Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Arakis Ltd.*
(UK)

AD 452

Small-molecule disease- modifying anti-rheumatic drug

Rheumatoid arthritis

Phase II trial with methotrexate in 99 patients showed the drug was safe and well tolerated (4/7)

Biogen Idec
Inc.
(BIIB) and
Elan Corp.
plc
(Ireland;
NYSE:ELN)

Tysabri

Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells

Multiple sclerosis

Two-year data from AFFIRM Phase III monotherapy trial in 942 patients met all primary and secondary endpoints, including disability progression and relapse rate (4/12)

Chiron Corp.
(CHIR) and
Berlex Inc.

Betaseron
(FDA-approved)

Interferon beta-1b

Multiple sclerosis

Preliminary data from 16-year trial show safety and benefit of the drug over the long term (4/14)

Genentech
Inc.
(NYSE:DNA)
and Biogen
Idec Inc.
(BIIB)

Rituxan
(FDA-approved)

Rituximab; antibody that binds to the CD20 antigen on the surface of normal and malignant B cells

Rheumatoid arthritis

Phase III REFLEX trial showed drug with methotrexate displayed a statistically significant improvement in symptoms vs. placebo and methotrexate in those who inadequately responded to anti- TNF therapies (4/6)

Human Genome
Sciences Inc.
(HGSI)

LymphoStat-B

Belimumab; human monoclonal antibody that inhibits activity of B-lymphocyte stimulator

Rheumatoid arthritis

Phase II trial in 283 patients showed safety and tolerability, and a reduction in RA signs and symptoms in a statistically significant manner (4/6)

Serono SA
(Switzerland;
NYSE:SRA)

Onercept

Recombinant tumor necrosis factor binding protein

Psoriasis

Phase III trials were stopped after 12 weeks due to an inadequate risk-benefit profile; two patients developed sepsis (4/6)

CANCER

Adventrx
Pharmaceuticals
Inc.
(AMEX:ANX)

CoFactor

Form of folic acid designed to enhance the antitumor effects of 5-FU

Metastatic colorectal cancer

Is starting a pivotal Phase III trial under an FDA SPA that will test drug vs. leucovorin in a chemotherapy regimen in 600 patients (4/25)

Adventrx
Pharmaceuticals
Inc.
(AMEX:ANX)

CoFactor

Form of folic acid designed to enhance the antitumor effects of 5-FU

Metastatic colorectal cancer

Data from ongoing Phase II trial suggest there is negligible risk of toxicity from the drug (4/19)

Agennix Inc.*

Talactoferrin

Oral, recombinant human lactoferrin

Advanced non- small-cell lung cancer

Phase II trial in 110 patients showed improved responses with drug plus chemotherapy regimen vs. the regimen plus placebo (4/19)

Alfacell Corp.
(ACEL)

Onconase

Ranpirnase; cytotoxic ribonuclease

Non-small-cell lung cancer

Trial data showed drug enhanced chemosensitivity with cisplatin or carboplatin, with manageable toxicity (4/20)

American
Pharmaceutical
Partners Inc.
(APPX)

Abraxane (FDA-approved)

Paclitaxel protein-bound particles for injection; albumin-bound

Metastatic breast cancer

Began Phase II trial to test the drug with Herceptin in first-line treatment in 70 patients with with locally advanced or metastatic disease (4/4)

Amgen Inc.
(AMGN) and
Abgenix Inc.
(ABGX)

Panitumumab

Fully human monoclonal antibody that targets the epidermal growth factor receptor

Metastatic colorectal cancer

Began Phase III PACCE trial to evaluate the drug with other agents in first-line treatment in about 1,000 patients (4/26)

Antisoma plc
(UK; LSE:ASM)

AS1404

Vascular-targeting agent designed to disrupt tumor blood vessels

Hormone- refractory prostate cancer

Is starting a Phase II trial of the drug in combination with docetaxel (4/19)

A.P. Pharma
Inc.
(APPA)

