Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Basilea
Pharmaceutica
Ltd.
(Switzerland;
SWX:BSLN)

Alitretinoin

Naturally occurring vitamin A derivative

Severe, chronic hand eczema

Phase III data showed that patients can benefit from retreatment with the drug (4/25)

Cerimon
Pharmaceuticals
Inc.*

Simulect (FDA-approved)

Basiliximab; a monoclonal antibody designed to block the IL- receptor

Ulcerative colitis

Started enrolling patients in a Phase IIb study (4/4)

Merrimack
Pharmaceuticals
Inc.*

MM-093

An immunomodulator; a recombinant version of human alpha-fetaprotein

Rheumatoid arthritis

Started a Phase II study (4/17)

Senetek plc
(OTC BB:SNTKY)

PRK 124

Pyratine 6 compound

Acne rosacea

Started trials after a prior study showed it was well tolerated and exhibited reductions in erythema (4/11)

CANCER

Advaxis Inc.
(OTC BB:ADXS)

Lovaxin C

A modified Listeria- based live vaccine

Advanced, recurrent or progressive cervical cancer

Completed enrollment and dosing of the third cohort of patients in a Phase I/II trial (4/17)

Alchemia Ltd.
(Australia; ASX:ACL)

HyCAMP

Formulation of the anticancer drug irinotecan

Metastatic colorectal cancer

Phase II data showed the patients were able to receive more doses than regular irinotecan and median progression-free survival for HyCAMP patients was 5.2 months, compared to 2.4 months for the irinotecan arm (4/26)

Ambit
Biosciences
Corp.*

AC220

Designed to inhibit FLT3, a kinase that is mutated in about one-third of AML cases

Acute myeloid leukemia

Dosed the first patients in a Phase I trial that will enroll between 20 and 40 patients (4/10)

Ambrilia
Biopharma Inc.
(Canada; TSX:AMB)

PCK3145

Synthetic peptide analogue of prostate secretory protein

Metastatic prostate cancer

Phase I/II data showed evidence of clinical activity (4/24)

Amgen Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa; red-blood cell booster

Anemia in patients with active cancer

Phase III data showed that transfusion occurrences from weeks five to 17 favored Aranesp but were not statistically significant between the groups (4/13)

Amgen Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa; red blood cell booster

Extensive-stage small-cell lung cancer receiving platinum-containing chemotherapy

Top-line Phase III data showed it did not raise safety concerns (4/19)

Antigenics
Inc.
(AGEN)

Oncophage

Vitespen; cancer vaccine

High-grade glioma

Updated Phase I/II data indicated the drug was associated with significant tumor-specific immune responses in all 12 patients treated (4/16)

Array
BioPharma Inc.
(ARRY)

ARRY-704

A selective, orally active MEK inhibitor aimed at blockingsignal transduction pathways

Cancer

Dosed the first patient in a Phase I trial (4/12)

Ariad
Pharmaceuticals
Inc.
(ARIA)

AP32573

mTOR inhibitor

Metastatic sarcomas

Company changed the planned primary endpoint for an upcoming Phase III trial, from progression-free survival to overall survival (4/6)

AVAX
Technologies
Inc.
(OTC BB:AVXT)

M-Vax

Autologous vaccine

Metastatic melanoma

Phase I/II data confirm that immunological responses induced by M-Vax were similar to those observed with an earlier version of the product (4/16)

BioDelivery
Sciences
International
Inc.
(BDSI)

BEMA Fentanyl

Polymer fentanyl disc that adheres to the inner lining of the cheek, where it dissolves in about 30 minutes

Breakthrough cancer pain

In a Phase III trial, the drug hit the primary endpoint, Summary of Pain Intensity Difference at 30 minutes, compared to placebo (4/25)

Bionovo Inc.
(OTC BB:BNVI)

BZL101

An oral drug designed to induce cancer cell apoptosis

Cancer

Started a Phase I/II trial (4/18)

Celgene Corp.
(CELG)

Revlimid (FDA-approved)

