Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Active
Biotech AB
(Sweden; SSE:ACTI) and Chelsea Therapeutics
International
Ltd.
(CHTP)

ABR- 224050

Oral inhibitor of dihydroorotate dehydrogenase

Rheumatoid arthritis

Completed microdosing study in human volunteers; they plan to conduct further preclinical testing before additional Phase I trials, which are expected to begin in 2008 (3/13)

Alba
Therapeutics
Corp.*

AT-1001

Orally administered zonulin receptor antagonist

Celiac disease

Completed enrollment and dosing of patients in its Phase IIa trial(3/8)

Cytochroma Inc.*

CTA018

Cream; vitamin D analogue

Chronic plaque psoriasis

Completed enrollment in a Phase II trial with 147 subjects (3/6)

La Jolla
Pharmaceutical
Co.
(LJPC)

Riquent

Abetimus sodium; B-cell toleragen

Systemic lupus erythematosus

Phase III data indicated patients treated with 900 mg or 300 mg of Riquent per week had greater reductions in antibodies to double-stranded DNA than patients treated with 100 mg per week or placebo (3/8)

Medarex Inc.
(MEDX) and
MedImmune Inc.
(MEDI)

MEDI-545

A fully human monoclonal antibody targeting interferon-alpha

Psoriasis

Started a Phase I trial (3/23)

Ocera
Therapeutics
Inc.*

AST-120

Oral spherical adsorptive carbon

Crohn's disease

Met the 50% enrollment target in a 240-patient pivotal trial (3/26)

CANCER

Abraxis
BioScience
Inc.
(ABBI)

ABI-008

An albumin-bound chemotherapeutic; nabdocetaxel

Hormone-refractory prostate and metastatic breast cancer

Will begin enrollment in two Phase I/II trials in the second quarter (3/21)

Adherex
Technologies
Inc.
(AMEX:ADH)

ADH-1

Cadherin antagonist; small peptide, tumor/vascular- targeting agent

Melanoma

Started a Phase I trial of systemic ADH-1 plus isolated limb infusion melphalan (3/27)

Aeolus
Pharmaceuticals
Inc.
(OTC BB:AOLS)

AEOL 10150

Small-molecule catalytic antioxidant

To protect healthy cells in radiation therapy

Phase I data showed it was safe and well tolerated at doses up to 2 mg/kg/day (3/22)

Amgen Inc.
(AMGN)

Vectibix (FDA-
approved)

Panitumumab; fully human monoclonal antibody directed against the epidermal growth factor receptor

Colorectal cancer

Company stopped a Phase III trial of Vectibix as a first-line treatment due to a lack of efficacy and toxicity concerns (3/23)

Antisoma plc
(UK; LSE:ASM)

AS1404

Small molecule derived from xanthenone acetic acid; vascular disrupting agent

Non-small-cell lung cancer

A second, confirmatory Phase II trial of AS1404 in combination with carboplatin and paclitaxel chemotherapy showed a response rate of 50% in 30 patients; 43% of patients had disease stabilization, while only 7% had progressive disease (3/8)

BioCryst
Pharmaceuticals
Inc.
(BCRX)

Fodosine

Forodesine; ; blocks an enzyme called purine nucleoside phosphorylase

T-cell acute lymphoblastic leukemia/ lymphoma

Company is backing off development for an intravenous formulation due to lack of benefits; also, a stability problem prompted the company to suspend a Phase IIb study (3/27)

Celldex
Therapeutics
Inc.
(BE:C4W)

Vaccine targeting an epidermal growth factor receptor variant, or EGFRvIII

Glioblastoma

Company is sponsoring a Phase II trial that will enroll 81 patients whose tumors produce the altered protein(3/22)

Chemokine
Therapeutics
Corp.
(Canada;
TSX:CTI; OTC BB:CHKT)

CTCE-9908

Chemokine CXCR4 antagonist

Ovarian cancer

Phase Ib/II data showed no dose-limiting toxicities and two of three patients responded positively and exhibited stable disease (3/12)

Chroma
Therapeutics
Ltd.*
(UK)

CHR-2798

Oral inhibitor of aminopeptidases

Refractory acute myeloid leukemia

Entered its first Phase II trial in elderly patients (3/26)

Ciphergen
Biosystems
Inc.
(CIPH)