APF530

The anti-emetic granisetron in a polymer-based drug delivery system

Chemotherapy- induced nausea and vomiting

Began Phase II trial to test safety, tolerability and pharmacokinetics in up to 30 patients (4/28)

CancerVax
Corp.
(CNVX)
and Serono SA
(Switzerland;
NYSE:SRA)

Canvaxin

Therapeutic whole-cell vaccine that expresses more than 20 antigens

Stage IV melanoma

Monitors recommended stopping the Phase III trial after a second interim analysis showed the data are unlikely to provide a survival benefit vs. placebo; a Phase III trial in Stage III melanoma continues (4/6)

Celgene
Corp.
(CELG)

Revlimid

Lenalidomide; derivative of Thalomid (thalidomide)

Multiple myeloma

Phase III trial in 354 relapsed or refractory patients showed a statistical significance with dexamethasone vs. dexamethasone alone in time to disease progression (4/11)

Cell Genesys
Inc.
(CEGE)

CG0070

Oncolytic virus therapy engineered to include the therapeutic gene for GM-CSF

Recurrent bladder cancer

Began Phase I trial to evaluate safety, dosing and responses in 36 patients who have failed BCG therapy (4/26)

Cell
Therapeutics
Inc.
(CTIC)

Trisenox (FDA-approved)

Arsenic trioxide

Multiple myeloma

Phase II trial with MAC regimen showed objective responses in 22 of the 37 relapsed or refractory patients (4/11)

ChemGenex
Pharmaceuticals
Ltd.
(Australia;
ASX:CXS)

Ceflatonin

Homoharringtonine

Chronic myelogenous leukemia

Began Phase II trial in combination with Gleevec in CML patients who have developed resistance to Gleevec (4/7)

Chiron Corp.
(CHIR) and XOMA
Ltd.
(XOMA)

CHIR-12.12

Fully human, antagonist antibody that targets the CD40 antigen

Advanced chronic lymphocytic leukemia

Began single-agent trial in 40 patients to evaluate safety, dosing, tolerability and pharmaco-kinetics (4/18)

Genentech
Inc.
(NYSE:DNA)

Herceptin
(FDA-approved)

Trastuzumab; monoclonal antibody against HER2/neu protein

HER2-positive breast cancer

Two Phase III trials in nearly 5,500 early stage patients were stopped early after an interim analysis showed improvements in disease-free and overall survival (4/25)

Genentech
Inc.
(NYSE:DNA)

Avastin (FDA-approved)

Bevacizumab; antibody designed to inhibit vascular endothelial growth factor

Metastatic breast cancer

Interim data from Phase III trial in 722 patients showed drug plus paclitaxel in first-line treatment improved progression-free survival vs. chemotherapy alone (4/15)

Genmab A/S
(Denmark; CSE:
GEN)

HuMax-CD4

Zanolimumab; human antibody that targets the CD4 receptor on T lymphocytes

Cutaneous T-cell lymphoma

Reached agreement with FDA on SPA for pivotal trial that first will test new antibody material in 18 patients, then will test response rates in 70 patients (4/19)

GlycoGenesys
Inc.
(GLGS)

GCS-100LE

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

Multiple myeloma

Began Phase I/II trial to evaluate safety, dosing and responses as a monotherapy and in combination therapy (4/5)

GPC Biotech
AG
(Germany;
GPCB)

Satraplatin

Oral platinum compound

Hormone- refractory prostate cancer

Monitors in the Phase III SPARC trial recommended the trial continue after reviewing safety data from the first 262 patients (4/19)

Human Genome
Sciences Inc.
(HGSI)

HGS-ETR1

Agonistic human monclonal antibody to TRAIL receptor 1

Advanced solid tumors

Phase I trial in 44 patients showed safety and tolerability; stable disease was observed in 10 patients (4/18)

Incyte Corp.
(INCY)

INCB7839

Inhibitor of sheddase, an enzymatic activity attributed to the ADAM family of proteins

Solid tumors

Began a Phase I trial to assess the safety and pharmacokinetics in healthy volunteers (4/6)

Kosan
Biosciences
Inc.
(KOSN)

KOS-862

Epothilone D, a polyketide

Metastatic breast cancer

Monitors recommended Phase II monotherapy trial continue to full enrollment following an interim analysis (4/5)

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

GTI-2040

Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase

Advanced renal-cell carcinoma

Final data from Phase II trial in 33 patients confirmed promising interim findings reported earlier (4/12)

Medarex Inc.
(MEDX) and
Bristol-Myers
Squibb Co.

