Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Abbott Laboratories

Humira (FDA-approved) to block TNF-alpha

Adalimumab; fully
human antibody
designed

Crohn's disease

Presented Phase III data showing a statistically significant increase in remission at four weeks in CLASSIC trial in 229 patients; also, open-label trial in 29 hard- to-treat patients also showed clinical benefit (5/18)

Abbott Laboratories

Humira (FDA- approved)

Adalimumab; fully
human antibody
designed to block
TNF-alpha

Rheumatoid arthritis

Published 52-week data show drug with methotrexate resulted in significantly less structural joint damage and improved physical function (5/10)

Androclus Therapeutics*

AT-001 (dnaJP1)

Short, engineered oral
peptide designed to
have disease-specific
immunomodulatory
activity

Rheumatoid arthritis

Published Phase I/II data showed no side effects and a change from pro-inflammatory to regulatory T-cell function (5/14)

Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland)

Antegren (natalizumab)

Humanized
monoclonal
antibody; alpha-4
antagonist in the
selective
adhesionmolecule inhibitor class

Crohn's disease

Phase III trial in 339 patients who responded to the drug in ENACT-1 showed they maintained clinical response and remission rates through six months at a statistically significant rate; also said European filing planned for 4Q:04 (5/18)

Centocor Inc. (unit of Johnson & Johnson) and Schering-Plough Corp.

Remicade (FDA- approved)

Infliximab;
monoclonal antibody
that targets and binds
to tumor necrosis
factor-alpha

Crohn's disease

Began SONIC trial comparing drug to the immunosuppressant azathioprine, alone and vs. the combination of both drugs; the primary endpoint is steroid-free remission (5/17)

Immunomedics Inc. (IMMU)

Epratuzumab

Humanized
anti-CD22
antibody labeled
with ayttrium-90

Lupus

Intitial Phase II results on 11 patients demonstrated no adverse events and early evidence of symptomatic improvement (5/11)

Incyte Corp. (INCY)

INCB3284

Oral CCR2
antagonist

Rheumatoid arthritis

Began Phase I trial to assess safety and tolerability in healthy volunteers (5/11)

Protein Design Labs Inc. (PDLI)

Daclizumab (FDA-approved as Zenapax)

Humanized
monoclonal antibody;
interleukin-2 receptor
antagonist

Ulcerative colitis

Phase II trial failed to meet its primary endpoint of patients achieving remission at week eight at either of two doses (5/16)

CANCER

Adventrx Pharmaceuticals Inc. (AMEX:ANX)

CoFactor

Biomodulator of 5-
fluorouracil

Metastatic colorectal cancer

Began Phase II trial to evaluate the drug in untreated patients or those who have relapsed from 5-FU/leucovorin therapy (5/4)

Aphton Corp. (APHT)

G17DT

Immunotherapy
vaccine designed to
induce antibodies that
bind to both gastrin 17
and glygastrin 17

Gastric carcinoma

Published Phase II data showed G17DT immunization was capable of raising functional antibodies to gastrin 17 (5/27)

Bioenvision Inc. (AMEX:BIV)

Clofarabine

Second-generation
purine nucleoside
analogue

Acute myeloid leukemia

Phase II trial is ending early after exceeding expectations, to expedite start of pivotal trial; nine of 14 older patients in study experienced a complete response from single-agent therapy (5/19)

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

MCC

Mycobacterial cell-
all- DNA complex
produced from
Mycobacterium phlei

Superficial bladder cancer

Phase I/II trial in 55 patients produced complete responses of 43% to 64%, depending on the dose (5/20)

Callisto Pharmaceuticals Inc. (OTC BB:CLSP)

Atiprimod

Drug designed to
inhibit VEGF and
interleukin-6

Relapsed multiple myeloma

Began Phase I/II trial in up to 40 patients to assess dosing, pharmacokinetics and responses (5/26)

Cell Therapeutics Inc. (CTIC)

Trisenox (FDA-approved)

Arsenic trioxide

Multiple myeloma

Published Phase II data showed responses were achieved in 33% of 24 patients tested; six patients achieved stable disease (5/19)

Cell Therapeutics Inc. (CTIC)

Trisenox (FDA-approved)

Arsenic trioxide

Myelodysplatic syndrome

Published Phase II data showed drug with thalidomide produced multilineage hematologic responses in 25% of 28 patients (5/19)

CIMA Labs Inc. (CIMA)