Lenalidomide

Multiple myeloma

Preliminary results of Revlimid in combination with low-dose dexamethasone suggests a survival advantage over patients receiving Revlimid plus the higher, standard-dose of dexamethasone (4/4)

Cell Genesys
Inc.
(CEGE)

GVAX

Immunotherapy

Prostate cancer

Final Phase II data showed a follow-up of 22 patients with metastatic hormone-refractory disease indicated a median survival of 35 months (4/3)

Cell
Therapeutics
Inc.
(CTIC)

Xyotax

A biologicall enhanced version of Taxol

Advanced non-small-cell lung cancer

Xyotax qualifies for fast-track designation to treat PS2 women with first-line, advanced cancer (4/11)

ChemGenex
Pharmaceuticals
Ltd.
(Australia;
CXSP)

Ceflatonin

Homoharringtonine or HHT

Chronic myeloid leukemia

Began a new Phase II/III trial in patients who have failed or are intolerant to treatment with two or more prior tyrosine kinase inhibitors (4/3)

Cleveland
BioLabs Inc.
(CBLI)

Curaxin CBLC102

Oral agent that targets p53 and NF-kB

Advanced, hormone- refractory prostate cancer

The Phase II efficacy trial progressed to the next phase; it will start with 15 patients and will add 13 more once a PSA response is achieved in at least one patient (4/5)

Coley
Pharmaceutical
Group Inc.
(COLY)
and Pfizer Inc.

PF-3512676

Toll-like receptor 9 agonist drug candidate

Advanced non-small-cell lung cancer

Completed patient enrollment in two pivotal Phase III trials (4/10)

Cougar
Biotechnology
Inc.*

CB7630

Abiraterone acetate; oral, irreversible CYP450c17 enzyme inhibitor

Prostate cancer

Phase I/II data showed inhibition of androgen synthesis resulted in a high response rate in castration-refractory prostate cancer (4/17)

Expression
Genetics Inc.*

EGEN-001

Composed of interleukin-12 gene expression plasmid forulated with abiocompatible delivery polymer; uses the TeraPlas delivery technology

Advanced-stage, recurrent ovarian cancer

Completed a Phase I study, showing the treatment was well- tolerated with no apparent dose-related trends (4/16)

Genentech Inc.
(NYSE:DNA), OSI
Pharmaceuticals
Inc.
(OSIP) and
F. Hoffmann-La
Roche Ltd.
(Switzerland)

Tarceva (FDA-approved)

Erlotinib; small-molecule HER1/EGFR inhibitor

Advanced pancreatic cancer

Study results show a 22% improvement in survival when Tarceva is added to gemcitabine chemotherapy (4/25)

Genmab A/S
(Denmark;
CSE:GEN)

HuMax-EGFr

Zalutumumab; human antibody that targets the epidermal growth factor receptor

Non-small-cell lung cancer

Started a Phase II study of HuMax-EGFr in combination with chemo-radiation (4/13)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium injection; aimed at blocking the production of Bcl-2

Advanced melanoma

Company said it will conduct a new randomized Phase III trial (4/18)

Human Genome
Sciences Inc.
(HGSI)

HGS-ETR1

Mapatumumab; agonistic human monoclonal antibody to TRAIL receptor

Advanced solid malignancies

Phase I data showed the drug could be administered safely and repetitively to 49 patients with advanced solid malignancies (4/27)

ImClone
Systems Inc.
(IMCL)

Erbitux (FDA-approved)

Cetuximab; monoclonal antibody that inhibits the epidermal growth factor receptor

Pancreatic cancer

Missed the primary endpoint, failing to improve overall survival to a statistically significant degree in a Phase III trial (4/10)

ImClone
Systems Inc.
(IMCL)

Erbitux (FDA-approved)

Cetuximab; monoclonal antibody that inhibits the epidermal growth factor receptor

Metastatic colorectal cancer

Open-label Phase III study comparing Erbitux plus irinotecan to irinotecan alone in patients who failed first-line therapy showed that progression-free survival and response rate were significantly higher in the Erbitux-treated group; the trial missed the primary endpoint, however (4/16)

