Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

CombinatoRx
Inc.
(CRXX)

CRx-140

Combination of low dose of cyclosporine and loratadine

Psoriasis

Phase II trial failed to demonstrate statistical significance on primary or secondary endpoints (2/22)

Inotek
Pharmaceuticals
Corp.*

IMS

Analogue of inosine, an endogenous purine

Inflammatory bowel disease

Began Phase I trial to evaluate tolerability, safety and pharmaco-kinetics in healthy volunteers (2/22)

NPS
Pharmaceuticals
Inc.
(NPSP)

Teduglutide

Analogue of the hormone glucagon-like peptide-2

Crohn's disease

Phase IIa trial in 100 patients showed a consistent trend toward efficacy, and responses favoring the highest dose group (2/27)

Rigel
Pharmaceuticals
Inc.
(RIGL)

R788

Oral syk kinase inhibitor

Rheumatoid arthritis

Phase I trial with methotrexate showed tolerability and no significant adverse pharmacokinetic interactions (2/22)

CANCER

Abeille
Pharmaceuticals
Inc.*

AB-1001

Transdermal patch that delivers a commercially available 5HT3-antagonist

Chemotherapy- induced nausea and vomiting

Began Phase I trial to evaluate pharmacokinetics in healthy volunteers (2/1)

Access
Pharmaceuticals
Inc.
(AMEX:AKC)

AP5346

A DACH polymer platinate

Head and neck cancer

Began trial to compare platinum delivery to oxaliplatin(2/23)

Aegera
Therapeutics
Inc.*
(Canada)

AEG35156

Agent targeting the X-linked inhibitor of apoptosis protein

Advanced acute myeloid leukemia

Began open-label Phase I trial to evaluate the agent in combination with ara-C and idarubicin (2/15)

AEterna
Zentaris Inc.
(Canada; AEZS)

Neovastat

Antiangiogenic agent

Non-small-cell lung cancer

Recruitment in Phase III trial was stopped due to slow enrollment; an interim efficacy analysis will be conducted after 320 events (2/17)

Ariad
Pharmaceuticals
Inc.
(ARIA)

AP23573

Agent designed to inhibit cell-signaling protein mTOR

Advanced cancers

Began Phase Ib trial to evaluate safety, tolerability and activity with doxorubicin in up to 60 patients (2/14)

ArQule Inc.
(ARQL)

ARQ 197

Small-molecule inhibitor of the c-Met receptor tyrosine kinase

Metastatic tumors

Began Phase I trial to evaluate tolerability, safety, dosing and preliminary activity (2/1)

BioVex Inc.*

OncoVEX- GMCSF

Oncolytic virus designed to selectively kill tumor cells

Malignant melanoma

Began Phase II trial to evaluate tumor response rates and other efficacy endpoints in 50 patients (2/14)

Callisto
Pharmaceuticals
Inc.
(AMEX:KAL)

Atiprimod

Drug designed to inhibit VEGF and interleukin-6

Advanced solid tumors

Phase I/IIa trial showed encouraging results in patients with carcinoid tumors (2/28)

Cell Genesys
Inc.
(CEGE)

GVAX

Vaccine comprising non-patient- specific tumor cells modified to secrete GM-CSF

Advanced prostate cancer

Follow-up data from Phase II trial indicated that median survival had not yet been reached, and will be no less than 29.1 months (2/27)

Cell
Therapeutics
Inc.
(CTIC)

Xyotax

Paclitaxel linked to a biodegradable polyglutamate polymer

Advanced non-small-cell lung cancer

Updated data from PGT202 Phase II trial supported earlier observations on the beneficial effect of estrogen on Xyotax efficacy (2/15)

Cel-Sci Corp.(AMEX:CVM)

Multikine

Mixture of human cytokines designed to stimulate an immune response

Head and neck cancer

Long-term follow-up data from Phase II trial showed substantially increased survival rates and a higher rate of two-year local regional control vs. historical controls (2/21)

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

PXD101

Small-molecule histone deacetylase inhibitor

T-cell lymphomas

Began Phase II trial to evaluate efficacy and safety; 25 patients will be enrolled initially, to be followed by 70 more if activity is shown (2/1)

Cytogen
Corp.
(CYTO)

Quadramet (FDA-approved)

Samarium-153 bound to a small- molecule, bone-seeking phosphonate

Bone metastases from prostate cancer

Presented positive data from various studies of the agent both alone and with chemotherapy (2/27)

Genentech
Inc.
(NYSE:DNA)

Avastin (FDA-approved)

Bevacizumab; antibody designed to inhibit vascular endothelial growth factor

Colon cancer

Enrollment in Phase III AVANT trial was suspended to allow monitors to review safety data; adverse events were higher in the Avastin arm of the study (2/13)

Genitope
Corp.
(GTOP)

MyVax

Personalized immuno-therapy based on a patient's tumor

Chronic lymphocytic leukemia

Began Phase I/II trial to evaluate the product in 70 patients (2/27)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced chronic lymphocytic leukemia