OraVescent Fentanyl

Fentanyl formulated
with transmucosal
delivery technology

Breakthrough cancer pain

Began Phase III trial; details were not disclosed (5/6)

Cytogen Corp. (CYTO)

Quadramet

Samarium-153
lexidron injection;
skeletal-targeting
radiopharmaceutical

Pain from prostate cancer that has spread to the bone

Published data from 152-patient trial demonstrated statistical significance for pain relief and a decrease in opioid use (5/10)

Cytokinetics Inc. (CYTK) and GlaxoSmithKline plc (UK)

SB-743921

Small-molecule
inhibitor of kinesin spindle protein

Solid tumors

Began Phase I trial to assess dosing, safety, tolerability and pharmacokinetics in patients with advanced cancers (5/13)

Epeius Biotechnologies Corp.*

Rexin-G

Tumor-targeted,
injectable gene therapy
vector

Metastatic cancer

Patient treated in the Philippines experienced tumor shrinkage; the FDA has OK'd Phase I/II trial in in the U.S. (5/13)

GenVec Inc. (GNVC)

TNFerade

Adenovector with
TNF-alpha gene and a
radiation-responsive
promoter

Pancreatic and esophageal cancers

Update on 37 patients in Phase II pancreatic trial showed a dose-related improvement in local tumor control; early data from Phase II esophageal trial showed indications of activity (5/17)

GlobeImmune Inc.*

GI-4000 series

Immunotherapy
products targeting the
Ras protein

Cancers

Beginning Phase I trials in 15 to 25 patients with solid tumors to evaluate safety, immunogenicity and clinical benefit (5/25)

GlycoGenesys Inc. (GLGS)

GCS-100LE

Ethanol-free
formulation of the
company's GCS-100
complex carbohydrate
drug

Solid tumors

Began Phase I trial to assess safety, pharmacokinetics and dosing in up to 30 patients (5/12)

Hybridon Inc. (AMEX:HBY)

IMOxine (HYB2055)

Immunomodulatory oligo-nucleotide;
TLR9 agonist

Cancers

Company is extending Phase I trial after initial data showed product was safe and produced immunological activity in patients with metastatic disease (5/10)

Lorus Therapeutics Inc. (Canada; TSE:LOR)

GTI-2040

Targets the R2
component of
ribonucleotide
reductase, which is
required for DNA
synthesis

Unresectable colon cancer

Began trial in combination with oxaliplatin and capecitabine to assess dosing and pharmacody- namic effects on cellular markers (5/4)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene

Histamine
dihydrochloride in
combination with
interleukin-2

Acute myeloid leukemia

Phase III trial in 320 patients with AML in complete remission showed a statistically significant increase in leukemia-free survival (5/12)

Millennium Pharmaceuticals Inc. (MLNM)

Velcade (FDA-approved)

Bortezomib;
proteasome
inhibitor

Indolent non- Hodgkin's lymphoma

Final Phase III analysis showed Velcade produced a statistically significant survival benefit vs. high-dose dexamethasone; monitors had stopped the trial early after seeing the benefit (5/17)

Millennium Pharmaceuticals Inc. (MLNM)

Velcade (FDA-approved)

Bortezomib;
proteasome
inhibitor

Indolent non- Hodgkin's lymphoma

Began Phase II trial in combination with rituximab to assess efficacy, safety and tolerability in up to 66 relapsed or refractory patients (5/13)

NeoPharm Inc. (NEOL)

IL13-PE38QQR

Tumor-targeting agent designed to deliver bacterial cytotoxic PE38

Glioblastoma multiforme

Presented additional Phase I/II data that support company's Phase III Precise trial (5/6)

Novogen Ltd. (NVGN)

NV-18

Agent derived from company's phenoxodiol, which is designed to induce apoptosis

Solid tumors

Began Phase I trial to test three delivery methods in six patients (5/12)

OxiGene Inc. (OXGN)

Combretastatin A4 Prodrug

Vascular-targeting
drug designed to
block flow of blood
to tumor

Cancers

UK investigator reported anti- tumor activity and no unexpected toxicity in Phase I trial (5/17); interim data from three combination Phase I/II trials in solid tumors showed positive trends (5/17)

Salmedix Inc.*

SDX-105

Bendamustine HCl; alkylating agent

Non-Hodgkin's lymphoma

Began Phase II trial, in combination with Rituxan, in 60 patients with relapsed, indolent or slowly progressing disease who are not refractory to Rituxan (5/4)