Ovarian triage test

Diagnostic

To detect ovarian cancer

Data demonstrated it correctly identified 84% of the ovarian cancer cases, compared to only 33% identified using standard diagnosis methods (3/5)

CuraGen Corp.
(CRGN) and
TopoTarget A/S
(Denmark; CSE:
TOPO)

PDX101

Belinostat, a small- molecule histone deacetylase inhibitor

Multiple myeloma

Began patient dosing in a Phase II trial of PDX101 in combination with Velcade; the study is expected to enroll up to 35 patients (3/27)

Cytogen Corp.
(CYTO)

Quadramet

Samarium Sm-153 lexidronam injection

Hormone-refractory prostate cancer

Started a Phase II trial of Quadramet in combination with the NIH's targeted therapeutic vaccine PSA-TRICOM (3/1)

EntreMed Inc.
(ENMD)

Panzem

2-methoxyestradiol or 2ME2

Metastatic renal cell carcinoma

Began a Phase II trial of Panzem alone and in combination with Sutent (3/6)

Enzon
Pharmaceuticals
Inc.
(ENZN)

EZN-2968

A Hypoxia-inducible factor-1 alpha or HIF-1 alpha antagonist

Advanced solid tumors or lymphoma

First patient was enrolled in an open-label, non- andomized study (3/29)

Erimos
Pharmaceuticals
Inc.*

EM-1421

Terameprocol; a small molecule designed to prevent the production and activation of survivin

Recurrent high-grade glioma brain tumors

Began dosing patients in a Phase I/II study (3/26)

GPC Biotech AG
(Germany; GPCB)
and Spectrum
Pharmaceuticals
Inc.
(SPPI)

Satraplatin

Oral platinum compound

Refractory cancer

Phase III data showed that pain response rates for patients treated with satraplatin plus prednisone (24.2%) were statistically superior compared to the pain response rates for patientsin the placebo arm (13.8%) (3/22)

Hana Biosciences
Inc.
(HNAB)

Talvesta

Talotrexin for injection; nonclassical antifolate; analogue of aminopterin

Solid tumors

Discontinued a Phase I trial due to toxicity issues, specifically leukoencephalopathy (3/23)

MAT Biopharma*
(France)

Ferritarg P

A 90 Yttrium radio-labeled rabbit polyclonal antibody

Relapsed or refractory Hodgkin's disease

Began an escalating-dose Phase I/II study (3/7)

Maxygen
Inc.
(MAXY)

MAXY-G34

Pegylated form of granulocyte- olony stimulating factor

Chemotherapy-induced anemia

Phase I trial in 40 healthy volunteers showed dose-responsive potency in neutrophil generation as measured by neutrophil count and CD34+ stem cells (3/14)

Myriad Genetics
Inc.
(MYGN)

Azixa (MPC-6827)

Believed to have a dual mode of action as a cytotoxin and a vascular disrupting agent

Brain cancer

Started the first Phase II trial (3/8)

Myriad Genetics
Inc.
(MYGN)

Azixa (MPC-6827)

Believed to have a dual mode of action as cytotoxin and a vascular disrupting agent

Metastatic brain cancer

Started a Phase II trial in patients with melanoma that has spread to the brain (3/27)

Neoprobe Corp.
(OTC BB:NEOP)

Lymphoseek

A radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure called intraoperative lymphatic mapping

For use in melanoma or breast cancer

Company is moving into the second stage of a Phase II trial, which will involve an additional 40 patients with melanoma or breast cancer (3/5)

Neose
Technologies
Inc.
(NTEC)

NE-180

Pegylated form oferythropoietin

Anemia in cancer patients

Got an OK from the FDA to begin clinical trials in the U.S. (3/15)

Neose
Technologies
Inc.
(NTEC)

GlycoPEG-GCSF

Long-acting granulocyte colony stimulating factor

Neutropenia associated with cancer chemo-therapy

Started the second Phase I trial (3/21)

Nektar
Therapeutics
Inc.
(NKTR)

NKTR-102

Pegylated, small-molecule formulation of the cancer drug irinotecan

Refractory solid tumors

Began Phase I trial to evaluate safety, tolerability and pharma- cokinetics in up to 30 patients (3/13)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Bavituximab

A monoclonal antibody designed to target and bind to phosphatidylserine

Advanced cancer

Completed enrollment of the planned 12 evaluable patients in its Phase Ib trial of bavituximab in combination with common chemotherapy (3/22)

