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Neurex' SNX-111 Clinical Data Presented at Meeting of American Pain Society; Early results indicate exciting potential.


LOS ANGELES--(BUSINESS WIRE)--Nov. 13, 1995--At the American Pain Society Meeting in Los Angeles today, Dr. William Brose n. 1. Pottage made by pouring some boiling liquid on meal (esp. oatmeal), and stirring it. It is called beef brose, water brose, etc., according to the name of the liquid (beef broth, hot water, etc.) used. , Director of the Pain Clinic at Stanford University, presented his clinical experience with SNX-111 in the treatment of severe pain.

The results in seven patients form part of the Phase I/II study with SNX-111 which is sponsored by Neurex Corporation and is being conducted at several centers in the U.S.

"Based on what I have seen in the patients I have treated, SNX-111 has the potential to provide symptomatic relief symptomatic relief (sim·t·maˑ·tik r  in patients who have failed all other pain therapy, without the typical side effects seen with opiates Opiates
Analgesic, pain killing drugs, such as heroin and morphine that depress the central nervous system.

Mentioned in: Withdrawal Syndromes
." Dr. Brose commented. "If this profile holds up in controlled studies, SNX-111 will represent the first of a new and exciting class of compounds to treat severe pain."

All of the patients entering the study had severe pain as a result of their cancer or had non-malignant neuropathic pain and had failed all other pain therapy, including intraspinal opiates. Of the seven patients, six responded symptomatically in the dose escalation phase and four went into long-term treatment and were maintained on the drug essentially symptom free for periods of up to eight months.

Neurex intends to initiate controlled studies with SNX-111 in the treatment of severe cancer pain by the end of 1995.

Neurex Corporation (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: NXCO), located in Menlo Park, California Menlo Park is a city in San Mateo County, California in the United States of America. It is located at latitude 37°29' North, longitude 122°9' East. Menlo Park had 30,785 inhabitants as of the 2000 U.S. Census. , is developing products for acute care principally in the area of cardiorenal and neurological diseases. The Company's focus is for therapies to be used in the emergency room, intensive care unit and pain clinic. The Company's products under development, CORLOPAM(R) and SNX-111, are currently in human trials, each with potential in multiple indications. The Company's strategy is to develop and commercialize its products for acute care treatment in hospital settings, such as emergency rooms, intensive care units and pain clinics. -0-

Safety and efficacy of SNX-111 in the

management of intractable nerve injury pain

in humans: preliminary results

Introduction

-- The marine cone snail produces peptide toxins which paralyze par·a·lyze
v.
To affect with paralysis; cause to be paralytic.


fish within seconds.

-- SNX-111 (Neurex, Menlo Park) is the synthetic form of one such

peptide toxin. It blocks N-type, neuron specific, voltage

sensitive calcium channels in mammals.

-- N-type calcium channels are predominantly located in lamina LAMINA - A concurrent object-oriented language.

["Experiments with a Knowledge-based System on a Multiprocessor", Third Intl Conf Supercomputing Proc, 1988].
 1

of the dorsal horn.

-- Intrathecal intrathecal /in·tra·the·cal/ (-the´k'l) within a sheath; through the theca of the spinal cord into the subarachnoid space.
Intrathecal 
 administration of SNX-111 in animals revealed a

very potent, efficacious, non-toxic analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs  action.

-- In this Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. , safety and estimation of

efficacy for intrathecally administered SNX-111 were investigated.

Methods

-- 7 patients with chronic pain (Tbl), unresponsive to intrathecal

opioids, received escalating doses of intrathecal SNX-111.

-- Patients satisfaction, pain, and possible side effects were

assessed every 4 hours.

Results

-- 6/7 patients reported partial or complete pain relief at

SNX-111 doses ranging from 0.3 to 10 ng/kg/hour (Tbl).

-- Adverse events included: - reversible nystagmus Nystagmus Definition

Rhythmic, oscillating motions of the eyes are called nystagmus. The to-and-fro motion is generally involuntary. Vertical nystagmus occurs much less frequently than horizontal nystagmus and is often, but not necessarily, a sign of
 (3 patients),

orthostatic hypotension (1 patient), and dysphoria dysphoria /dys·pho·ria/ (-for´e-ah) [Gr.] disquiet; restlessness; malaise.dysphoret´icdysphor´ic

gender dysphoria
 (1 patient).

-- No evidence of neuromuscular blockade occurred.

Conclusion

-- The N-type calcium channel blocker SNX-111 relieved nerve

injury pain unresponsive to high doses of intrathecal opioids.

-- Causality between SNX-111 and recorded adverse events is

uncertain.

-- SNX-111 has the potential to provide unique analgesia analgesia /an·al·ge·sia/ (an?al-je´ze-ah)
1. absence of sensibility to pain.

2. the relief of pain without loss of consciousness.
 in

neuropathic pain.

-0-

Patient            Diagnosis                        Results


1       Metastatic chondrosarcoma, direct   Complete relief of
        invasion of thecal sac and canal    allodynic component of
                                            component of lower extremity
                                            pain


2       Metastatic colon cancer, multiple   Complete relief of
        lesions invading neural foramina    lancinating, neuritic
        of lumbar spine                     pain hips and legs


3       Hepatoma and Hemochromatosis,
        chronic back pain                   Nearly complete relief
                                            of back and thoracic
                                            radicular pain


4       Metastatic adrenal carcinoma,
        sacral neuralgia                    Partial relief of
                                            neuropathic pelvic and
                                            perineal pain


5      Breast and colon cancer,
       metastasis in thecal sac and canal   Complete relief of
                                            neuropathic hip and leg
                                            pain


6      Brachial plexus avulsion injury      No relief of
                                            deafferentation type pain


7      Brachial plexus avulsion injury      Complete relief of
                                            deafferentation type pain


CONTACT: Neurex Corporation

Dr. Paul Goddard, 415/833-1288
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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