Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Antisense
Therapeutics
Ltd.
(Australia;
ASX:ANP) and Isis Pharmaceuticals
Inc.
(ISIS)

ATL1102
(ISIS 107248)

Antisense drug that
inhibits VLA-4

Multiple
sclerosis

Companies began a Phase I trial (8/27)

Astralis Ltd.
(OTC BB:ASTR)

Psoraxine

A protein to stimulate
cells from a patient's
immune system to reverse
the inflammatory process

Plaque
psoriasis

Company began
Phase I trials (8/4)

Berlex
Laboratories
Inc.
(U.S. affiliate
of Schering AG;
Germany)

Leukine
(FDA-approved)

Sargramostim
recombinant;
granulocyte macrophage-colony stimulating factor

Crohn's disease

Company will begin a Phase III trial (8/28)

Celltech Group
plc
(UK; LSE:CCH)

CDP 571

An anti-TNF-alpha
antibody

Crohn's disease

Company decided to end development of CDP 571, a year after it failed to reach the primary endpoint in Phase III trials (8/27**)

ILEX Oncology
Inc.
(ILXO)

Campath
(FDA-approved)

Alemtuzumab; humanized monoclonal antibody directed against the CD52 antigen prevalent on leukemia and lymphoma cells

Relapsing and
remitting multiple sclerosis

An independent data safety monitoring board recommended the Phase II study continue; enrollment is more than half complete (8/25)

CANCER

Allos Therapeutics
Inc.
(ALTH)

RSR13

Efaproxiral; synthetic
small molecule

Non-small-cell lung cancer

Phase II data showed that median survival was 20.6 months in patients taking RSR13, compared to 14.6 months for patients in the sequential chemoradiotherapy arm and 17 months for patients in the concurrent chemoradiotherapy arm (8/12)

Antigenics Inc.
(AGEN)

Oncophage

Vaccine; uses heat-shock proteins to activate
cellular immune responses

Metastatic colorectal cancer

Phase II data showed that more than half of the 29 patients demonstrated significant immunological response (8/19)

Antisoma plc
(UK; LSE:ASM)

AS1403 (formerly TheraFab)

A fragment of the
monoclonal antibody HMFG1 linked to a radioactive isotope

Non-small-cell lung cancer

Company decided to discontinue development after a Phase I trial showed unacceptable levels of toxicity (8/22)

Genentech Inc. (NYSE:DNA) and
OSI
Pharmaceuticals
Inc.
(OSIP)

Tarceva

Erlotinib; epidermal growth factor receptor

Malignant glioma

Companies began a Phase II trial (8/8)

IGI Inc.
(AMEX:IG)

PTH

Topical drug encapsulated
in a Novasome cream; parathyroid
hormone-related peptide antagonist

Chemotherapy- induced alopecia in breast cancer patients

Company began Phase I/II trials (8/20)

Kosan
Biosciences Inc.
(KOSN)

17-AAG

17-allylamino-
geldanamycin

Cancer

Company began several Phase Ib trials of 17-AAG in combination with other cancer agents (8/7)

KuDOS Pharmaceuticals
Ltd.*
(UK)

Patrin

4-bromothenylguanine; inhibits the enzyme alkylguanine alkyltransferase

Metastatic colorectal cancer

Company began a Phase II trial (8/18)

Ligand Pharmaceuticals Inc. (LGND)

Targretin (FDA-approved)

Bexarotene capsules

Non-small-cell lung cancer

Company exceeded a 600-patient enrollment goal in the first of two pivotal Phase III studies of Targretin (8/15)

Lorus
Therapeutics
Inc. (Canada; OTC BB:LORFF)

GTI-2040

Antisense drug

Metastatic breast cancer

Company will begin a Phase II trial of GTI-2040 in combination with capecitabine; the National Cancer Institute is sponsoring the trial (8/12)

Novacea Inc.*

DN-101

Contains high amounts of calcitrol, a naturally occurring hormone and biologically active form
of vitamin D