Point
Therapeutics
Inc.
(POTP)

Talabostat

A pan-inhibitor of dipeptidyl peptidase enzymes

Non-small-cell lung cancer; pancreatic cancer

Phase III trial of talabostat plus Taxotere is behind schedule; Phase II data of talabostat plus Gemzar in pancreatic cancer patients will not meet its primary endpoint (3/1)

Protherics plc
(UK; LSE:PTI)

OncoGel

A formulation of paclitaxel for local administration

For surgical removal of tumors in patients with recurrent glioblastoma multiforme

Enrolled the first patient in a study that will enroll 36 total (3/27)

Semafore
Pharmaceuticals
Inc.*

SF1126

P13 kinase inhibitor

Solid tumors

Started a Phase I trial (3/26)

Sunesis
Pharmaceuticals
Inc.
(SNSS)

SNS-032

A selective, small-molecule inhibitor of cyclin-dependent kinases 2, 7 and 9

Advanced B-cell malignancies

Began dosing in a Phase I trial (3/6)

Transgene
SA
(France;
Eurolist:TNG)

TG 1042

Adenoviral vector containing the human interferon gamma gene

Relapsing cutaneous B-cell lymphoma

Began first stage of Phase II trial that will evaluate regression, disappearance of lesions, safety and quality of life in 13 patients in the U.S. and Europe (2/14)

Xanthus
Pharmaceuticals
Inc.*

Clomet

DMPEN, 4-demethylpen- clomedine

Solid tumors

Began a Phase I dose-escalation study (3/22)

CARDIOVASCULAR

AtheroGenics
Inc.
(AGIX)

AGI-1067

Oral agent designed to inhibit the production of VCAM-1 and other molecules in the inflammatory process

Atherosclerosis

Phase III ARISE trial in more than 6,100 patients failed to show significance vs. placebo in reducing a composite of major adverse cardiovascular events; it did meet secondary endpoints (3/19)

CV
Therapeutics
Inc.
(CVTX)

Ranexa (FDA- approved)

Ranolazine; partial inhibitor of fatty-acid oxidation

Angina

After missing its primary endpoint, the company believes positive safety data will support use in frontline angina treatment but no longer plans to seek approval for acute coronary syndrome (3/7)

Diffusion
Pharmaceuticals
LLC*

Trans sodium crocetinate

Agent designed to enhance the diffusion of oxygen into tissue

Oxygen- deprivation diseases

Began Phase I trial to evaluate pharmacokinetics and tolerability in 48 healthy volunteers (3/16)

Inotek
Pharmaceuticals
Corp.*

INO-1001

Inhibitor of the nuclear cell death enzyme poly (ADP-ribose) polymerase

Cardiac reperfusion injury

Phase II data demonstrated its safety and its potential as a preventative agent; the trial was conducted in 40 subjects (3/27)

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 301012

Second-generation antisense drug designed to inhibit apoB-100

Homozygous familial hyperholest-erolemia

Phase II data showed a significant lipid-lowering activity; the product was safe and well tolerated (3/26)

KAI
Pharmaceuticals
Inc.*

KAI-9803

An isozyme-selective delta protein kinase C inhibitor

To reduce injury associated with heart attack

Phase I/II data showed it may reduce damage to the heart and improve cardiac function in heart attack patients undergoing balloon angioplasty (3/26)

Liponex Inc.
(Canada; TSX:LPX)

CRD5

Works by increasing the synthesis and secretion of apoliprotein A-I

Dyslipidemia

Phase I/II data showed it failed to significantly increase high density lipoprotein (HDL) (3/8)

InterMune Inc.
(ITMN)

Actimmune
(FDA-approved)

Interferon gamma-1b

Idiopathic pulmonary fibrosis

Company scrapped the Phase III trial after an independent data monitoring board found lack of survival benefit compared to placebo (3/6)

Osiris
Therapeutics
Inc.
(OSIR)

Provacel

Adult stem cell product

Heart attack

A 53-patient study established safety and showed that patients had significantly lower rates of adverse events and significant improvements in heart, lungand overall condition (3/26)

Pervasis
Therapeutics
Inc.*

Vascugel

Allogeneic cell therapy designed to restore natural repair and regenerationpathways in the vasculature

