Univax Biologics announced Wednesday that it has initiatedPhase II human clinical studies for its vaccine to reduce seriousinfections in patients with kidney failure.
About 200 patients with end-stage renal disease (ESRD) whoare undergoing continuous ambulatory peritoneal dialysis willbe enrolled in the trials for the vaccine, NyperVAX+Staph A,which is designed to combat bacterial Staphylococcus aureusinfections, according to W. Scott Harkonen, Univax's vicepresident of medical and regulatory affairs.
"In early-stage human clinical trials, the vaccine, which is beingdeveloped and tested in conjunction with the NationalInstitutes of Health, was shown to produce high levels ofopsonic (killing) antibodies against S. aureus," said Harkonen.In laboratory testing, these antibodies have been shown to beactive against over 90 percent of the isolates responsible for S.aureus infections.
According to Univax (NASDAQ:UNVX) of Rockville, Md., anestimated 130,000 kidney dialysis patients in the U.S. andanother 330,000 worldwide who face severe medicalcomplications from staph infection could benefit from thevaccine.
BioWorldAug. 20, 1993Vol. 5, No. 162
THE BENEFITS OF INTELLECTUAL BIGAMY
Editor's Note: Today's Science carries a "Public Forum" editorialby noted chemist and industrialist Carl Djerassi(a) titled "BasicResearch: The Gray Zone." With the permission of Science andthe author, we have excerpted below portions of this essaymost pertinent to biotechnology. The full article also contains aset of recommendations to prevent potential conflicts ofinterest.
Explicitly or implicitly, the assumption is always made thatacademic eggheads in white coats should leave the job [ofpractically implementing basic research discoveries] toindustrial entrepreneurs. But dramatic changes are under way,and nowhere more strikingly than in the field of biomedicalapplications. While many news columns have noted thepervasive connection of most top biotechnology researchers inAmerican universities to industry, the associated financialrewards are invariably criticized; the implication being thatmoney in academia unfailingly corrupts. We tout America'sthriving entrepreneurship (almost entirely based on prospectsof financial gains) while deprecating flourishing academicentrepreneurship, forgetting that the biotechnology industry inAmerica would never have taken off without the activeinvolvement of academic investigators in hundreds of fledglingenterprises. Associated rewards in terms of stock options orstock ownership (standard currency in any industrialentrepreneurial setting) invite instant suspicion and criticism;the position of the Howard Hughes Medical Institute thatStanford's Irving Weissman resign his position after hefounded SyStemix Inc. is a dramatic example. ...
The Hughes Institute would hardly have objected if Weissmanhad launched his discovery solely by way of the balloon of ascientific publication, even if the latter had then led to a Nobelcheck exceeding $1 million. The Hughes Institute would hardlyhave blinked if some industrial enterprise, say in Japan orEurope, had used these published results, uncontaminated andhence unprotected by a patent application, to develop humancancer therapeutics and reaped all ensuing financial benefits.
Why object automatically if the academic discoverer wishes tocontinue shepherding his or her scientific baby along the roadto practical maturity, prompted in part by financial gains? Whyshould such a person have to abandon the academic laboratoryto do so? Monogamy is great for stable marriages, but what isthe evidence against the benefits of intellectual bigamy inacademia (with its associated financial benefits to theindividual and eventually to society)?. ...
These are not theoretical questions, as my own experienceattests. Years before the biotechnology explosion, I straddledboth sides of a then much less penetrable wall by servingsimultaneously as a chemistry professor at Stanford Universityand as an officer (including chief executive officer) of research-intensive industrial enterprises; the industrial position carriedhandsome compensation in terms of salary and stock options.There are other examples of such professional bigamy (mostcommonly disclosed in annual proxy statements) that haveresulted in direct benefits to a wide community. I estimate thatmy own industrial activities, during my concurrent academicservice, were responsible for several thousand jobs, most ofthem highly technical, in the San Francisco Bay Area. ...
I can think of few better ways to stimulate societalresponsibility for one's basic research than to be formallyinvolved in the necessary technology transfer from thelaboratory to the ultimate consumer. The perception of thecorrupting influence of money cannot be changed, but becauseit applies to virtually all areas of contemporary society, whynot focus primarily on reality rather than perception?
(a)The author is a professor of chemistry at Stanford University.For many years he also held concurrent positions in themanagement of industrial enterprises (president ofSyntexResearch and chief executive officer of Zoecon Corp.) Amore detailed account of his own pertinent personal experience(summarized in the above excerpt) appears in his recentlypublished autobiography, The Pill, Pygmy Chimps and Degas'Horse (Basic Books, N.Y. 1992, 1993).
(c) 1997 American Health Consultants. All rights reserved.