MDX-010 and MDX-1379

Fully human anti-CTLA-4 antibody; gp100 melanoma peptide vaccine

Metastatic melanoma

Seven of 56 patients in Phase II trial achieved complete or partial responses, with five responses ongoing for more than two years (4/20)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Bortezomib; proteasome inhibitor

Lung cancer

Began Phase II PEAK trial in patients with either advanced bronchioalveolar carcinoma (BAC) or adenocarcinoma with BAC features that has progressed (4/25)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA- approved)

Bortezomib; proteasome inhibitor

Multiple myeloma

Presented data from single-agent and combination studies showing benefit across the MM treatment paradigm (4/13)

Myriad
Genetics Inc.
(MYGN)

MPC-6827

Pro-apoptotic drug candidate

Solid tumors

Began Phase I trial to evaluate safety and pharmacokinetics in patients with advanced tumors (4/27)

NeoPharm
Inc.
(NEOL)

IL13-E38QQR

Tumor-targeting agent designed to deliver bacterial cytotoxic PE38

Glioblastoma multiforme

Updated data from Phase I trial in 42 patients showed prolonged progression-free survival (4/18)

Novacea Inc.*

AQ4N

Banoxantrone; hypoxic cell- activated antitumor therapy

B-cell neoplasms

Began Phase I/II trial in up to 55 patients to evaluate safety, tolerability, pharmacokinetics, dosing and responses (4/20)

Oncolytics
Biotech Inc.
(Canada; ONCY)

Reolysin

Formulation of the human reovirus

Advanced solid tumors

Began Phase I trial to evaluate dosing, safety and activity in up to 36 refractory patients (4/7)

Onyx
Pharmaceuticals
Inc.
(ONXX) and
Bayer Pharma-
ceuticals Corp.

BAY 43-9006 (sorafenib)

RAF kinase and VEGF inhibitor

Advanced renal- cell carcinoma

Interim data from Phase III trial showed significant improvement in the duration of disease stabilization; decision was made to offer the drug to all patients in the trial (4/18)

PharmaMar
SA
(Spain;
subsidiary of
Zeltia Group)

Yondelis

Trabectedin; ET-743; derived from the sea squirt Ecteinascidia turbinata

Ovarian cancer

Began a Phase III trial to compare drug plus liposomal doxorubicin to the liposomal drug alone in 650 patients (4/4)

Point
Therapeutics
Inc.
(POTP)

Talabostat (PT-100)

Small molecule designed to stimulate proliferation of hematopoietic progenitor cells

Non-small-cell lung cancer

Phase II trial with docetaxel achieved the desired tumor response criteria; the patients had Stage IIIb/IV NSCLC (4/28)

Vion
Pharmaceuticals
Inc.
(VION)

Cloretazine (VNP40101M)

Sulfonylhydrazine DNA alkylating agent

Pediatric brain tumors

The Pediatric Brain Tumor Consortium began a Phase I trial in children to evaluate dosing (4/13)

ZioPharm Inc.*

ZIO-101

Organic arsenic compound

Hematological cancers

Starting a Phase I dose-ranging trial in patients (4/5)

CARDIOVASCULAR

Affymax Inc.*

Hematide

Peptide-based erythropoiesis-stimulating agent

Anemia

Began a Phase II trial to evaluate safety and pharmacokinetics in patients with chronic kidney disase who are not on dialysis (4/7)