SuperGen Inc. (SUPG)

Nipent (FDA-approved)

Pentostatin for
injection

Hematopoietic stem cell transplantation

Published data from study in 55 patients showed regimen with extracorporeal photopheresis, pentostatin and reduced-dose total-body irradiation showed evidence of reducing graft-vs.-host disease (5/21)

Tibotec Therapeutics (unit of Ortho Biotech Products LP)

Doxil (FDA-approved)

Liposomal
formulation of doxorubicin

Metastatic breast cancer

Published Phase III trial in 539 patients showed comparable survival vs. doxorubicin with less cardiotoxicity (5/20)

Titan Pharmaceuticals Inc. (AMEX:TTP)

Pivanex

Agent designed to inhibit histone deacetylases class of enzymes

Chronic lymphocytic leukemia and refractory malignant melanoma

Began Phase II trial in each indication to assess the preliminary safety and efficacy of single-agent administation (5/24)

Vion Pharmaceuticals Inc. (VION)

Triapine

Inhibitor of ribonucleotide reductase (inhibits a step in DNA
synthesis)

Cancers

Published Phase I data showed drug could be administered on an every-other-week schedule with tolerable and reversible toxicity (5/6)

Vion Pharmaceuticals Inc. (VION)

Cloretazine (VNP40101M)

Sulfonyl hydrazine DNA alkylating agent

Refractory leukemia

Published Phase I data established maximum tolerated dose and single-agent activity was seen (5/6)

Wilex AG* (Germany)

WX-UK1

Noncytotoxic small molecule designed to inhibit the urokinase plasminogen-activator system

Solid tumors

Began Phase I trial to evaluate safety and activity in combination with capecitabine in up to 54 patients with advanced solid tumors (5/25)

Wilex AG* (Germany)

Rencarex (WX-G250)

Chimeric monoclonal IgG1 antibody that binds to the MN cell- surface antigen

Renal-cell carcinoma

Got FDA OK for pivotal Phase III trial as an adjuvant therapy in patients at high risk of recurrence after resection of the primary tumor (5/10)

Xanthus Life Sciences Inc.*

Xanafide (amonafide)

A new salt formulation of the cancer compound amonafide

Metastatic prostate cancer

Began Phase I/II study in 40 hormone-refractory patients to define and validate the safety of a phenotypically driven dosing regimen, as well as efficacy (5/25)

YM BioSciences Inc. (Canada; TSE:YM)

TheraCIM hR3

Humanized anti- epidermal growth
factor receptor monoclonal antibody

Head and neck cancer

Published data showed the drug was well tolerated and may enhance radiation-induced tumor responses (5/12)

CARDIOVASCULAR

Alteon Inc. (AMEX:ALT)

ALT-711

Alagebrium chloride; A.G.E. crosslink breaker

Hypertension

Post hoc analysis of Phase IIb SAPPHIRE/SILVER trials showed a significant reduction in systolic blood pressure in difficult-to-treat patients (5/19)

Avigen Inc. (AVGN)

Coagulin-B

Adeno-associated
virus gene therapy vector containing the Factor IX gene

Hemophilia B

Stopped Phase I trial after mild liver toxicity was observed coincident with doses in which Factor IX expression decreases (5/27)

BioSurface Engineering Technologies Inc.*

HepaSil

Chemically modified heparin designed for controlled release from medical devices

Vascular grafts

Published data showed the product improved acute and subacute patency of small-bore synthetic vascular grafts (5/12)

Cardiome Pharma Corp. (Canada; TSE:COM)

RSD1235

Intravenous agent designed to selectively block ion channels in the heart

Atrial fibrillation and atrial flutter

Monitoring board found no safety issues and recommended Phase III ACT I trial continue (5/7)

Cerus Corp. (CERS)

Intercept Blood System

Pathogen-inactivation system for red blood cells that uses the compound S-303

Blood transfusions

Phase IIIc trial in 35 patients with thrombotic thrombocytopenic purpura met its primary and secondary endpoints vs. control plasma (5/19)

Corgentech Inc. (CGTK) and Bristol-Meyers Squibb Co.