Vascular patency

Began two Phase II trials to evaluate safety and benefit for the maintenance of vascular patency after creation of arteriovenous access graft and AV fistula for patients undergoing dialysis for end-stage renal disease (3/19)

Scios Inc.
(unit of Johnson
& Johnson)

Natrecor
(FDA-
approved)

Nesiritide; recombinant B-type natriuretic peptide

Persistently symptomatic chronic decompensated heart failure

A 920-patient Phase II study showed a neutral effect on the primary endpoint, a composite of death and cardiorenal hospitalization at 12 weeks (3/26)

Symphogen A/S*
(Denmark)
and Biovitrum
AB
(Sweden;
SSE:BVT)

Sym001
(Anti-RhD)

Recombinant, polyclonal antibody, which is comprised of 25 different anti-Rhesus D antibodies

Idiopathic thrombocyto-penic purpura and to prevent hemolytic disease in newborns

Began a Phase I trial to test the safety, pharmacokinetics and pharmacodynamics in healthy volunteers (3/12)

The Medicines
Co.
(MDCO)

Angiomax
(FDA-
approved)

Bivalirudin; direct thrombin inhibitor

Acute coronary syndrome

One-year findings from the ACUITY trial show that those receiving Angiomax had similar rates of ischemic clinical outcomes compared with more complicated standard therapy (3/26)

CENTRAL NERVOUS SYSTEM

Acadia
Pharmaceuticals
Inc.
(ACAD)

ACP-103

Selective 5-HT2A inverse agonist

Schizophrenia

Phase II co-therapy trial with anti-psychotic agents in 423 patients demonstrated a statistically significant reduction as measured by a syndrome scale; secondary endpoints also were met (3/19)

Alexza
Pharmaceuticals
Inc.
(ALXA)

AZ-001

Aerosol version of the intravenous drug prochlorperazine; delivered with Alexza's Staccato device

Migraine

Phase IIb data showed all doses of the drug hit the primary end- point of two-hour pain relief compared to placebo (3/26)

Alkermes Inc.
(ALKS)

ALKS 29

Oral compound

Alcohol dependence

Completed enrollment in a Phase I/II trial (3/6)

Allon
Therapeutics
Inc.
(Canada;
TSX:NPC)

AL-108

An intranasally formulated eight amino acid neuro-protective peptide based on NAP

Alzheimer's disease; schizophrenia

Phase Ib trial confirmed AL-108 was safe and well tolerated in 32 healthy elderly subjects after seven days of dosing (3/7); plans to start a Phase II in schizophrenia-related cognitive impairment (3/27)

Anesiva Inc.
(ANSV)

Zingo

A needle-free system that delivers lidocaine powder into the skin via compressed gas

Pain

Began a Phase III trial testing Zingo's pain relief in those undergoing peripheral venous access procedures, such as intravenous line placements and blood draws (3/28)

Arena
Pharmaceuticals
Inc.
(ARNA)

APD125

Selective inverse agonist for 5-HT2A receptors

Chronic insomnia

Started dosing in a 100-patient Phase II trial of APD125 (3/5)

Avicena
Group Inc.
(OTC BB:AVGO)

PD-02

Ultra-pure form of creatine designed to boost production of ATP, or adenosine triphosphate

Parkinson's disease

NIH started a Phase III trial with more than 1,720 patients (3/22)

Avigen Inc.
(AVGN)

AV650

Tolperisone; oral agent approved in the EU for treating spasticity and muscle spasms

Spasticity

Got OK to start Phase II trial that will assess safety, tolerability, lack of sedation and initial efficacy in spinal cord injury patients suffering from spasticity (3/14)

Biogen Idec Inc.
(BIIB) and
PDL BioPharma
Inc.
(PDLI)

Daclizumab (FDA-approved as Zenapax)

Humanized monoclonal antibody; interleukin-2 receptor antagonist

Relapsing multiple sclerosis

Phase II met its primary endpoint in patients being treated with interferon beta; they showed a significant reduction in the number of new or enlarged gadolinium-contrast-enhancing lesions at week 24 (3/12)

CeNeRx
BioPharma
Inc.*

Tyrima

Has a triple mechansim of action; reversible inhibitor of monoamine oxidase A

Depression and anxiety

Phase I trial in 41 subjects demonstrated safety and tolerability; the drug achieved high plasma levels (3/13)

