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) January 19, 2000
--------------------------------
NEUROBIOLOGICAL TECHNOLOGIES, INC.
--------------------------------------------------
(Exact name of registrant as specified in Charter)
Delaware 0-23280 94-3049219
- ---------------------------- ---------------- -------------------
(State or Other Jurisdiction (Commission File (IRS Employer
of Incorporation) Number) Identification No.)
1387 Marina Way South, Richmond, California 94084
- --------------------------------------------------------------------------------
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (510) 215-8000
-----------------------------
None
- --------------------------------------------------------------------------------
(Former Name or Former Address, if Changed Since Last Report)
<PAGE>
Item 5. Other Events
On January 19, 2000, Neurobiological Technologies, Inc. announced the
preliminary results of its Memantine clinical trials for painful diabetic
neuropathy. The press release is attached as Exhibit 99.1 hereto.
Item 7. Financial Statements and Exhibits
(a) Exhibits
Exhibit 99.1 Press release issued by the Company on January 19, 2000
<PAGE>
SIGNATURE
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 herewith duly authorized.
Date: January 19, 2000 NEUROBIOLOGICAL TECHNOLOGIES, INC.
By: /s/ Paul E. Freiman
--------------------------------
Paul E. Freiman
President and Chief Executive Officer
<PAGE>
EXHIBIT INDEX
Exhibit Description
- ------- -----------
Exhibit 99.1 Press release issued by the Company on January 19, 2000
EXHIBIT 99.1
------------
Contact:
- --------
Paul E. Freiman Victor Libet
President and Chief Executive Officer Russell-Welsh, Inc.
Neurobiological Technologies, Inc. 650.312.0700 ext. 25
510.215.8000
NEUROBIOLOGICAL TECHNOLOGIES, INC. REPORTS POSITIVE RESULTS FOR 40 MG MEMANTINE
IN ITS PHASE IIB DOSE-RANGING TRIAL FOR PAINFUL DIABETIC NEUROPATHY
Richmond, Calif. - January 19, 2000 - Neurobiological Technologies, Inc.
(OTC-BB: NTII) today announced preliminary results of the company's
placebo-controlled Phase IIB, dose-ranging human clinical trial of Memantine, an
orally-available neuroprotective agent for the treatment of painful peripheral
neuropathy in diabetics. This three-armed study comparing daily doses of
placebo, 20 mg and 40 mg of Memantine, demonstrated statistically significantly
less nocturnal pain intensity with 40 mg of Memantine compared to placebo after
eight weeks of dosing. In the group dosed with 20 mg of Memantine, positive
trends were seen, but statistical significance was not observed.
The trial evaluated nighttime pain intensity as reported by the patients
themselves. Patients rated their pain intensity twice daily in a diary by
marking a visual analogue scale 100 millimeters long. The more intense the
patient's pain, the closer he or she marked to the right end of the scale
(100mm). Diary entries began at the screening visit and continued throughout the
eight-week dosing period.
"By the end of this trial, patients receiving daily dosing of 40 mg Memantine
experienced significantly less severe, chronic nighttime pain than patients
receiving placebo," said Lisa U. Carr, M.D., Ph.D., vice president of medical
affairs at NTI(R). "So far these results confirm and extend our findings from an
earlier Phase IIA study. We are now analyzing further efficacy assessments in
order to fully evaluate the clinical implications of these findings with regards
to Memantine's ability to improve overall symptoms of neuropathy. We also expect
to utilize the 40 mg dose in working with the FDA to design a Phase III study."
"It has been exciting to help evaluate Memantine for this very important unmet
medical need," said Sherwyn Schwartz, M.D., trial investigator at the Diabetes &
Glandular Disease Clinic in San Antonio, Texas. "Most diabetics will experience
some form of neuropathy and many cannot obtain adequate pain relief from
existing treatments. If a Phase III clinical trial confirms these results,
Memantine will bring new hope to my long-suffering patients."