E2F Decoy (edifoligide)

Oligonucleotide designed to inactivate the cell-cycle transcription factor
E2F

Arterio-venous graft failure

Began Phase I/II trial in 60 patients with end-stage renal disease who require hemodialysis (5/18)

Encysive Pharmaceuticals Inc. (ENCY)

Thelin (sitaxsentan)

Small molecule designed to block endothelin

Pulmonary arterial hypertension

New data from pivotal Phase IIb/III STRIDE-1 trial support use in earlier-stage patients and showed benefit after one year (5/24)

Inflazyme Pharmaceuticals Ltd. (Canada; TSE:IZP)

GH9001

Medium-molecular-weight heparin combined with low-molecular-weight dermatan sulfate

Prevention of blood clotting

Company dropped development after Phase Ib trial showed elevated liver enzymes in those given repeated doses (5/13)

Myogen Inc. (MYOG)

Ambrisentan

Type-A selective endothelin receptor antagonist

Pulmonary aterial hypertension

Presented Phase II data showing a statistically significant increase in the primary endpoint, six- minute walk distance, in all dose groups evaluated (5/24)

Nuvelo Inc. (NUVO)

rNAPc2

Recombinant
nematode
anticoagulant protein
c2 originally isolated from hookworms

Acute coronary syndromes

Reinitiated Phase IIa ANTHEM/ TIMI 32 trial; will enroll another 98 patients to bring total to 175; Nuvelo licensed the drug from Dendreon Corp. in February (5/13)

TransTech Pharma Inc.*

TTP889

Small-molecule
inhibitor of Factor IX/IXA

Thromboembolic disorders

Completed Phase I trial and said Phase II will begin in September (5/10)

CENTRAL NERVOUS SYSTEM

Axonyx Inc. (AXYX)

Phenserine

Inhibitor of acetylcholin-esterase and beta-amyloid precursor protein

Alzheimer's disease

Blinded review of Phase IIb trial confirmed the original power requirements and the ability of the study to achieve its objectives (5/6)

Boston Life Sciences Inc. (BSLI)

Altropane

Molecular targeting radioimaging agent

Parkinson's disease diagnosis

Began Phase III trial in 500 subjects to test differentiation of Parkinsonian and non-Parkinsonian tremors (5/20)

Corcept Therapeutics Inc. (CORT)

Corlux (mifepristone)

Oral GR-II antagonist with potential mitigating effects on cortisol

Psychotic major depression

Corcept '03 trial with 221 patients demonstrated statistical significance in reducing the psychotic features (5/3)

Endo Pharmaceuticals Inc. (ENDP) and SkyePharma plc (UK; SKYE)

DepoMorphine

Sustained-release, injectable, liposomal formulation of
morphine

Post-operative pain

Presented data from four studies that demonstrated product may be an effective and convenient option for managing pain (5/7)

Guilford Pharmaceuticals Inc. (GLFD)

Aquavan Injection

Water-soluble prodrug of propofol

Sedation

Began Phase III program to test the product in those undergoing procedures that require mild to moderate sedation (5/10)

Incara Pharmaceuticals Corp. (OTC BB:ICRA)

AEOL 10150

Catalytic antioxidant compound

Amyotrophic lateral sclerosis

Filed IND for Phase I trial to test the product in healthy volunteers (5/5)

Neurochem Inc. (Canada; NRMX)

Alzhemed

Small molecule designed to interfere with association between glycosaminoglycans
and A-beta protein

Alzheimer's disease

Starting 18-month Phase III trial in about 950 patients with mild to moderate disease; a similar trial is planned for Europe (5/19)

Neurocrine Biosciences Inc. (NBIX)

Indiplon

Immediate-and modified-release formulations of a non-enzodiazapine agent that targets GABA-A receptor

Insomnia

Presented data from various studies showing effectiveness of he drug across different patient populations; Phase I trial showed modified-release does not effect respiratory function (5/6)

Neurocrine Biosciences Inc. (NBIX)

Indiplon

Immediate-release formulation of non- benzodiazapine agent that acts on a specific site of the GABA-A receptor

Insomnia

Study in healthy volunteers demonstrated drug taken in the middle of the night was safe and well tolerated without next-day residual effects (5/4)

NeurogesX Inc.*

NGX-4010

Trans-capsaicin
dermal patch delivery system

Post-herpetic neuralgia

Phase II trial showed a 33% reduction in pain scores over four weeks vs. 4% for control (5/14)

Orphan Medical Inc. (ORPH)

Xyrem (FDA-approved)

