disease, as strong patent coverage is needed to justify and secure the huge investments required to develop new drugs in major diseases like COPD. “This timely grant of the patent in COPD provides concrete support for the theme adopted for the 2012 World COPD Day to be held on November 14, 2012, “It’s Not Too Late.” In fact dramatic improvements in the treatment of COPD are the best hope for the many, many millions of current sufferers from COPD.” says Dr. Indu Parikh, President and CEO of BioMarck Pharmaceuticals.
COPD is a common lung disease affecting approximately 13 million people in the United States and more than 150 million people worldwide. COPD is the only major disease for which mortality is increasing. COPD is currently the third leading cause of death in the United States, and the fourth leading cause of death worldwide. In addition to its high mortality, COPD also causes a great deal of morbidity, including chronic cough, chronic shortness of breath, exercise intolerance, and recurrent hospitalizations for exacerbations (the latter are often precipitated by infections). Annual costs of COPD in the United States were $49.9 billion in 2010. Two physiologic hallmarks of COPD are excessive production of mucus and chronic pulmonary inflammation.
COPD has many causes ranging from environmental or work exposures to air pollutants to genetic disorders, but the most common cause of COPD is smoking. No cures of COPD are available, although several medications have been shown to improve symptoms and reduce hospitalizations. Beta agonists, anti-muscarinic agents, and corticosteroids constitute the backbone of the best available treatment of COPD. The worldwide pharmaceutical market in COPD exceeds $30 billion per year. However, given the high residual morbidity and mortality of COPD, best available treatment leaves much room for improvement.
About The MARCKS Protein And The MANS Peptide
The MARCKS protein (Myristoylated Alanine-Rich C-Kinase Substrate) is a ubiquitous 332-amino acid protein the sequence of which is highly conserved across all mammalian species. The function of the MARCKS protein remained unknown until Dr. Kenneth Adler at North Carolina State University and colleagues showed in 2001 that in lung cells, the MARCKS protein mediates release of mucus. The MARCKS protein is now known to mediate release of a wide array of substances from many different cell types.
About The MANS Peptide
Dr. Adler et al. demonstrated that the MARCKS protein mediates mucus release from lung cells by showing that the 24-amino acid N-terminal sequence of the MARCKS protein, called the MANS peptide (MyristoylAted N-terminal Sequence), blocks release of mucus from lung cells. Subsequent work by Dr. Adler and colleagues showed that MANS peptide also blocks release of cytokines and inflammation in the lungs, proving the additional role of the MARCKS protein in release of inflammatory mediators. BioMarck has a worldwide exclusive license from North Carolina State University on the sequence of the MANS peptide and on use of MANS peptide’s mucus-inhibiting and anti-inflammatory properties in variety of lung diseases.
BIO-11006 is a ten-amino acid peptide identified by BioMarck. BIO-11006 is the shortest N-terminal sequence of the MANS peptide (and of the MARCKS protein) that blocks release of mucus from lung cells equally well or better than the MANS peptide itself. In BIO-11006, the myristoyl present at the N-terminal in the MARCKS protein and at the N-terminal of the MANS peptide is replaced with acetate to increase solubility. The structure of BIO-11006 is Ac-Gly-Ala-Gln-Phe-Ser-Lys-Thr-Ala-Ala-Lys-OH. The solubility of BIO-11006 is 100 mg/mL. The half-life of BIO-11006 in isolated human plasma is 1-2 minutes, thereby preventing systemic exposure after topical administration in the lungs. The half-life of BIO-11006 in explanted mucus from patients with COPD is greater than 1.9 hours, providing sufficient half-life after pulmonary deposition by inhalation to cause topical pharmacologic effects in the lungs. In clinical trials, BIO-11006 has been administered as a nebulized solution once or twice per day over periods ranging from 5 to 15 minutes. There are no known technical barriers to a future dry powder (DPI) formulation.
BIO-11006 has been studied in three placebo-controlled clinical trials in which a total of 239 subjects have participated: two Phase 1 trials in a total of 67 normal volunteers, and a 172-patient, double-blind, placebo-controlled Phase 2a trial in patients with stable moderate COPD (GOLD Classes 2-3) on best available treatment. In the Phase 1 studies, single nebulized doses of up to 1000 mg were well-tolerated in volunteers, and single daily repeat nebulized doses of up to 125 mg/day were well tolerated in volunteers for 14 days. In the Phase 2a trial, four doses of BIO-11006 administered for three weeks were compared to placebo in patients with stable moderate COPD on best available treatment. In the Phase 2a the 75 mg twice per day dose showed promising improvements in FEV1 during treatment that persisted for the four week post-treatment observation period, and reasonable safety. As a result, BioMarck plans to carry the 75 mg twice per day dose forward into Phase 2b.
About BioMarck Pharmaceuticals
BioMarck Pharmaceuticals Ltd. is a private drug development company located in a Research Triangle Park, North Carolina that was founded in 2002 based on the discovery at North Carolina State University that the MANS peptide blocks mucus release in lung cells by inhibiting the function of the MARCKS protein. BioMarck subsequently identified BIO-11006 as its lead compound, and selected COPD as the first clinical indication. The latter was selected as the initial indication because COPD is one of the most-prevalent poorly-treated symptomatic diseases in man, and because its incidence continues to increase as a result of the worldwide epidemic of smoking. Asthma and cystic fibrosis are additional indications BioMarck plans to target later.
To date BioMarck has raised approximately $16M in private equity, and an additional $4M from three SBIR grants, to fund its research and drug development programs in COPD. Those programs have resulted in the identification of BIO-11006, successful IND filing for BIO-11006, and completion of three clinical trials of BIO-11006- including a 172-patient, double-blind, placebo-controlled trial in patients with stable moderate COPD on best available therapy
BioMarck has designed a $15M Phase 2b program for BIO-11006 in COPD that is planned to culminate in a double-blind, placebo-controlled Phase 2b trial in 300 patients with stable moderate COPD on best available therapy. The planned Phase 2b trial is designed to compare four doses of BIO-11006 (10 mg, 25 mg, 50 mg, and 75 mg) twice a day for three months to placebo. BioMarck has a fourth SBIR grant for $3M pending that if awarded will fund approximately 1/5 of the planned $15M Phase 2b program. BioMarck intends to raise an additional $2M from current investors and $10M in outside funding via partnership or equity investments to fund of its planned Phase 2b program.
About World COPD Day
World COPD Day is organized by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) in collaboration with health care professionals and COPD patient groups throughout the world. Its aim is to raise awareness about chronic obstructive pulmonary disease (COPD) and improve COPD care throughout the world. The first World COPD Day was held in 2002. Each year organizers in more than 50 countries worldwide have carried out activities, making the day one of the world's most important COPD awareness and education events. World COPD Day 2012 will take place on Wednesday, November 14 around the theme “It’s Not Too Late.” This positive message was chosen to emphasize the meaningful actions people can take to improve their respiratory health, at any stage before or after a COPD diagnosis. GOLD was launched in 1997 by the NIH and WHO to work with health care professionals and public health officials to boost awareness of chronic obstructive pulmonary disease (COPD) and decrease the morbidity and mortality caused by this respiratory illness.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, all contents of this press release. While BioMarck Pharmaceuticals Ltd. believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that outcomes of ongoing or planned preclinical and clinical trials may not be favorable; that the initiation of a Phase 2b program to evaluate additional doses and longer durations of treatment with BIO-11006 may be prevented or delayed; that the company may not be able to successfully develop new treatments for COPD; and other risks not explicitly stated nor known. BioMarck disclaims any obligation to update the information contained in this press release as new information becomes available.