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. |