Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Aastrom Biosciences Inc. (ASTM)

--

CB-1 cord blood cell therapy

Adult leukemia

Company initiated patient enrollment in a clinical trial (2/27)

Aphton Corp. (APHT)

Anti-gastrin vaccine

Vaccine that induces antibodies in patients that neutralize gastrin-17

Advanced pancreatic cancer

Phase II results indicated a greater increase in survival in treated patients compared to increases in a prior trial; the study produced an overall median survival rate of 8.6 months after initiation of therapy (2/9)

BioChem Pharma Inc. (Canada; BCHE)

Troxatyl

Troxacitabine

Leukemia

Phase I data published in the Journal of Clinical Oncology show that Troxatyl demonstrated broad antileukemic activity (2/2)

Biomira Inc. (BIOM)

Theratope

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

Metastatic breast cancer

Company recruited 903 patients for its Phase III trial and the study will remain open until March (2/5)

British Biotech plc (UK; BBIOY)

Marimastat

Matrix metalloproteinase inhibitor

Solid tumors

Marimastat failed in two Phase II trials and the company also decided to drop BB-3644, its second generation matrix metalloproteinase inhibitor meant to avoid the dose-limiting side effects of marimastat, because it caused the same musculoskeletal pain (2/13)

Cell Therapeutics Inc. (CTIC)

PG-TXL

Paclitaxel/polyglutamate polymer therapeutic

Cancer

Preliminary data presented at the European Organization for ReSearch and Treatment of Cancer indicated PG-TXL is well tolerated at doses more than 150% greater than the current approved dose of Taxol (2/6)

EntreMed Inc. (ENMD)

Panzem (2ME2)

2-methoxyestradiol, an antiproliferative

Prostate cancer

Company started a Phase II trial (2/15)

FeRx Inc.*

MTC-DOX

Doxorubicin released through Magnetic Target Carriers, microparticles, composed of elemental iron and activated carbon

Metastatic liver cancer

Company initiated a Phase I/II trial (2/20)

Genta Inc. (GNTA)

Genasense

Antisense compound geared toward blocking the production of Bcl-2

Advanced multiple myeloma

Genta entered a Phase III trial with Genasense (2/13)

Genta Inc. (GNTA)

Genasense

Antisense compound geared toward blocking the production of Bcl-2

Chronic lymphocytic leukemia

Company initiated a Phase III trial (2/28)

GenVec Inc. (GNVC)

TNFerade

A compound to be used with radiation therapy

Cancer

Company initiated a Phase I trial of TNFerade intended for use in combination with radiation therapy (2/15)

ImClone Systems Inc. (IMCL)

IMC-C225

Monoclonal antibody designed to target and block the epidermal growth factor receptor

Non-small-cell lung cancer

Company commenced patient treatment in a Phase II trial (2/6)

MGI Pharma Inc. (MOGN)

Irofulven

Hydroxymethylacylfulvene

Advanced-stage pancreatic cancer

MGI began dosing patients in its pivotal Phase III trial of irofulven (2/7)

Progen Industries Ltd. (Australia; PGLAF)

PI-88

Sulfated oligosaccharide

Cancer

Company concluded its Phase Ib trial and confirmed its plans to proceed with Phase II trials (2/2)

Protein Design Labs Inc. (PDLI)

SMART 1D10 Antibody

Binds to an HLA-DR determinant found on many pre-B and B-cell lymphomas

Relapsed or refractory B-cell non-Hodgkin's lymphoma

Company began a Phase II trial (2/20)

Ribozyme Pharmaceuticals Inc. (RZYM) and Chiron Corp. (CHIR)

Angiozyme

Antiangiogenic ribozyme targeting vascular endothelial growth factor

Breast cancer

Companies initiated a Phase II trial (2/8)

SuperGen Inc. (SUPG)

Rubitecan

Oral chemotherapeutic in the camptothecin class

Pancreatic cancer

Company completed patient enrollment in a Phase III study (2/20)

Telik Inc. (TELK)

TLK286

Small-molecule candidate developed through the application of TRAP chemogenomics technology

Cancer

Company completed a Phase I trial (2/21)

Therion Biologic Corp.* and the National Cancer Institute

CEA-Tricom

Vaccine that incorporates a triple dose of co-stimulatory molecules as well as the CEA tumor antigen

Cancer

Company initiated a Phase I trial (2/20)

Valentis Inc. (VLTS)

Interleukin-2

Gene medicine

Recurrent or refractory squamous cell carcinoma of the head and neck

Company completed enrollment of a randomized Phase IIb trial (2/15)

Vical Inc. (VICL)

Allovectin-7

DNA lipid complex containing the human gene encoding the HLA-B7 antigen

Late-stage metastatic melanoma and early stage cancer of the oral cavity and oropharynx