Innovive
Pharmaceuticals
Inc.
(OTC BB:IVPH)

INNO-406

An oral dual Bcr-Abl and Lyn-kinase inhibitor

Gleevec-resistant or intolerant chronic myelogenous leukemia

Phase I data showed the drug was well tolerated at doses up to 240 mg twice-daily (4/16); data showed clinical activity, a 55-fold reduction in Bcr-Abl transcript levels (4/17)

Introgen
Therapeutics
Inc.
(INGN)

Advexin

Adenoviral vector containing the p53 tumor suppressor gene

Recurrent head and neck cancer

Phase II data showed that abnormal p53 correlated with increased survival and tumor responses following Advexin treatment (4/16); started the efficacy analyses of its Advexin Phase III study (4/24)

Introgen
Therapeutics
Inc.
(INGN)

INGN 401

Intravenously administered lipid nanoparticle product candidate

Stage IV lung cancer

In a Phase I trial, the gene FUS1 delivered via INGN-401 had cancer-suppressing activity in metastatic non-small-cell lung cancer tumors (4/18)

Kosan
Biosciences
Inc.
(KOSN)

KOS-953

Tanespimycin, Hsp90 inhibitor

Multiple myeloma

Phase I data showed no effect on QTc interval in more than 85 patients, indicating that two prior cases were not related to drug treatment (4/16)

MediGene AG
(Germany;
FSE:MDG)

EndoTAG-1

A combination of paclitaxel and a delivery system made up of cationic lipids; designed to specifically destroy the blood vessels of tumors

Breast cancer; pancreatic cancer

Started a Phase II trial (4/13); Completed recruitment of 200 patients for a Phase II trial (4/25)

NeoPharm Inc.
(NEOL)

LE-SN38

Liposomal formulation of the active metabolite of irinotecan

Colorectal cancer

Phase II interim analysis showed a failure to meet the primary endpoint of tumor response (4/2)

Nereus
Pharmaceuticals
Inc.*

NPI-0052

Second-generation proteasome inhibitor

Multiple myeloma

Enrolled the first patient in a Phase I trial (4/16)

OncoGenex
Technologies
Inc.*

OGX-011

Second-generation anti-sense drug designed to inhibit the production of clusterin, a cell-survival protein

Metastatic breast cancer

Phase II data of OGX-011 in combination with docetaxel showed a partial response in five of 15 patients and disease stabilization in nine patients (4/17)

Oncolytics
Biotech Inc.
(Canada; ONCY;
TSX:ONC)

Reolysin

Intravenous formulation of the human reovirus that targets the activated Ras pathway

Bone or soft tissue sarcomas

Started a Phase II, open-label, single-agent cancer trial involving patients whose cancer has metastasized to the lung (4/11)

Pharmion Corp. (PHRM)

Vidaza

Azacitidine, oral; DNA demethylating agent

Myelodysplastic syndromes, acute myeloid leukemia and malignant solid tumors

The open-label Phase I study was completed; company is starting a multidose Phase I trial (4/23)

Progen
Pharmaceuticals
Ltd.
(Australia;
PGLA)

PI-88

Anti-angiogenesis drug also designed to inhibit tumor-promoting factors

Liver cancer

Phase II data showed PI-88 demonstrated an improvement in disease-free rate, the primary endpoint, of 25% and a prolong- ation in the time to tumor recurrence from 27 to 48 weeks (4/16)

Provectus
Pharmaceuticals
Inc.
(OTC
BB:PVCT)

Provecta

Agent designed to be retained in tumor cells while leaving normal estrogen tissue unharmed

Stage III/IV metastatic melanoma

Completed dosing in the final patient enrolled in its Phase I study (4/24)

Spectrum
Pharmaceuticals
Inc.
(SPPI)

EOquin

Apaziquone for intravesical instillation; activated by reductase enzymes found in cancer cells

