Clinical Trial Update: April 2001

Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Abgenix Inc. (ABGX) and Immunex Corp. (IMNX)

ABX-EGF

Monoclonal antibody created with XenoMouse technology directed against the human epidermal growth factor receptor

Kidney cancer

Companies will initiate an 80-patient North American Phase II trial (4/18)

AnorMED Inc. (Canada; TSE:AOM) and AstraZeneca plc (UK)

ZD0473

Platinum-based anticancer agent

Ovarian cancer

AstraZeneca initiated a Phase III trial (4/5)

Biomira Inc. (BIOM)

Theratope

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

Metastatic breast cancer

Company closed enrollment in its Phase III trial (4/2)

Cell Genesys Inc. (CEGE)

GVAX

Prostate cancer vaccine used in combination with chemotherapy

Prostate cancer

Company initiated the first in a series of trials to evaluate a highpotency version of GVAX (4/17)

Gem Pharmaceuticals Inc.*

GPX-100

Analogue of doxorubicin

Cancer

Phase I/II data showed no signs of cardiotoxicity and the maximum tolerated dose was established (4/4)

Myriad Genetics Inc. (MYGN)

MPC-7869

Pure (R-enantiomer) form of flurbiprofen

Cancer

Phase IIa data showed extended daily dosing was well tolerated (4/26)

Peregrine Pharmaceuticals Inc. (PPHM)

Cotara

Radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill tumors from the inside out

Soft tissue sarcoma

Company will evaluate the drug in a Phase I trial at Stanford University (4/9); company initiated the trial (4/12)

Peregrine Pharmaceuticals Inc. (PPHM)

Cotara

Radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill tumors from the inside out

Liver cancer

Company will evaluate the drug in a Phase I trial used in combination with radiofrequency ablation (4/19)

Pharmacyclics Inc. (PCYC)

Xcytrin

Injection therapy; motexafin gadolinium

Cancer

Phase Ib/II trial results show the therapy increased local tumor control (4/2)

Receptron Inc.*

RCN-01303

Based on hormone receptor technology; it modulates the endogenous thrombopoietin receptor

Cancer chemotherapy-induced platelet deficiency

Company initiated clinical trials (4/2)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Thymosin alpha/synthetic peptide

Cancer

One-year follow-up data indicated the combination treatment of Zadaxin plus transarterial chemoembolization resulted in statistically significant improvement in survival rates at six, nine and 12 months of 91%, 88% and 78%, respectively (4/23)

SR Pharma plc (UK; LSE:SPA)

SRL 172

Immune potentiator

Non-small-cell lung cancer

Phase III data show the drug did not meet its primary endpoint (4/18**)

Titan Pharmaceuticals Inc. (AMEX:TTP)

Gallium maltolate

Orally active formulation of gallium, a semi-metallic element that inhibits ribonucleotide reductase

Metastatic prostate cancer and refractory multiple melanoma

Company initiated Phase II testing (4/2)

Titan Pharmaceuticals Inc. (AMEX:TTP)

CeaVac and TriAb

Combination therapy of two monoclonal antibodies

Non-small-cell lung cancer

Company initiated a Phase II study (4/10)

Valentis Inc. (VLTS)

VLTS-587

Intravenously administered human interleukin-2 gene medicine

Lung cancer

Company dosed the first four patients in a Phase I trial (4/19)

Vical Inc. (VICL)

Leuvectin

Gene-based drug injected directly into tumors that uses lipid DNA complex with a gene encoding interleukin-2 to stimulate an immune response

Metastatic kidney cancer

Company discontinued the Phase II trial and plans to start a new one with a higher dose (4/20)

CARDIOVASCULAR

CV Therapeutics Inc. (CVTX)

Ranolazine

Part of pFOX (partial fatty acid oxidation) inhibitors

Chronic angina

Company completed patient enrollment in its Phase III trial (4/10)

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

Veletri

Tezosentan; intravenous dual endothelin receptor antagonist

Heart failure

Phase III results showed the drug did not meet its primary endpoint of significantly improving symptoms of dyspnea associated with acute heart failure (4/20)

Vasogen Inc. (Canada; AMEX:MEW; TSE:VAS)

­

Immune modulation therapy

Peripheral vascular disease (PAD)

Company plans to begin a clinical trial enrolling up to 500 patients with moderate to severe PAD (4/26)

CENTRAL NERVOUS SYSTEM

Adolor Corp. (ADLR)

ADL 10-0101

Agonist of kappa opioid receptor

Pain

Two trials showed positive results of reducing pain and itch (4/6)

Ceregene Inc. (subsidiary of CellGenesys Inc.; CEGE)