American
Pharmaceutical
Partners Inc.
(APPX)

Coroxane

Nanoparticle, albumin- bound paclitaxel

In-stent restenosis

Phase I study in 23 patients produced information on dosing (4/5)

Cardiome
Pharma Corp.
(Canada; CRME)

RSD1235

Oral formulation of drug designed to selectively block ion channels in the heart

Atrial fibrillation

Phase Ib trial showed drug was absorbed and tolerated; company began a Phase Ic trial to assess multi-day dosing (4/25)

Cardiome
Pharma Corp
(Canada; CRME)

Oxypurinol

Xanthine oxidase inhibitor that is the active metabolite of allopurinol

Congestive heart failure

Physician-sponsored EXOTIC-EF trial in 20 patients showed a statistically significant improvement in left ventricle ejection fraction (4/7)

CV
Therapeutics
Inc.
(CVTX)

Ranexa (ranolazine)

Partial inhibitor of fatty- acid oxidation

Chronic angina

Phase III ERICA trial run under FDA SPA in 565 patients met the primary endpoint of reducing weekly angina frequency vs. placebo (4/18)

GTC
Biotherapeutics
Inc.
(GTCB)

ATryn

Recombinant human antithrombin

Hereditary antithrombin deficiency

Starting a safety and efficacy trial in at least 17 HD patients who are undergoing high-risk procedures; the data will be combined with an earlier 14-patient trial used in an EMEA MAA filing (4/6)

ImaRx
Therapeutics
Inc.*

SonoLysis

Therapy that uses ultrasound to cavitate gas- filled microbubbles to dissolve blood clots

Acute ischemic stroke

Began Phase II trial in 40 patients to test if ultrasound can safely enhance the clot-dissolving ability of t-PA (4/5)

ImaRx
Therapeutics
Inc.*

SonoLysis

Therapy that uses ultrasound to cavitate gas-filled microbubbles to dissolve blood clots

Peripheral arterial occlusive disease

Began a Phase I/II trial to evaluate safety and efficacy in 12 patients (4/12)

ImaRx
Therapeutics
Inc.*

SonoLysis

Therapy that uses ultrasound to cavitate gas-filled microbubbles to dissolve blood clots

For use in clotted dialysis grafts

Phase I/II trial in 22 dialysis patients showed no safety concerns, and improvements in the study's endpoints (4/1)

Medicure Inc.
(Canada; TSE:MPH)

MC-1

Small-molecule cardioprotective agent

For use in coronary artery bypass graft surgery

Monitors recommended continuation of the Phase II/III MEND-CABG trial following a safety review (4/19)

Northfield
Laboratories
Inc.
(NFLD)

PolyHeme

Oxygen-carrying blood substitute derived from human blood

Blood loss

Monitors recommended Phase III trial in treating hemorrhagic shock following traumatic injury continue, after third interim analysis involving 250 patients (4/11)

Nuvelo Inc.
(NUVO)

Alfimeprase

Modified fibrolase delivered via catheter; thrombolytic agent

Acute peripheral arterial occlusion

Began Phase III NAPA-2 trial in 300 patients to measure avoidance of open vascular surgery within 30 days of treatment (4/18)

CENTRAL NERVOUS SYSTEM

Alkermes Inc.
(ALKS)

Vivitrex

Long-acting, injectable form of naltrexone

Alcohol dependence

Phase III trial in 624 patients showed a statistically significant reduction in the rate of heavy drinking relative to placebo (4/5)

Avanir
Pharmaceuticals
Inc.
(AMEX:AVN)

Neurodex

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Pseudobulbar affect

Phase III trial in 150 multiple sclerosis patients with PBA showed improvements in several endpoints (4/14)

Ceregene
Inc.*

CERE-110

Gene therapy that uses AAV2-based vector to deliver nerve growth factor

Alzheimer's disease

Phase I trial in six patients showed the agent was tolerable, and reduced cognitive decline (4/25)

Guilford
Pharmaceuticals
Inc.
(GLFD)