Noninvasive bladder cancer

Phase IIb data showed it was well tolerated and not systemically absorbed (4/19)

SuperGen Inc.
(SUPG)

MP470

Oral, multitargeted tyrosine kinase inhibitor

Advanced stage solid tumor cancers

Company is beginning a Phase I trial in up to 30 patients (4/27)

Telik Inc.
(TELK)

Telcyta

Cell-activated chemo drug designed to exploit the overexpression of gluta- thione S-transferase P1-1

Non-small-cell lung cancer

Phase II data showed statistically significant improvements in progression-free survival and overall survival in patients who got Telcyta maintenance therapy compared with those who didn't (4/17)

Threshold
Pharmaceuticals
Inc.
(THLD)

Glufosfamide

Small molecule targeting abnormal glucose metabolism

Soft-tissue sarcoma

Started patient enrollment in a Phase II trial (4/9)

Viventia
Biotech Inc.*
(Canada)

Vicinium

Armed antibody administered using intravesical instillation

Locally persistent non- invasive bladder cancer

Began patient treatment in an open-label Phase II trial that will enroll about 30 patients (4/3)

CARDIOVASCULAR

Aastrom
Biosciences Inc.
(ASTM)

Tissue
Repair Cells

Consists of a mixture of stem and progenitor cell populations, produced from a small amount of bone marrow taken from the patient

Peripheral arterial disease

Started a Phase IIb trial (4/30)

Anthera
Pharmaceuticals
Inc.*

A-002

An inhibitor of secretory phospholipase A2

Stable coronary artery disease

Started enrolling patients in a Phase II trial (4/13)

Cytokinetics
Inc.
(CYTK)

CK-1827452

A cardiac myosin activator

Acutely decompensated or chronic heart failure

Started a Phase II program (4/12)

Dyax Corp.
(DYAX)

DX-88

Recombinant small protein designed to inhibit human plasma kallikrein; ecallantide

Hereditary angioedema

Phase III data showed it hit the primary and secondary end- points (4/13); started patient treatment in a Phase III confirmatory study (4/17)

Genzyme Corp.
(GENZ)

Renvela

Sevelamer carbonate

Hyperphosphatemia in chronic kidney disease

A single-arm, open-label trial involving 49 patients demon- strated a statistically significant reduction in serum phosphorus (4/16)

Icagen Inc.
(ICGN) and
McNeil Pediatrics
Division of McNeil-
PPC Inc.

ICA-17043

Senicapoc; an ion channel modulator

Sickle cell disease

Company is stopping the Phase III ASSERT trial due to a low probability of achieving a reduction in crisis rate, the primary end- point(4/4)

Liponex Inc.*
(Canada)

CRD5

Agent designed to increase HDL (good cholesterol) levels

Dyslipidemia

Phase I/II data indicated that all blood chemistry and blood pres- sure measurements were within normal or expected ranges and the drug was shown to be safe (4/12)

Rigel
Pharmaceuticals
Inc.
(RIGL)

R788

Oral syk kinase inhibitor

Immune thrombocytopenic purpura

Company is expanding a Phase II trial based on encouraging preliminary drug activity; also, it began enrolling patients in an open-label Phase II B-cell lymphoma trial (4/11)

Stem Cell
Therapeutics
Corp.
(Canada;
CDNX:SSS)

NTx-265

Technology designed to increase the growth of innate adult stem cells

Acute stroke

Phase IIa data showed four of five subjects safely completed a regimen initiated 24 to 48 hours after stroke with no drug-related serious adverse events, while showing substantial recovery (4/10)

Theravance
Inc.
(THRX) and
GlaxoSmithKline
plc (UK)

GSK642444
and
GSK159797

Long-acting beta2 agonist compounds

Asthma and chronic obstructive pulmonary disease

Phase IIb data showed clinically significant increases in bronchodilation at least equivalent to salmeterol given twice daily (4/3)

CENTRAL NERVOUS SYSTEM

Addex Pharma SA*(Switzerland)

