Company** Product Description Indication Status (Date)
CANCER
Amgen Inc. MGDF Recombinant human Various cancers Some patients in trial devel-
megakaryocyte growth oped neutralizing antibodies;
and development so did some in separate platelet
factor donor trial; company discon-
tinued MGDF program (9/11)
Biomira Inc. Theratope Synthetic, carbohydrate- Metastatic breast cancer Bridging study on improved
(Canada) and vaccine based vaccine (mimic of following chemotherapy formulation of vaccine is
Chiron Corp. cancer antigen sialyl-Tn fully enrolled (9/18)
plus carrier molecule KLH)
Celgene Corp. Thalomid Thalidomide; thought to End-stage, refractory Results of trial conducted by
(FDA- act by modulating levels multiple myeloma researchers at Arkansas Can-
approved) of tumor necrosis factor- cer Research Center present-
alpha ed at Leukemia Society of
America meeting in Wash-
ington (9/28)
Cell Genesys Inc. GVAX Cancer vaccine; 2nd-gen- Prostate cancer Reported preliminary results
eration product that is non- of ongoing Phase I/II trial at
patient-specific (allogeneic); 5th Annual CaP Cure Sci-
consists of irradiated, gen- entific Retreat at Lake Tahoe,
etically modified prostate Nevada (9/14)
cancer cells that secrete
granulocyte macrophage-
colony stimulating factor;
intradermal injection
Enzon Inc. and PEG- Long-acting dosage form Malignant melanoma Schering-Plough initiated
Schering-Plough Intron A of Intron A (recombinant Phase III trial (9/21)
Corp. (NYSE:SGP) interferon alfa-2b) conju-
gated to polyethylene
glycol
The Immune — Vaccine consisting of Recurrent refractory Initiated Phase Ib trial (9/16)
Response Corp. combination of 3 colon colon cancer
tumor cell lines plus a
fibroblast cell line that
secretes interleukin-2
NeoPharm Inc. LEP Liposomal encapsulated Various cancers Initiated Phase I trial (9/22)
paclitaxel
Onyx ONYX-015 Genetically engineered Pancreatic cancer (as both Initiated Phase I/II trial (9/29)
Pharmaceuticals adenovirus that repli- single agent and in combi-
Inc. cates in and kills tumor nation with gemcitabine
cells deficient in p53 intravenous)
tumor suppressor gene
product
Osiris Stromagen Infused, autologous Metastatic breast cancer Initiated Phase I/II trial (9/30)
Therapeutics human mesenchymal patients receiving high-
Inc.* stem cell product, dose chemotherapy and
expanded ex vivo hematopoietic stem cell
transplants
Sugen Inc. SU 101 Small-molecule signal Non-small cell lung cancer Initiated Phase II trial (9/18)
transduction inhibitor; (administered prior to sur-
specifically inhibits gery or radiation and
platelet-derived growth chemotherapy)
factor receptor signaling
CARDIOVASCULAR
CV Therapeutics CVT-510 Selective adenosine A(1) Atrial arrhythmia Initiated Phase I trial (9/30)
Inc. agonist
Transkaryotic GA-EPO Gene-activated erythro- Treatment of anemia in Hoechst Marion Roussel
Therapies Inc. and poietin (EPO); gene in patients with renal failure initiated Phase III trial (9/29)
Hoechst Marion human cells is activated who are receiving dialysis;
Roussel Inc. in situ to produce EPO also treatment in pre-
dialysis patients
CENTRAL NERVOUS SYSTEM
CoCensys Inc. Ganaxolone Synthetic version of Moderate to severe Completed Phase II trial (9/10)
naturally occurring migraine headaches
neuroactive steroids
(epalons) that bind to
gamma amino butyric
acid (GABA)-A
receptors in brain
(tablet formulation)
Immunex Corp. Novantrone Mitoxantrone for injection To reduce incidence of Reported preliminary results
(FDA- (intravenous) relapse and disease of Phase III trial at 14th Con-
approved) progression in multiple gress of the European Com-
sclerosis mittee for Treatment and Re-
search in Multiple Sclerosis
in Stockholm (9/10)
DIABETES
Chrysalis Chrysalin Synthetic peptide that Mild to moderate FDA cleared protocol for
Biotechnology accelerates healing of chronic diabetic ulcers Phase I/II trial (9/24)
Inc.* wounds and broken
bones; topical
Ergo Science Ergoset Low-dose, oral formu- Type II diabetes (mono- Presented clinical data at
Corp. Tablets lation of bromocriptine therapy as adjunct to SG Cowen Securities Corp.