­

Gene therapy involving surgical implantation of cells producing nerve growth factor into the brain

Alzheimer's disease

Company treated its first patient in a Phase I study (4/10)

ConjuChem Inc. (Canada; TSE:CJC)

CJC-1008

DAC:Opioid drug

Pain

Company completed a Phase I study that found CJC-1008 was better tolerated than Dynorphin A, had a longer half-life than the peptide and showed no unexpected serious side effects (4/10)

Isis Pharmaceuticals Inc. (ISIP)

ISIS 104838

Antisense inhibitor of TNF-alpha; intravenous and subcutaneous delivery

Rheumatoid arthritis

Phase I studies demonstrated better dosing schedules than first-generation antisense drugs (4/5)

NeoTherapeutics Inc. (NEOT)

Neotrofin

Leteprinim potassium

Rheumatoid arthritis

Company opened enrollment for a pivotal Phase III trial of 500 patients at more than 50 U.S. sites (4/10)

ReGen Therapeutics plc (UK; LSE:RGT)

Colostrinin

Proline-rich polypeptide complex isolated from ovine colostrum

Alzheimer's disease

Company said the steering committee supervising its 90-patient trial recommended the study be continued to its end (4/18**)

Repligen Corp. (RGEN)

Secretin

Hormone produced by a part of the intestine called the duodenum

Autism

Phase II results showed secretin did not meet its primary endpoint (4/4)

Scios Inc. (SCIO)

SCIO-469

Oral p38 kinase inhibitor

Rheumatoid arthritis

Phase Ib data indicated SCIO-469 was well tolerated in healthy volunteers over a two-week dosing period (4/30)

The Immune Response Corp. (IMNR)

­

T-cell receptor peptide vaccine

Multiple sclerosis

Tests showed the vaccine induced a specific response in 80% of patients treated (4/30)

DIABETES

DepoMed Inc. (AMEX:DMI)

Metformin GR

Extended-release, or gastric-retentive, formulation

Type II diabetes

Interim Phase II data indicated the product is statistically similar to its immediate-release counterpart, Glucophage (4/25)

INFECTION

BioChem Pharma Inc. (Canada; BCHE; TSE:BCH)

Zeffix

Lamivudine; nucleoside analogue (oral)

Hepatitis B

Company said data indicated Zeffix induces a complete virologic response in about 23% of children suffering from hepatitis B compared to 13% in the placebo group (4/23)

Cubist Pharmaceuticals Inc. (CBST)

Cidecin

Daptomycin for injection; a novel cyclic lipopeptide antibiotic derived from a fermentation product of streptomyces roseosporous

Complicated skin and soft tissue infections caused by Gram-positive bacteria

Phase III data showed Cidecin achieved the endpoint of statistical equivalence to the antibiotic standards of care (4/3)

ICOS Corp. (ICOS)

Pafase

Recombinant human serum protein that inactivates platelet-activating factor

Severe sepsis

Company began enrollment of 2,500 patients in a pivotal Phase III trial (4/27)

ID Biomedical Corp. (Canada; IDBE; TSE:IDB)

­

Subunit intranasal influenza vaccine

Influenza

The vaccine proved safe and well tolerated in a human trial (4/24)

Inspire Pharmaceuticals Inc. (ISPH)

INS365

P2Y(2) receptor agonist

Chronic bronchitis

Company temporarily suspended enrollment in a Phase II trial due to difficulty in efficacy assessment (4/24)

InterMune Pharmaceuticals Inc. (ITMN)

Actimmune

A gamma interferon therapy

Systemic fungal disease

Company completed enrollment in a Phase II trial of 79 patients with cryptococcal meningitis (4/5)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene (formerly Maxamine)

Histamine dihydrochloride; an adjuvant to interleukin-2

Hepatitis C

Company said a multinational clinical study will begin (4/16); company presented Phase II results of Ceplene in combination with interferon-alpha, which showed 40% of evaluable patients sustained a complete viral response (4/20)

PowderJect Pharmaceuticals plc (UK; LSE:PJP)

­

DNA vaccine administered with PowderJect's needle-free system

Hepatitis B

Phase I study indicated the vaccine induced protective levels of antibodies in 80% of volunteers who hadn't responded to three doses of commercial vaccine (4/24)

Progenics Pharmaceuticals Inc. (PGNX)

PRO 542

Fusion protein that incorporates HIV binding region of human cell surface receptor (CD4) into a human antibody molecule that binds to GP120

HIV

Article in The Journal of Infectious Diseases suggests PRO 542 and T-20, which is developed by Trimeris Inc. and Hoffmann-LaRoche Inc., showed significantly enhanced anti-HIV activity when used in combination (4/5)