ADX48621

A negative allosteric modulator of the metabotropic glutamate

Generalized anxiety disorder and

receptor 5 inflammatory pain

Began a Phase I trial (4/11)**

Addex
Pharma SA*
(Switzerland)

ADX10059

A selective, negative allosteric modulator of metabotropic glutamate receptor 5

Migraine

Completed a Phase IIa trial with 129 patients; it achieved its pri- mary objective, a statistically significant absence of pain at two hours after dosing (4/20)

Ceregene Inc.*

CERE-120

A gene therapy product consisting of an adeno- associated virus vector carrying the gene for neurturin

Parkinson's disease

Enrollment is under way in a Phase II trial (4/13)

BioMS Medical
Corp.
(Canada;
TSX:MS)

MBP8298

Synthetic peptide

Secondary, progressive multiple sclerosis

A monitoring board recommended continuation of the pivotal Phase II/III trial (4/5)

Ceregene Inc.*

CERE-120

Gene therapy product that delivers the neurturin gene via an adeno-associated virus Type II vector

Parkinson's disease

Phase I data showed the treatment was well tolerated and patients demonstrated a 36% reduction in Parkinson's symptoms at 12 months (4/16)

EpiCept Corp.
(EPCT)

EpiCept NP-1

A topical prescription analgesic cream

Peripheral neuropathies

Started two Phase IIb trials (4/10)

EPIX
Pharmaceuticals
Inc.
(EPIX)

PRX-07034

A 5-HT6 antagonist

Obesity, Alzheimer's disease and cognitive impairment

Phase Ib data showed PRX-07034 was well tolerated up to 600 mg once per day, with no dose-limiting toxicity identified and no serious adverse events (4/18)

Hunter-Fleming
Ltd.*
(UK)

HF0220

Cell-protective, naturally occurring human steroid

Mild to moderate Alzheimer's disease

Enrolled the first patients into a Phase IIa biomarker study (4/11)**

Inflazyme
Pharmaceuticals
Ltd.
(Canada;
TSX:IZP) and
Helicon Thera-
peutics Inc.*

IPL455,903

PDE-4 inhibitor

Age-associated memory impairment

Helicon reported unfavorable efficacy data from a Phase IIa trial; the drug showed safety and tolerability, but not significant positive effects on memory and learning (4/9)

Kalypsys Inc.*

KD7040

A topical inducible nitric oxide synthase inhibitor

Neuropathic pain

Started a second Phase I trial (4/16)

Memory
Pharmaceuticals
Corp.
(MEMY)

MEM 1003

A neuronal L-type calcium channel modulator

Alzheimer's disease

Completed enrollment in a Phase IIa trial (4/6)

Opexa
Therapeutics
Inc.
(OPXA)

Tovaxin

T-cell vaccine

Multiple sclerosis

Top-line data from an open-label Phase I/II dose-escalation trial showed the therapy was safe and produced a 90% reduction in annualized relapse rates (4/3)

Pharmos Corp.(PARS)

Cannabinor

Intravenous cannabinoid; synthetic CB2- elective agonist

Postoperative pain

Phase IIa data showed it produced a statistically significant decrease in pain vs. placebo when administered at the lowest dose of 12 mg (4/24)

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

Trexima

A migraine-specific tablet designed to treat inflammation and vasodilation

Headaches

Two efficacy studies of more than 2,900 migraine sufferers demon- strated that Trexima provided superior headache relief at two hours and four hours compared to placebo, and 2- through 24-hour sustained pain-free results vs. sumatriptan or naproxen monotherapy (4/4)

Valeant
Pharmaceuticals
International
(NYSE:VRX)

Retigabine

First-in-class neuronal potassium channel opener

Epilepsy

Phase II data showed it was efficacious with a demonstrated reduction in monthly seizure rates (4/11)

DIABETES

Alimera Sciences
Inc.*
and
pSivida Ltd.
(Australia; PSDV)

Medidur

A tiny, injectable intravitreal insert that delivers a low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years

Diabetic macular edema

Enrollment for the Phase III global trial has exceeded 50% (4/23)

