Syn X Pharma (Toronto, Ontario, Canada) is widening its product focus from stroke diagnostics to cardiac therapeutics. The company has an ongoing agreement with the University of Liege (Liege, Belgium) to fund basic research on myostatin and to receive the exclusive rights to commercialize potential applications of that research. U.S. patent No. 6,103,466, issued to the University of Liege, covers a method for determining the presence of muscular hyperplasia in a mammal. This is the first in a series of patents filed by, and now pending, to the university to secure intellectual property rights to discoveries regarding both the gene and protein myostatin, which has been identified as an inhibitor that limits striated (skeletal and heart) muscle growth.
George Jackowski, president and chief scientific officer of Syn X, said the first issued patent allows the company to develop genetic diagnostic tests to verify and measure the presence of gene mutations that cause muscular hyperplasia, or increased muscle growth, in mammals, including humans. Subsequent patents will allow Syn X to develop transgenic animals that possess specific myostatin mutations, then to create therapeutic medicines that encourage both cardiac and skeletal muscle growth. Previous research has demonstrated that switching off the myostatin gene in mice and other mammals results in the development of animals with muscular hyperplasia, sometimes referred to as "double muscling." In addition, it is known that in animals that have experienced a myocardial infarction, there is very high concentration of myostatin in the dead and damaged heart cells, while the unaffected, healthy cells show low concentration of the protein.
"To date, most research on myostatin has focused on animal health applications that could lead to cattle or poultry with more meat," Jackowski said. "Our intent is to carry this research to conclusions that benefit human health, both in reversing the loss of muscle mass associated with aging, and in remodeling and rebuilding heart muscle damaged by myocardial infarction. There is a desperate need for new medicines to help people recover cardiac function after a heart attack, and to prevent the development of deadly conditions such as congestive heart failure."
Syn X has been capitalizing on its antibody-based expertise to create and develop innovative diagnostic and risk assessment tests for applications in preventive medicine and patient management. The company also is involved in the development of risk assessment tests for Syndrome X-related diseases, a cluster of conditions that begins with insulin resistance or high blood pressure, which increases an individual's chance of developing diabetes, heart disease and stroke.
Syn X has already developed a Strokepanel test to diagnose stroke, licensed last year by Genzyme (Cambridge, Massachusetts) for worldwide manufacture and distribution. It also is working with the University of Ottawa Heart Institute Research Corp. (Ottawa, Ontario, Canada) to speed development of its point-of-care diagnostic test for congestive heart failure. Syn X will work closely with Adolfo de Bold, director of the cardiovascular endocrinology laboratory at the University of Ottawa Heart Institute and discoverer of the polypeptide hormones atrial natriuretic factor (ANF) and B-type natriuretic peptide (BNP) – markers for congestive heart failure. The markers are key to the development of a hand-held diagnostic test to identify heart failure.
News of new financings
Corvas International (San Diego, California) said it has completed a $115 million public offering of 5,750,000 shares of its common stock at $20 per share. The total includes the exercise of the underwriters' over-allotment option of 750,000 shares. The offering was led by CIBC World Markets and co-managed by Prudential Vector Healthcare, a unit of Prudential Securities, and U.S. Bancorp Piper Jaffray.
EP MedSystems (EPMD; Mount Arlington, New Jersey) reported entering into a debt financing of up to $3.2 million with Medtronic (Minneapolis, Minnesota) in the form of a secured promissory note bearing interest at 2% above the prime rate. It is repayable in three years and is secured by a pledge of stock owned by EPMD Chairman David Jenkins in another company. EP MedSystems received $1.6 million at closing and funding of the remaining portion of the loan will occur on or about Dec. 31. EP MedSystems makes cardiac electrophysiology products used to diagnose and treat certain cardiac disorders.
Hemosol (Toronto, Ontario, Canada) said it signed a $35 million senior credit facility with National Bank of Canada and The Bank of Nova Scotia to finance a portion of the construction and land costs for its new $65 million Hemolink manufacturing facility in Mississauga, Ontario. Hemolink is a purified human-derived hemoglobin replacement product manufactured through a series of proprietary processes which offer greater assurance of safety from viral and bacterial contamination and universal compatibility with all blood types, according to the company. Hemosol also said it expects to conclude a $12.5 million credit facility with a subordinated lender to fund the remaining balance of the construction and land costs. Completion of construction is expected in 1Q02 "with validation to follow in the third quarter of 2002," said John Kennedy, president and CEO. The facility will have an initial production capacity of 200,000 units per year and this can be increased to 600,000 units per year.