Company began Phase II trials in each indication (2/8)

Xenova Group plc (UK; XNVA)

XR9576

A P-glycoprotein modulator

To prevent multidrug resistance in cancer

Phase IIa results were positive; company plans to move compound into Phase III (2/28**)

Xenova Group plc (UK; XNVA)

XR5000

Topoisomerase inhibitor

Ovarian, glioblastoma and non-small-cell lung cancers

Company decided to discontinue development after the drug failed to show significant responses in three Phase II trials (2/28**)

CARDIOVASCULAR

Actelion Ltd. (Switzerland; SWX: ATLN) and Genentech Inc. (NYSE:DNA)

Tezosentan

Intravenous dual endothelin receptor antagonist

Heart failure

Phase III data showed the compound demonstrated positive hemodynamic results (2/13)

The Medicines Co. (MDCO)

Angiomax

Bivalirudin

Angioplasty

Company reached its enrollment target of 1,000 patients in a Phase IIIb randomized trial (2/26)

United Therapeutics Corp. (UTHR)

Beraprost

Oral therapeutic; form of prostacyclin, which is produced in blood vessels to keep them dilated and free of platelet aggregation

Pulmonary hypertension

Company completed enrollment in its Phase III study of oral beraprost (2/26)

CENTRAL NERVOUS SYSTEM

Pain Therapeutics Inc. (PTIE)

PTI-601

Opioid treatment

Moderate pain

Company completed patient enrollment for an additional Phase II trial (2/23)

Pozen Inc. (POZN)

MT 100

Pain-relief formulation that combines a fast-release metoclopramide and an extended-release naproxen sodium

Migraine

MT 100 met its final Phase III trial primary endpoints (2/21)

Scios Inc. (SCIO)

SCIO-469

Oral p38 kinase inhibitor

Rheumatoid arthritis

Company initiated a Phase Ib trial (2/7)

INFECTION

Acambis plc (UK; ACAM; LSE:ACM)

ChimeriVax

Vaccine derived from the live, attenuated 17D strain of the yellow fever virus

Japanese encephalitis

Phase I/II trial results showed the vaccine was safe, well tolerated and highly immunogenic after a single dose (2/14**)

Access Pharmaceuticals Inc. (AMEX:AKC)

OraDisc

An amlexanox formulation in a polymer disc designed to adhere to the disease site

Canker sore

Initial data from a 400-patient trial showed evaluable patients reached the primary clinical end-point, complete healing, by day five (2/8)

Enzo Biochem Inc. (NYSE:ENZ)

HGTV43

Stem cell gene therapy that contains three Enzo-developed antisense genes designed to intefere with the functioning of two HIV-1 genes

HIV

Phase I results presented at the 8th Conference on Retroviruses and Opportunistic Infections showed the anti-HIV-1 genes could be successfully put into the stem cells, which survived, grew and developed into CD4+ cells for a minimum of six months (2/6)

Gilead Sciences Inc. (GILD)

Tenofovir DF

Tenofovir disoproxil fumarate

HIV

Preliminary Phase III results show the compound met its primary endpoint, mainly a reduction in viral load (2/20)

IntraBiotics Pharmaceuticals Inc. (IBPI)

Protegrin IB-367

A rinse; synthetically derived analogue of naturally occurring protegrins

Ventilator-associated pneumonia

Phase I data indicated the drug safely reduces bacterial levels in the mouths of patients at risk of experiencing ventilator-associated pneumonia (2/14)

Serono Inc. (unit of Serona SA; Switzerland; NYSE:SRA; SWX:SEO)

Serostim

Somatropin, rDNA origin for injection; a recombinant human growth hormone

HIV-associated adipose redistribution syndrome

Company initiated a double-blind placebo-controlled study involving 200 patients (2/20)

Tibotec Group NV (Belgium)*

TMC120

A non-nucleoside reverse transcriptase inhibitor

HIV

Phase II data showed TMC120 to be highly potent (2/9)

Triangle Pharmaceuticals Inc. (VIRS)

Coviracil

Nucleoside reverse transcriptase inhibitor

HIV

Preliminary Phase III data indicate that 61% of patients in the Coviracil group and 64% of patients in the lamivudine group had fewer than 50 copies/ml at week 48; data were presented at the 8th Conference on Retroviruses and Opportunistic Infections (2/5)

Triangle Pharmaceuticals Inc. (VIRS)

DAPD

Dioxolane guanosine reverse transcriptase inhibitor

HIV

Phase I/II data indicates the compound has a positive pharmacokinetics profile and is well tolerated (2/6)

VaxGen Inc. (VXGN)

AIDSVAX

Bivalent vaccine composed of recombinant gp120 (envelope protein) from two strains of HIV-1 that are prevalent in Southeast Asia and the Pacific Rim