Sodium oxybate oral solution

Narcolepsy

Phase IIIb SXB-15 trial in 228 patients met endpoints of improving excessive daytime sleepiness (5/19)

Phase 2 Discovery Inc.*

PD-6735

Melatonin analogue; agonist at melatonin-1 and melatonin-2 receptors

Insomnia

Phase II trial in 40 patients produced statistically significant improvements in sleep latency (5/20)

Phase 2 Discovery Inc.*

PD-6735

Melatonin analogue; agonist at melatonin-1 and melatonin-2 receptors

Sleep disorders

Phase I trial showed all doses were well tolerated without increased adverse events (5/20)

Pozen Inc. (POZN) and Glaxo-SmithKline plc (UK)

Trexima (MT 400)

Single-tablet combination of sumatriptan (5- T1B/1D agonist) and naproxen sodium

Migraine

Began Phase III program that will consist of two pivotal trials and a long-term safety study (5/18)

Progenics Pharmaceuticals Inc. (PGNX)

Methylnaltrexone (MNTX)

Agent designed to block peripheral
opioid receptors

Chronic pain in opioid-induced constipation

Completed Phase I trial in 61 healthy volunteers showing drug was well tolerated and exhibited predictabl epharmacokinetics (5/25)

Saegis Pharmaceuticals Inc.*

SGS742

Selective, orally
active GABA-B receptor agonist

Alzheimer's disease

Began Phase II trial to evaluate safety and efficacy of drug in patients with mild to moderate disease (5/3)

Sepracor Inc. (SEPR)

Estorra

Eszopiclone tablets

Insomnia

Presented data from multiple trials in different patient popu- lations; an approvable letter has been issued for the drug (5/6)

DIABETES

ConjuChem Inc. (Canada; TSE:CJC)

DAC:GLP-1

Insulinotropic
hormone GLP-1 created with firm's DAC technology

Type II diabetes

Began Phase II trial in combination with Metformin to assess HbA1C levels vs. control (5/26)

Generex Biotechnology Corp. (GNBT)

Oralin

Oral insulin spray formulation

Type I diabetes

Company completed dose- finding study in advance of a Phase IIb trial (5/3)

INFECTION

Anadys Pharmaceuticals Inc. (ANDS)

ANA380 (LB80380)

Nucleoside analogue

Hepatitis B

Phase I/IIa trial in 28 patients showed the product was safe and reduced viral load (5/11)

Avant Immunotheraeutics Inc. (AVAN)

LFn-p24

Anthrax-derived poly- peptide called lethal factor fused to the HIV-1 gag p24 protein

HIV

Phase I trial of the vaccine began to assess safety and immunogenicity in 18 healthy volunteers (5/13)

AVI BioPharma Inc. (AVII)

AVI-4020

Neugene antisense
drug

West Nile virus

Phase I/II trial in 10 patients showed the presence of the drug in cerebrospinal fluid; no safety issues were reported (5/4)

Chiron Corp. (CHIR)

Tifacogin

Recombinant form of tissue factor pathway inhibitor

Severe community-acquired pneumonia

Began Phase III CAPTIVATE trial in 1,200 patients worldwide with a primary endpoint of reduced mortality at 28 days (5/18)

Genzyme Corp. (GENZ)

Tolevamer sodium

Investigational
polymer therapy

Clostridium difficile-associated diarrhea

300-patient Phase II trial showed tolevamer met the noninferiority endpoint with safety and efficacy similar to vancomycin (5/3)

Human Genome Sciences Inc. (HGSI)

Albuferon

Albumin interferon- alpha; long-acting form of interferon-alpha

Hepatitis C

Began a Phase II trial in Canada in 40 interferon-naive patients to assess safety, tolerability, pharmacology and dosing (5/26)

Idenix Pharmaceuticals Inc.*

NM283

Antiviral agent
designed to inhibit the HCV RNA
polymerase

Hepatitis C

Phase I/II trial in 82 patients showed the drug was safe and produced dose-related reductions in serum HCV RNA (5/18)

InterMune Inc. (ITMN)

Infergen (FDA- approved)

Interferon alfacon-1

Hepatitis C

Investigator-sponsored studies of combination therapy with ribavirin in nonresponders showed sustained virologic response rates of about 25% (5/17)

InterMune Inc. (ITMN)

Infergen and Actimmune (both FDA-approved)