Advanced non-small-cell lung cancer

Patient enrollment began in a Phase I/II trial of DN-101 in combination with Taxotere (8/18)

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Prospective drug to
treat benign prostatic hyperplasia

Benign prostatic hyperplasia

Phase I data showed initial patients treated with NX-1207 have not shown clinically signficant toxic effects from the drug (8/19)

Seattle Genetics
Inc.
(SGEN)

SGN-15

cBR96-doxorubicin immunoconjugate
product candidate

Non-small-cell lung cancer

Phase II data showed a median survival of 11.4 months for patients receiving SGN-15 plus Taxotere compared to 5.1 months for patients receiving Taxotere alone (8/12)

SuperGen Inc.
(SUPG)

Dacogen

Decitabine; inhibitor of
DNA methyltransferase

Advanced melanoma and renal cell cancer

Company initiated patient enrollment in a Phase I study of Dacogen for injection in combination with Chiron Corp.'s Proleukin (8/27)

Telik Inc.
(TELK)

Telcyta

A small-molecule antitumor drug that is activated by GST-P1-1

Non-small-cell lung cancer

Phase II data showed an 11% objective response rate in the 19 evaluable patients; the overall disease stabilization rate was 69% (8/14)

Titan Pharmaceuticals Inc. (AMEX:TTP)

Pivanex

Acts by inhibiting enzymes called histone deacetylases

Non-small-cell lung cancer

Clinical data showed no dose-limiting toxicity at any level and showed that the combination was generally well tolerated (8/12)

CARDIOVASCULAR

Alexion Pharmaceuticals Inc. (ALXN)

Pexelizumab

Short-acting, single-chain antibody C5 complement inhibitor

To reduce death and myocardial infarction in patients undergoing coronary artery bypass graft surgery

Phase III data showed the compound narrowly missed its primary endpoint (8/5)

AtheroGenics Inc. (AGIX)

AGI-1067

V-protectant drug; oral anti-inflammatory agent

Atherosclerosis and post-angioplasty restenosis

Company completed enrollment in a Phase IIb trial (8/6)

AVI BioPharma Inc. (AVII)

Resten-NG

Antisense drug to be delivered using AVI's microbubble delivery
system

Patients undergoingangioplasty and stent placement

Company began a Phase II study of Resten-NG (8/19)

Cardiome Pharma Corp. (Canada; TSE:COM)

RSD1235

Atrial antiarrhythmic
drug candidate

Atrial fibrillation

Company began patient dosing in its first of three Phase III studies (8/6)

Encysive Pharmaceuticals Inc. (ENCY)

Argatroban (FDA-approved)

A direct thrombin
inhibitor anticoagulant

Blood clots

Clinical data showed Argatroban significantly reduced thrombosis and deaths due to clots without increasing the risk of bleeding (8/12)

Endomatrix
Inc.*

Provasca

An endothelial
dysfunction therapy

Cardiovascular disease

Company began a clinical trial (8/27)

ISTA Pharmaceuticals Inc. (ISTA)

Vitrase

Ovine hyaluronidase

Vitreous hemorrhage

Phase III data demonstrated a statistically significant reduction in vitreous hemorrhage density as early as one month and through three months following a single intravitreous injection of Vitrase when compared to a single injection of saline solution (8/21)

SuperGen Inc. (SUPG)

Dacogen

Decitabine; inhibitor of
DNA methyltransferase

Sickle cell anemia

Phase I/II data showed Dacogen was well tolerated, with the only significant toxicity being neutropenia (8/20)

CENTRAL NERVOUS SYSTEM

Myriad Genetics Inc. (MYGN)

MPC-7869

R-flurbiprofen

Alzheimer's disease

Clinical data showed MPC-7869 reduces levels of Abeta42 more effectively than any other compound tested (8/5)

DIABETES

Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co.

