August
4, 2003
Local pharmaceutical
firms progress drug trials as conference comes to town
By Dyke Hendrickson
Mass High Tech
CardioTech International
Inc., based in Woburn, recently announced that it is selecting international
distributors for its advanced hydrophilic wound dressing, which absorbs
large quantities of wound exudates and provides protection to the wound
without the need to remove the dressing for inspection.
The wound dressing
received FDA clearance for marketing on May 31, 2002 as a Class I Exempt
device.
The hydrophilic
dressing will be marketed domestically by CardioTechs subsidiary,
Gish Biomedical.
Merrimack Pharmaceuticals
Inc., based in Cambridge, has announced the initiation of a Phase I
study for its immunomodulatory drug candidate, MM-093, a recombinant
version of human alpha-fetoprotein (AFP).
The double-blind,
placebo-controlled Phase I study will take place at the Guys Drug
Research Unit of Guys and St. Thomas Hospital in London.
The development
of MM-093 will be focused on autoimmune diseases such as rheumatoid
arthritis, multiple sclerosis and myasthenia gravis areas in
which published and proprietary pre-clinical data provide a compelling
rationale for its use, company officials say.
Dyax Corp. of Cambridge
and Debiopharm S.A. of Switzerland recently announced that they received
European orphan drug designation for the Engineered Protein Inhibitor
of Human Neutrophil Elastase, DX-890, for the treatment of cystic fibrosis.
European orphan
drug designation is granted for products that are intended to treat
life-threatening or chronically debilitating conditions affecting no
more than five in 10,000 persons.
Orphan drug status
of DX-890 in Europe can confer numerous benefits to its development,
including clinical protocol assistance and advice, reduced registration
fees when filing for product approval and, on marketing authorization,
marketing exclusivity for a period of up to 10 years, officials say.
Medwave Inc., based
in Danvers, recently announced that it has entered into an agreement
to perform a clinical study at the University of Arizona Medical Center
in Tucson, Ariz.
The study will compare
the Medwave Vasotrac Monitor to an invasive arterial catheter with patients
undergoing various surgical procedures.
The goal of the
study is to determine if the use of the Vasotrac in specific surgical
patients will allow for the elimination of the invasive arterial catheter
as a monitoring tool.
Drug Discovery Technology
2003 is one of Bostons largest life sciences conferences of the
year. It will take place Aug. 11-13 at the Hynes Convention Center.
And a local nonprofit event, BiotechTuesday, will take place for attendees
and nonattendees alike.
The eighth annual
drug discovery conference is expected to draw close to 6,000.
Keynote addresses
are scheduled to be delivered by Mark McClellan, commissioner of the
Food and Drug Administration, and Gov. Mitt Romney.
A special industry
award will be given to Craig Mello, a professor at the University of
Massachusetts Medical School and a pioneer in RNA interference (RNAi).
A networking event
in conjunction with the national conference will be hosted by organizers
of Biotech Tuesday on Tuesday, Aug. 12, at the Kings nightclub in Boston.
The venue is located at 10 Scotia St., which is close to the Hynes.
BiotechTuesday is
a monthly networking event for the New England biotech community.
Organizer Peter
Kolchinsky says that those involved in the life sciences are encouraged
to attend. He said there will be complimentary beverages and appetizers
(while they last) and light activities such as billiards.
Those interested
in attending can register online at www.biotechtuesday.com.