Interferon alfacon-1 and interferon
gamma-1b

Hepatitis C

Began Phase II trial in up to 80 nonresponding patients to test therapy with or without ribavirin; a goal is to see if Actimmune can replace ribavirin as an adjunct to Infergen in these patients (5/13); retrospective analysis showed 15 of 32 nonresponders had undetectable levels of HCV RNA in their blood (5/17)

MedImmune Inc. (MEDI) and Wyeth

CAIV-T

Intranasal, cold-adapted trivalent influenza vaccine; next generation of FluMist

Influenza

Phase III trials in infants and children showed better protection against flu than the traditional injectible flu vaccine (5/3)

Progenics Pharmaceuticals Inc. (PGNX)

PRO 140

Humanized monoclonal antibody designed to block the CCR5 co- receptor

HIV

Began Phase I trial in healthy volunteers to evaluate tolerability and pharmacologic profile (5/4)

Rigel Pharmaceuticals Inc. (RIGL)

R803

Small-molecule non- nucleoside HCV polymerase inhibitor

Hepatitis C

Began a Phase I/II trial to assess safety, tolerability and pharmacokinetics of multiple doses in HCV patients (5/24)

Samaritan Pharmaceuticals Inc. (OTC BB:SPHC)

SP-01A

Agent designed to decrease levels of the stress hormone
cortisol

HIV

Phase I/II trial demonstrated positive safety profile and encour-aging efficacy data (5/6)

Tanox Inc. (TNOX)

TNX-355

Humanized anti-CD4 monoclonal antibody

HIV

Began Phase II trial in 80 patients to evaluate safety and activity in combination with optimized background therapy as assessed by viral load reduction (5/5)

Theravance Inc.*

Telavancin (TD-6424)

Injectable antibiotic believed to have multiple mechanisms
of action

Infections

Presented various data from Phase I trials that will help in later studies (5/11)

Vertex Pharmaceuticals Inc. (VRTX)

Merimepodib (VX-497)

Small-molecule
inhibitor of the enzyme inosine mono-phosphate dehydrogenase

Hepatitis C

Began Phase II trial in 315 patients who will receive merimepodib or placebo with peginterferon and ribavirin (5/25)

Vicuron Pharmaceuticals Inc. (MICU)

Dalbavancin

Glycopeptide agent from the same class as vancomycin

Catheter-related bloodstream infections

Presented Phase II data showing superior efficacy of drug combined with vancomycin (5/4)

ViroPharma Inc. (VPHM)

Pleconaril

Intranasal form of antiviral designed to inhibit function of the picornavirus capsid

Common cold

Completed Phase I trial in 93 adult volunteers showing it was safe and well tolerated, and appeared to produce clinical benefit (5/25)

Zengen Inc.*

CZEN-002

Non-azole antifungal synthetic octapeptide

Vulvovaginal candidiasis

Phase I/II trial in 17 patients showed signs of efficacy and that the product was safe and well tolerated (5/25)

MISCELLANEOUS

Anika Therapeutics Inc. (ANIK)

--

Hyaluronic acid-based cosmetic tissue augmentation therapy

Nasolabial folds

Began a pivotal trial in up to 200 patients that will compare the product to a dermal filler made from collagen (5/10)

Avanir Pharmaceuticals Inc. (AMEX:AVN)

AVP 13358

Molecule designed to inhibit IgE production and suppress IL-4 and IL-5 responses

Asthma/ allergy

Phase I trial in 54 healthy volunteers showed drug was well tolerated at all doses and displayed positive availability in the blood- stream (5/3)

Barrier Therapeutics Inc. (BTRX)

Sebazole

Topical formulation of 2.0% ketoconazole,
an antifungal agent

Seborrheic dermatitis

Began Phase III trial to test the drug vs. placebo in 440 patients to measure clearance of the condition (5/26)

BioBalance Corp. (OTC BB:BBAL)

Probactrix

Strain of E. coli in a BioBalance
formulation

Proximal inflammation of the small intestine

Twelve of 18 patients in a clinical trial showed a clinical response of reduced abdominal symptoms (5/18)

ConjuChem Inc. (Canada; TSE:CJC)

DAC:GFR1

Chemically modified form of growth-releasing factor bonds to albumin

Growth homone deficiency in children

Began Phase I study in up to 48 subjects to assess safety and tolerability, and to measure pharmacokinetic profiles (5/5)

DUSA Pharmaceuticals Inc. (DUSA)

Levulan (FDA- approved)

Photodynamic
therapy

Facial photodamage

Began Phase II trial that first will evaluate light dosages, then test efficacy vs. vehicle in 64 and 60 patients, respectively (5/20)

Eyetech Pharmaceuticals Inc. (EYET) and Pfizer Inc.

