ORTH HOLLYWOOD, Calif.--(BUSINESS WIRE)--Nov. 24, 1998--North American Scientific
Inc. (Nasdaq:NASI) Tuesday announced that it has signed a letter of intent to acquire Theseus
Medical Imaging Corp., Cambridge, Mass., (Theseus) for $3 million in cash, NASI stock, or a
combination thereof.
Pending completion of the transaction, NASI anticipates advancing Theseus up to $3.5 million in
operating funds to be used to complete phase II activities for the two lead Theseus products, Apomate
and Leukomate, and for other operating and research purposes; advances made prior to closing shall
be in the form of notes secured by Theseus' intellectual property.
Apomate and Leukomate represent the development of a new generation of in vivo
radiopharmaceutical agents designed to provide images that assess the biological responses of
individual patients to medical therapy.
The biodistribution of these agents has been designed to reflect dynamic physiologic and biochemical
responses in the body to therapeutic interventions such as anti-cancer treatment and the treatment of
chronic and acute diseases characterized by inflammation.
These new nuclear-medicine imaging agents are intended to assist physicians in selecting the most
effective treatment options and serve as an aid in day-to-day therapeutic management.
Theseus' lead agent, Apomate, is a Technetium-99m-labeled radiopharmaceutical agent intended for in
vivo imaging of a biological process known as apoptosis, or programmed cell death.
It incorporates technology developed and licensed from the work of Drs. Francis Blankenberg,
Jonathan Tait, and H. William Strauss, and their colleagues, as recently described in their article in the
Proceedings of the National Academy of Sciences titled, "In vivo detection and imaging of
phosphatidylserine expression during programmed cell death" (Vol. 95, pp. 6349-54, 1998).
Apoptosis is now recognized as a central feature of diseases such as cancer, autoimmune diseases and
transplant rejection. Essentially all treatments for cancer, whether radiotherapy, immunotherapy or
chemotherapy, are intended to kill the cancer by inducing apoptosis in the tumor cell targets.
Tc-99m Apomate was shown in preclinical studies to have increased uptake in tumors responding to
treatment by binding to apoptosis- specific cell surface markers within one to two hours of anti-cancer
treatment; it showed no increase in uptake after treatment of tumors that did not respond to treatment.
Normally it takes weeks or even months of treatment with potentially toxic drugs until response to
treatment can be evaluated by gross changes in tumor size. It is expected that patients who will
respond to a particular anti-cancer treatment will show increased Tc-99m Apomate uptake within
hours of their first treatment because of the apoptotic response by their tumors.
It is expected that patients who will not respond to treatment may be rapidly identified because their
tumors will not show significant apoptosis and will not show increased Tc-99m Apomate uptake in
response to treatment.
The latter group of patients could then be offered alternative treatments and may be spared weeks of
potentially dangerous and ineffective treatment that may diminish their quality of life and offer little
therapeutic benefit.
Moreover, prompt discontinuation of ineffective treatment could allow the prompt trial of alternative
treatment options before the tumor increases significantly in size and before toxicity from ineffective
treatment limits the choice of therapeutic alternatives.
If successful, Apomate would provide, for the first time, a noninvasive technique for evaluating the
real-time response of individual patients to anti-cancer treatments and provide guidance for physicians,
allowing the selection of optimal treatment.
Apoptosis has also been shown to be an important marker of organ rejection in patients with organ
transplants. Preclinical work has shown that cardiac-transplant rejection as shown by apoptosis in
tissue samples from cardiac transplants in rodents correlated well with Tc-99m Apomate cardiac
uptake.
The company intends to study the use of Tc-99m Apomate in assessing the adequacy of
immunosuppression in organ transplants.
Phase I studies of Tc-99m Apomate have been carried out in more than 30 volunteers. Theseus has
reported that there were no safety issues raised during the study, and biodistribution of the imaging
agent appeared favorable for the planned phase II studies in patients with lymphoma, breast cancer
and lung cancer, which are expected to begin the the first quarter of 1999.
The technology licensed by Theseus was identified and developed by Robert Bender, Dr. Allan Green
and Irwin Gruverman, principals of Theseus.
Green and Gruverman were instrumental in the past growth and development of the New England
Nuclear Radiopharmaceutical Division and in the identification, development and regulatory approval
of a number of radiopharmaceutical agents, including Thallium Tl-201, for cardiac imaging, Tc-99m
MDP for bone imaging, and Gallium Ga-67 for imaging of tumors and infection.
Gruverman is a founder and chairman of North American Scientific, and Green is a director of the
company.
Final acquisition of Theseus by North American Scientific is subject to completion of a satisfactory
due-diligence review, receipt of a financial-fairness opinion from a qualified independent third party,
and negotiation of a definitive acquisition agreement and approval thereof by a majority of independent
NASI board members.
NASI and Theseus have identified additional research and development activities to extend the
applications and product lines for the licensed technology.
L. Michael Cutrer, NASI's president and chief executive officer, said, "The proposed acquisition of
Theseus is consistent with our long-range plans to identify and manufacture products designed to
diagnose, treat, and manage cancer and other proliferative diseases utilizing radioisotope technologies."
Theseus Medical Imaging identifies, develops and commercializes diagnostic agents capable of imaging
physiologic and biochemical responses to medical treatments as an aid to individual patient
management.
North American Scientific manufactures a broad line of products for medical, environmental and
research applications.
Statements included here that are not historical facts may be considered forward-looking statements
that are subject to a variety of risks and uncertainties. There are a number of important factors that
could cause actual results to differ materially from those expressed in any forward-looking statements
made by the company, including the risk factors included in the company's Annual Report on Form
10-KSB for the fiscal year ended Oct. 31, 1997, as well as other items identified from time to time in
the company's filings with the Securities and Exchange Commission.
CONTACT: North American Scientific Inc., North Hollywood
Alan Edrick, 818/503-9201
or
Theseus Medical Imaging Corp., Cambridge
Allan M. Green, 617/348-1786 |