Clinical Data
Inc.
(CLDA)

Vilazodone

Designed as a selective serotonin reuptake inhibitor and a 5HTIA partial agonist

Depression

Completed enrollment in a pivotal Phase III study with 410 patients (3/26)

Corcept
Therapeutics
Inc.
(CORT)

Corlux

Mifepristone; oral GR II antagonist with potential mitigating effects on cortisol

Psychotic major depression

The last of three Phase III trials failed to meet its primary endpoint (3/20)

Depomed Inc.
(DEPO)

Gabapentin GR

An extended-release formulation of gabapentin formulated with Depomed's AcuForm delivery technology

Postherpetic neuralgia

Completed patient enrollment in its pivotal Phase III trial with 407 patients (3/8)

Encysive
Pharmaceuticals
Inc.
(ENCY)

TBC3711

A next-generation, highly selective endothelin receptor antagonist

Resistant hypertension

First patient has been enrolled in its Phase II dose- manging study (3/21)

EPIX
Pharmaceuticals
Inc.
(EPIX)

PRX-00023

Selective 5-HTIA partial agonist

Adults with major depressive disorder and an additional diagnosis of anxiety

Started a Phase IIb trial (3/29)

Evotec AG
(Germany; FSE:EVT)

EVT 302

A monoamine oxidase B enzyme

For smoking cessation

Started a Phase I study (3/22)

LAB
International
Inc.
(Canada;
TSX:LAB)

Fentanyl Taifun

A fast-acting fentanyl formulation delivered using the company's Taifun dry-powder inhaler platform

Breakthrough pain

Phase IIb data from 24 patients showed successful dose titration resulting in effective control of pain episodes (3/5)

MAP
Pharmaceuticals
Inc.*

Tempo Migraine

An inhaled formulation of dihydroergotamine

Migraine pain

It met its primary endpoints in a Phase II program, showing it was well tolerated in those with impaired pulmonary function (3/1)

MediciNova
(MNOV)

MN-166

Works by inhibiting leukotriene activity, phosphodiesterases and nitric oxide synthase

Relapsing multiple sclerosis

Phase II data in 297 patients showed the compound did not hit the primary endpoint of reducing the number of lesions on cranial MRI scans, but positive indicators did show up in radiological outcome measures; an independent data safety monitoring board recommended the trial continue (3/27)

Memory
Pharmaceuticals
Corp.
(MEMY)

MEM 1003

Calcium channel modulator

Bipolar disorder

MEM 1003 failed to demonstrate efficacy in treating acute mania in patients with bipolar disorder in an 84- patient Phase IIa study (3/5)

Memory
Pharmaceuticals
Corp.
(MEMY)

MEM 3454

Nicotinic alpha-7 receptor partial agonist

Alzheimer's disease

Began Phase IIa trial to evaluate safety, tolerability and cognitive effects of three doses vs. placebo in 80 subjects with mild to moderate AD

MGI Pharma
Inc.
(MOGN)

Aquavan

Fospropofol disodium

Sedative used during bronchoscopy

Pivotal study met its primary endpoint (3/20)

Myriad Genetics
Inc.
(MYGN)

Flurizan

First in a new class of drugs known as Selective Amyloid Lowering Agents

Alzheimer's disease

Phase II data showed that overall, 42% of patients on Flurizan had improvement or no decline in one or more of three primary end- points, cognition, global function and activities of daily living, compared to 10% for the placebo group (3/5); completed enrollment of more than 800 patients in its global Phase III trial (3/20)

Pharmacopeia
Drug Discovery
Inc.
(PCOP) and
Schering-Plough
Corp.

PS386113

Compound that addresses immunoregulation

Inflammatory disease

Started a Phase I trial (3/28)

Pozen Inc. (POZN)

PA 325

A formulation of 325 mg of aspirin surrounded by a 20-mg coating of an immediate release formulation of a proton pump inhibitor

Pain

A proof-of-concept, 80-subject study demonstrated a statistically significant benefit on gastrointestinal damage over aspirin (3/6)

Talecris Bio-
therapeutics Inc.*

Plasmin

Locally acting fibrin-binding thrombolytic derived from human plasma

Acute peripheral arterial occlusion

Enrolled the first patient in its Phase I/II trial (3/20)

TorreyPines
Therapeutics
Inc.
(TPTX)