Phase III trial met endpoint of showing benefit of improving remission rates when added to chemotherapy (2/15)

GPC Biotech
AG
(Germany;
FSE:GPC)

Satraplatin

Oral platinum compound

Advanced solid tumors

Phase I trial in 17 patients showed drug appeared to be well tolerated, with no significant toxicitie observed (2/27)

InterMune
Inc.
(ITMN)

Actimmune (FDA-approved)

Interferon gamma-1b

Advanced ovarian cancer

Stopped Phase II GRACES trial in combination with chemotherapy after an interim analysis did not show a survival benefit (2/2)

Introgen
Therapeutics
Inc.
(INGN)

INGN 225

Immunotherapy that uses an adenovector to deliver the p53 gene

Advanced lung cancer

Phase I/II trial showed 62% of patients had objective tumor responses following treatment with chemotherapy (2/21)

Isis
Pharmaceuticals
Inc.
(ISIS)

LY23275796

Second-generation antisense agent that targets eukaryotic initiation factor-4E

Cancers

Partner Eli Lilly and Co. began Phase I development of the product (2/1)

Northwest
Biotherapeutics
Inc.
(OTC BB:NWBT)

DCVax-Brain

Dendritic cell-based immunotherapy made from patients' cells

Brain cancer

Updated findings from Phase I trial in 10 patients showed increased survival vs. approved agents (2/22)

Norwood
Abbey Ltd.
(Australia; ASX:NAL)

Lupron Depot

Leuprolide acetate for depot suspension

Cancers

Began Phase II trial to evaluateimmune recovery in 80 patients undergoing autologous bone marrow transplants (2/22)

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

Nexavar (FDA-approved)

Sorafenib; RAF kinase and VEGF inhibitor

Non-small-cell lung cancer

Began 900-patient Phase III trial to compare treatment with carboplatin and paclitaxel to those drugs alone (2/16)

OxiGene
Inc.
(OXGN)

CA4P

Combretastatin A4P; vascular disrupting agent

Advanced non-small- cell lung cancer

Is starting a Phase II trial to evaluate the product in combination with chemoradiotherapy (2/3)

Point
Therapeutics
Inc.
(POTP)

Talabostat

Small molecule designed to stimulate proliferation of hematopoietic progenitor cells

Metastatic non-small- cell lung cancer

Began Phase III trial to evaluate the drug with pemetrexed in up to 800 patients (2/8)

Rexahn Corp.*

RX-0201

Signal inhibitor that blocks the protein kinase Akt

Cancers

Phase I trial showed a limited side-effect profile (2/14)

Telik Inc.
(TELK)

Telintra tablets

Glutathione analogue inhibitor of GST P1-1

Myelodysplastic syndrome

Began Phase I/IIa trial to evaluate the tolerability and pharmcokinetics of tablet formulation (2/22)

Ziopharm
Oncology Inc.
(OTC BB:ZIOP)

ZIO-201

Isophosphoramide mustard; alkylating agent

Sarcoma

Began a Phase I/II trial in the U.S. and UK (2/23)

CARDIOVASCULAR

Aldagen Inc.*

Aldesort

Product designed to isolate a potent population of stem cells from patient's bone marrow

Advanced heart failure

Is starting a trial that initially will test safety in 10 patients, then in a 60-patient study (2/21)

Avant Immuno-
therapeutics
Inc.
(AVAN)

TP-10

Soluble complement inhibitor

For use in cardiac surgery

Phase IIb trial in women undergoing high-risk cardiac surgery using cardiopulmonary bypass did not meet primary efficacy endpoint (2/27)

CV
Therapeutics
Inc.
(CVTX)

Ranexa (FDA-approved)

Ranolazine; partial inhibitor of fatty- acid oxidation

Acute coronary syndromes

MERLIN TIMI-36 trial will continue as planned based on an interim efficacy analysis (2/9)

DeCode
Genetics Inc.
(Iceland; DCGN)

DG041

Small-molecule antagonist of the EP3 receptor for prostaglandins E2

Peripheral artery disease

Phase I trial demonstrated safety, tolerability and inhibition of platelet aggregation (2/21)

Isis Pharmaceuticals
Inc.
(ISIS)

ISIS 301012

Oral formulation of second- generation anti-sense inhibitor of ApoB-100

Cholesterol management

Phase I trial in healthy volunteers demonstrated oral bioavailability and pharmacological activity (2/7); additional data from study that showed reductions in both apoB-100 and LDL-C, also showed reduced serum triglycerides (2/9)

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 301012

Oral formulation of second- generation anti-sense inhibitor of ApoB-100

Familial hyper- cholesterolemia

Began Phase II trial to evaluate safety and efficacy in FH patients who are not achieving cholesterol target levels on lipid-lowering therapy (2/6)

Myogen Inc.
(MYOG)

