SPTA News!!
Sparta Pharmaceuticals Inc. Announces Clinical Findings at American
Association for Cancer Research Conference
HORSHAM, Pa.--(BUSINESS WIRE)--April 1, 1998--Sparta Pharmaceuticals Inc. (NASDAQ:SPTA, SPTAU, SPTAW,
SPTAZ AND SPTAL) announced pharmacokinetic results of an ongoing Spartaject(TM) busulfan Phase I clinical trial.
The company's Spartaject(TM) Technology is a drug delivery system that accommodates poorly water soluble and water
insoluble compounds by encapsulating fine particles with a fatty (phospholipid) layer, thereby permitting the creation of a
suspension of the drug, and allowing its intravenous injection without the use of potentially toxic solubilizing agents.
The study was presented yesterday by Lori Hollis, Pharm. D., Louise Grochow, M.D., colleagues at Johns Hopkins University
School of Medicine and Duke University, at a meeting of the American Association for Cancer Research at Ernest N. Moral
Convention Center, New Orleans.
Patients in the ongoing study are being treated with a new intravenous (i.v.) form of busulfan for bone marrow ablation prior to
bone marrow transplantation. Busulfan is currently available only in tablet form.
Use of the tablet is associated with substantial variability in busulfan blood levels. This variability may contribute to toxicity or
problems with bone marrow engraftment or relapse of the patients' underlying disease.
As presented, parenteral administration (i.v.) of busulfan may permit more consistent drug exposure, simplify drug
administration and therapeutic monitoring, and may further reduce the incidence of VOD (vascular occlusion disease). Busulfan
(oral) and Spartaject busulfan (i.v.) were administered to patients. Safety and bioavailability at low and high dose were
assessed. No unexpected toxicities have been noted. As expected, to date, the data demonstrate the busulfan blood levels
were less variable after Spartaject busulfan than after oral busulfan.
Approximately 11,000-12,000 patients in the U.S. receive bone marrow transplants each year. The European market is
believed to be of similar size. If approved, Spartaject busulfan will be directed at this large and expanding market opportunity.
Administering busulfan intravenously rather than requiring patients to take a hundred tablets a day would be an attractive
treatment. Spartaject busulfan is nearing the end of Phase I trials in the U.S. and U.K. and the company presently plans to
initiate major Phase II trials late this year.
This press release contains certain forward-looking statements within the meaning of the ''safe harbor'' provisions of the Private
Securities Litigation Reform Act of 1995.
Such statements are made based on management's current expectations and beliefs, and actual results may vary from those
currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, including
the success and timing clinical trials and the receipt of necessary approvals by the FDA.
The company undertakes no obligation to release publicly any revisions which may be made to reflect events or circumstances
after the date hereof.
Sparta is a development stage pharmaceutical company engaged in the business of acquiring rights to, and developing for
commercialization, technologies and drugs for the treatment of a number of life threatening diseases including cancer,
cardiovascular disorders, chronic metabolic diseases and inflammation.
The company has focused on acquiring compounds that have been previously tested in humans and animals and technologies
that may improve the delivery or effectiveness of previously tested, and in some cases marketed, drugs.
Sparta's portfolio of compounds in development includes four potential oncology products and one for the treatment of Type II
diabetes in clinical trials and an emerging platform technology in recombinant and small molecule protease inhibitors.
Contact:
Sparta Pharmaceuticals Inc.
Jerry B. Hook, Ph.D.
Chairman, President & CEO
215/442-1700, Ext. 205
or
Martin Rose, M.D.,J.D.
Vice President, Clinical & Regulatory Affairs
215/442-1700, Ext. 219 |