(ergot alkaloid; generic diet to improve glycem- 13th Annual Life Sciences
dopamine agonist) ic control in diabetics) Conference (Cowen confer-
ence) in San Francisco (9/24)
Inhale — Dry powder formulation To improve glycemic Reported preliminary results
Therapeutics Inc. of insulin; delivered via control in Types I and II of Phase IIb trial at European
and Pfizer Inc. pulmonary delivery system diabetes Association for the Study of
(NYSE:PFE) Diabetes meeting in Barce-
lona, Spain (9/9)
INFECTION
Aronex Nyotran Liposomal formulation of Severe systemic fungal Presented data from Phase II
Pharmaceuticals antifungal agent Nystatin infections trial at 38th Interscience Con-
Inc. ference on Antimicrobial
Agents and Chemotherapy
(ICAAC) in San Diego (9/28)
Aviron FluMist Nasal spray formulation Prevention of influenza Presented new data from 2nd
of influenza vaccine; infection in children year of Phase III trial at
attenuated, cold-adapted ICAAC (9/27)
live virus vaccine
Cell Genesys Inc. Gene Procedure by which Combination therapy Completed patient enroll-
therapy patient's own T cells are with antiretroviral drugs ment in Phase II trial; also
collected, genetically for HIV infection and presented results of 1st
modified to recognize and AIDS Phase II trial at ICAAC
destroy HIV-infected cells, (9/28)
then returned to patient
Gilead Sciences PMPA Oral prodrug of nucleo- Combination therapy Initiated Phase II trial (9/4)
Inc. tide analogue known to with antiretroviral drugs
inhibit reverse transcrip- for treating HIV infection
tase in treatment-experienced
patients
Preveon Adefovir dipivoxil; HIV infection and AIDS Completed patient enroll-
reverse transcriptase ment in 3 clinical trials
inhibitor (oral dosage) (Phases II and II/III) and
concluded 4th trial (Phase
III) (9/23)
Gilead Sciences GS4104 Neuraminidase inhibitor Treatment and preven- Presented results of U.S. and
Inc. and F. Hoff- (oral formulation) tion of viral influenza international Phase III trials
mann-La Roche (strains A and B) at ICAAC (9/25)
Ltd. (Switzerland)
ImmuCell Corp. TravelGAM Bovine anti-Escherichia Traveler's diarrhea Preliminary results of Phase
coli immunoglobulins II trial were negative; company
will not pursue this clinical
indication (9/22)
Lidak Lidakol N-docosanol 10% cream; Recurrent outbreaks of Presented results of pivotal
Pharmaceuticals long-chain fatty acid that oral herpes (cold sores Phase III trials at ICAAC
interferes with viral entry or fever blisters caused (9/26)
into cells by herpes simplex virus)
MedImmune Inc. MEDI-501 Virus-like particle-based Genital warts; cervical Presented new data from
vaccine for human papil- cancer Phase I trial at ICAAC (9/28)
loma virus (HPV) Type 11
MedImmune Inc. Synagis Palivizumab; humanized Treatment and prevention Results from pivotal Phase III
(FDA- monoclonal antibody to of serious RSV disease in trial published in 9/98 issue
approved) respiratory syncytial virus certain high-risk infants of Pediatrics (9/3)
(RSV); binds to fusion pro- and children (causes pneu-
tein on viral surface monia, bronchitis)
Synagis Palivizumab; humanized Treatment and prevention Presented new data from
(FDA- monoclonal antibody to of RSV infection in adult Phase I trial at ICAAC (9/28)
approved) respiratory syncytial virus recipients of hematopoi-
(RSV); binds to fusion pro- etic stem cell transplants
tein on viral surface
NeXstar Pharma- MiKasome Liposomal formulation of HIV infection and AIDS Presented results from 2nd
ceuticals Inc. antibiotic amikacin Phase I trial at ICAAC (9/28)