Avanir
Pharmaceuticals
Inc.
(AVNR)

Zenvia

A combination of dextro-methorphan and the enzyme inhibitor quinidine

Diabetic neuropathic pain

Phase III data showed it met the primary endpoint of pain reduction(4/18)

Metabasis
Therapeutics
Inc.
(MBRX)

MB07803

Second member of a new class that inhibits a metabolic pathway in the liver called gluconeogenesis

Type II diabetes

Started a Phase IIa trial (4/4)

Pharmacopeia
Drug Discovery
Inc.
(PCOP)

PS433540

A dual-acting angiotensin and endothelin receptor antagonist

Hypertension and diabetic nephropathy

Phase I data showed the drug was well tolerated at all six doses administered (4/10)

XOMA Ltd.
(XOMA)

XOMA 052

An anti-inflammatory monoclonal antibody targeting interleukin 1-beta

Type II diabetes

Plans to start two Phase I trials (4/12)

INFECTION

Achillion
Pharmaceuticals
Inc.
(ACHN)

ACH-806

NS4A antagonist

Hepatitis C virus

Data validates the clinical activity of ACH-806 (4/16)

AlphaVax Inc.*

Human version of an alphavaccine; and a flu alphavaccine that contains the hemag- glutinin gene from a single flu strain

Cytomegalo- virus and influenza

Began immunizing volunteers in trials (4/11)

Arpida Ltd.
(Switzerland;
SWX:ARPN)

AR-709

A DHFR inhibitor administerred as radiolabeled microdoses pneumoniae

Streptococci and multidrug- resistant Streptococcus

Arpida said the microdoses achieved good distribution within the lungs in a first-in-man study (4/4)**

Astellas
Pharma
(Japan;
FSE:YPH) and
Theravance Inc.
(THRX)

Telavancin infections

Lipoglycopeptide; bactericidal injectable antibiotic

Complicated skin and skin structure

Two Phase III trials showed telavancin compared favorably to standard therapy (4/2)

Astellas
Pharma
(Japan;
FSE:YPH)

Mycamine

Micafungin sodium

Candida infections

Mycamine compared favorably to standard therapy and provided significant safety advantages (4/2)

Helix
BioPharma
Corp.
(Canada;
TSX:HBP)

Topical interferon alpha-2b

Human papillomavirus

Treatment caused abnormal Pap smears to revert to normal for 46.7% of women in a Phase II trial (4/2)

Human Genome
Sciences Inc.
(HGSI)

Albuferon

Albinterferon alfa-2b; long- acting form of interferon alpha, created with albumin fusion technology

Genotype 1 chronic hepatitis C virus

Phase IIb data of Albuferon in combination with ribavirin in patients naive to interferon alpha-based treatment regimens showed it provided at least comparable efficacy to Pegasys. with a 59% rate of sustained virologic response at 12 weeks vs.54% for Pegasys (4/16)

Idenix
Pharmaceuticals
Inc.
(IDIX)

Valopicitabine

An HCV RNA polymerase inhibitor

Hepatitis C virus

Phase IIb data of valopicitabine in combination with pegylated interferon alfa-2a showed that 53% of treatment-naive patients achieved undetectable HCV levels; a second study showed the end- f treatment sustained viral response rates and post- treatment SVR rates were comparable for treatment- experienced patients (4/12)

Idenix
Pharmaceuticals
Inc.
(IDIX) and
Novartis AG
(Switzerland)

Sebivo

Telbivudine; once-a-day tablet

Hepatitis B virus

Results from a comparative study showed Sebivo provided more rapid and profound viral suppression than adefovir (4/13)

Immtech
Pharmaceuticals
Inc.
(AMEX:IMM)

DB289

Pafuramidine maleate; oral agent

Uncomplicated malaria caused by Plasmodium Falciparum

Started a Phase IIb trial (4/9)

Intarcia
Therapeutics
Inc.*

Omega interferon

Recombinant, glycosylated human type-1 interferon

Hepatitis C virus

Phase II data showed the combination of omega interferon with ribavirin was well tolerated and had robust antiviral activity (4/13)

