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Company** Product Description Indication Status/Date
Name
CANCER
Avax O-Vax Therapeutic vaccine; Advanced ovarian Presented results of on-
Technologies Inc. tumor cells removed cancer going Phase I/II trial at
from patient, modified 89th annual meeting of
with hapten (DNP; di- the American Association
nitrophenyl), then for Cancer Research
reinjected into patient (AACR) in New Orleans
(along with cyclophos- (3/31)
phamide) to stimulate
patient's immune system
AVI Biopharma CTP-37 Synthetic peptide conju- Metastatic colorectal Announced preliminary
and Immuno- Vaccine gate vaccine designed to cancer results of Phase II trial
Therapy Corp.* elicit immune response (3/26)
to human chorionic
gonadotrophin
Cell Lisofylline Compound designed to To prevent or reduce Primary endpoints were
Therapeutics Inc. inhibit production of incidence of serious and not met in 1st Phase III
phosphatidic acid and fatal infections, mucos- trial (according to pre-
reduce oxidative dam- itis and treatment- liminary results) (3/25)
age (protects epithelial related mortality in
cells from damage by cancer patients with
free radicals; anti- hematological malig-
inflammatory) nancies undergoing
radiation and/or
chemotherapy
Cel-Sci Corp. Multikine Natural mixture of Treatment of head and Expanded ongoing clin-
human cytokines, neck cancer prior to ical trials (at 4 Canadian
including interleukin-2 surgery or radiation sites) to include 2 U.S.
therapy sites (3/17)
Coulter Pharma- Bexxar Murine monoclonal Low-grade and trans- Reached target enroll-
ceutical Inc. antibody against CD20 formed low-grade non- ment in pivotal Phase
antigen on B cells; Hodgkin's lymphoma in trial (3/23)
radiolabeled with I-131 patients who are refract-
ory to chemotherapy
Endorex Corp. ImmTher Macrophage activator Adjuvant therapy for Initiated Phase II trial
derived from muramyl Ewing's sarcoma (bone (3/17)
dipeptide (naturally cancer in children)
occurring component
of bacterial cell walls);
designed to stimulate
patient's immune system
Imutec Virulizin Biological response Advanced-stage pancre- Completed patient en-
Pharma Inc. modifier extracted from atic cancer in patients lment in Phase I/II trial
(TSE:IMT; Canada) bovine reticuloendo- who have failed prior (3/11)
thelium; activates therapies
macrophages
Ligand Pharma- Panretin Gel Chemically synthesized Kaposi's sarcoma Presented final analysis
ceuticals Inc. (LGD 1957) version of 9-cis-retinoic in AIDS patients of Phase I/II trial (intra-
acid (natural hormone patient controlled study)
derived from vitamin A) at American Academy of
(topical gel formulation) Dermatology (AAD)
meeting in Orlando (3/1);
reported final results of
international, pivotal
Phase III trial (3/26)
Neoprobe Corp. RIGScan I-125-labeled mono- Surgical detection and Preliminary follow-up
CR49 clonal antibody for use management of meta- data on Phase III trial
with hand-held isotope static colorectal cancer reported at 51st annual
detector for radioimmu- Cancer Symposium of
noguided surgery the Society of Surgical
Oncology in San Diego
(3/31)
NeoRx Corp. and Avicidin Multi-step process in Metastatic prostate Janssen initiated Phase II
Janssen Pharma- which a murine antibody and colon cancers trial (3/4)
ceutica NV (Bel- linked to strepavidin is
gium; subsidiary of administered and allowed
Johnson & to accumulate on surface
Johnson; NYSE:JNJ) of tumor cells; then biotin
linked to yttrium-90 is
administered, binding to
strepavidin and killing
tumor cells
Onyx Pharma- ONYX-015 Genetically engineered Recurrent and refractory Initiated 3rd Phase II trial