Aquavan

Water-soluble prodrug of propofol

Sedation

Reached agreement with FDA on a revised clinical development plan; it intends to re-initiate previously planned studies (4/21)

Memory
Pharmaceuticals
Inc.
(MEMY)

MEM 1414 and MEM 1917

Phosphodiesterase-4 inhibitors

Alzheimer's disease and depression

Partner Hoffmann-La Roche Inc. decided not to pursue further development of the compounds, neither of which had gone past Phase I trials (4/15)

Neurochem
Inc.
(Canada;
NRMX)

Alzhemed

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

Alzheimer's disease

Monitors recommended continuation of Phase III trial after reviewing safety data from 562 patients (4/27)

Neurologix
Inc.
(OTC BB:NRGX)

--

GAD gene delivered by adeno-associated virus viral vector

Parkinson's disease

Update on Phase I trial showed no treatment-related adverse effects; 11 patients have been followed up to a year or more (4/22)

NovaDel
Pharma Inc.
(AMEX:NVD)

--

Lingual spray version of alprazolam, a drug sold by Pfizer Inc. as Xanax

Anxiety

Pilot pharmacokinetic trial demonstrated therapeutic ranges of the drug in the blood (4/27)

Pozen Inc.
(POZN) and
GlaxoSmithKline
plc (UK)

Trexima (MT400)

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

Migraine

Second of two pivotal Phase III trials achieved statistical significance for all regulatory endpoints; NDA submission is planned for 3Q:05 (4/21)

Sepracor
Inc.
(SEPR)

Lunesta
(FDA-approved)

Eszopiclone tablets

Insomnia

Second six-month, Phase IIIb/IV trial in 828 patients showed statistically significant improvements vs. placebo in various efficacy endpoints (4/11)

Somaxon
Pharmaceuticals
Inc.*

--

Low dose of the approved depression drug doxepin

Insomnia

Phase II trial in 71 elderly patients demonstrated efficacy in primary and all secondary endpoints (4/21)

Targacept
Inc.*

Ispronicline (TC-1734)

Agonist at neuronal nicotinic acetylcholine receptors

Memory impairment

Began a trial that will include 174 patients between 50 and 80 years of age (4/22)

XenoPort
Inc.*

XP13512

Transported prodrug of gabapentin (Pfizer Inc.'s Neurontin)

Post-herpetic neuralgia

Phase IIa trial in 101 patients showed a statistically significant reduction in pain vs. placebo (4/7)

DIABETES

ConjuChem
Inc.
(Canada;
TSE:CJC)

DAC:GLP-1

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

Type II diabetes

Additional data from 81 patients in Phase II trial showed reduced blood glucose levels; further trials will be run with a new dilutent (4/18)

INFECTION

Acambis plc
(UK; ACAM)

MVA3000

Modified vaccinia ankara attenuated smallpox vaccine

Smallpox infection

Phase I trial in 88 healthy subjects showed no serious adverse events (4/28)

Corus Pharma
Inc.*

Cayston (Corus 1020)

Aztreonam lysinate formulated for inhalation

P. aeruginosa infections in cystic fibrosis

Began AIR-CF2 Phase III trial to test safety and efficacy in cystic fibrosis patients (4/25)

Genzyme Corp.
(GENZ)

Tolevamer

Non-antibiotic polymer therapy

C. difficile- associated diarrhea

Began a Phase III trial that will compare the drug to vancomycin in more than 1,000 patients (4/4)

GenVec Inc.
(GNVC)

--

Adenovector vaccine containing three HIV antigens

HIV

Phase I trials in 36 healthy volunteers showed the vaccine was well tolerated and immunogenic at each dose level (4/15)

Gilead Sciences
Inc.
(GILD)

Truvada (FDA-approved)

Combination of the approved drugs Emtriva and Viread

HIV

Study of drug plus Bristol-Myers Squibb Co.'s Sustiva failed to demonstrate bioequivalence; new formulations are being tested (4/26)

