Company**

Product

Description

Indication

Status (Date)

CANCER

Aronex Pharmaceuticals Inc.

Atragen

Liposomal formulation of all-trans retinoic acid; induces tumor cells to differentiate into mature normal cells (injection)

Advanced renal cell carcinoma (combination therapy with alpha interferon)

Initiated Phase I/II trial (1/7)

Diatide Inc.

NeoTect

Small molecule synthetic peptide labeled with technetium-99m; peptide designed to adhere to somatostatin receptor

In vivo imaging agent for suspected malignant tumors of the lung

Report of clinical study published in 1/14/99 issue of Chest (1/14)

Ilex Oncology Inc. and Symphar SA (Switzerland)

SR-45023A

Orally active bisphosphonate ester derivative; binds to nuclear receptor FXR and selectively induces apoptosis in malignant cells (but not normal ones)

Advanced metastatic cancer

Initiated Phase I trial (1/5)

Onyx Pharmaceuticals Inc.

ONYX-015

Genetically engineered adenovirus that replicates in and kills tumor cells deficient in p53 tumor suppressor gene product (administration via hepatic artery)

Colorectal cancer that has metastasized to the liver (as monotherapy; also in combination with 5-FU and leucovorin)

Initiated new Phase I/II trial (1/14)

CARDIOVASCULAR

Alexion Pharmaceuticals Inc.

5G1.1-SC

Humanized single-chain antibody designed to intervene in complement cascade (complement inhibitor)

Patients undergoing cardiopulmonary bypass during coronary artery bypass graft surgery

Initiated Phase IIb trial (1/13)

CytRx Corp.

Flocor

Purified poloxamer 188; surfactant molecule that alters the way cells and molecules interact with water

Vascular occlusive crisis in sickle cell disease

After review of Phase III trial results on 1st 50 patients, Safety and Data Monitoring Review Board recommended that company proceed with trial (1/12)

Emisphere Technologies Inc. and Elan Corp. (Ireland)

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Oral formulation of heparin (anticoagulant)

Prevention of deep vein thrombosis in patients plc undergoing surgery for hip replacement

Announced preliminary results of Phase II trial (1/11)

Icos Corp.

LeukArrest (formerly Hu23F2G)

Humanized monoclonal antibody that blocks CD11/CD18-mediated cell adhesion (inhibits movement of neutrophils from blood into tissue)

Acute iscehmic stroke

Initiated Phase III trial in North America (1/25)

CENTRAL NERVOUS SYSTEM

Boston Life Sciences Inc.

Altropane

Radioimaging probe for dopamine neurons

Photon emission computed tomography imaging agent for early diagnosis of Parkinson¿s disease

Announced interim results of Phase II trial (1/26)

NeoTherapeutics Inc.

Neotrofin (AIT-082)

Small molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors

Mild-to-moderate Alzheimer¿s disease

Announced results of Phase Ib trial (1/11); announced results of Phase IIa trial (1/27)

Sibia NeuroSciences Inc.

SIB-1508Y

Small molecule compound that is selective for certain nicotinic acetylcholine receptor (NAChR) subtypes in the brain; the receptors regulate the release of dopamine and acetylcholine

Patients with mid-to-late stage Parkinson¿s disease (combination therapy with L-dopa at half of the usual dosage)

Initiated 2nd Phase II trial (1/4)

Sibia Neurosciences Inc.

SIB-1553A

Small molecule compound; subtype-selective nicotinic acetylcholine receptor agonist; stimulates release of acetylcholine in brain

Alzheimer¿s disease

Completed multi-dose Phase I trial and initiated Phase II trial (1/7)

DIABETES

Amylin Pharmaceuticals Inc.

Pramlintide

Synthetic analogue of human pancreatic hormone amylin

To improve glucose control in patients with Type I diabetes and in insulin-using patients with type II diabetes label

Reported new clinical data from 4 completed Phase III trials (1/11); announced preliminary results from open long-term studies (1/25)

INFECTION

Alpha-Beta Technology Inc.

