Phase III Trial in Progress by Milkhaus Laboratory For Preleukemic Disorder.BOXFORD, Mass.--(BW HealthWire)--Sept. 8, 1997--Milkhaus Laboratory Inc., a clinical stage biopharmaceutical company, announced today that it is conducting a Phase III trial of its investigational agent, LDI-200, for the treatment of a preleukemic condition known as myelodysplastic syndrome or MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there . It is a forty patient, open-label, randomized trial comparing treatment with LDI-200 to the current standard treatment of transfusions and antibiotics. As with the company's earlier leukemia trial, it is being conducted at The New York Medical College New York Medical College is a center for graduate medical education located in Westchester County, a suburb half an hour north of New York City. This private university comprises the School of Medicine, which grants the M.D. in Valhalla, New York Valhalla is a hamlet and census-designated place (CDP) located in the town of Mount Pleasant in Westchester County, New York, United States. The population was 5,379 at the 2000 census. . The myelodysplastic syndromes are a heterogeneous group of blood disorders characterized by defective blood cell production, or hematopoiesis Hematopoiesis The process by which the cellular elements of the blood are formed. The three main types of cells are the red cells (erythrocytes), which serve to carry oxygen, the white cells (leukocytes), which function in the prevention of and recovery from , by the bone marrow. There are estimated to be 10,000 new cases of MDS in the United States per year, some of whom will develop overt leukemia, while others will suffer complications from bone marrow failure. No treatment has been consistently effective. Dr. John McMichael, the company's founder and president said, "Our first clinical trial with LDI-200 involved patients with acute myelogenous leukemia acute myelogenous leukemia n. Abbr. AML Myelogenous leukemia characterized by rapid abnormal increase in the number of myeloblasts and progression of symptoms. who were refractory to standard therapy. We were encouraged with the results of that study, in particular the effect of our therapeutic agent in patients with lower numbers of leukemic blast cells in their blood and in their bone marrow." He continued, "Our clinical trial data and our in vitro cell work suggested that the probable mechanism of action of LDI-200 was to induce apoptosis, the process of normal cell death that has gone awry in leukemia and other forms of cancer. Based on these results and the evidence that apoptosis is required for proper bone marrow function, it seemed reasonable to think our therapeutic agent might prove effective in treating MDS." The company currently has underway IND-based clinical trials of therapeutic agents for solid tumors, cancer-associated pain, benign prostatic hyperplasia benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. ("BPH"), chronic fatigue syndrome chronic fatigue syndrome (CFS), collection of persistent, debilitating symptoms, the most notable of which is severe, lasting fatigue. In other countries it is known variously as myalgic encephalomyelitis, chronic fatigue and immune dysfunction syndrome, and and cystic fibrosis. It has established a broad patent position for its regulatory signaling technology. CONTACT: Milkhaus Laboratory Inc. John S. Glass, 508/887-2086 |
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