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Monday June 21, 7:30 am Eastern Time
Company Press Release
Techniclone Expands Solid Tumor Brain Cancer
Study to Include UCLA
TUSTIN, Calif.--(BUSINESS WIRE)--June 21, 1999--Techniclone Corporation (NASDAQ:TCLN - news), a developer of
leading-edge unique therapeutics for the advanced treatment of cancer, announced today that the University of California Los
Angeles (UCLA) is now opened as an additional clinical trial site in its ongoing Phase II trial for the treatment of malignant
glioma (solid tumor brain cancer). This trial was started at the Medical University of South Carolina. Patient screening at the
UCLA site will begin this week under the direction of the principal investigator, Dr. Timothy Cloughesy. The Company has
identified several additional clinical sites for this Cotara(TM) trial, including Temple University (under the direction of Dr.
Douglas Laske), which should be opening within the next 30-45 days.
Techniclone's Cotara(TM) therapy represents an innovative approach to the treatment of cancer. Instead of targeting living
cancer cells, Cotara(TM) only targets dead and dying cells. The drug binds only to DNA in cells having porous nuclear and
cellular membranes and since only dead and dying cells are porous, the DNA functions as a highly abundant but selective
target. Dead and dying cells account for up to 50% of the mass of a tumor and are found primarily at the tumor core. Once
concentrated in necrotic regions throughout the tumor, the drug is able to expose neighboring living tumor cells to beta radiation.
Each successive treatment with Cotara(TM) kills more tumor cells, thereby increasing the necrotic area of the tumor. Thus,
Cotara(TM) should become more effective upon subsequent doses, contrary to conventional chemotherapy, which may
become less effective with subsequent doses due to increased drug resistance.
The Phase II clinical study, which began in December 1998 at the Medical University of South Carolina, has a planned
enrollment of 60 patients, comprised of 20 newly diagnosed glioblastoma multiforme (GBM) patients and 20 patients each with
recurrent (GBM) and anaplastic astrocytoma (AA), respectively.
The protocol allows patients to receive two doses administered eight weeks apart with dosage for each patient to be
individualized based on a unique algorithm developed by Techniclone during the Company's Phase I investigation.
Commented Larry Bymaster, CEO, ''Each year, approximately 17,000 Americans are diagnosed with primary brain tumors,
of which approximately 75% result in death within the first 12 months. Techniclone's clinical trials treat patients with malignant
glioma, the most deadly form of brain tumors. Since there are very few treatment options available for this disease, we believe
Cotara(TM) could offer a useful alternative therapy.
''In the past, victims were faced with two treatment options, both of which have proven ineffective over the long term. If the
tumor is operable, doctors are only able to remove the bulk of the tumor leaving behind microscopic 'tentacles' which ultimately
results in re-growth. Treatments such as external beam radiation and chemotherapy have minimal effectiveness, since these
treatments are limited by the damage they cause to the surrounding brain tissue and their systemic side effects profile''.
Continued Mr. Bymaster, ''The potential market for Cotara(TM), however, is not limited to the treatment of solid tumor brain
cancer. In fact, by targeting exposed DNA found universally in all dead or dying cells, it is possible that Cotara(TM) could be
effective across a broad spectrum of cancers. In the U.S. alone, there were almost 1.1 million new cases of solid tumor cancer
in 1998, 500,000 of which resulted in death. Unlike existing therapies that require the development and testing of different
antibodies for each type of cancer, Cotara(TM) could potentially be used in treating many forms of cancers. In fact, we have
recently begun a Phase I/II trial for treatment of advanced prostate, pancreatic and liver cancer in Mexico City''.
Company Overview: Techniclone Corporation is a biopharmaceutical company focused on the development, commercialization
and licensing of unique technologies for the treatment of cancer primarily based on its ''collateral targeting technologies.'' These
technologies therapeutically target cell structure and cell types, rather than surface cancer cells, as a means to attack solid
tumors, without causing damage to surrounding healthy tissue. In addition to Cotara(TM), the Company has two other
collateral targeting agents: Vasopermeation Enhancement Agents (VEA) and Vascular Targeting Agents (VTA), both of which
are in pre-clinical stages of development. VEAs are monoclonal antibodies that increase tumor blood vessel permeation for
enhanced uptake of chemotherapeutic agents versus normal tissues, while VTAs are agents that block the flow of
oxygen/nutrients to a solid tumor's vascular network, causing clotting and necrosis. VTAs also can deliver a wide variety of
therapeutic agents to a solid tumor, including therapeutic agents, biologic agents, toxins and radioisotopes. The Company also
has a direct tumor targeting agent called Oncolym® for the treatment of advanced non-Hodgkin's B-cell Lymphoma which was
recently licensed to Schering AG, Germany, who is now responsible for all existing and future Oncolym® clinical trial programs
as well as marketing.
Additional information on the Company and its products can be found at www.techniclone.com.
Safe Harbor Statement: This release may contain certain forward-looking statements that are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the Company's
expectations as a result of risk factors discussed in Techniclone's reports on file with the U.S. Securities and Exchange
Commission, including, but not limited to, the Company's report on Form 10Q for the quarter ended January 31, 1999 and
Form 10K for the year ended April 30, 1998.
Contact:
Investor Relations:
DeMonte Associates, New York
Cynthia DeMonte, 212/420-0088
or
Media Relations:
Rubenstein PR, New York
Clint Cantwell, 212/843-80 |
