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_______________________________________________________________________________
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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):
June 24, 1998
PACIFIC PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in its charter)
Delaware
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(State or other jurisdiction of incorporation)
1-9613 36-3258753
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(Commission File Number) (IRS Employer Identification Number)
6730 Mesa Ridge Rd.
Suite A
San Diego, California 92121
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (619) 550-3900
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Item 5. Other Events.
On June 24, 1998, Pacific Pharmaceuticals, Inc. (the "Company") received
notice from the American Stock Exchange ("AMEX") that Amex intends to take
action to remove the Company's Common stock from the AMEX because the Company
no longer satisfies all of the financial guidelines of the AMEX for continued
listing. The Company issued a news release dated June 25, 1998 announcing
that the Company will exercise its right to appeal to the Board of Governors
of AMEX the decision to remove the Company's Common Stock from the AMEX.
There can be no assurance that the appeal by the Company will be successful,
and that the listing will be continued. The Company is taking measures to
ensure that in the event of an unsuccessful appeal, an orderly transition
will occur and that its Common Stock will commence trading on the Electronic
Bulletin Board.
The Board of Directors of the Company has formed a Strategic Committee
consisting of H. Laurence Shaw, Jack H. Halperin and Michael S. Weiss. The
Strategic Committee will address issues in connection with the AMEX action
and the Company's appeal thereof, and will continue to explore opportunities
to enhance shareholder value, including financing and strategic alliance
options, business combinations, and the continuation of growing the Company
according to its current business plan. There can be no assurance that any
opportunities will be available or any transactions consummated on favorable
terms.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) EXHIBITS. The following exhibit accompanies this Report:
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<CAPTION>
EXHIBIT
NUMBER EXHIBIT DESCRIPTION
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<S> <C>
99.61 News release dated June 25, 1998 announcing that the
Company will exercise its right to appeal to the Board
of Governors of the AMEX the decision to remove the
Company's Common Stock from the AMEX.
</TABLE>
2
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
PACIFIC PHARMACEUTICALS, INC.
By: /s/ James Hertzog
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James Hertzog
Date: June 26, 1998 Controller-Principal Accounting Officer
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INDEX TO EXHIBITS
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<CAPTION>
EXHIBIT SEQUENTIALLY
NUMBER DESCRIPTION OF EXHIBIT NUMBERED PAGE
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<S> <C> <C>
99.61 News release dated June 25, 1998 announcing
that the Company will exercise its right to
appeal to the Board of Governors of the
AMEX the decision to remove the Company's
Common Stock from the AMEX.
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EXHIBIT 99.61
Contact: Linda B. Preucil (AMEX) PHA
Director of Business Relations WWW.PACIFICPHARM.COM
908/497-0160
[email protected]
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FOR IMMEDIATE RELEASE
PACIFIC PHARMACEUTICALS, INC. APPEALS DELISTING DECISION
BY THE AMERICAN STOCK EXCHANGE
San Diego, CA. June 25, 1998. Pacific Pharmaceuticals, Inc. (AMEX:PHA)
announced that it will exercise its right to appeal to the Board of
Governors of the American Stock Exchange (AMEX) the decision yesterday to
remove the Company's Common Stock from the AMEX. AMEX believes that the
Company no longer fully satisfies all of the financial guidelines of the AMEX
for continued listing. There can be no assurance that the appeal by Pacific
Pharmaceuticals will be successful, and that the listing will be continued.
The Company is taking measures to ensure that in the event of an unsuccessful
appeal, an orderly transition will occur and that its Common Stock will
commence trading on the Electronic Bulletin Board.
Pacific has three cancer therapies, two of which are in the clinical phase of
development under US Food and Drug Administration (FDA) Investigational New
Drug Applications (INDs). These therapies include O6 Benzyl Guanine (BG), a
chemosensitizer that may overcome the resistance to a commonly used group of
chemotherapeutic agents, a boronated porphyrin (BOPP) for use in photodynamic
therapy (PDT), and a cancer immunotherapy for the treatment of metastatic
cancer. Both BG and BOPP are in human studies.
Pacific's collaborators believe that BG is capable of destroying the
resistance of cancer cells to a class of chemotherapeutic agents known as O6
alkylating agents, currently used to treat various cancers such as brain,
melanoma and lymphoma. "The potential now exists to treat cancers previously
thought to be unresponsive to this class of cancer drugs," commented Dr.
Henry S. Friedman, Professor of Pediatrics and Associate Professor of Surgery
and Medicine at the Duke University Medical Center. "The combination of
enhanced efficacy and reduced cancer drug resistance in patients treated with
O6 Benzyl Guanine may provide a considerable improvement in the treatment of
certain types of cancers." Studies led by Pugh Scholar Dr. Anthony E. Pegg
and his team have shown a correlation between low levels of the repair
protein AGT in tumors and enhanced responsiveness to treatment. Multiple
Phase I human clinical trials conducted at the University of
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EXHIBIT 99.61
Chicago, Duke University Medical Center and Case Western University are
nearing completion in different cancer types, including brain, color and
renal carcinoma.
BOPP is currently in a Phase I safety study in brain cancer patients under
the direction of Professor Andrew Kaye, a world renowned neurosurgeon and
authority on the use of photodynamic therapy for the adjunctive treatment of
brain tumors. This study is being conducted under a FDA IND at the Royal
Melbourne Hospital, Australia. To date, five patients have entered the study
and received BOPP. Photodynamic therapy is a platform technology suitable for
a variety of disorders including cancer, and various other disorders
including cardiovascular, gynecologic, and gastrointestinal disorders.
Discussions are ongoing with various potential corporate partners.
The cancer immunotherapy technology is undergoing preparation for the
clinical phase of development. In preclinical studies conducted to date, a
prolonged immune response has been demonstrated which results in the
clearance of metastatic tumor. In addition, rechallenge of surviving animals
with tumor results in tumor rejection in 100% of the tested survivors. A
pre-IND meeting held with the FDA resulted in an accelerated timetable to
enter clinical trials.
THIS NEWS RELEASE CONTAINS FORWARD LOOKING STATEMENTS. THE ACTUAL RESULTS
COULD VARY FROM THOSE EXPECTED DUE TO A VARIETY OF RISKS SET FORTH FROM TIME
TO TIME IN THE COMPANY'S FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION,
INCLUDING THE COMPANY'S REGISTRATION STATEMENT ON FORM S-3, AS DECLARED
EFFECTIVE ON SEPTEMBER 4, 1997, AND THE COMPANY'S FORM 10-K WHICH WILL BE
FILED FOR THE YEAR ENDED MARCH 31, 1998. THE COMPANY'S PRODUCTS, INCLUDING
BG, MUST UNDERGO AN EXTENSIVE REGULATORY APPROVAL PROCESS CONDUCTED BY THE
FDA AND APPLICABLE AGENCIES IN OTHER COUNTRIES, AND THERE CAN BE NO ASSURANCE
THAT REGULATORY APPROVAL WILL BE OBTAINED FOR BG OR ANY COMPANY PRODUCT. THE
COMPANY UNDERTAKES NO OBLIGATION TO PUBLICLY RELEASE THE RESULTS OF ANY OF
THESE FORWARD LOOKING STATEMENTS WHICH MAY BE MADE TO REFLECT EVENTS OR
CIRCUMSTANCES AFTER THE DATE HEREOF OR TO REFLECT THE OCCURRENCE OF
UNANTICIPATED EVENTS.