NGX267

A functionally selective muscarinic receptor agonist

Cognitive impairment associated with schizophrenia

Began a Phase I trial of NGX267 given once daily for four days to healthy male volunteers (3/12)

Xytis
Pharmaceuticals
Inc.*

Anatibant

Selective, small-molecule bradykinin B2 receptor antagonist

Traumatic brain injury

Began Phase II trial that will evauate safety, tolerability, mortality and functional improvments in 400 patients in nine countries (3/13)

YM
BioSciences
Inc.
(Canada;
AMEX:YMI; TSX:YM)

AeroLEF

Inhaled-delivery composition of free and liposome- encapsulated fentanyl

Moderate to severe post-surgical pain

Enrollment has been completed in a Phase IIb trial (3/6)

DIABETES

DiObex Inc.*

DIO-902

A cortisol synthesis inhibitor; 2S, 4R ketoconazole

Type II diabetes

Phase IIa trial showed significant reductions in total and LDL cholesterol, as well as trends toward an improvement in glycemic control, in all doses vs. placebo(3/26)

Phenomix Corp.*

PHX1149

An orally administered inhibitor of the serine protease DPP4

Type II diabetes

Completed a Phase IIa trial, which met its primary endpoint of improved postprandial glucose as well as secondary endpoints related to HbA1c and GLP-1 levels (3/5)

Transition
Therapeutics
Inc.
(Canada;
TSX:TTH)

E1-I.N.T.

Combination of epidermal growth factor analogue and gastrin analogue

Type II diabetes

Interim Phase IIa data showed that E1-I.N.T. significantly lowered blood glucose levels for patients using metformin with or without thiazolidine-diones (3/5)

INFECTION

Acambis plc
(UK; LSE:ACM)

ChimeriVax-JE

Single-dose vaccine against Japanese encephalitis

Japanese encephalitis

It met and exceeded the primary immunogenicity endpoint in a pivotal Phase III trial (3/1)

Acambis plc
(UK; LSE:ACM)

ChimeriVax

Vaccine against West Nile virus

West Nile virus

Began Phase II testing in older adults (3/21)

Arpida Ltd.
(Switzerland;
SWX:ARPN)

AR-709

DHFR inhibitor with microbiological activity against streptococci and multidrug resistant Streptococcus pneumoniae

Complicated skin and skin structure infections

Radiolabeled microdoses of AR0709 achieved good distribution within the lungs in a first- in-man study (3/29)

Avexa Ltd.
(Australia;
ASX:AVX)

ATC

Apricitabine; a nucleoside reverse transcriptase inhibitor

HIV

Phase IIb data showed that those who received ATC achieved an average reduction of greater than 0.8 log10 (85%) in the level of HIV in the blood after 21 days of treatment compared with a reduction of less than 0.03 log10 in patients treated with 3TC (3/20)

Barrier
Therapeutics
Inc.
(BTRX)

Pramiconazole

Formerly Azoline; broad-spectrum, oral antifungal agent

Tinea (pityriasis) versicolor

Phase IIb data showed it met the primary endpoint of effectively treating the common skin fungal infection (3/27)

Biota
Holdings Ltd.
(Australia;
PK:BTAHY)

BTA798

Small-molecule inhibitor of human rhinovirus

Rhinovirus

Phase I data showed the drug was safe and well tolerated at all doses in 32 healthy volunteers (3/26)

Dynavax
Technologies
Corp.
(DVAX)

Heplisav

Immunostimulatory sequence-based vaccine targeting Toll-like receptor 9

Chronic hepatitis B virus

Started a Phase I trial (3/1)

Enzo
Biochem Inc.
(NYSE:ENZ)

Gene therapy using HGTV43 vector to deliver antisense genes designed to interfere with HIV-1 growth

HIV

Began Phase I/II trial in patients with compromised CD4+ cell counts, to test if treatment will create sufficient HIV-1-resistant CD4+ cells to defer disease progression to AIDS (3/13)

Genelabs
Technologies
Inc.
(GNLB)

Vaccine for HEV

Hepatitis E virus

Data show it was 95.5% effective in preventing disease and had a safety profile similar to placebo (3/1)

Gilead Sciences
Inc.
(GILD)

