Company** Product Description Indication Status (Date)
CANCER
Biomira Inc. Theratope Synthetic, carbohydrate- Metastatic breast Initiated 23-patient
(Canada) and vaccine based vaccine (mimic cancer bridging study leading to
Chiron Corp. of antigen sialyl-Tn on international, pivotal
protein carrier) Phase III trial; bridging
study to confirm immune
response to and safety of
improved product formu-
lation (4/29)
Genetronics Electropor- Drug delivery method Squamous cell carci- Initiated Phase II trials
Biomedical Ltd. ation therapy that uses electric fields noma of the head and (4/28)
to open pores in human neck in patients who
cells to allow easier and have failed conventional
more efficient delivery therapies
of chemotherapeutic
drug bleomycin
LeukoSite Inc. and Campath-1H Humanized monoclonal Chronic lymphocytic Initiated pivotal inter-
Ilex Oncology Inc. antibody that specific- leukemia in patients who national trial (4/1)
ally targets and binds to have failed standard 2nd-
CD52 cell surface anti- line therapy
gen on lymphocytes
Ligand Panretin Chemically synthesized Kaposi's sarcoma in Presented interim and
Pharmaceuticals Capsules version of 9-cis-retinoic AIDS patients final results of open-
Inc. acid (natural hormone label Phase II trials at
derived from vitamin A) 2nd National AIDS Mal-
(oral dosage) ignancy Conference, in
Bethesda, Md. (4/7)
Matrix IntraDose Biodegradable gel Advanced or recurrent Results of international
Pharmaceutical Inc. containing cisplatin squamous cell carcinoma Phase I/II trial published
and epinephrine (intra- of the head and neck and in 4/98 issue of the
tumoral injection) other localized cancers Journal of the American
Academy of Otolaryn-
gology Head and Neck
Surgery (4/27)
Sparta Spartaject Suspension of busulfan Bone marrow ablation Presented interim results
Pharmaceuticals Busulfan in phospholipid layer prior to bone marrow of international Phase I
Inc. (intravenous) transplantation in cancer trial at 89th annual meet-
ing of the American
Association for Cancer
Research in New Orleans
(3/31)#
CARDIOVASCULAR
Alexion 5G1.1-SC C5 inhibitor; humanized Prevention of inflamma- Presented results of Phase
Pharmaceuticals single-chain monoclonal tion and damage in I/II and Phase II trials at
Inc. antibody designed to cardiopulmonary bypass New Frontiers in Cardiac
intervene in the comple- surgery Surgery Symposium (at
ment cascade (bolus the Society of Cardiovas-
injection) cular Anesthesiologists
meeting) (4/26)
Epix Medical Inc. MS-325 MRI contrast agent; Enhancement of cardio- Results of 3 Phase II
and Mallinckrodt magnetically active, logy imaging in evalua- trials presented at Inter-
Inc. (NYSE:MKG) injectable small mole- tion of peripheral national Society for
cule that binds to vascular, carotid and Magnetic Resonance in
albumin coronary artery disease Medicine 6th annual
meeting, in Sydney, Aus-
tralia (4/15)
Ibex Technologies Neutralase Heparinase I, a heparin- Heparin neutralization Initiated 1st international
Inc. (TSE:IBT; Canada) degrading enzyme in patients undergoing Phase III trial (4/8)
(bolus injection) 1st-time cardiac bypass
surgery
Interneuron CerAxon Citicholine sodium; Reduction of infarct In preliminary analysis of
Pharmaceuticals organic molecule that size and improvement Phase III trial, product
Inc. consists of cytidine and in neurological function did not outperform pla-
choline (components in patients with ischemic cebo in primary or prin-
of brain cell membranes) stroke cipal secondary endpoint;
company decided to with-
draw NDA pending
results of additional tests
(4/20)
T Cell Sciences Inc. TP10 Soluble complement To reduce heart tissue Results of Phase I trial
receptor 1; a comple- damage following angio- reported at 47th annual
ment inhibitor designed plasty or thrombolysis meeting of the American
to prevent release of in patients with acute College of Cardiology,
inflammation-causing myocardial infarction in Atlanta (4/7)
factors and to minimize
complement-mediated
injury
CENTRAL NERVOUS SYSTEM
Anesta Corp. ACTIQ Oral transmucosal Treatment of break- Results of prospective
fentanyl citrate through pain in cancer pivotal trial published in
patients 4/98 issue of Journal of
the National Cancer
Institute (4/22)
Boston Life Altropane Radioimaging probe Photon emission Published results of
