MEDMONITOR - Pearls from Recent Medical Journals and Conferences (19/2/02)
THE LANCET, February 16, 2002; 359: 540: Enbrel can induce lupus.
Use of Immunex's (NASDAQ: IMNX) Enbrel was linked to the development of lupus erythematosus (lupus) in four patients at Rush Medical College in
Chicago, according to the first published report linking Enbrel use with
this autoimmune disease. Two cases were confirmed and two were considered
"probable," with all four recovering once off Enbrel. Lupus is a rare adverse effect of commonly administered drugs, occurring with the use of
more than 80 agents including Johnson & Johnson's (NYSE: JNJ)
Remicade, Celebrex, beta-blockers, penicillin, tetracyclines, dilantin, INH, oral
contraceptives, and various vaccines.
Though adding to the adverse effect profile of Enbrel, the Lancet letter's
impact on sales is unlikely to be substantial. The occurrence of lupus in
Enbrel patients is quite rare, as is drug-induced lupus overall. The letter
is designed to heighten awareness among physicians so that the drug is discontinued as soon as signs and symptoms are recognized. Experience with
the other drugs suggests that complications will be minimal, if any. Drug-induced lupus does not progress to kidney or central nervous system
involvement as it does with common systemic lupus erythematosus.
--
THE NEW ENGLAND JOURNAL OF MEDICINE, February 14, 2002; 346:491-496: Study
shows StaphVAX is a promising vaccine against staph infection.
StaphVAX, Nabi's (NASDAQ: NABI) recombinant conjugate vaccine against the
bacterium Staphylococcus aureus, proved safe and immunogenic for approximately 40 weeks in patients with end-stage renal disease undergoing
hemodialysis. The vaccine stimulates a patient's immune system by virtue of
the two S. aureus capsular polysaccharide antigens (types 5 and 8 - you'll
often hear it described as "bivalent") conjugated to nontoxic recombinant
Pseudomonas aeruginosa exotoxin A.
Researchers administered one injection of the vaccine to 892 hemodialysis
patients and one injection of placebo to 906 patients. Between weeks 3 and
40, 11 vaccinated study subjects developed S. aureus in their bloodstreams
during 618.9 person-years, and 26 cases placebo recipients developed S. aureus in their bloodstreams during 627.0 person-years, a statistically
significant difference. Almost 90% of vaccine recipients generated antibodies to the two capsular polysaccharides, and the remainder of the
immunogenicity profile was reassuring. The short-term efficacy profile was,
overall, appropriate for a patient population requiring short-term immunity,
such as end-stage patients of all sorts and elective surgery candidates at
risk for S. aureus bacteremia (blood infection). The immunogenicity profile
was especially reassuring considering that many individuals with end-stage
renal disease have suppressed immune function.
Nabi plans to experiment with booster shots to maintain immunity for longer
periods of time, and with other forms of immunization for such at-risk populations as premature infants. The company expects that immunogenicity
results from its preliminary booster study will be available during the first half of 2002. Nabi plans to begin a confirmatory phase III trial of
StaphVAX in end-stage kidney patients in 2003 to support eventual BLA submission. The company plans to submit a BLA to the FDA in 2005, likely
asking for an expedited review, since it would serve a unique therapeutic
purpose, and hopes to gain approval in 2006.
S. aureus is a major cause of hospital-acquired infections, including bloodstream infections - bacteremias. Community-acquired Staph infections
are also of increasing concern. According to U.S. Centers for Disease Control and Prevention figures, each year more than two million U.S.
patients develop an infection while exposed receiving healthcare in a hospital. S. aureus associated with a death rate of approximately 10 to 25%.
--
AMERICAN JOURNAL OF PAIN MANAGEMENT, January 2002; 12:16-23: Small study
shows that Topamax may be used to treat several types of pain.
Johnson & Johnson's Topamax (topiramate) may have a role in the treatment of various neuropathic and sympathetically maintained pain syndromes. A
small study with patients with reflex sympathetic dystrophy, migraine headache, cluster headaches, radiculopathy, discogenic disease, and phantom
limb pain, as well as classical pain resulting from skin graft and third-degree burns, or diabetic and other neuropathies received escalating
doses of Topamax throughout the study period. Overall, more than half of the
patients had a greater than 50% improvement in symptoms, 14.6% of the patients experienced greater than 70% reduction in symptoms, and only 12.2%
experienced a poor response. Two patients discontinued use of Topamax due to
nausea, and another 16 because of dizziness and sedation.
This study needs to be confirmed in larger, randomized, controlled trials in
order for Topamax to be accepted as one of the legions of medicines designed
to impact these pain syndromes. Topamax has been approved since October 1999
for tonic-clonic seizures in adults and children.
Earlier this month Johnson & Johnson announced that it was discontinuing
clinical trials for the agent in obesity, indicating that while efficacious
at reducing weight, concerns were raised regarding adverse effects among
patients taking high doses. J&J will attempt to improve the adverse effect
profile of Topamax for its use in obesity. Using technology developed by the
recently acquired Alza Corp., J&J plans to develop a controlled-release
formulation of the drug.
In mid September Topamax tablets and sprinkle capsules were approved as an
adjunctive treatment for the Lennox-Gastaut Syndrome (LGS), one of the most
severe forms of epilepsy.
--
JOURNAL OF CLINICAL ONCOLOGY, February 15, 2002; 20(4):1069-1074: MDA-7
expression correlates with melanoma severity.
Downregulation of MDA-7 protein expression in primary melanomas makes it
possible for these tumors to progress to invasive and metastatic stages.
Melanoma differentiation antigen-7 (MDA-7) is a tumor suppressor protein
that keeps melanomas at bay. Previous studies demonstrated that MDA-7 protein expression varied inversely with cancer severity. The protein was
present in early stage melanomas and absent in metastatic melanoma cells.
The current study did one better by demonstrating this correlation in matched samples from the same patient. MDA-7 protein expression was
significantly reduced in melanoma cells that were invading normal tissue.
Results of this study support the development of Introgen's (NASDAQ:
INGN) INGN241gene therapy construct in the treatment of melanoma. Phase I clinical
trials are ongoing in melanoma, after compelling preclinical work demonstrated that treatment of tumor cells with INGN241 led to selective
tumor cell killing via apoptosis (programmed cell suicide.) INGN241 in combination with Genentech's (NYSE: DNA) Herceptin demonstrated virtually
synergistic positive experimental effects in preclinical laboratory models
of breast cancer.
BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
February 19, 2002
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BTECH NEWS, published by Btech Investor, Inc., highlights selected events in
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