Sarawak Medi- Canolide A Non-nucleoside reverse HIV infection and AIDS in Initiated Phase Ib trial (9/30)
Chem Pharmaceu- transcriptase inhibitor treatment-naive patients
ticals Inc.* (joint (originally isolated from
venture between tree found in Sarawak
MediChem Research rain forest)
Inc. and the state of
Sarawak, Malaysia)
Trimeris Inc. T-20 Antiviral fusion- HIV infection and AIDS Initiated dosing in Phase II
inhibiting compound trial (9/16)
(delivered by continuous
or intermittent subcut-
aneous infusion pump)
U.S. Bioscience FddA Lodenosine; acid-stable, Combination therapy FDA cleared protocol for
Inc. purine-based reverse with Zerit and Crixivan for Phase II trial (9/10)
transcriptase inhibitor treating HIV infection in
treatment-naive patients
Vertex VX-497 Small molecule drug Hepatitis C virus infection Initiated Phase II trial (9/21)
Pharmaceuticals designed to inhibit inosine in patients unresponsive
Inc. monophosphate dehydro- to alpha interferon therapy
genase (essential for pro-
duction of nucleotides)
Vertex Pharma- Agenerase Amprenavir; 2nd-generation Combination therapy with Presented interim results of
ceuticals Inc. and HIV protease inhibitor; Retrovir and Epivir in HIV Phase III trial at ICAAC
Glaxo Wellcome twice-daily dosage infection and AIDS (9/27)
plc (NYSE:GLX; U.K.)
Xoma Corp. Neuprex Recombinant bactericidal/ Complicated intra-abdom- Presented Phase II results at
permeability-increasing inal infections ICAAC (9/24)
protein (rBPI)
MISCELLANEOUS
Agouron AG 3340 Small synthetic mole- Age-related macular Initiated Phase II trial (9/15)
Pharmaceuticals cule designed to select- degeneration
Inc. ively inactivate matrix
metalloproteases (also has
anti-angiogenic activity)
(oral dosage)
Amgen Inc. OPG Osteoprotegerin; recombi- Bone protection in osteo- Initiated Phase I trial (9/9)
nant version of naturally porosis and cancer-related
occurring protein that bone metastasis
regulates bone mass
Axys APC-366 1st-generation tryptase Asthma In Phase I trials, some individ-
Pharmaceuticals inhibitor; dry powder uals exhibited signs of bron-
Inc. and Bayer AG inhaler drug formulation chospasm; clinical studies
(Germany) will be discontinued (9/29)
Gliatech Inc. Adcon-P Anti-adhesion barrier To inhibit scarring and ad- Presented results of pilot
solution (semisynthetic hesions following pelvic trial at Cowen conference
carbohydrate polymer) and abdominal surgery (9/25)
The Immune TCR T cell receptor peptide Moderate to severe Presented results of explora-
Response Corp. Vaccine vaccine (combines 3 psoriasis tory Phase II trial at 5th Euro-
T cell receptor peptides pean Congress on Psoriasis/
with an adjuvant) 7th International Psoriasis
Symposium in Milan, Italy
(9/5)
Immunex Corp. Enbrel Recombinant, soluble Juvenile rheumatoid Reported results from 2nd
p75 tumor necrosis factor arthritis segment of trial (9/3)
receptor (TNFr) linked
to the Fc portion of
human IgG1
InSite Vision Inc. ISV-205 Product that inhibits pro- Glaucoma Initiated Phase II trial (9/11)
tein product of TIGR gene
SciClone CPX Oral drug that appears to Cystic fibrosis Initiated Phase II trial (9/17)
Pharmaceuticals bind to defective CFTR
Inc. protein (cystic fibrosis trans-
membrane regulator) and
permit transport of
chloride ions
Texas TBC 1269 Small molecule compound Mild to moderate Announced preliminary
Biotechnology that inhibits selectin (anti- asthma results of Phase II trial (9/9)
Corp. inflammatory)
NOTES:
* 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. 14-15.