SPARTA
Asulacrine clinical trial commenced in United Kingdom RII retinamide clinical trial began in United States U.S. patent awarded to Wichita State University for two novel classes of serine protease inhibitors licensed exclusively to Sparta Pharmaceuticals, Inc. Private placement financing completed Dr. Colin Bier appointed to Sparta's Board of Directors
Dear Sparta Shareholder;
Several major goals were achieved during the third quarter of 1996, including the initiation of two clinical trials. U.S. patent approval for Wichita State's two novel classes of serine protease inhibitors was a major step forward. International patent filings have also been made.
Sparta's collaborator in the United Kingdom, the Cancer Research Campaign, initiated a second Phase I/pharmacokinetic trial with a new oral formulation of asulacrine, a potential anticancer agent to which Sparta has an option. We believe this compound has potential in treating breast and lung cancer.
The previous Phase I trial for asulacrine, which used an intravenous formulation, was completed in late 1995. Local toxicity of the i.v. formulation led to the development of the oral version. We are hopeful that the new oral formulation will prove to be an effective method to administer this promising agent to patients.
On August 30, Sparta began its first U.S. clinical trial with RII retinamide, a retinoid compound, for the treatment of myelodysplastic syndromes (MDS). Retinoids, which are derivatives of Vitamin A, were first discovered by Chinese scientists to have therapeutic effects on certain types of leukemia and other serious diseases. They work by a mechanism referred to as "re-differentiation" to normalize cells that have become abnormal, or dysplastic.
MDS are a heterogeneous group of bone marrow disorders for which there is currently no standard therapy except supportive care in the form of blood transfusions and anti-infective therapy, when appropriate. Sparta believes RII has the potential to alter the course of these difficult diseases, and to lessen the effects of MDS on their patient's quality of life and the economics of the health care system in general.
Although this trial is classified as a Phase I/II trial, Sparta has approval to administer RII retinamide to patients for periods of 6-24 weeks. Thus, patient selection is a very important aspect of this trial. In order to accelerate patient enrollment, multiple clinical sites are now being added.
With support from a Sparta funded grant, Dr. William C. Groutas, of Wichita State University, has created two novel classes of serine protease inhibitors. These compounds may have potential to treat many debilitating diseases, for which little or no effective treatments are currently available, such as: asthma, emphysema, cystic fibrosis, bronchitis, colitis, psoriasis, sepsis and other inflammatory states.
There have been promising results in vitro, regarding potency and specificity of the various compounds. In addition, these molecules are readily modified to tailor specificity for a defined target enzyme. Sparta has been granted an exclusive, worldwide license to develop and commercialize these compounds for human therapeutic use.
Sparta completed the closing of its previously announced private placement of equity securities on August 23. Aggregate gross proceeds amounted to $12,965,000. Total net proceeds raised in this year so far amount to $13,330,000.
Proceeds from this private placement are expected to be used to conduct initial human clinical trials of SpartajectTMbusulfan, RII Retinamide and L.A.D.D.(Trade Mark) 5-FP, for research and development activities and for working capital purposes. Sparta is extremely pleased by the favorable response we received from investors in this financing. These funds provide a solid base upon which to build our cancer chemotherapy franchise and to support our growing preclinical program in serine protease inhibitors.
Dr. Colin Bier was appointed to Sparta's Board of Directors. Dr. Bier has had extensive management experience in the biomedical sector, and he serves on the board of several private and publicly traded pharmaceutical companies. He is a leading authority on toxicology, pharmaceutical and biotechnology regulations and strategic development. We thank you for your interest in and support of Sparta.