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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: March 18, 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, among other things, that it was initiating pre-clinical
testing for two complex eye disorders. The Company's Press Release dated March
18, 1999, is filed 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 March 18, 1999, announcing
among other things, that it was initiating pre-clinical
testing for two complex eye disorders.
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: March 19, 1998
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EXHIBIT INDEX
Exhibit Description
No.
99 Press release of the Company, dated March 18, 1999, announcing
among other things, that it was initiating pre-clinical
testing for two complex eye disorders.
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Exhibit 99
AT THE COMPANY: AT THE FINANCIAL RELATIONS BOARD:
John Smolik Leslie Hunziker Caroline Price Darcy Brentz
President & CEO General Info. Analyst Inquiries Media Info.
(423) 769-4012 (312) 266-7800
Photogen Initiates Pre-Clinical Testing for Two
Complex Eye Disorders
KNOXVILLE, Tenn., March 18 -- Photogen Technologies, Inc. (OTC: PHGN), working
with the laser group of Coherent, Inc. (NASDAQ: COHR), has jointly designed and
built what is believed to be the first medical ultrafast laser device for
treating ocular melanoma (a cancer of the eye) and advanced macular degeneration
(the most common cause of vision loss in people over 55 years of age). The new
laser device utilizes Photogen's proprietary multi-photon activation technology,
and makes use of special laser beam focusing and scanning capabilities.
Pre-clinical trials for ocular melanoma and advanced macular degeneration, using
this ultrafast laser device with various photoactive agents, have already begun
at Massachusetts Eye and Ear Infirmary (MEEI), a Harvard Medical School teaching
affiliate with which Photogen has a research agreement. The trials are expected
to be completed in the near future.
"We have assembled our first prototype ultrafast laser treatment system
utilizing our technology that we believe provides more focused laser beam
penetration, better spatial control and greater depth of penetration," 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 this new ultrafast laser."
Photogen's multi-photon activation system is different from conventional
photodynamic therapy in that it uses 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. In contrast, competitors are using a single
photon-activation system based on continuous wave, shorter wavelength light,
which results in shallower penetration and less precise targeting of the
treatment site.
The ocular melanoma study, a joint Photogen/MEEI research project, is already in
progress using this new ultrafast laser system under the supervision of Dr. Lucy
Young, M.D., Ph.D., a board certified ophthalmologist. According to Dr. Young,
Photogen's
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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. Dr. Young's pre-clinical trial is expected to
be completed by early summer, at which time the study is expected to move into
human clinical trials.
The trial for macular degeneration, also a joint Photogen/MEEI project, is being
conducted by Dr. Joan Miller, M.D., a renowned researcher in this field with
more than 50 scientific and scholarly publications to her credit. This study
will evaluate the effectiveness of a variety of drugs using two different
wavelengths. Macular degeneration is a form of vision deterioration that is
caused by blood-vessel leakage behind the eye. One form of macular degeneration
is characterized by abnormal new blood vessels growing under the retina, leading
to severe vision loss. Currently, treatment is limited thermal laser
photocoagulation. Conventional photodynamic therapy utilizes a photoactive drug
delivered systematically to the new blood vessels followed by light application
to seal the abnormal blood vessels. Unfortunately, while relatively selective,
there is some damage to collateral tissue with this method.
Photogen believes that it will be able to restrict the area of activation to the
new abnormal blood vessels without risk of damaging other areas of the eye. This
initial study is intended to provide evidence that Photogen's process is safe
and effective and to generate the data needed in designing and gaining approval
to begin human studies. Pending results of this study, it is anticipated that a
human trial would be the next phase toward commercialization.
Moreover, if these treatments are substantiated, it is believed they can be
applied to treatments for other eye conditions such as glaucoma.
In addition to these ophthamalic applications, Photogen is working with Coherent
to develop a series of laser device prototypes for treatment of other diseases
including Barretts esophagus, a pre-cancerous throat condition, as well as
tumors of the lung and prostate utilizing Photogen's proprietary technology.
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. 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
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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 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.
To receive Photogen Technologies, Inc.'s latest news release and
other corporate documents, free of charge via fax,
simply dial 1-800-PRO-INFO.
Use company ticker PHGN.
