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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
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Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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DATE OF REPORT: May 19, 1999
(Date of earliest event reported)
PHOTOGEN TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
NEVADA 0-23553 36-4010347
(State or other jurisdiction (Commission File Number) (I.R.S. Employer
of incorporation or Identification No.)
organization)
7327 OAK RIDGE HIGHWAY, SUITE B
KNOXVILLE, TENNESSEE 37931
(Address of principal executive offices) (Zip Code)
(423) 769-4011
(Registrant's telephone number including area code)
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ITEM 5. OTHER EVENTS.
Photogen Technologies, Inc. (the "Company") issued a press release
announcing the preliminary results of an animal feasibility study of its
proprietary phototherapeutic technology for use in the treatment of ocular
melanoma, a cancer of the eye. The Press Release, dated May 19, 1999, is
attached as Exhibit 99 hereto.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) The following exhibit is filed with this report:
99 Press release of the Company, dated May 19, 1999, announcing the
preliminary results of an animal feasibility study of its proprietary
phototherapeutic technology for use in the treatment of ocular
melanoma, a cancer of the eye.
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.
Photogen Technologies, Inc.
By: /s/ John Smolik
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John Smolik, President
Date: May 20, 1999
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EXHIBIT INDEX
Exhibit Description
No.
99 Press release of the Company, dated May 19, 1999, announcing the
preliminary results of an animal feasibility study of its
proprietary phototherapeutic technology for use in the treatment
of ocular melanoma, a cancer of the eye.
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Exhibit 99
Photogen-TRADEMARK-
Technologies, Inc.
Photogen Technologies, Inc. * 7327 Oak Ridge Highway * Knoxville, TN 37931
Voice: 423-769-4012
Fax: 423-769-4013
Internet: www.photogen.com
AT THE COMPANY: AT THE FINANCIAL RELATIONS BOARD:
JOHN SMOLIK LESLIE HUNZIKER CAROLYN PRICE DARCY BRETZ
PRESIDENT & CEO GENERAL INFO. ANALYST INQUIRIES MEDIA INFO.
(423) 769-4012 (312) 266-7800
FOR IMMEDIATE RELEASE
WEDNESDAY, MAY 19, 1999
Photogen Announces Favorable Preliminary Results
in Ocular Melanoma Studies
KNOXVILLE, Tenn., May 19 /PRNewswire/ -- Photogen Technologies, Inc. (OTC
Bulletin Board: PHGN - news), announced preliminary results of an animal
feasibility study of its proprietary phototherapeutic technology for use in the
treatment of ocular melanoma, a cancer of the eye. The study, a joint research
project of Photogen and the Massachusetts Eye and Ear Infirmary (MEEI), is being
led by Lucy Young, M.D., Ph.D., and was designed to evaluate the use of
ultrafast lasers for cancer treatment. Photogen's technology when applied to
ocular melanoma does not rely on the introduction of a drug into the body, but
rather, activates naturally occurring melanin precursors in the cancerous tumor
in order to selectively kill diseased cells. Tests are being conducted using a
rabbit ocular melanoma model. The preliminary results of the study are showing
that tumors can be eliminated with one or more treatments and that the effects
of the treatment are confined to the immediate area of the tumor with little or
no collateral damage to healthy tissues. The results confirm earlier work by
Photogen using subcutaneous melanoma tumors in mice.
"We are encouraged by Dr. Young's results, although preliminary and involving a
small number of animals, which so closely match our own findings," said John
Smolik, Photogen's president and chief executive officer. "The trials at MEEI
are the first step toward developing a variety of applications for treating
diseases or disorders of the eye using ultrafast lasers and our photoactivation
technologies. Concurrent with the ocular melanoma
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trial, we are conducting feasibility studies at MEEI with a variety of
photoactive drugs for advanced macular degeneration, the leading cause of
blindness among older Americans, a market estimated to exceed $800 million
per year."
Dr. Young, a board certified ophthalmologist at MEEI, a Harvard Medical School
teaching affiliate, said, "The new laser treatment appears to be very effective
in the destruction of ocular melanoma. We were able to effectively treat the
melanoma at two different wavelengths, suggesting broad efficacy of the
ultrafast activation technology. Our next goals are to validate these results,
optimize treatment parameters, and gain more information about post-treatment
metastases. Should this early work be subsequently borne out in human trials,
this technology could lead to enhanced survival rates and better visual outcome
for patients suffering from ocular melanoma." About 2,000 cases of the disease
are diagnosed in the U.S. each year.
Photogen's system is believed to be the first ultrafast laser device for
treating retinal disease. The new laser device utilizes Photogen's proprietary
multi-photon activation technology, and makes use of special laser beam focusing
and scanning capabilities.
Photogen's multi-photon activation technology is different from conventional
photodynamic technology in that it uses rapidly pulsed, longer wavelength light
to more effectively stimulate photoactive agents. This results in defined
eradication of the affected area, more precise execution and deeper penetration
of therapeutic light into diseased tissue.
Photogen Technologies, Inc. is a development-stage company focused on creating
photodynamic-related health-care products based on its proprietary multi-photon
excitation and other related technologies. The company has discovered new
methods for using laser-generated light to activate photoactive agents within
deep tissue sufficient to produce a range of beneficial therapeutic and
diagnostic outcomes. These technologies involve methods, materials and devices
that may be used to produce light and photoactive agents that will destroy
diseased cells, remove tissue or identify and diagnose disease. Photogen's
proprietary technology is covered under U.S. patent 5,829,448, along with
additional pending applications in the U.S. and worldwide. The company has no
products or operating revenues at this time.
Statements in this release that are not strictly historical are
"forward-looking" statements that are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks, which may cause the
company's actual results in the future to differ materially from expected
results. These risks and uncertainties include: the ability of the company to
develop a product and obtain regulatory approval for its use; the ability of the
company to successfully market and sell any products and equipment; the
company's ability to manufacture products in sufficient quantities; the
company's ability to maintain intellectual property protection for its
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proprietary products, to defend its existing intellectual property rights from
challenges by third parties, and to avoid infringing intellectual property
rights of third parties; unforeseen operating risks; the company's ability to
secure collaborative agreements with third parties for various research,
development, manufacturing, marketing and other functions; competition; risks
associated with the dependence on manufacturers of the company's proposed
products; the availability of capital to finance planned activities; and the
extent to which the clinicians performing the procedures are able to obtain
third-party reimbursement. These risks are qualified in their entirety by
cautionary language and risk factors set forth in the company's filings with the
Securities and Exchange Commission.