Human Genome
Sciences Inc.
(HGSI)

Albuferon

Long-acting form of interferon alpha that uses the company's albumin fusion technology

Hepatitis C

Phase II trial showed the drug was well tolerated, had a prolonged half-life and showed antiviral activity, with durable dose-dependent reductions in viral load (4/14)

Idenix
Pharmaceuticals
Inc.
(IDIX)

NM283

Valopicitabine; oral nucleoside analogue

Hepatitis C

Phase IIa data from nine patients taking drug and pegylated interferon showed a 99.99% reduction in viral load at 24 weeks (4/14)

Metabasis
Therapeutics
Inc.
(MBRX)

Pradefovir (formerly remofovir)

Prodrug of the approved HBV drug adefovir (Gilead Sciences Inc.'s Hepsera)

Hepatitis B

Partner Valeant Pharmaceuticals Inc. presented data on 40 patients showing drug was well tolerated and associated with reductions in serum HBV DNA (4/22)

MedImmune
Inc.
(MEDI)

--

Intranasal vaccine using an attenuated parainfluenza virus type-3

Respiratory syncytial virus

Began Phase I trial to evaluate safety, tolerability and immunogenicity in 120 healthy adults (4/15)

Osel Inc.*

Lactin-V

Vaginal capsule containing a natural human bacterial organism vaginosis

Urinary tract infection and bacterial

Began Phase II trials in the recurrent form of each indication (4/12)

Theravance
Inc.
(THRX)

Telavancin

Lipoglycopeptide antibiotic believed to have multiple mechanisms of action

Infections

Presented data from Phase I trials that showed positive pharmacokinetics (4/7)

Vical Inc.
(VICL)

--

Two formulations of the company's vaccine against cytomegalovirus

Cytomegalovirus infection

Phase I trials of the bivalent and trivalent formulations demonstrated safety; a Phase II trial of the bivalent formulation is being planned (4/27)

Vical Inc.
(VICL)

--

Vaccine encoding two surface proteins of the West Nile virus

West Nile virus

The National Institutes of Health began a trial to evaluate safety and immune responses in 15 healthy volunteers (4/19)

MISCELLANEOUS

Ardana plc (UK;
LSE:ARA) and
AEterna Zentaris
Inc.
(Canada; AEZS)

EP-1572

Orally available peptidomimetic; growth hormone secretagogue

Growth hormone and other disorders

Phase I trial in 36 male volunteers showed the drug induced a significant rise in growth hormone levels (4/19)

BioMarin
Pharmaceutical
Inc.
(BMRN)

Phenoptin

Sapropterin hydrochloride; form of the enzyme co-factor 6R-BH4

Phenylketonuria

Began a Phase III trial to assess safety and reductions in blood Phe levels in 100 patients (4/7)

CollaGenex
Pharmaceuticals
Inc.
(CGPI)

COL-3

Second-generation agent from the company's inhibitors of multiple proteases and cytokines program

Rosacea

Phase II trial in 13 patients showed those treated with drug had significantly fewer inflammatory lesions than those on placebo (4/15)

Discovery
Laboratories
Inc.
(DSCO)

Surfaxin

Engineered version of natural human lung surfactant

Respiratory distress syndrome in premature babies

Published data from Phase III SELECT and STAR trials showed drug provides potential advantages to existing surfactant therapy (4/4)

DOR BioPharma
Inc.
(AMEX:DOR)

orBec

Oral formulation of beclomethasone dipropionate; a corticosteroid

Graft-vs.-host disease

Said it intends to file an NDA; Phase III data released in December showed a missed primary endpoint but efficacy on secondary endpoints (4/20)

Evolutec
Group plc
(UK; AIM:EVC)

rEV131

Histamine-binding protein

Allergic rhinitis

Is starting a Phase II trial in 80 patients to assess improvement in nasal symptoms vs. placebo (4/18)

Genzyme
Corp.
(GENZ)