Macugen

Pegaptanib sodium; vascular endothelial growth factor inhibitor

Diabetic maculare dema

Preliminary data from Phase II trial were statistically significant vs. sham injection for increasing lines gained on visual chart (5/3)

FemmePharma Inc.*

FP1096

Investigational drug delivered intravaginally

Endometriosis

Phase II trial in 30 patients showed a statistically significant improvement in symptoms of the disorder (5/5)

Genaera Corp. (GENR)

Squalamine

Anti-angiogenesis agent; VEGF inhibitor

Wet age- related macular degeneration

Began enrollment of 18 patients in Phase II trial to test pharmacokinetics and safety (5/4)

Genentech Inc. (NYSE:DNA), Tanox Inc. (TNOX) and Novartis AG (Switzerland)

Xolair (FDA- approved)

Omalizumab; humanized monoclonal antibody to IgE

Asthma

Began Phase III trial designed to enroll 570 patients between 6 and 12 years old, and assess safety and efficacy (5/17)

Genzyme Corp. (GENZ)

Seprafilm (FDA- approved)

Hyaluronic acid-based adhesion barrier

Small-bowel obstruction

A five-year study involving nearly 1,800 patients showed Seprafilm reduced the relative risk of a first adhesive obstruction (5/11)

Hemispherx Biopharma Inc. (AMEX: HEB)

Ampligen

RNA drug with potential action as an immuno-modulator and antiviral

Chronic fatigue syndrome

Pivotal Phase III trial vs. placebo met its primary endpoint in performance measured by a tread- mill test (p=0.022) (5/3)

Isolagen Inc. (AMEX:ILE)

Isolagen Process

Autologous cellular therapy

Periodontal disease

Phase I data showed growth of the papilla and bone deposition; company also said it was starting a Phase II trial (5/11)

Isotechnika Inc. (Canada; TSE:ISA)

TAFA-93

Small-molecule
prodrug of the mTOR inhibitor rapamycin

Various conditions

Began a Phase I trial at a single center in Canada that will include about 50 subjects (5/7)

Nastech Pharmaceutical Co. Inc. (NSTK)

PYY3-36 Nasal Spray

High-affinity Y2 receptor agonist

Obesity

Presented Phase I data showing agent was delivered effectively and produced no serious adverse events (5/26)

Nastech Pharmaceutical Co. Inc. (NSTK)

PTH1-34

Intranasal
administration of human parathyroid hormone 1-34

Osteoporosis

Began Phase I study to assess nasal absorption and safety (5/3)

OxiGene Inc. (OXGN)

Combretastatin A4 Prodrug

Vascular-targeting
drug designed to
block flow of blood
to tumor

Wet age-related macular degeneration

Data from seven patients in Phase I/II trial showed no serious adverse events and some evidence of clinical activity (5/17)

Palatin Technologies Inc. (AMEX:PTN)

PT-141

Intranasally delivered melanocortin agonist

Erectile dysfunction

Presented Phase IIb data in 271 patients showing favorable safety and efficacy (5/10)

Santarus Inc. (SNTS)

Rapinex

Immediate-release formulation of the proton pump inhibitor omeprazole

Prevention of upper gastrointestinal bleeding

Presented data from Phase III trial that showed statistical signifance in the primary endpoint; approval filing has been made with FDA (5/19)

Sucampo Pharmaceuticals Inc.*

SPI-0211

Chloride channel activator

Constipation

Withdrawal study duplicated the positive results of pivotal Phase III trial (5/11); 128-subject study showed agent caused no rebound effect; dosing was stopped (5/25)

Sucampo Pharmaceuticals Inc.*

SPI-0211

Chloride channel activator

Irritable bowel syndrome

Phase II trial in 195 patients with constipation-predominant IBS (5/11)

Theratechnologies Inc. (Canada; TSE:TH)

ThGRF

Transdermal formulation of parathyroid hormone

Osteoporosis

Phase I study with ALZA Corp.'s Macroflux delivery technology demonstrated positive delivery, bioavailability, activity and safety (5/3)


Notes:

* Privately held

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

AMEX = American Stock Exchange; NYSE = New York Stock Exchange

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