The randomized, double-blind, placebo-controlled dose-ranging trial enrolled 421
patients at 21 trial sites nationwide and was jointly managed by Quintiles CNS
Therapeutics. Patients were required to have a minimum mean pain intensity
rating of 30 mm prior to enrollment. Patients were randomized to one of three
treatment groups. Two groups of patients received twice daily oral doses of
Memantine, escalating to either 20 mg or 40 mg; the remaining patients received
placebo. The company expects that further trial
<PAGE>
results will be presented at the 52nd Annual Meeting of the American Academy of
Neurology in San Diego, April 29 - May 6, 2000.
Background Information: Peripheral Neuropathy
Painful peripheral neuropathy, or chronic pain related to damaged peripheral
nerves, is one of the most common complications of diabetes. According to the
American Diabetes Association, 10.3 million people have been diagnosed with
diabetes in the United States, and 60-70 percent of people with diabetes have
some form of diabetic nerve damage. Although not all patients with nerve damage
suffer from pain, the company estimates that there were approximately 1,200,000
cases of diabetic neuropathic pain in the U.S. and Europe in 1998.
Diabetics with painful neuropathy experience chronic pain in the lower legs and
feet, making it difficult to stand or walk. At night, pain often interferes with
sleep. Loss of sleep dramatically reduces quality of life. Some patients obtain
relief from tight control of blood glucose levels. Others use topical analgesic
creams and non-steroidal anti-inflammatory drugs (NSAIDs). If these prove
ineffective, drugs such as antidepressants, anticonvulsants or opioids are
prescribed. In the end, the company estimates that approximately half of these
patients do not obtain adequate pain relief.
The causes of painful diabetic neuropathy are not completely understood. A
number of published studies have shown that peripheral nerve damage disrupts
pain pathways in the nervous system, causing nerves to send abnormal signals
that the brain interprets as pain. In effect, the brain is bombarded with pain
signals until its ability to process them is compromised. This leads to a
chronic hypersensitivity to pain perception and can result in progressive
neurological damage.
Background Information: Memantine
Memantine is an orally-available compound that appears to restore the
function of damaged nerve cells and block abnormal excitatory signals by
modulating the N-methyl-D-aspartate (NMDA) receptor on cell membranes. It has
been shown to be effective as a neuroprotective agent for moderate to severe
dementia. The company's collaborator, Merz + Co. GmbH & Co. of Frankfurt,
Germany is conducting Phase III clinical trials of Memantine in Europe and the
U.S. for treatment of this condition. In a Phase III human clinical trial of
Memantine in Europe sponsored by Merz, severely demented subjects treated with
Memantine had statistically significant improvement compared to placebo in
internationally accepted measures of functional independence, including bathing,
dressing and self-care. Merz expects to report data from additional late-stage
trials in this indication in spring 2000.
The NIH is evaluating Memantine in a Phase II trial for AIDS-related dementia.
Allergan, Inc. of Irvine, California is testing Memantine in the clinic as a
treatment for opthalmic nerve damage associated with glaucoma. Merz has marketed
Memantine in Germany since 1989 with the labeling "dementia syndrome."
There are issued patents covering each of the aforementioned conditions.
<PAGE>
NTI Corporate Profile
NTI is an emerging drug development company focused on the clinical evaluation
and regulatory approval of neuroprotective drugs. The company's strategy is to
in-license and develop early-stage drug candidates that target major medical
needs and that can be rapidly commercialized. NTI is currently developing
Memantine for multiple neurological conditions and evaluating XERECEPT(TM) as a
treatment for peritumoral brain edema.
Note: Except for the historical information contained herein, the matters
discussed in this press release are forward-looking statements that involve
risks and uncertainties, including NTI's ability to properly design, implement
and complete planned trials and meet regulatory requirements, dependence on
third parties and future capital needs and the uncertainty of additional
financing, as well as other risks detailed from time to time in the company's
Securities and Exchange Commission filings. Actual results may differ materially
from those projected. These forward-looking statements represent the company's
judgment as of the date of the release. The company disclaims, however, any
intent or obligation to update these forward-looking statements.
# # #
