Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Aphton Corp. (APHT)

GnRH pharmacine

Anti-GnRH immunogen

Advanced prostate cancer

The company presented data of a pilot study showing positive results (9/25)

Atrix Laboratories Inc. (ATRX)

Leuprogel

New Atrigel formulation containing leuprolide acetate; injected subcutaneously

Testosterone level reduction to reduce prostate cancer risk

Company presented interim data in the multicenter, Phase III trial that enrolled 120 patients (9/26)

Aventis Pharmaceuticals (unit of Aventis SA [NYSE:AVE])

Taxotere

Docetaxel; semisynthetic agent derived from needles of the European yew tree

Non-small-cell lung cancer

Researchers presented findings of a multicenter, randomized Phase III study comparing docetaxel plus cisplatin, docetaxel plus carboplatin and vinorelbine plus cisplatin, as well as results from several other clinical trials at the 9th World Conference on Lung Cancer (9/11)

Axcan Pharma Inc. (AXCA; TSE: AXP)

Photofrin (FDA-approved)

Photosensitive drug (porfimer sodium; produces toxic oxygen compound when light-activated)

High-grade dysplasia associated with Barrett's esophagus and esophageal cancer

Positive Phase III data were presented at the 6th World Congress of the International Organization for Statistical Studies on Diseases of the Esophagus (9/5)

Biomira Inc. (BIOM; TSE:BRA)

Theratope vaccine

Synthetic carbohydrate-based vaccine; mimic of cancer antigen si alyl-Tn plus carrier molecule KLH

Metastatic breast cancer

Company announced at the Stephens Inc. Anticancer Biopharmaceutical Investment Conference that it will surpass 700 patients in its pivotal Phase III trial (9/18)

British Biotech (UK; BBIOY)

Marimastat

Oral matrix metalloproteinase inhibitor

Advanced ovarian cancer

Company announced results that showed the combination of carboplatin and marimastat had no statistically significant advantage over carboplatin alone in either primary or secondary endpoints (9/26)

Calydon Inc.*

CV787

Oncolytic virus that replicates in human prostate cancer cells

Metastatic prostate cancer

Company began Phase I/II trial (9/28)

Cell Genesys Inc. (CEGE)

GVAX

Cancer vaccine comprised of tumor cells that have been irradiated and genetically modified to secrete granulocyte macrophage-colony stimulating factor

Non-small-cell lung cancer

Researchers presented follow-up data at the 9th World Conference on Lung Cancer; 18 of 25 patients demonstrated enhanced antitumor immunity (9/12)

Cytran Inc.*

IM862

Naturally occurring peptide administered as nose drops

Kaposi's sarcoma

Company is seeking 200 patients for a Phase III, randomized, placebo-controlled, double-blind study being conducted with the AIDS Malignancy Consortium of the National Cancer Institute (9/14)

EntreMed Inc. (ENMD)

2-Methoxy-estradiol (2ME2)

Oral compound; naturally occurring antiproliferative and antiangiogenic agent

Advanced breast cancer

First Phase I trial began testing 2ME2 in combination with cytotoxic chemotherapy, Taxotere (9/18)

Genta Inc. (GNTA)

Genasense

Antisense compound; synthetic DNA strands that bind to mRNA for the bc12 gene

Malignant melanoma

Company said enrollment should be completed in the Phase III trial by mid-summer 2001; it also plans to initiate studies in multiple myeloma, chronic lymphocytic leukemia and acute myelocytic leukemia by the first quarter of 2001 (9/19)

Genzyme Molecular Oncology (GZMO)

Gene therapy cancer vaccine

Combines melanoma tumor antigens MelanA/MARTI and gp100

Melanoma

Company initiated a Phase I/II trial to assess safety, efficacy and potency of the gene therapy cancer vaccine (9/26)

ImmunoGen Inc. (IMGN) and SmithKline Beecham (NYSE:SBH)

huC242-DM1/SB-408075

Tumor-Activated Prodrug

Colorectal and pancreatic cancer

Company said the product entered a second Phase I/II trial (9/21)

Immunomedics Inc. (IMMU)

LymphoCide

Humanized anti-CD22 monoclonal antibody, epratuzumab

Non-Hodgkin's lymphoma (NHL)

Company is beginning a Phase III pivotal trial in patients with low-grade or indolent NHL (9/26)

MGI Pharma Inc. (MOGN)

Irofulven

Hydroxymethylacyl-fulvene

Liver cancer

Company initiated a Phase II trial at Beth Israel Deaconess Medical Center (9/27)

OSI Pharmaceuticals Inc. (OSIP)

OSI-774

Orally active inhibitor of the epidermal growth factor receptor

Non-small-cell lung cancer

Investigators presented early data of a Phase II study at the 9th World Conference on Lung Cancer; four of 12 patients had objective partial responses and another four had disease stabilization (9/13)