ceuticals Inc. adenovirus that repli- head and neck cancer (aggressive treatment
cates in and kills tumor regimen) (3/13)
cells deficient in p53
tumor suppressor gene
product
Pharmacyclics Gd-Tex Radiation sensitizer Radiation treatment for Completed patient en-
Inc. gadolinium texaphyrin brain metastases rollment in Phase II trial
(synthetic molecule) (3/10)
coupled with photo-
sensitizing agent
Progenics Pharm- MGV Cancer vaccine; com- High-risk melanoma Presented initial results
aceuticals Inc. bines cancer antigens and sarcoma of Phase I/II trials at
GD2 and GM2, separ- AACR meeting (3/31)
ately coupled to carrier
protein keyhole limpet
hemocyanin (KLH)
and mixed with QS-21
adjuvant
Ribi Melacine Therapeutic cancer Combination therapy Data Safety and Monitor-
ImmunoChem vaccine made of lysed with Intron A (inter- ing Board recommended
Research Inc. and cells from 2 human mela- feron alpha-2b) for continuing pivotal Phase
Schering-Plough noma cell lines with a treating Stage IV malig- III trial (1st interim
Corp. (NYSE:SGP) broad array of melanoma nant melanoma review of data) (3/25)
antigens, combined with
Ribi's Detox adjuvant
(contains monophos-
phoryl lipid A and myco-
bacterial cell-wall
skeleton)
Schering-Plough rAd/p53 Gene therapy; recombi- Various types of cancer, Presented data from on-
Research Institute nant adenovirus encod- including metastatic going Phase I trials at the
and Canji Inc. (units ing human p53 tumor colon, ovarian, head and AACR meeting (3/31)
of Schering-Plough suppressor gene neck, non-small lung
Corp.; NYSE:SGP) cancer and melanoma
Sequus Pharma- SPI-077 Long-circulating Stealth Solid tumors, including Presented data from on-
ceuticals Inc. liposome formulation non-small cell lung going Phase I trial at the
of cisplatin cancer AACR meeting (3/31)
Targeted E1A Gene E1A tumor suppressor Metastatic or recurrent Presented preliminary
Genetics Corp. Therapy gene product; consists of breast and ovarian results of 2 Phase I trials
(tgDCC-E1A) E1A gene formulated in cancers at the AACR meeting
lipid-based gene delivery (3/30)
system; intratumoral
injection
Techniclone Oncolym LYM-1 murine mono- Intermediate- and high- Initiated Phase II/III trial
Corp. clonal antibody to HLA- grade refractory or (3/30)
DR10 protein (cell- relapsed non-Hodgkin's
surface marker present B-cell lymphoma
on 80% of lymphoma
cells), labeled with I-131
Techniclone TNT Tumor necrosis therapy; Malignant glioma Initiated Phase I trial
Corp. and Cam- chimeric monoclonal (brain tumor; inter- (3/31)
bridge Antibody antibody that targets stitial delivery
Technology Ltd. DNA-associated histone system)
antigens, labeled with
I-131 (targets necrotic
center of tumor)
Wisconsin POH Perillyl alcohol (syn- Advanced carcinomas Initiated enrollment in
Genetics Inc. thetic monoterpene) of the breast, ovary and 3 Phase II trials (spon- (wholly owned sub-
prostate sored by the National
sidiary of Endorex Cancer Institute) (3/3)
Corp.)
CARDIOVASCULAR
Alliance Pharma- Imagent Contrast agent; aqueous To improve echocardio- Initiated Phase III trials
ceutical Corp. and dispersion of micro- grams performed to test (3/31)
Schering AG bubbles containing mix- cardiac function
(Germany) ture of perfluoro-chemi-
cal vapor and a physio-
logical gas
Baxter Healthcare HemAssist Blood substitute; Severe traumatic Terminated Phase III
Corp. (subsidiary of diaspirin cross-linked hemorrhagic shock trail after interim
Baxter Interna- hemoglobin (made from review of data by Data
tional Inc.; unused human donor Monitoring Committee
NYSE:BAX) blood) showed that patients in
treatment group had in-
creased mortality com-
