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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): March 20, 2000
COLLATERAL THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE
(State or other jurisdiction of incorporation)
000-24505 33-0661290
(Commission File Number) (IRS Employer Identification No.)
11622 El Camino Real, San Diego, CA 91230
(Address of principal executive offices) (Zip Code)
(858) 794-3400
(Registrant's telephone number, including area code)
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ITEM 5. Other Events
Attached hereto is a press release issued by the registrant on March
20, 2000.
ITEM 7. Financial and Exhibits.
(c) EXHIBITS.
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EXHIBIT NO. DESCRIPTION
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99.1 Press Release, dated March 20, 2000
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has caused this report to be signed on its behalf by the
undersigned.
COLLATERAL THERAPEUTICS, INC.
Date: March 20, 2000 /s/ Christopher J. Reinhard
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Christopher J. Reinhard
President and Chief Operating and
Financial Officer
(Principal Financial and Accounting Officer)
2
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Exhibit 99.1
COLLATERAL THERAPEUTICS ANNOUNCES POSITIVE CLINICAL
RESULTS FOR LEAD CARDIOVASCULAR GENE THERAPY PRODUCT
LARGE-SCALE PIVOTAL CLINICAL TRIALS PLANNED
SAN DIEGO, California - March 20, 2000, Collateral Therapeutics, Inc.
(Nasdaq: CLTX) today announced positive preliminary results of a double-blinded,
placebo-controlled Phase 1/2 clinical trial of the Company's lead non-surgical
angiogenic gene therapy product candidate, GENERX-TM- (Ad5FGF4), for the
treatment of patients with stable exertional angina due to coronary artery
disease. Based on these results, Collateral and it's development partners
Schering AG of Germany and Berlex Laboratories plan to initiate large-scale
Phase 2b/3 pivotal trials to advance the commercial development of GENERX.
"To the best of our knowledge, this marks the first time that a
scientifically well-controlled clinical trial of a non-surgical cardiovascular
gene therapy has produced positive results and demonstrated a safe and
well-tolerated treatment effect," said Jack W. Reich, Ph.D., Chairman and Chief
Executive Officer of Collateral Therapeutics. "Based on these data, Collateral
and Schering AG plan to meet with the FDA and other health authorities to review
clinical development plans designed to support licensing applications for this
product candidate. These results further support Collateral's objective to
establish new standards of care by developing a portfolio of non-surgical
cardiovascular gene therapy products that have the potential to provide simpler
and more cost-effective alternatives to currently available treatments for heart
disease."
The AGENT (Angiogenic GENe Therapy) trial was designed as a Phase 1/2
ascending-dose trial having two primary objectives: (1) to assess the safety of
GENERX at a range of dose levels; and (2) to evaluate clinical measures of
efficacy and select appropriate doses of GENERX to take forward into large-scale
clinical trials. 67 patients with stable exertional angina, chest pain caused by
a lack of oxygen in the heart muscle, which is triggered by exertion or
emotional stress, were enrolled at 12 major medical centers across the country.
Patients received a one-time, non-surgical, intracoronary administration of a
placebo or GENERX and were evaluated for safety and efficacy for 12 weeks in
this double-blind, placebo-controlled study.
Based on results from this clinical trial, GENERX appeared to be safe
and well tolerated at all dose levels evaluated in the study. In addition,
substantial improvements in exercise time on a treadmill were observed at
multiple dose levels in patients treated with GENERX. At one dose level, which
will be carried forward into larger clinical trials, more than half of the
GENERX-treated patients exhibited a substantial prolongation of their total time
on a treadmill. The extent of prolongation observed compared favorably to
percutaneous transluminal coronary angioplasty and to coronary artery bypass
graft surgery.
"It is clear that we have seen very positive biological effects in
patients. Based on results from the AGENT trial, the next logical step is to
proceed with expanded clinical trials to
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fully characterize the therapeutic utility of this treatment approach," noted
Robert L. Engler, M.D., Professor of Medicine at the University of California,
San Diego, and the VA Medical Center, and a co-founder of the Company, who
assisted in the design of the trial. "The results from this placebo-controlled,
double-blind Phase 1/2 clinical trial confirm the Company's preclinical research
and further support the Company's thesis that an adenoviral-based cardiovascular
gene therapy product can be safely delivered to the human heart using a standard
catheter, in order to achieve a positive therapeutic effect based on
Collateral's methods of gene therapy."