Stressgen Biotechnologies Corp. (Canada; TSE:SSB)

HspE7

Immunotherapeutic; recombinant fusion product composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7

Genital warts caused by human papillomavirus

Company completed enrollment of its Phase II trial (4/10)

Stressgen Biotechnologies Corp. (Canada; TSE:SSB)

HspE7

Immunotherapeutic; recombinant fusion product composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7

Anal dysplasia caused by human papillomavirus

Phase II data showed 16 of 22 patients were downgraded to low-grade dysplasia (4/24)

The Immune Response Corp. (IMNR)

Remune

HIV-1 Immunogen used in addition to HAART (highly active antiretroviral therapy)

HIV

Phase III trial data showed that patients treated with Remune showed a reduction in viral load regardless of concomitant antiretroviral drug therapy (4/23)

Vertex Pharmaceuticals Inc. (VRTX)

GW433908

HIV protease inhibitor; prodrug of the approved Agenerase (amprenavir)

HIV

Company began a third pivotal Phase III trial, which will compare two doses of the compound in combination with ritonavir and in combination with ritonavir and lopinavir (4/24)

MISCELLANEOUS

Alkermes Inc. (ALKS)

Medisorb
Naltrexone

Injectable therapeutic

Alcohol dependency

Company initiated enrollment in a second trial (4/3)

Alliance Pharmaceutical Corp. (ALLP)

Oxygent

Intravascular oxygen carrier comprised of liquid perfluorochemical core particles surrounded by a surfactant and suspended in a water-based solution; perflubron emulsion

General surgery

Phase III data showed the average number of units of blood required by the control patients was twice the number required by patients treated with Oxygent (4/9)

Andrx Corp. (ADRX)

Avicor

Compound diminishes blood levels of beta amyloid protein in patients with hyperlipidemia

Hyperlipidemia

Company completed a Phase II study on the effects of Avicor on metabolism of beta amyloid protein (4/12)

Atrix Laboratories Inc. (ATRX)

Atrisone

Combination of dapsone and Atrix's drug delivery system, SMP

Moderate to severe acne

Company began patient enrollment in its Phase III trial (4/18)

Demegen Inc. (OTC BB:DBOT)

P-113

Peptide-containing mouth rinse

Oral candidiasis

Company will initiate a Phase I/II trial (4/19)

Discovery Laboratories Inc. (DSCO)

Surfaxin

Humanized, peptide-containing surfactant designed to lower surface tension at the air-water interface in the lungs

Idiopathic respiratory distress syndrome

Company will begin a Phase III trial in premature infants; the trial will enroll 1,500 patients (4/4)

Human Genome Sciences Inc. (HGSI)

Repifermin

Keratinocyte growth factor-2 (KGF-2)

Chronic venous ulcers

Company began enrolling patients in the Phase IIb trial, which will enroll 700 patients (4/5)

ICOS Corp. (ICOS) and Eli Lilly & Co.

Cialis

PDE5 inhibitor

Erectile dysfunction

Phase III data showed efficacy among 64% of patients with diabetes-related erectile dysfunction (4/6)

Inhale Therapeutic Systems Inc. (INHL) and Aventis Behring LLC

­

Inhalable form of alpha-1 proteinase inhibitor

Inherited form of emphysema caused by alpha-1 antitrypsin deficiency

Companies completed a Phase Ib trial, which showed all doses tested were well tolerated (4/10)

IntraBiotics Pharmaceuticals Inc. (IBPI)

Protegrin IB-367 Rinse

Synthetically derived analogue of naturally occurring protegrins

Oral mucositis

Phase III results indicate the compound did not meet its primary endpoint of reducing ulceration (4/26)

La Jolla Pharmaceuticals Co. (LJPC)

LJP 394

Molecule (toleragen) that binds to the surface of B cells and shuts off production of antibodies to double-stranded DNA

Lupus kidney disease

The Central Texas Kidney Association began treating the first 300 patients selected for an international Phase III trial (4/11)

NexMed Inc. (NEXM)

Femprox

Topical formulation combining NexMed's NexACT penetration drug delivery technology with alprostadil

Sexual arousal disorder

Trial results indicated that Femprox was safe and well tolerated (4/30)

PhotogenTechnologies Inc. (PHGN)

PH-10

Topical treatment; photodynamic agent that selectively reduces inflammation of the epidermis and decreases plaque thickness

Psoriasis

Company began a Phase I trial (4/25)

Sepracor Inc. (SEPR)

Ticalopride

Isomer of propulsid

Heartburn

Trials were suspended due to unspecified adverse events (4/23)

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.

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange

NEXT WEEK: Non-U.S. clinical trials and FDA actions in April.

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