pared to controls (3/31)
Centocor Inc. ReoPro Chimeric monoclonal To enhance effective- Preliminary results of
and Eli Lilly & Co. (FDA- antibody fragment to ness of coronary stents EPILOG Stent Phase III
(NYSE:LLY) approved) GPIIb/IIIa platelet in angioplasty patients trial reported at meeting
receptor being treated for coro- of American College of
nary artery disease Cardiology (ACC) in
(to reduce ischemic Atlanta (3/31)
complications)
Cypress Cyplex Infusible platelet To control bleeding in Initiated expanded Phase
Bioscience Inc. membranes (manufac- patients with low levels II trial (3/30)
tured from human of circulating platelets
platelets, which are (secondary to chemo-
heat treated and therapy and/or radiation
lyophilized) therapy)
CytRx Corp. Flocor Purified poloxamer Vascular occlusive Initiated Phase III trials
188; surfactant molecule crisis in sickle cell (3/18)
that alters the way cells disease
and molecules interact
with water
Epix Medical Inc. MS-325 MRI contrast agent; Enhancement of cardio- Completed patient enrol-
and Mallinckrodt magnetically active, logy imaging in evalua- lment in Phase II trial
Inc. (NYSE:MKG) injectable small mole- tion of peripheral (3/12)
cule that binds to vascular disease
albumin
Genentech Inc. VEGF Genetically engineered To promote blood ves- Small clinical study per-
vascular endothelial sel growth around formed at Hennepin
growth factor (VEGF) blockages in coronary County Medical Center
infused into coronary arteries in patients in Minneapolis using
artery with severe heart Genentech's VEGF
disease protein product; results
presented at ACC meet-
ing (3/30)
Immunex Corp. Enbrel Recombinant, soluble Congestive heart failure Initiated Phase I trial
p75 tumor necrosis (3/31)
factor receptor (TNFr)
linked to the Fc portion
of human IgG1
CENTRAL NERVOUS SYSTEM
Neurex Corp. Ziconotide Selective N-type neuron- Chronic malignant pain Completed patient enrol-
(formerly specific calcium channel caused by cancer or lment in Phase III trial;
SNX-111) blocker (derived from AIDS trial halted early be-
snail toxin) cause independent anal-
ysis indicated statisti-
cally significant results
(3/31)
DIABETES
Alteon Inc. and Pimagedine Compound designed to Treatment of Type I Safety Monitoring Com-
Genentech Inc. block abnormal glucose/ diabetics with overt mittee recommended
protein complexes nephropathy (ACTION I continuation of ACTION I
(advanced glycosylation trial) and treatment of Phase III trial but cessa-
end-products) that lead Type II diabetics with tion of ACTION II Phase
to diabetic complica- overt nephropathy III trial, in which there
tions (ACTION II trial) was increased incidence
of side effects (3/18);
FDA concurred with both
recommendations
(3/23)
INFECTION
Enzo HGTV43 Genetic antisense To stop viral progres- FDA cleared protocol
Therapeutics Inc. medicine; insertion of sion in HIV-infected for Phase I trial (3/31)
(subsidiary of gene that synthesizes patients
Enzo Biochem antisense molecule to
Inc.) HIV-1 directly into
blood cells (patient's
stem cells treated ex
vivo to render them
HIV-resistant, then
reinfused into patient)
Progenics PRO 542 Fusion protein that HIV infection in adults Presented initial results
Pharmaceuticals incorporates HIV- with measurable circu- of Phase I/II trial at the
Inc. binding region of lating virus Keystone Symposium
cell surface receptor on HIV Pathogenesis
into a human antibody and Treatment in Park
molecule City, Utah (3/17)
Shaman Pharma- Provir Oral formulation of Diarrhea in AIDS Initiated enrollment in
ceuticals Inc. compound SP-303, patients pivotal Phase III trial
which is isolated from (being conducted in U.S.