GS 9137

Elvitegravir; integrase inhibitor

HIV

Phase II data showed statistically significant reductions in viral load among HIV-positive, treatment-experienced patients given 125 mg of GS 9137 once daily, boosted with 100 mg of ritonavir, compared to those receiving a boosted protease inhibitor (3/2)

Horizon
Therapeutics
Inc.*

HZT-501

A formulation of ibuprofen combined with the H2 receptor antagonist famotidine; an NSAID

Mild to moderate pain

Started its Phase III program, which will enroll a total of 1,200 patients between two trials (3/27)

Indevus
Pharmaceuticals
Inc.
(IDEV)

Nebido

Testosterone undecanoate product; a long-acting injectable therapy

Hypogonadism

Preliminary data indicate an ongoing Phase III will achieve its primary endpoint (3/26)

Iomai Corp.
(IOMI)

Vaccine patch

Travelers' diarrhea

Data showed that volunteers who received the vaccine before being exposed to high levels of entero- toxigenic E. coli bacteria had less severe diarrhea and were signifi- cantly less likely to require intravenous fluids than patients who were not vaccinated (3/5)

Nventa Bio-
pharmaceuticals
Corp.
(TSX:NVN)

HspE7

Vaccine

Human papil-lomavirus- related diseases

Phase II data demonstrated an overall response rate of 78% among the 58 evaluable patients (3/6)

Ocera
Therapeutics
Inc.*

AST-120

Oral spherical adsorptive carbon

Pouchitis

Initiated a Phase II exploratory study (3/26)

Optimer
Pharmaceuticals
Inc.
(OPTR)

Difimicin (OPT-80/PAR101)

Narrow-spectrum antibiotic agent

Clostridium difficile- associated diarrhea

Monitors in Phase IIb/III trial said the product would move into Phase III studies, following review of Phase IIb data; the trial in 664 patients will compare the drug to oral vancomycin (3/14)

Panacos
Pharmaceuticals
Inc.
(PANC)

Bevirimat (PA-457)

HIV maturation inhibitor

HIV

Revised trial design for Phase IIb trial after tablet formulation used in first cohort produced inadequate plasma levels of drug; the next cohort will use an oral liquid formulation (3/12)

Replidyne Inc.
(RDYN)

Faropenem medoxomil

Ester prodrug derivative of the beta-lactam antibiotic faropenem

Acute otitis media

Phase II data showed it met its primary objective of showing faropenem was effective in eradicating pathogens from the middle ear (3/6)

Tibotec
Pharmaceuticals
Ltd.*
(Ireland)

TMC278

A next-generation non-nucleoside reverse transcriptase inhibitor

HIV

Phase IIb data showed that 81% of patients receiving the drug in combination with other antiretro-viral agents had reached the primary endpoint of a confirmed plasma viral load <50 copies/mL at 48 weeks (3/1)

Trimeris Inc.
(TRMS)

Fuzeon (FDA-approved)

Enfuvirtide; HIV fusion inhibitor

HIV

Data showed that 98% of those who received Isentress along with Fuzeon and a darunavir boost achieved undetectable levels of HIV (3/2)

MISCELLANEOUS

7TM Pharma
A/S*
(Denmark)

TM30339

Y4 receptor selective agonist

Obesity

Began a Phase I/II trial (3/8)

Advanced
Magnetics Inc.
(FSE:AMU)

Ferumoxytol

Intravenous iron replacement therapy

Chronic kidney disease

A data monitoring committee met for the final time and identified no safety concerns with the Phase III studies (3/5); completed enrollment in its final Phase III study in 230 patients on dialysis (3/20)

AEterna Zentaris
Inc.
(Canada; AEZS)
and Shionogi
& Co. Ltd. (Japan)

Cetrorelix

A luteinizing hormone-releasing hormone antagonist

Benign prostatic hyperplasia

Phase IIa data showed the drug was safe and well tolerated at all dosage regimens (3/22)

AlphaRx Inc.
(OTC BB:ALRX)

Indaflex

Topical non-steroidal anti- inflammatory drug formulation of indomethacin

Osteoarthritis of the knee

Completed the treatment phase of its double-blind, controlled, multicenter Phase II trial (3/5)

Amicus
Therapeutics*

Plicera

Isofagomine tartrate, AT2101

Gaucher disease

Phase I data showed it was well tolerated and that oral administration resulted in a significant elevation of target enzyme levels (3/21)