Pharmacyclics Inc. (PCYC)

Xcytrin

Motexafin gadolinium injection

Stage IIIA non-small-cell lung cancer; glioblastoma multiforme

Company initiated two Phase I trials (9/7)

SafeScience Inc. (SAFS)

GBC-590

Carbohydrate lectin inhibitor that competitively binds to unique lectins on cancer cells and disrupts the metastatic process

Colorectal carcinoma

Company completed enrollment of a Phase II trial with 23 patients (9/21)

StressGen Biotechnologies (TSE:SSB)

HspE7

Recombinant fusion product composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7, derived from the human papilloma virus dysplasia

Advanced cancer of the uterine cervix

Company initiated patient treatment in a Phase II trial(9/6)

SuperGen Inc. (SUPG)

Nipent (FDA-approved)

Pentostatin for injection; chemotherapeutic drug that inhibits adenosine deaminase (blocks DNA synthesis)

GVHD

Studies presented at the Leukemia 2000 medical conference show Nipent is active in GVHD and a number of hematological malignancies (9/18)

SuperGen Inc. (SUPG)

Rubitecan

Oral chemotherapy in the camptothecin class

Chronic myeloid leukemia, chronic myelomonocytic leukemia and myelodysplastic syndrome

Studies presented at the Leukemia 2000 medical conference show that 43% of patients tested experienced a complete response, partial response or hematologic improvement (9/15)

Therion Biologics Corp.* and the National Cancer Institute

Prostvac VF

Vaccine

Prostate cancer

Company and NCI have initiated two additional Phase II trials (9/7)

Vical Inc. (VICL)

Leuvectin

Gene encoding interleukin-2 (complexed with lipid) administered by direct intratumoral injection

Prostate cancer

Company announced interim results from an ongoing Phase II trial showing Leuvectin to be safe and well tolerated (9/25)

Zarix Inc.*

Thymitaq

Nolatrexed dihydrochloride

Unresectable hepatocellular carcinoma

Initiated patient enrollment in pivotal Phase III randomized study (9/28)

CARDIOVASCULAR

AtheroGenics Inc. (AGIX)

AGI-1067

Anti-inflammatory compound with antioxidant properties

Post-angioplasty restenosis

Company completed enrollment of 300 patients in the Phase II trial (9/26)

Avant Immunotherapeutics Inc. (AVAN)

TP10

Soluble form of complement receptor 1, designed to inhibit complement proteins

Infants undergoing cardiac surgery

Company plans to initiate a double-blind, placebo-controlled Phase IIb study (9/15)

COR Therapeutics Inc. (CORR)

Integrilin

Eptifibatide injection; small-molecule compound (derived from rattlesnake venom) that inhibits GPIIb/IIIa receptor that mediates platelet aggregation

Unstable angina

PURSUIT study results were published in Circulation showing Integrilin added to aspirin and heparin significantly reduced the occurrence of heart attack or death (9/5)

Corvas International Inc. (CVAS)

rNAPc2

Injectable anticoagulant recombinant protein, discovered in its original form in flood-feeding hookworms

Deep-vein thrombosis

Company announced positive results from a Phase II trial showing it reduces the risk of developing DVT by greater than 50% as compared to low molecular weight heparins (9/14)

Diacrin Inc. (DCRN) and Temple University

Skeletal muscle cells

Autologous myoblasts

To repair damaged heart muscle

Company and university transplanted a patient's skeletal muscle cells into a damaged area of his heart in Phase I trial (9/25)

Genzyme Transgenics Corp. (GZTC) and Genzyme General (GENZ)

rhATIII

Recombinant human antithrombin III produced in the milk of goats

To restore heparin sensitivity and manage coagulation during cardiopulmonary bypass surgery

Companies said the primary endpoint of reduction in the use of frozen plasma was statistically significant in a second Phase III trial (9/7)

Scios Inc. (SCIO)

Natrecor

Nesiritide; a recombinant form of B-type natriuretic peptide, a naturally occurring hormone that aids healthy functioning of the heart

Acute congestive heart failure

Results of the Vasodilation in the Management of Acute Congestive heart failure (VMAC) trial were presented at the 73rd SSAHA meeting in New Orleans (9/7)

CENTRAL NERVOUS SYSTEM

Axonyx Inc. (AXYX)

Phenserine

Brain-targeted, reversible inhibitor of acetylcholinest-erase enzyme

Alzheimer's disease

Company announced results of a Phase I trial, which confirm the drug to be safe and well tolerated; the company intends to start a Phase II trial by the end of the year (9/12)

Biogen Inc. (BGEN)