Sciences Inc. for dopamine neurons computed tomography physician-sponsored
imaging agent for Phase I/II trial in 4/98
diagnosing Parkinson's issue of Synapse (4/30)
disease
CoCensys Inc. Ganaxolone Synthetic version of Migraine headaches Completed 2 Phase I
naturally occurring and epilepsy trials (4/14)
neuroactive steroids
(epalons) that bind to
gamma-amino-butyric
acid (GABA)-A receptors
in brain (tablet dosage)
Elan Corp. plc Neurobloc Botulinum toxin type B Cervical dystonia Announced that each of 2
(Ireland) and (formerly (exotoxin produced by Phase III trials achieved
Axogen Ltd. BotB) Clostridium botulinum; statistical significance for
(Bermuda) prevents release of prospectively defined
neurotransmitter primary endpoint (4/21)
acetylcholine)
Genzyme Tissue NeuroCell-PD Implants of fetal pig Advanced Parkinson's Presented interim results
Repair and Diacrin and neural cells; intended to and Huntington's of Phase I trials at the
Inc. NeuroCell-HD function as replacement diseases annual meeting of the
for brain cells lost to American Association
disease of Neurology (AAN), in
Minneapolis (4/28)
ImmuLogic Cocaine Vaccine uses cocaine To be used as part of Initiated Phase I trial
Pharmaceutical vaccine derivative bound to an a treatment program (4/16)
Corp. immunogenic carrier to to prevent relapse in
elicit cocaine-specific cocaine-abstinent
antibodies that bind individuals who are
drug in bloodstream addicted to cocaine
NeuroSearch A/S NS2710 Benzodiazepine-based Anxiety disorders FDA cleared protocol for
(CSE:NEUS; Denmark) GABA-A receptor Phase II trial (4/14)
modulator
NPS NPS 1506 Small molecule; inter- Neuroprotection in Results of Phase I trial
Pharmaceuticals acts with N-methyl-D- stroke reported at AAN meeting
Inc. aspartate (NMDA) recep- (4/30)
tor to block flow of
calcium into brain cells
INFECTION
Alpha-Beta Betafectin Complex carbohydrate- Prevention of serious Completed interim anal-
Technology Inc. PGG-Glucan based product infections in patients ysis of Phase II trial,
undergoing surgery for which supports continu-
Crohn's disease or ulcer- ation of trial (4/21)
ative colitis (inflam-
matory bowel disease)
Amgen Inc. Infergen Concensus alpha inter- Chronic hepatitis C Results of retreatment
(FDA- feron; non-natural virus infection in trial published in 4/98
approved) recombinant type 1 patients who either issue of Hepatology (4/6)
alpha interferon failed to respond or
relapsed after prior
alpha interferon
therapy (retreatment
with high-dose
Infergen)
Gilead Sciences Adefovir dipivoxil; Chronic hepatitis B Results of international
Inc. reverse transcriptase virus infection Phase II trial presented at
inhibitor (oral dosage) 11th International Confer-
ence on Antiviral Research
(ICAR), in San Diego (4/10)
Preveon Adefovir dipivoxil; Combination therapy Reported that preliminary
reverse transcriptase with antiviral drugs analysis of Phase II/III
inhibitor (oral dosage) (protease inhibitor; trial shows the data are
reverse transcriptase statistically significant
inhibitors) for HIV (4/6)
infection in patients
already taking anti-
HIV drugs
Preveon Adefovir dipivoxil; Combination therapy Reported interim data
reverse transcriptase with antiviral drugs from open-label trial at
inhibitor (oral dosage) (protease inhibitor; ICAR meeting (4/5)
reverse transcriptase
inhibitors) for HIV
infection in treatment-
naive patients
Interferon Alferon N Highly purified, multi- Hepatitis C virus Completed interim anal-
Sciences Inc. Injection species, natural-source infection ysis of Phase III trial;
(FDA- human alpha interferon product equivalent but
approved) not superior to control
drug (alpha interferon);
when all patients com-
plete protocol, company
will perform final anal-
ysis of data (4/2)
Isis Fomivirsen Antisense inhibitor of Newly diagnosed and Presented summary of
Pharmaceuticals Inc. (ISIS 2922) cytomegalovirus (CMV) advanced CMV retinitis results of international
and Ciba Vision replication in AIDS patients Phase III trials at ICAR
Corp. (unit of Novartis meeting (4/5)
AG; Switzerland)
NABI H-BIG Reformulated hepatitis Post-exposure prophy- Completed pivotal phar-
5% SDF B immune globulin 5% laxis of hepatitis B macokinetic trial (4/21)
virus infection