AOP Orphan
Pharmaceuticals
AG*
(Austria)
and Lantibio Inc.*

Moli1901

Duramycin; polycystic peptide that targets phospholipid phosphati- dylethanolamine

Cystic fibrosis

Phase II data showed that subjects ages 12 and older tolerated daily administration of the inhaled drug over 28 days (3/6)

CollaGenex
Pharmaceuticals
Inc.
(CGPI)

Incyclinide

Anti-inflammatory

Acne

Phase II data showed the minimum effective dose was 10 mg per day (3/1); started enrollment in a 40 mg cohort in the Phase II trial (3/29)

Collegium
Pharmaceutical
Inc.*

Once-a-day combination product

Seasonal allergic rhinitis

Proof-of-concept study showed benefit for its product on nasal symptoms (3/5)

Emisphere
Technologies
Inc.
(EMIS)

Eligen

Technology that orally delivers glucagon-like peptide-1 and peptide YY 3-36

Obesity

Phase I studies show the technology can orally deliver GLP-1 and PYY (3/29)

Isotechnika Inc.
(Canada; TSX:ISA)

ISA247

Immunosuppressive agent

Kidney transplant

An independent data monitoring committee recommended continuation of the Phase IIb, following an interim review (3/27)

Kamada Ltd.
(Israel;
TASE:KMDA)

API

Alpha-1 antitrypsin inhibitor

Congenital emphysema and cystic fibrosis

Began Phase III trials (3/5)

Lev
Pharmaceuticals
Inc.
(OTC BB:LEVP)

C1-INH

C1-esterase inhibitor

Hereditary angioedema

Pivotal Phase III trial in 71 patients demonstrated a clinically and statistically significant reduction in the time to sustained relief of acute HAE symptoms, vs. placebo (3/14)

Medivir AB
(Sweden; SSE:
MVIRB)

MIV-701

Inhibits the enzyme cathepsin K

Osteoporosis

Is starting its first human trial (3/6)

NicOx SA
(France; FSE:NXO)and Pfizer Inc.

PF-03187207

A nitric oxide-donating prostaglandin F2-alpha analogue

Glaucoma

Started the first in a series of trials (3/28)

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Investigational agent for BPH

Benign prostatic hyperplasia

Long-term, 8- to 19-month data in 116 patients showed statistically significant improvements in both symptom scores and treatment outcomes (3/19)

Pharmaxis Ltd.
(Australia; PXSL;
ASX:PXS)

Bronchitol

Mannitol formulation delivered via an inhalation device

Cystic fibrosis

Phase II trial closed enrollment after entering 25 subjects, fewer than the 42 originally expected (3/2)

Potentia
Pharmaceuticals
Inc.*

POT-4

Complement inhibitor

Age-related macular degeneration

Entered Phase I trials (3/20)

Progenics
Pharmaceuticals
Inc.
(PGNX) and
Wyeth
Pharmaceuticals

A new formulation of oral methylnaltrexone

Opioid-induced constipation

Began clinical testing of a new formulation after the initial formulation did not exhibit sufficient clinical activity to advance into Phase III testing (3/7)

Protox
Therapeutics
Inc.
(Canada;
CDNX:PRX)

PRX302

Prodrug designed to kill cancer cells upon activation by prostate specific antigen

Benign prostatic hyperplasia

Started a Phase I study (3/28)

Radius*

BA058

An analog of hPTHrP (human parathyroid hormone-related protein)

Osteoporosis in postmenopausal women

Started a Phase II trial (3/20)

Regeneron
Pharmaceuticals
Inc.
(REGN)

VEGF
Trap-Eye

A fully human, soluble VEGF fusion protein

Age-related macular degeneration

Top-line Phase II data showed the product improved vision (3/27)

Savient
Pharmaceuticals
Inc.
(SVNT)

Puricase

Pegylated recombinant porcine urate oxidate

Treatment-failure gout

Reached its Phase III enrollment target of 200 patients in two six-month trials (3/6)

ViaCell Inc.
(VIAC)

ViaCyte

To be used in the cryo-preservation and thawing of human oocytes

To expand reproduction options

Began a pivotal study, which will enroll about 300 women (3/20)


Notes:

* Privately held.

BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; NIH = National Institutes of Health; SPA = Special protocol assessment.

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

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; BE = Berlin Stock Exchange; CDNX = Canadian Venture Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TASE = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange.

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