In addition, in preparation for including an expanded patient
population within the large-scale trials, Collateral and Schering AG are also
currently evaluating a broader population of patients, including patients who
previously underwent coronary artery bypass graft surgery and those with more
severe forms of coronary artery disease.
Patient safety is the Company's primary consideration in any clinical
trial. The study showed that GENERX appears to be safe and well tolerated at all
dose levels studied. Safety information from the trial has been submitted to
appropriate regulatory agencies in compliance with U.S. federal safety reporting
requirements. In addition, the clinical trial protocol was presented to and
approved by the Recombinant DNA Advisory Committee (RAC) at public hearings on
June 18, 1998. As reported in December 1999, the death of one patient enrolled
in the trial (which occurred approximately five months after the one-time
product administration) was determined to have been unlikely to be causally
related to the therapy, following evaluations by independent investigators,
company medical directors, and an independent safety review panel.
The angiogenic gene therapy product candidate GENERX was developed by
Collateral based on scientific discoveries and technology pioneered by the
Company's chief scientific officer and co-founder, H. Kirk Hammond, M.D., and
his colleagues at the VA Medical Center and the University of California, San
Diego. Subsequent development of GENERX has been conducted in close
collaboration with Schering AG of Germany, and with Schering's U.S. subsidiaries
Berlex Laboratories and Berlex Biosciences.
GENERX is a non-surgically administered gene therapy designed to
stimulate angiogenesis (new blood vessel growth), providing an alternate route
for blood to flow around blocked or clogged arteries. Envisioned as an
out-patient procedure that could be administered by cardiologists, GENERX
involves a one-time, non-surgical administration of an adenoviral gene therapy
vector containing the human Fibroblast Growth Factor-4 (FGF-4) angiogenic gene
delivered into the coronary arteries through a standard catheter.
Angina is chest pain caused by myocardial ischemia, a condition in
which the amount of oxygen the heart muscle requires exceeds the amount
available due to coronary artery blockage (atherosclerosis). According to the
American Heart Association (AHA), angina affects approximately 6.2 million
Americans, with 300,000 new cases diagnosed each year. Angina is a symptom of
coronary artery disease (CAD), which affects more than 60 million Americans and
is a leading cause of death in the United States. Current treatment options for
CAD include drug therapy, which is usually life-long, can be costly, and may be
associated with undesirable
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side effects, or invasive procedures that require hospitalization, including
angioplasty and bypass surgery. According to the AHA, approximately 480,000
angioplasties and nearly 600,000 bypass surgeries are performed each year in the
United States. Collateral's approach to angiogenic gene therapy is being
developed to potentially reduce the need for these interventions by offering a
non-surgical alternative that may only require a single treatment.
Collateral Therapeutics, Inc., headquartered in San Diego, is a leader
in the discovery and development of innovative non-surgical gene therapy
products for the treatment of cardiovascular diseases. Collateral Therapeutics
is developing non-surgical cardiovascular gene therapy products focused on: (1)
angiogenesis, as a treatment approach for coronary artery disease, peripheral
vascular disease and congestive heart failure; (2) myocardial adrenergic
signaling, as a treatment for congestive heart failure; and (3) heart muscle
regeneration, to improve cardiac function for patients who have suffered a heart
attack.
Statements in this press release that are not strictly historical may
be "forward-looking" statements, which involve risks and uncertainties. There
can be no assurance that Collateral Therapeutics, Inc. will be able to
commercially develop cardiovascular gene therapy products, that necessary
regulatory approvals will be obtained or that any clinical trials will be
successful or that the proposed treatments will prove to be safe and/or
effective. The actual results may differ from those described in this press
release due to risks and uncertainties that exist in the Company's operations
and business environment, including, without limitation, the Company's early
stage of product development and the limited experience in the development of
gene therapies in general, its dependence upon proprietary technology and
current competition, history of operating losses and accumulated deficits, the
Company's reliance on collaborative relationships, and uncertainties related to
clinical trials, safety, efficacy, the ability to obtain the appropriate
regulatory approvals, patent protection and market acceptance, as well as other
risks detailed from time to time in the Company's filings with the Securities
and Exchange Commission. The Company undertakes no obligation to release
publicly the results of any revisions to these forward-looking statements to
reflect events or circumstances arising after the date hereof.
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