the croton plant; it is and Puerto Rico) (3/30)
thought to act by
inhibiting secretion of
chloride from intestinal
cells
MISCELLANEOUS
Anergen Inc. AnervaX Therapeutic peptide Rheumatoid arthritis Completed analysis of
vaccine; synthetic Phase IIa trial (3/5)
20-amino-acid peptide
that targets DR4 and
DR1 human leukocyte
antigen (HLA) mole-
cules; interferes with
activation of T cells
Cellegy Pharma- Glylorin Monolaurin Non-bullous congeni- Announced that the pro-
ceuticals Inc. and tal ichthyosiform duct did not achieve sta-
Glaxo Wellcome erythroderma tistical significance
plc (NYSE:GLX; U.K.) in its primary outcome
variable in a Phase III
trial conducted by
Glaxo Wellcome (3/4)
Creative OP-1 Device that combines Bone graft; to induce Clinical trial data, demon-
Biomolecules Device genetically engineered normal bone regenera- strating that treatment is
Inc. and Stryker bone morphogenic pro- tion in tibial non-union equivalent to autograft-
Corp. (NYSE:SYK) tein (OP-1) with resorb- fractures ing were presented at
able collagen scaffold American Academy of
that is surgically Orthopedic Surgeons
implanted in bone (AAOS)meeting in
fractures and defects New Orleans (3/23)
Discovery ST-630 Biologically active Post-menopausal Completed Phase Ia trial
Laboratories Inc. analogue of vitamin D osteoporosis (3/24)
in softgel capsules
Discovery SuperVent Tyloxapol (non-anionic Cystic fibrosis Completed Phase I/IIa
Laboratories Inc. Aerosol alkylaryl and polyether open-label trial (3/31)
Solution alcohol)
Dura Pharma- Albuterol Powder aerosol form- Asthma Results of 2 clinical
ceuticals Inc. and Spiros ulation of albuterol studies presented at
Spiros Develop- delivered to lungs via American Academy of
ment Corp. II Inc. Spiros inhaler Allergy, Asthma and
(NASDAQ:SDCOZ) Immunology (AAAAI)
annual meeting in Wash-
ington (3/16)
Gliatech Inc. Adcon-L Anti-adhesion barrier To inhibit postopera- New clinical findings pre-
gel (semisynthetic tive adhesions involving sented at AAOS meeting
carbohydrate polymer) spinal cord and nerve (3/19)
roots following back
surgery
Gliatech Inc. Adcon-L Anti-adhesion barrier To inhibit postopera- Pivotal clinical trial re-
gel (semisynthetic tive peridural scars sults published in 3/98
carbohydrate polymer) (following lumbar issue of The American
disc surgery) Journal of Orthopedics
(3/4)
Icos Corp. rPAF-AH Human recombinant To decrease incidence Initiated Phase II trial
platelet-activating and severity of post- (3/16)
factor (PAF) acetyl- endoscopic retrograde
hydrolase; regulates cholangiopancrea-
levels of PAF by con- tography (ERCP)
verting it to inactive pancreatitis
form
Immunex Corp. Enbrel Recombinant, soluble Juvenile rheumatoid Presented preliminary
p75 tumor necrosis arthritis results of clinical trial at
factor receptor (TNFr) the American Academy
linked to the Fc portion of Pediatrics' Pediatric
of human IgG1 Rheumatology Into The
Next Century meeting in
Park City, Utah (3/15)
Immunex Corp. Nuvance Soluble interleukin-4 Moderate asthma Presented results of pilot
(IL-4) receptor; blocks study at AAAAI meeting
binding of IL-4 to its (3/14)
receptor on surface of
B and T cells
InKine Pharma- CBP-1011 Oral glucocorticoid Idiopathic thrombo- FDA accepted protocol
ceutical Co. Inc. analogue cytopenic purpura amendments for Phase
III trial (broadens patient
enrollment parameters
and changes dosing regi-
men) (3/24)
Life Medical Repel-CV Bioresorbable, polymer- Prevention of post- FDA approved investiga-
Sciences Inc. based adhesion barrier operative adhesions tional device exemption
(NASDAQ:CHAI) film in cardiovascular for pilot clinical trial
surgery (3/23)
Sonus Pharma- EchoGen Fluorocarbon-based Contrast radiography Completed enrollment in
ceuticals Inc. Emulsion ultrasound contrast in transrectal ultra- international Phase III
agent sonography of prostate trial (3/24)
Transcend Thera- Procysteine Product that delivers Acute respiratory Safety Monitoring Board
peutics Inc. and I.V. cysteine into cells to distress syndrome completed interim safety
Boehringer Ingel- neutralize tissue-damag- evaluation of data from
heim Interna— ing reactive oxygen 150 patients in Phase III
tional (Germany) species by boosting trial and recommended
cellular production of continuation of trial
glutathione (3/11); however, after it
had reviewed data on 213
patients, it found that the
incidence of all-cause
mortality was higher in
treatment group than the
placebo and thus the
Phase III trial was suspen-
ded (3/20)
Transkaryotic — Alpha-galactosidase A Protein replacement Presented results of
Therapies Inc. (alpha-gal, a lysosomal product for treating Phase I trial (conducted
enzyme) Fabry disease at the National Institutes
of Health) at the 5th
Joint Clinical Genetics
meeting in Los Angeles
(3/1)
NOTES:
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. 11-12.