Avonex

Recombinant interferon beta-1a

Clinically definite multiple sclerosis

Company announced publication in New England Journal of Medicine study results showing Avonex significantly reduces the rate of individuals developing CDMS (9/25)

Nymox Pharmaceutical Corp. (NYMX)

7C Gold test

Measures neural thread protein in urine

Alzheimer's disease

Company announced at the 2nd Manhattan Alzheimer Conference that new clinical studies show positive results (9/14)

Pharmos Corp. (PARS)

Dexanabinol

Non-psychotropic-synthetic analogue of marijuana (intravenous)

Severe traumatic brain injury

Company presented results of a Phase II trial demonstrating the drug improved orientation and memory, at the annual meeting of the Congress of Neurological Surgeons (9/27)

Sepracor Inc. (SEPR)

(S)-zopiclone

A single-isomer version of racemic zopiclone, a non-benzodiazepine, rapid-acting hypnotic

Insomnia

Company began Phase III patient enrollment (9/6)

Titan Pharmaceuticals Inc. (AMEX:TTP)

Zomaril

Iloperidone; antipsychotic that has an antagonistic activity on a wide range of brain receptors for dopamine and serotonin, with preferential affinity for 5HT2A serotonin receptors in humans

Schizophrenia

Company announced positive safety and efficacy data from a Phase III study involving more than 600 patients in the U.S., Europe, Canada, Australia and South Africa (9/25)

DIABETES

Amylin Pharmaceuticals Inc. (AMLN)

Symlin and AC2993

Pramlinitide acetate; synthetic analogue of human pancreatic hormone amylin; and synthetic exendin-4; 39-amino-acid peptide that exhibits anti-diabetic activity similar to the mammalian hormone glucagon-like peptide

Type I and Type II diabetes

Phase III data of Symlin were presented at the 36th Annual Meeting of the European Society for the Study of Diabetes showing 52 weeks of treatment improved glycemic and weight control in people with Type I diabetes; data of AC2993 trials also were presented (9/18)

DepoMed Inc. (AMEX:DMI)

Metformin GR

Company's extended-release form of Glucophage

Type II diabetes

Company initiated a Phase II trial comparing Metformin GR with Glucophage (9/27)

Diamyd Medical AB* (Sweden)

Insulin

Oral formulation

Type I diabetes

The Lancet published Phase II study results; no statistical difference was found between the oral administration of insulin and a placebo (9/13)

Flamel Technologies S.A. (France; FLMLY)

Metformin

Formulation of controlled-released Metformin using Micropump technology

Type II diabetes

Company announced successful results of a Phase I study (9/25)

INFECTION

Abbott Laboratories

Kaletra

Lopinavir/ritonavir; protease inhibitor

HIV

Data presented at ICAAC show Kaletra used in combination with other antiretroviral therapy provides effective viral suppression for almost two years in most patients (9/17)

Agouron Pharmaceuticals Inc. (a Pfizer Inc. [NYSE:PFE] company)

Capravirine

Non-nucleoside reverse transcriptase inhibitor

HIV

Company initiated additional trial as part of combination therapy in people who have failed previous therapy (9/18)

AntexBiologics Inc. (AMEX:ANX)

Helivax

Oral vaccine produced using Nutriment Signal Transduction technology, which regulates bacterial growth

Helicobacter pylori

Enrollment was completed in the Phase I trial; Results to be announced in the first quarter of 2001 (9/12)

Aronex Pharmaceuticals Inc. (ARNX)

Nyotran

Liposomal formulation of nystatin

Invasive aspergillus

Data presented at ICAAC showed Nyotran was well tolerated with objective responses in 6 out of 19 evaluable patients (9/19)

Cubist Pharmaceuticals

Cidecin

Daptomycin for injection

Bacteremia; Gram-positive infections

Data were prestented at the 40th ICAAC meeting on Phase I and II trials, showing no serious adverse events and positive results in treating Gram-positive infections, including bacteremia (9/19)

Gilead Sciences Inc. (GILD)

Tenofovir DF

Tenofovir disoproxil fumarate

HIV

Phase II results were presented at ICAAC showing the drug was associated with significant and sustained antiviral activity (9/18)

Micrologix Biotech Inc.* (Canada)

MBI 226

Antimicrobial drug

Bacterial and fungal bloodstream infections

Phase III trial initiated (9/20)

Nabi (NABI)

StaphVAX

Staphylococcus aureus conjugate vaccine

S. aureus bacteremia

Phase III results presented at ICAAC showed reduction in infection for the first 10 months of the study, but the trial did not reach statistical significance by demonstrating a decrease at the one-year follow-up (9/19)

Ribozyme Pharmaceuticals Inc. (RZYM) and Eli Lilly & Co. (NYSE:LLY)

LY466700

Chemically synthesized ribozyme designed to selectively cut hepatitis C virus RNA in a conserved region and inhibit viral replication