Iomai Corp.
(IOMI)

Vaccine that uses heat labile toxin produced by E. coli

Travelers' diarrhea

Phase II data showed the vaccine produced positive results even at the lowest dose tested (4/26)

LigoCyte
Pharmaceuticals
Inc.*

Intranasally-delivered, dry powder vaccine based upon virus-like particles

Norovirus

Started a Phase I trial (4/3)

MacroChem
Corp.
(OTC BB:
MACM)

EcoNail

A topical antifungal lacquer; contains econazole and MacroChem's enhancer SEPA

Onychomycosis

Completed enrollment in a 40-patient, open-label Phase II study (4/11)

NanoBio Corp.*

NB-002

Topical treatment

Onychomycosis

Began enrolling patients in a Phase II trial designed to enroll about 1,000 patients (4/3)

Nautilus
Biotech*
(France)

Belerofon

Long-lasting human interferon alpha; subcutaneous

Chronic hepatitis C virus

Started a Phase I trial (4/2)

Novagali Pharma
SA*
(France)

Vekacia

A topical cyclosporine A cationic emulsion

Vernal kerato-conjunctivitis

Phase III data showed that both symptoms and signs of disease improved in patients taking Vekacia (4/4)

Orchestra Therapeutics Inc.|(formerly The
Immune Response
Corp.; IMNR)

Remune and

IR103

HIV-1 immunogen; and HIV-1 immunogen with Amplivax

HIV

Company is terminating the Phase II programs and looking for strategic alternatives for them (4/4)

Pharmexa-
Epimmune
(unit
of Pharmexa A/S;
Denmark; CSE:
PHARMX) and
Bavarian Nordic
A/S
(Denmark;
CSE:BAVA)

EP1233 and MVA-BN Polytope

HIV vaccine and multi- valent vaccine vector

HIV

Started Phase I testing (4/30)

Vertex
Pharmaceuticals
Inc.
(VRTX)

VX-950

Protease inhibitor telaprevir

Hepatitis C virus

Data from the first trial of VX-950 in combination with pegylated interferon and ribavirin showed a high rate of rapid viral response and a low rate of on-treatment viral breakthrough (4/16)

ViroPharma Inc.
(VPHM)

HCV-796

An oral HCV polymerase inhibitor

Hepatitis C virus

Phase Ib data of HCV-796 with pegylated interferon alfa-2b demonstrated additive antiviral effects of the drug across multiple genotypes of HCV infection (4/13)

MISCELLANEOUS

Addex
Pharmaceuticals
SA
(Switzerland)

ADX10059

A selective mGluR5 negative allosteric modulator

Gastroesophageal reflux disease

Phase IIa data showed the compound met its primary endpoint and showed statistically significant improvements in many of the secondary measures (4/17)

Adolor Corp.
(ADLR)

Entereg

A peripherally acting mu-opioid receptor antagonist; alvimopan

Opioid-induced constipation

Top-line Phase III data showed an increased risk of serious cardiovascular events in patients receiving Entereg compared to placebo (4/10)

Advanced
Magnetics Inc.
(FSE:AMU)

Ferumoxytol

Intravenous iron replacement therapy

To replace iron

Reported positive results from two additional Phase III trials; it met all primary and secondary endpoints in the first study and showed treatment- elated adverse events in 5.2% of patients receiving ferumoxytol and 4.2% of those receiving placebo (4/12)

AEterna
Zentaris Inc.
(Canada; AEZS)

Cetrorelix antagonist

A luteinizing hormone- releasing hormone

Benign prostatic hyperplasia

Began the first Phase III study (4/19)

Affymax Inc.*

Hematide

Synthetic, peptide-based erythropoiesi stimulating agent

For dialysis patients

Phase II data showed that mean hemoglobin levels can be main- tained at clinically acceptable levels following a switch to Hematide dosed monthly from three-times-weekly epoetin alfa (4/12)