Betafectin PGG-Glucan

Complex carbohydrate-based product

Prevention of serious infections in patients undergoing upper gastrointestinal surgery

Discontinued Phase III trial; interim analysis of data showed insufficient evidence of clinical benefit to warrant continuation of trial; company is liquidating its assets (1/22)

AntexBiologics Inc. (OTC Bulletin Board:ANTX)

Helicobacter vaccine

Oral, whole-cell vaccine; consists of inactivated Helicobacter pylori plus mucosal adjuvant

Gastric ulcers

Announced results of Phase I trial (1/27)

IntraBiotics Pharmaceuticals Inc.*

Protegrin IB-367

Synthetic analogue of protegrin family of mammalian antimicrobial peptides (liquid formulation delivered via nebulizer)

Respiratory infections in cystic fibrosis patients

Initiated Phase I trial (1/20)

IntraBiotics Pharmaceuticals Inc.*

Ramoplanin Ointment

Naturally occurring antibiotic that kills Gram-positive bacteria (administered intranasally)

Prevention of nosocomial infections due to Staphylococcus aureus, including methicillinresistant strains

Initiated Phase II trial (1/13)

Maxim Pharmaceuticals Inc.

MaxDerm

Topical gel or solution; active ingredient is H2 receptor agonist (same as in cancer drug Maxamine)

Herpes labialis (cold sores)

Announced preliminary results of clinical study (1/11)

Shaman Pharmaceuticals Inc. (OTC Bulletin Board: SHMN)

Provir

Oral formulation of compound SP-303, which is isolated from the croton plant; it is thought to act by inhibiting secretion of chloride from intestinal cells

AIDS-related diarrhea

Initiated open-label study (1/12)

Targeted Genetics Corp.

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Adoptive immunotherapy; HIV-positive (gag-specific) cytotoxic T lymphocyrtes isolated from patient, expanded in culture, then infused back
into patient

HIV infection and AIDS

Results of Phase I trial published in 1/99 issue of Nature Medicine (1/4)

ViroPharma Inc.

Pleconaril

Oral liquid formulation of a small molecule inhibitor of several RNA viruses (blocks replication)

Severe meningococcemia (viral meningitis) in adults

Announced results of 2nd of 4 Phase III trials; product did achieve statistical significance in primary endpoint (1/6)

MISCELLANEOUS

Abgenix Inc.

ABX-IL8

Fully human monoclonal antibody that binds to interleukin-8 (produced via XenoMouse technology)

Moderate-to-severe rheumatoid arthritis

Initiated Phase I trial (1/28)

Axys Pharmaceuticals Inc.

APC 2059

Topical cream formulation of tryptase inhibitor (tryptase involved in mast cell-mediated inflammation)

Psoriasis

Initiated Phase I trial (1/5)

GelTex Pharmaceuticals Inc.

CholestaGel

Cholesterol reducer; non-absorbed hydrogel that binds to and eliminates bile acids from intestinal tract

Reduction of LDL (low-density lipid) cholesterol in treatmentof hyper-cholesterolemia

Presented results of Phase III trial at 17th annual Hambrecht & Quist Healthcare Conference in San Francisco (H&Q conference) (1/11)

Gliatech Inc.

Adcon-P

Adhesion control barrier; resorbable carbohydrate polymer liquid

To inhibit scarring and adhesions in the peritoneal cavity in patients under-going laparoscopic gynecological surgery

Initiated pivotal trial (1/28)

Icos Corp.

ICM3

Monoclonal antibody designed to block activity of adhesion molecule ICAM-3

Psoriasis

Initiated Phase I/II trial (1/14)

Icos Corp. and Eli Lilly and Co.

IC 351

Selective phosphodiesterase 5 inhibitor (thought to reinforce normal physiological signals to increase blood flow)

Erectile dysfunction

Presented results of 2 Phase II trials (in U.S. and Europe) at H&Q conference (1/14)

Medarex Inc. and Centeon LLC

MDX-33

Humanized bispecific antibody; modulates activity of immune system killer cells that can destroy platelets

Idiopathic thrombocytopenic purpura

Initiated Phase II trial (1/13)

Medarex Inc. and Eisai Co. Ltd. (Japan)

MDX-CD4

Fully human monoclonal antibody (created via HuMAb-Mouse technology) to CD4

Rheumatoid arthritis

Initiated Phase I trial (1/28)

Oxis Therapeutics Inc. (subsidiary of Oxis International Inc.)

BXT-51072

Small molecule compound that mimics action of natural antioxidant enzyme glutathione peroxidase (blocks activity of free radicals)

Mild-to-moderate ulcerative colitis (2nd-line therapy)

Announced preliminary results of Phase IIa trial (1/5)

Vertex Pharmaceuticals Inc.

VX-497

Inosine monophosphate dehydrogenase (IMPDH) inhibitor (blocks DNA synthesis)

Severe, chronic plaque-type psoriasis

Initiated Phase II trial (1/21)


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. x-y.

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