SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported) May 15, 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 May 15, 1996, Sparta Pharmaceuticals, Inc. issued a press release
filed as Exhibit 99.5 hereto announcing the clearance by the FDA to
begin clinical trials with 5-fluoro pyrimidinone (5-FP), an orally
bioavailable prodrug of the widely used anti-cancer agent, 5-
fluorouracil (5-FU).
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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99.5 -- Press Release, dated as of May 15, 1996, announcing
clearance by the FDA of 5-FP for clinical trials.
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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.
June 3, 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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99.5 -- Press Release, dated as of May 15, 1996,
announcing the clearance by 5
the FDA for clinical trials of 5-FP.
Exhibit 99.5
Release: IMMEDIATE
Contact:
Jerry B. Hook
President & CEO
Sparta Pharmaceuticals
(215) 442-1700, ext.205
SPARTA ANNOUNCES APPROVAL OF THIRD IND IN A YEAR
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HORSHAM, PA May 15, 1996 /PR NEWSWIRE/ -- Sparta Pharmaceuticals, Inc.
(Nasdaq: SPTA) announced today that the FDA has approved a recently filed IND
application which now allows Sparta to begin clinical trials with 5-fluoro
pyrimidinone (5-FP), an orally bioavailable pro-drug of the widely used anti-
cancer agent, 5-fluoroouracil (5-FU). This is the third of Sparta's compounds to
be granted IND approval in the past year, the others being SpartajectTM busulfan
and RII retinamide.
5-FP is the first compound from Sparta's L.A.D.D.TM Technology, a process
whereby certain inert prodrugs are administered orally but are activated in the
liver by an enzyme uniquely found there. Animal studies have demonstrated that
this technique allows the systemic delivery of 5-FU by administering 5-FP
orally. Sparta's first clinical trial, which will take place in Philadelphia,
will seek to confirm the findings in patients. Thereafter, Sparta intends to
develop 5-FP as an oral delivery form of 5-FU for those indications currently
approved for the active drug.
5-FU is widely used in the palliative management of gastrointestinal,
breast and head and neck cancers, with an estimated 250,000 patients receiving
the drug annually. However, only intravenous forms are currently available and,
since continuous intravenous infusion has become a preferred, though not
approved, mode of administration, an oral dosage form with the same activity
would be highly desirable from both patient convenience and cost standpoints.
"This is an exciting development for Sparta and for patients with a number of
common malignancies.", said Dr. William McCulloch, Sparta's Senior Vice
President of Research and Development. "We intend to confirm that this approach
is appropriate for patients and make the new drug available as quickly as
possible".
This news release contains forward-looking statements. Actual results
could vary from those currently expected and involve risks and uncertainties,
such as the inherent uncertainty of the drug development process, and the
duration and difficulty of obtaining necessary regulatory approvals. The company
undertakes no obligation to release publicly any revisions of these forward-
looking statements which may be made to reflect events or circumstances after
the date hereof.
Sparta Pharmaceuticals 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 and acute
inflammation.
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