Hepatitis C

Companies completed a safety and pharmacokinetic study that showed the drug was well tolerated over 28 days (9/11)

Ribozyme Pharmaceuticals Inc. (RZYM)

Heptazyme

Anti-hepatitis C ribozyme

Hepatitis C

Company repurchased its rights from Eli Lilly & Co. and will initiate Phase II trials (9/28)

Synsorb Biotech (Canada; TSE:SYB; SYBB)

Synsorb Pk

Orally delivered carbohydrate attached to inert, insoluble support; binds to toxins secreted by bacteria in the gastrointestinal tract

Prevention of hemolytic uremic syndrome

Company announced an additional clinical trial will be needed to complete development following discussions with regulatory authorities in the U.S. and Canada (9/26)

The Medicines Co. (MDCO)

CTV-05

A strain of human Lactobacillus

Bacterial vaginosis

Company started a large, randomized trial of CTV-05 as an adjunct to standard antibiotic treatment of bacterial vaginosis (9/6)

Triangle Pharmaceuticals Inc. (VIRS) and Abbott Laboratories (NYSE:ABT)

DAPD

Dioxolane purine nucleoside reverse transcriptase inhibitor that is rapidly converted in humans into its active metabolite, DXG

HIV

Preliminary data of a Phase I/II trial in which DAPD produced decreases in viral loads were presented at ICAAC (9/18)

ViroLogic Inc (VLGC)

PhenoSense HIV

Drug resistance test to detect and measure hypersusceptibility

HIV

Data presented at ICAAC show that hypersusceptibility to non-nucleoside reverse transcriptase inhibitors is prevalent among patients with previous HIV treatment experience (9/18)

MISCELLANEOUS

Alkermes Inc. (ALKS)

Medisorb Naltrexone

Injectable sustained-release formulation of naltrexone

Alcoholism and opiate abuse

Enrollment completed of 42 subjects in double-blind, placebo-controlled study (9/27)

Biopure Corp. (BPUR)

Hemopure

Hemoglobin glutamer-250 (bovine)

Alternative to red blood cell transfusion in patients undergoing orthopedic surgery

Company completed enrolling 680 patients in the U.S., Europe, Canada and South Africa in the pivotal Phase III trial (9/6)

Cellegy Pharmaceuticals Inc. (CLGY)

Tostrelle

Transdermal testosterone gel

Testosterone deficiency

Company completed a Phase I/II trial that showed the gel was well tolerated (9/20)

Curis Inc. (CRIS)

Chondrogel

Minimally invasive tissue augmentation product

Vesicoureteral reflux

Enrollment was completed in a pivotal Phase III trial; data are expected to be available in late 2001 (9/19)

Genzyme General (GENZ)

Fabrazyme

Agalsidase beta; enzyme replacement therapy

Fabry disease

Pivotal trial results were statistically significant and are published on the web site of the American Society of Human Genetics (9/6)

Human Genome Sciences Inc. (HGSI)

Repifermin

Keratinocyte Growth Factor-2

Chronic venous ulcers

Company said it will advance its clinical development program based on promising results from a Phase IIa trial reported at the World Wound Healing Congress (9/13)

InKine Pharmaceutical Co. (INKP)

Visicol

Sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP

Gastrointestinal endoscopy

Published article in the Sept. issue of Gastrointestinal Endoscopy of study of 305 patients undergoing diagnostic colonoscopy randomized to Colyte, Fleet Phospho-Soda and Visicol groups; results showed no significant differences in cleansing efficacy, but there was less nausea, abdominal pain and bloating in the sodium phosphate tablet group (9/13)

Iomed Inc. (AMEX:IOX)

Dexamethasone

Company's Phoresor System delivers dexamethasone

Epicondylitis

Company plans to begin next month a Phase III study (9/28)

Ligand Pharmaceuticals Inc. (LGND) and Pfizer Inc. (NYSE:PFE)

Lasofoxifene

A selective estrogen receptor modulator

Osteoporosis

Pfizer initiated Phase III trials (9/26)

NexMed Inc. (NEXM)

Alprox-TD

Topical treatment; incorporates alprostadil with NexACT drug delivery system

Erectile dysfunction

Company completed testing of 190 patients in a Phase II trial; the trial was randomized, double-blind and placebo-controlled (9/19)

PPL Therapeutics plc*

Alpha-1-Antitrypsin

Derived from sheep's milk

Cystic fibrosis

Company announced positive results in its one-year safety study (9/20)

Zonagen Inc. (ZONA)

Vasofem

Phentolamine mesylate-based product

Female sexual dysfunction

Encouraging data from a double-blind, randomized and placebo-controlled study were presented at the FIGO World Congress of Gynecologists (9/7)

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