Allergy
Therapeutics
plc
(UK;
PK:AGYTF)

Pollinex Quattro adjuvant

Short course hay fever vaccine with TLR4- gonist

Ragweed allergy

Began dosing in the pivotal Phase III trial (4/4)**

Amarin Corp.
plc
(UK; AMRN)

Miraxion

Compound that inhibits certain enzymes, including phospholipases and caspases

Huntington's disease

Drug failed to hit primary and secondary endpoints in two Phase III studies (4/24)

Antares Pharma
Inc.
(AMEX:AIS)

Anturol

Oxybutynin ATD transdermal gel

Overactive bladder

Study results showed it was absorbed on a bioequivalent basis after a single dose (4/19)

CoMentis Inc.*

ATG3

A topical eye drop therapy; formulation of mecamylamine; an antagonist of of the nicotinic acetylcholine receptor pathway

Neovascular age-related macular degeneration

Started a Phase II trial (4/10)

Eurand
International
SpA*
(Italy)

Zentase (formerly EUR-1008)

A porcine-derived pancreatic enzyme replacement therapy

Exocrine pancreatic insufficiency

Phase III data showed two trials met all primary and secondary endpoints (4/4)

GTx Inc.
(GTXI)

Ostarine

Selective androgen receptor modulator

Chronic kidney disease muscle wasting

Phase II data revealed that insulin and glucose levels were reduced and insulin resistance was improved among subjects receiving the 3 mg dose compared to baseline (4/17)

Lexicon
Genetics Inc.
(LEXG)

LX1031

Designed to act locally in the gastrointestinal tract by reducing the serotonin available for receptor activation

Irritable bowel syndrome

Started a Phase Ib trial with 40 healthy volunteers (4/24)

Neurotech
Pharmaceuticals
Inc.*

NT-501

Encapsulated Cell Technology product

Retinitis pigmentosa

Started enrollment in Phase II/III trials in visual loss associated with retinitis pigmentosa (4/17)

NicOx SA
(France; FSE:NXO)

Naproxcinod

From the COX-inhibiting nitric oxide-donating class

Osteoarthritis of the knee

Started the second pivotal Phase III trial, which will enroll 1,020 patients (4/3)

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Investigational agent for BPH

Benign prostatic hyperplasia

Completed a 42-month follow-up study, which evaluated symptomatic progress of patients involved in the company's two Phase I/II studies (4/18)

Obecure Ltd.*
(Israel)

OBE101

Candidate comprised of betahistamine

Obesity

Completed enrollment for a Phase II trial with 281 patients (4/11)

Osteologix Inc.
(OLGX)

NB S101

Once-daily tablet containing strontium malonate as its active ingredient

Osteoporosis

Completed enrollment in its Phase II study with 289 post- menopausal women with low bone mineral density (4/18)

Protalix
BioTherapeutics
Inc.*

prGCD

A plant cell-expressed recombinant form of human glycocerebrosidase

Gaucher's disease

Plans to start a Phase III trial (4/18)

Repros
Therapeutics
Inc.
(RPRX)

Proellex

Oral agent designed to block progesterone without blocking adrenal hormones

Uterine fibroids

Phase II data suggested that treatment resulted in a statistically significant improvement in symptoms associated with uterine fibroids and is generally well tolerated (4/3)

Resistentia
Pharmaceuticals
AB*
(Sweden)

RP01

An anti-IgE imunotherapy

Allergies

Started a Phase II trial with 42 patients (4/19)

XenoPort Inc.
(XNPT)

XP13512

Gabapentin prodrug

Restless legs syndrome

Drug met its endpoints in the first of three Phase III studies (4/25)

Y's Therapeutics
Co. Ltd.*
(Japan)

YSPSL

Recombinant P-selectin glycoprotein immunoglobulin

To prevent delayed graft function in kidney transplant patients

Completed patient enrollment in its Phase II trial (4/24)


Notes:

* Privately held. ** Denotes the date the item ran in BioWorld International.

BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; 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; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.

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