AIDS

Phase I/II data indicated that an adjuvant in development significantly reduces the amount of vaccine material required to induce an immune response (2/9)

Vertex Pharmaceuticals Inc. (VRTX)

VX-175

Amprenavir HIV protease inhibitor prodrug

HIV

Preliminary Phase II results indicated the drug in combination with abacavir and lamivudine produced a median decrease in HIV-1 RNA of about 2.0 log10 from baseline and a median increase of about 100 CD4+ cells (2/7)

MISCELLANEOUS

Access Pharmaceuticals Inc. (AMEX:AKC)

OraRinse

0.5% mucoadhesive solution of amlexanox

Mucositis

Compound did not show a statistically significant difference in the two arms of the study (2/20)

Alkermes Inc. (ALKS) and Janssen Pharmaceutica NV (Belgium; unit of Johnson & Johnson; NYSE:JNJ)

Risperdal

Intramuscular injectable sustained-release formulation of Risperdal, based on Alkermes' Medisorb injectable drug-delivery system

Psychosis

Companies completed two Phase III trials and are preparing for an NDA filing (2/20)

Avant Immunotherapeutics Inc. (AVAN)

CETi-1

Therapeutic vaccine against endogenous cholesterylester transfer protein (CETP)

Low levels of high-density lipoprotein cholesterol

Preliminary Phase I results indicated the vaccine produced an antibody response as early as a week after administration and for as long as 10 weeks in patients subjected to the highest dose level of 250 micrograms (2/21)

Corixa Corp. (CRXA)

PVAC

Immunotherapeutic based on a process and formulationderived from heat-killed Mycobacterium vaccae

Psoriasis

PVAC failed to meet the primary endpoint, at least a 50% reduction in Psoriasis Area and Severity Index score, in a Phase II trial (2/15)

DrugAbuse Sciences Inc.*

Naltrel

Depot naltrexone

Heroine addiction

Preliminary Phase II data showed the drug blocks opiate effects in a statistically significant manner (2/7)

Hemispherx Biopharma Inc. (AMEX:HEB)

Ampligen

Double-stranded synthetic RNA compound poly 1; poly C12U

Chronic fatigue syndrome

Preliminary findings in 13 patients suggest an increase in quality of life after 24 weeks of treatment (2/7)

Insmed Inc. (INSM)

INS-1

Oral insulin sensitizer used in combination with sulfonylurea

Polycystic ovarian syndrome; dyslipidemia

Phase II results showed statistically significant efficacy in trials for each indication (2/27)

InterMune Pharmaceuticals Inc. (ITMN)

Actimmune

Interferon gamma-1b

Cystic fibrosis

Company commenced enrollment in a Phase II trial (2/28)

MacroChem Corp. (MCHM)

Topiglan

Topical drug; 1% alprostadil and 5% Sepatopical formulation

Erectile dysfunction

The February issue of Urology carries a paper detailing a successful Phase II study demonstrating the safety and efficacy of Topiglan (2/20)

Millennium Pharmaceuticals Inc. (MLNM)

LDP-02

Humanized monoclonal antibody against alpha-4 beta-7, an integrin on inflammatory cells that causes the cells to adhere to the gastrointestinal tract

Ulcerative colitis

Company initiated a Phase II trial (2/9)

Neurocrine Biosciences Inc. (NBIX)

NBI-34060

Type 1 GABA-a receptor agonist; chemically distinct from benzodiazepines

Insomnia

Clinical results demonstrated the product works as a sedative-hypnotic (2/15)

Palatin Technologies Inc. (AMEX:PTN)

PT-141

Synthetic modification of PT-14, an analogue of a naturally occurring peptide hormone called alpha M.S.H.

Erectile dysfunction

Company began enrolling patients in a Phase I study of PT-141 (2/1)

QLT Inc. (QLTI)

Visudyne

Injected intravenously into a patient's arm; a nonthermal laser light is shined into the patient's eye to activate the drug

Wet age-related macular degeneration in patients with occult subfoveal choroidal neovascularization

Phase IIIb results show Visudyne is effective in reducing the risk of vision loss and probably prevents progression of occult CNV (2/8)

Theratechnologies Inc. (Canada; TSE:TH)

ThGRF 1-44

Growth hormone-releasing factor analogue

Sleep disorders

Company began the first of two Phase II trials

United Therapeutics Corp. (UTHR)

Beraprost

Oral therapeutic; form of prostacyclin, which is produced in blood vessels to keep them dilated and free of platelet aggregation

Intermittent claudication

Company completed enrollment in a Phase III study (2/20)

Notes:

* Privately held; ** Denotes the date the item ran in BioWorld International

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AEX = Australian Stock Exchange; AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application

ND = Not disclosed