Myozyme

Recombinant human acid alpha-lucosidase enzyme

Pompe disease

Interim analysis in pivotal trial in 18 patients showed likelihood of meeting primary endpoint; a BLA filing is planned for mid-2005 (4/25)

Hemispherx
Biopharma
Inc.
(AMEX:HEB)

Ampligen

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

Chronic fatigue syndrome

Presented data from trials showing drug improved exercise duration vs. both approved drugs and placebo (4/11)

Insmed Inc.
(INSM)

SomatoKine

Composition of insulin-like growth factor-1 and its primary binding protein, BP3

HIV-associated lipodystrophy

Began a Phase II trial to evaluate safety and efficacy for 12 weeks in 12 patients (4/20)

Inspire
Pharmaceuticals
Inc.
(ISPH)

INS37217 Ophthalmic

Denufosol tetrasodium; P2Y2 receptor agonist

Macular edema and retinal detachment

Phase II trial in retinal detachment is being stopped due to slow enrollment; pilot Phase II trials in macular edema are being planned (4/27)

Inspire
Pharmaceuticals
Inc.
(ISPH)

Diquafosol tetrasodium

Ophthalmic solution; P2Y2 receptor agonist

Corneal wound healing

Began pilot trial to test drug vs. placebo in 30 patients following photorefractive keratectomy (4/27)

Karo Bio
AB
(Sweden;
SSE:KARO)

--

Estrogen receptor compound

Various conditions

Partner Merck & Co. Inc. stopped a Phase I trial of the lead drug from their collaboration after adverse findings in ongoing animal studies (4/11)

Neurochem
Inc.
(Canada;
NRMX)

Fibrillex

Glycosaminoglycan mimetic with anti-amyloid properties

Amyloid A amyloidosis

Phase II/III trial in 183 patients showed improved kidney function measurements and death vs. placebo, but failed to reach statistical significance (4/18)

NPS
Pharmaceuticals
Inc.
(NPSP)

Preos

Recombinant human parathyroid hormone

Osteoporosis

Two analyses of Phase III TOP trial data corroborate earlier data showing improved bone microarchitecture and reduced vertebral fractures in high-risk postmenopausal osteoporotic women (4/7)

Omeros Corp.*

OMS103HP

Targeted therapeutic agent delivered directly to a surgical site

Improvement in knee function

Began Phase III trial to test drug in 900 patients undergoing arthroroscopic anterior cruciate ligament reconstruction (4/12)

Osiris
Therapeutics
Inc.*

Chondrogene

Formulation of adult mesenchymal stem cells

Regeneration of meniscus tissue

Began Phase I/II trial to evaluate safety and efficacy in 48 knee surgery patients (4/1)

Palatin Technologies
Inc.
(AMEX:PTN)

PT-141

Intranasally delivered melanocortin agonist

Erectile dysfunction

Trial with Viagra in 19 patients showed enhanced duration and quality of erectile activity vs. Viagra monotherapy (4/18)

PTC
Therapeutics
Inc.*

PTC124

Oral agent that targets nonsense mutations

Various disorders

Phase I trial showed target plasma concentrations were achieved and no drug-related adverse events were seen (4/11)

Rigel
Pharmaceuticals
Inc.
(RIGL)

R112

Intranasal agent designed to interrupt the signal from the IgE receptor

Allergic rhinitis

Phase II trial showed patients in a park-like setting had significant improvements in symptoms, and confirmed tolerability and safety (4/6)

Vivus Inc.
(VVUS)

Avanafil (TA-1790)

Oral phosphodiesterase type-5 inhibitor

Erectile dysfunction

Trial to test hemodynamic responses to glyceryl trinitrate showed drug compared favorably to Viagra (4/25)


Notes:

* Privately held.

BLA = Biologics license application; EMEA = European Medicines Agency; FDA = Food and Drug Administration; IND = Investigational new drug application; MAA = Marketing authorization application; NDA = New drug application; SPA = Special protocol assessment.

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

AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange.