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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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FORM 8-K/A
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported) September 3, 1996
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SPARTA PHARMACEUTICALS, INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-23076 56-1755527
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
111 Rock Rd. Horsham, PA 19044
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (215) 442-1700
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ITEM 1. Changes in Control of Registrant.
Not applicable.
Item 2. Acquisition or Disposition of Assets.
Not applicable.
Item 3. Bankruptcy or Receivership.
Not applicable.
Item 4. Changes in Registrant's Certifying Accountant.
Not applicable.
Item 5. Other Events
On September 3, 1996, Sparta Pharmaceuticals, Inc. issued a press
release filed as Exhibit 99.8 hereto announcing the commencement of
its first U.S. clinical trial with RII retinamide.
Item 6. Resignations of Registrant's Directors.
Not applicable.
Item 7. Financial Statements and Exhibits.
(a) Financial Statements of Sparta Pharmaceuticals, Inc.
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Not applicable.
(b) Pro Forma Financial Information
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Not applicable
(c) Exhibits
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99.8 -- Press Release, dated as of September 3, 1996, announcing
the commencement of Sparta's first U.S. clinical trial
with RII retinamide.
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Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this amendment to be signed on its behalf by the
undersigned thereunto duly authorized.
Sparta Pharmaceuticals, Inc.
October 21, 1996 By: /s/ Jerry B. Hook
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Date Jerry B. Hook, Ph.D. President,
Chief Executive Officer & Director
(principal executive officer)
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EXHIBIT INDEX
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Exhibit
Number Description Page
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99.8 -- Press Release, dated as of September 3, 5
1996, announcing the commencement of Sparta's
first U.S. clinical trial with RII retinamide.
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Contacts: Jerry B. Hook, Ph. D. William McCulloch, MD
President & CEO Senior Vice President, R&D
Sparta Pharmaceuticals, Inc. Sparta Pharmaceuticals, Inc.
(215) 442- 1700 (919) 361-3462
FOR IMMEDIATE RELEASE
Sparta Pharmaceuticals, Inc. Announces Start of Clinical Trials for RII
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Retinamide
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Horsham, PA, September 3, 1996 -- Sparta Pharmaceuticals, Inc.
(NASDAQ:SPTA, SPTAU, SPTAW and SPTAZ) announced today that is has commenced its
first U.S. clinical trial with RII retinamide, a retinoid compound, for the
treatment of myelodysplastic syndromes (MDS). Sparta obtained a worldwide
license (excluding China) of RII retinamide from the Institute of Materia Medica
in Beijing, China and has one of the foremost Chinese scientists in this field,
Dr. Jui (Rui) Han, on its Scientific Advisory Board. The first U.S. patient
received the new therapy, which is delivered orally in capsule form, in
California on August 30, 1996. 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. The conditions are ultimately fatal but, during the progression of
the disease, can cause significant morbidity and economic burden. Chinese
researchers have reported that in studies with more than one hundred fifty (150)
Chinese patients with MDS treated by RII retinamide, the compound demonstrated
efficacy with limited toxicity. MDS is a so-called "orphan" indication, and
Sparta has received Orphan Drug status for RII retinamide from the FDA.
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.
"RII has the potential to alter the course of these difficult
diseases," said Dr. William McCulloch, Sparta's Senior Vice President of
Research and Development, "and to lessen the effects of MDS on their patients'
quality of life and the economics of the health care system in general."
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 clinical trials. The
Company undertakes no obligation to release publicly any revisions which may be
made to reflect events or circumstances after the date hereof.
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Sparta Pharmaceuticals, Inc. is a development stage
pharmaceutical company engaged in the business of acquiring the rights to, and
developing for commercialization, technologies and drugs for the treatment of a
number of life threatening diseases, including cancer, cardiovascular disorders
and acute inflammatory diseases.
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