Ischemia Technologies (Denver, Colorado) has completed a second round of venture funding, closing on approximately $6.8 million in Series B preferred stock. The company said it has planned a second closing for this month, enabling other investors to participate up to a total round of $10 million. The funding will be used to conduct further clinical trials, obtain regulatory approval for the company's products, begin sales in Europe and the U.S. and develop new products and clinical uses for its proprietary diagnostic marker. The company's first product, the Albumin Cobalt Binding (ACB) Test, is a blood test intended for use to assist emergency physicians in diagnosing patients with chest pain. A negative ACB Test, combined with a negative troponin test, could lead physicians to stop the cardiac workup and turn their attention to other possible causes of chest pain, such as ulcers or muscle strain, according to the company. Ischemia Technologies has raised $12.8 million in total financing, including $4 million in Series A funding and $2 million in seed capital.
Guidant opens Cardiovascular Institute
Guidant (Indianapolis, Indiana) last month opened its new Cardiovascular Institute in its European head offices in Brussels, Belgium. The institute will train practitioners in new and emerging therapies for the treatment of vascular and coronary diseases. "This is an exceptional facility – as good as, or perhaps better than, any other in the world," said Ron Dollens, Guidant president and CEO. "The Cardiovascular Institute will certainly strengthen our presence in Europe and provide the training needed for the more rapid adoption of the life-saving innovations Guidant has developed." Three rooms at the institute will be devoted to practical training on virtual models and simulators, and are equipped with sophisticated high definition projectors. The auditorium is fully automated, with auto-tracking cameras and sophisticated light and sound controls. Additionally, it offers the ability to receive live transmissions of clinical cases from other European sites.
News of new grants
CryoLife (Kennesaw, Georgia), a tissue engineering company, reported receiving a $750,000 grant from the National Institutes of Health (NIH; Bethesda, Maryland) to advance its SynerGraft technology for the development of biologic vascular devices for applications in peripheral bypass surgical procedures. The SynerGraft technology is based on depopulated animal cells to provide a collagen matrix that has normal human tissue architecture, and it recently received CE-marking in Europe.
Inforum (Nashville, Tennessee) has been selected by the National Heart, Lung and Blood Institute (Bethesda, Maryland) to provide detailed profiles of populations most in need of information and education about cardiovascular disease, stroke and asthma. The information will be used to improve NHLBI treatment and prevention initiatives designed in response to Healthy People 2010, the federal government's national health improvement objectives. The amount of the funding was not disclosed. Inforum profiling capabilities provide the NHLBI with information on the demographic characteristics, health care use and attitudes, media habits and lifestyles of households most in need of services but least likely to seek preventive care for cardiovascular disease, stroke and asthma.
MetaPhore Pharmaceuticals (St. Louis, Missouri) has received a six-month $100,000 Small Business and Innovation Research grant to study the blood pressure drop that occurs during septic shock and leads to death in up to 50% of cases. Researchers from MetaPhore and the St. Louis University School of Medicine (also St. Louis) will study the levels of two key biological markers, one of which directly affects blood pressure, to see if what happens among human subjects correlates with the phenomenon they observed in recent animal studies. Findings of those studies, published in the Proceedings of the National Academy of Sciences in late summer, confirmed the role that oxygen free radicals, produced in excess during septic shock – particularly superoxide anions – play in deactivating the body's vascular regulation system.
Stanford University Medical Center (Stanford, California) has received a grant of $31.8 million from the Lucile Packard Foundation for Children's Health (Palo Alto, California), to establish a center to treat patients with pulmonary vascular disease and to support research dedicated to finding cures. The Vera Moulton Wall Center for Pulmonary Vascular Disease at Stanford will provide diagnostic and therapeutic services for adults and children with pulmonary vascular disease, focusing on pulmonary hypertension. It also will support and expand research collaboration between the schools of medicine and engineering at the university.