StaphVAX Staphylococcus aureus Prevention of bacteremia Initiated pivotal Phase III
type 5 and type 8 in hospitalized patients trials (3/23)#
capsular polysaccharide with end-stage renal
conjugate vaccine disease
Pentose PEN203 Topical antiviral drug; Cutaneous and genital Initiated 3 Phase I/II
Pharmaceuticals small molecule that is warts caused by human trials (2 in U.S., 1 in
Inc.* structural analogue of papillomavirus infection Europe) (4/14)
2-5 oligoadenylate
(inhibits viral replication
by activating ribonucle-
ase L, that degrades
viral RNA)
Peptide Oral Single-dose, oral vaccine To protect travelers Academic collaborators
Therapeutics Typhoid against Salmonella typhi from contracting typhoid at University of Maryland
Group plc (U.K.) (organism attenuated by fever initiated Phase II chal-
removal of 3 genes) lenge studies (in which
immunized subjects are
then exposed to unatten-
uated S. typhi ) (4/2)
Vical Inc. and Malaria Naked DNA vaccine Malaria Results of Phase I trial
Pasteur Merieux vaccine against Plasmodium (conducted by U.S. Naval
Connaught (member falciparum (intra- Medical Research Insti-
of the Rhone-Poulenc muscular injection) tute) presented at 3rd
Group; France) National Symposium on
Basic Aspects of Vac-
cines, in Washington
(4/30)
MISCELLANEOUS
Acute Therapeutics Surfaxin Sinapultide; lung sur- Acute respiratory Initiated Phase II/III
Inc. (majority-owned factant containing the distress syndrome pivotal trial (4/29)
subsidiary of Discov- peptide KL4 (a 21- from direct causes
ery Laboratories Inc.) amino-acid peptide (i.e., non-sepsis
modeled after the SP-B causes such as
protein in the human pneumonia)
surfactant system)
BioCryst BCX-34 Topical ointment form- Moderate-to-severe Announced preliminary
Pharmaceuticals ulation of product, which plaque psoriasis Phase II results; product
Inc. is small molecule inhib- was not statistically dif-
itor of purine nucleoside ferent from placebo; com-
phosphorylase pany will not pursue fur-
ther clinical develop-
ment of ointment formu-
lation of drug (4/29)
Discovery ST-630 Biologically active Postmenopausal Initiated Phase Ib trial
Laboratories Inc. analogue of vitamin D osteoporosis (4/2)
in softgel capsules
GelTex RenaGel Non-absorbed polymer- Control of elevated Initiated open-label trial
Pharmaceuticals based compound that phosphorus levels in (4/27)
Inc. and Genzyme binds to and eliminates pre-dialysis chronic
Corp. target substances from kidney failure
the intestinal tract
Genelabs GL701 Dehydroepiandrosterone Systemic lupus erythe- Completed patient enroll-
Technologies Inc. (DHEA) (naturally occurring hor- matosus in women ment in 2nd Phase III
mone produced by trial (4/30)
adrenal glands)
Hemispherx Ampligen Double-stranded syn- Chronic fatigue syn- FDA cleared protocol for
Bio-Pharma Inc. thetic RNA compound drome and chronic Phase III trial (4/14)
(NASDAQ:HEMX) poly I:poly C12U fatigue immune
dysfunction
Inspire INS316 Uridine 5'-triphosphate To clear airways in Announced results from
Pharmaceuticals (UTP; activates the patients with chronic Phase I/II trial (4/29)
Inc.* P2Y2 receptor that regu- bronchitis and in
lates process of muco- smokers
ciliary clearance)
Molecular Oralex Ultrasound contrast To enhance abdominal Completed North Amer-
Biosystems Inc. agent (oral formulation) ultrasound images ican Phase II trial (4/2)
Sepracor Inc. Norastemizole Active metabolite of Seasonal allergic Completed large-scale
astemizole; non-sedating rhinitis trial (4/27)
antihistamine
Vimrx VM 301 Semisynthetic derivative Wound healing in Initiated Phase I trial
Pharmaceuticals of compound isolated partial- and full-thick- (4/15)
Inc. from the sea whip (a ness wounds
marine organism; topical)
Xoma Corp. hu1124 Humanized monoclonal Moderate-to-severe Reported results of
(anti-CD11a) antibody to CD11a recep- plaque psoriasis Phase I trial (4/29)
tor on T cells (involved
in both T cell migration
and activation)
NOTES:
# Those items identified with a hatch mark concern events that occurred prior to 4/98.
CSE = Copenhagen Stock Exchange; TSE = Toronto Stock Exchange
* Private companies are indicated with an asterisk.
** Unless otherwise noted, the trading symbols for public biotechnology companies can be found by referring to the BioWorld Stock Report For Public Biotechnology Companies on pp. 9-10.

No Comments