Exenatide

Synthetic exendin-4

Type II diabetes

Phase III data showed the product hit its primary endpoint (8/7); results from another Phase III study showed that 44% of patients who completed 24 weeks of treatment achieved glucose level averages in the American Diabetes Association's target range (8/25)

ConjuChem Inc. (Canada; TSE:CJC)

DAC-GLP-1

An insulinotropic hormone that is a naturally occurring 30-amino-acid peptide;
uses DAC technology

Type II diabetes

Phase I/II data showed primary endpoints were met; the compound also was well tolerated (8/22)

DepoMed Inc. (AMEX:DMI) and Biovail Corp. (Canada)

Metformin GR

Once-daily, controlled- release formulation of metformin based on DepoMed's once-daily gastric retention technology

Type II diabetes

Phase III data showed Metformin GR controlled glucose levels after 48 weeks (8/6)

INFECTION

AVI BioPharma Inc. (AVII)

AVI-4020

Neugene drug

West Nile virus

Company initiated a Phase Ib trial in patients hospitalized with West Nile virus (8/4)

Genome Therapeutics
Corp.
(GENE)

Ramoplanin

Naturally occurring
antibiotic

Vancomycin-resistant enterococci

Company expanded its program, enrolling up to 50 patients, to investigate whether Ramoplanin can reduce the transmission of VRE by decreasing skin contamination through gastrointestinal decolonization (8/5)

Gilead
Sciences
Inc. (GILD)

Viread and Emtriva (FDA-approved)

Tenofovir disoproxil
fumarate and emtricitabine

HIV

Company began enrollment in a Phase III trial of Viread and Emtriva used in combination with efavirenz vs. a regimen of Combivir and efavirenz (8/12)

MISCELLANEOUS

Arriva-ProMetic Inc. (joint venture of ProMetic Life Sciences Inc., Canada, TSE:PLI; and Arriva Pharma- ceuticals Inc.)

--

Recombinant alpha-1- antitrypsin topical gel

Atopic dermatitis

Company completed a Phase I trial showing the gel was well tolerated (8/12)

BCY Life-Sciences Inc. (Canada; VSE:BCY)

DCF 987

Low-molecular-weight dextran

Cystic fibrosis

Company completed enrollment in a Phase II trial (8/8)

Bioniche Life Sciences Inc. (Canada; TSE:BNC)

Cystistat

Sodium hyaluronate

Interstitial cystitis

Company missed its primary endpoint in a pivotal trial (8/18)

Cellegy Pharmaceuticals Inc. (CLGY)

Cellegesic

Nitroglycerin ointment

Chronic anal fissures

Company is enrolling a confirmatory Phase III trial (8/6)

Genaera Corp. (GENR)

Squalamine

Anti-angiogenic drug that blocks a number of angiogenic growth factors, including vascular
endothelial growth factor

Choroidal neovascularization associated with age-related macular degeneration

Phase I/II data showed that Squalamine improved vision in patients with wet AMD (8/4)

Genentech Inc. (NYSE:DNA)

Lucentis (formerly called rhuFab V2)

Ranibizumab; a humanized therapeutic antibody
fragment developed to
bind and inhibit VEGF

Wet form of age-related macular degeneration

Phase Ib/II data showed that of 40 patients treated for six months who completed the study through day 210, 97.5% had stable or improved vision and 45% improved 15 letters or more on the Early Treatment Diabetic Retinopathy Study chart (8/19)

Inspire Pharmaceuticals Inc. (ISPH)

Diquafosol

Diquafosol tetrasodium ophthalmic solution

Dry eye disease

A Phase IIIb study showed diquafosol was well tolerated with the incidence of adverse events similar to placebo (8/13)

MacroChem
Corp.
(MCHM)

Topiglan

Combines alprostadil, a vasodilator, with SEPA, MacroChem's drug absorption enhancer; topical cream

Erectile dysfunction

Company is expanding a doubleblind Phase II trial of Topiglan in the U.S. (8/26)

Santarus Inc.*

SAN-05

Oral, immediate-release omeprazole suspension

Upper
gastro-intestinal bleeding

Phase III data showed
it met the primary endpoint (8/6)


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.

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