Ambrisentan

Oral endothelin receptor antagonist

Pulmonary arterial hypertension

Open-label study showed none of the 36 patients who discontinued other treatment due to liver function abnormalities had a recurrence of liver problems (2/13)

Nuvelo Inc.
(NUVO)

Alfimeprase

Modified fibrolase delivered via catheter; thrombolytic agent

Central venous catheter occlusion

Began SONOMA-3 pivotal Phase III trial, the second of two in the program; the trial will evaluate safety and efficacy in 800 patients (2/27)

Renovis Inc.
(RNVS)

NXY-059/ Cerovive

A neuroprotectant with free radical-trapping properties

Acute ischemic stroke

Phase III SAINT I trial showed a statistically significant reduction of stroke-related disability vs. placebo (2/8)

CENTRAL NERVOUS SYSTEM

Axonyx
Inc.
(AXYX)

Phenserine

Selective inhibitor of acetylcholinesterase

Alzheimer's disease

Further analysis from Phase I trial in healthy volunteers showed a significant reduction in levels of beta-amyloid 1-42 (2/14)

CytRx Corp.
(CYTR)

Arimoclomol

Small molecule designed to provide cellular protection by activating molecular chaperone proteins

Amyotrophic lateral sclerosis

Began open-label extension in patients who have completed Phase IIa trial of the drug (2/13)

DOV
Pharmaceutical
Inc.
(DOVP)

Bicifadine

Serotonin and norepinephrine reuptake inhibitor

Osteoarthritic pain

Began Phase II trial to evaluate efficacy, tolerability and pharma-cokinetics of the drug alone and with ibuprofen (2/7)

DOV
Pharmaceutical
Inc.
(DOVP)

Bicifadine

Serotonin and norepinephrine reuptake inhibitor

Diabetic peripheral neuropathy

Began Phase II trial to evaluate efficacy and safety and interaactions with oxycodone in 50 patients (2/6)

D-Pharm Ltd.*
(Israel)

DP-VPA

Lipid-modified formulation of valproic acid

Epilepsy

Phase II trial testing drug as add-on therapy showed a significant reduction in seizure frequency vs. placebo, with no significant adverse events (2/28)

Halozyme
Therapeutics
Inc.
(AMEX:HTI)

Hylenex (FDA-approved)

Formulation of recombinant human hyaluronidase

Pain

Began a trial testing subcutaneous administration of morphine with Hylenex in up to 18 patients (2/2)

Javelin
Pharmaceuticals
Inc.
(OTC BB:JVPH)

Rylomine

Intranasal morphine

Pain

Phase IIb trial in 187 patients with post-surgical pain met primary and secondary endpoints related to pain relief (2/23)

Jazz
Pharmaceuticals
Inc.*

Xyrem (FDA-approved)

Sodium oxybate oral solution

Fibromyalgia syndrome

Phase II trial in 188 patients demonstrated statistically significant pain relief vs. placebo (2/23)

Neurobiological
Technologies
Inc.
(NTII)

Xerecept

Synthetic mimic of corticotropin- releasing factor

Peritumoral brain edema

Began second of two pivotal Phase III trials; Celtic Pharma has rights to the drug (2/6)

Neurochem
Inc.
(Canada;
NRMX)

Alzhemed

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

Alzheimer's disease

Company is initiating an open-label extension study for ongoing North American Phase III trial (2/8)

New River
Pharmaceuticals
Inc.
(NRPH)

NRP290

Hydrocodone derivative

Pain

Phase I/II trial demonstrated positive bioavailability data (2/7)

Penwest
Pharmaceuticals
Co.
(PPCO)

PW4142

Controlled-release formulation of nalbuphine hydrochloride

Pain

Phase IIa trial in 165 patients demonstrated reduced pain intensity in a dose-dependent manner (2/10)

Prestwick
Pharmaceuticals
Inc.*

Tetrabenazine

Dopamine depletor that works by selectively blocking the VMAT2 transporter

Chorea associated with Huntington's disease

Pivotal Phase III trial demonstrated significantly improved clinical outcomes and reduced symptoms (2/14)

TheraQuest
Biosciences
LLC*

TQ-1017

Extended-release formulation of tramadol

Neuropathic pain

Is starting pilot Phase I trial to evaluate pharmacokinetics vs. short-acting tramadol (2/6)

TorreyPines
Therapeutics
Inc.*

NGX267

Selective muscarinic (M1) agonist

Alzheimer's disease

Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in 64 healthy elderly volunteers (2/27)

DIABETES

Arena
Pharmaceuticals
Inc.
(ARNA)

APD668

Orally active glucose-dependent insulinotropic receptor agonist

Type II diabetes

Partner Ortho-McNeil Inc. began a Phase I trial to evaluate safety, tolerability and pharmacokinetics in healthy volunteers (2/7)

ConjuChem
Inc.
(Canada;
TSE:CJC)

PC-DAC: Exendin-4

Modified exendin-4 analogue bonded to recombinant human albumin

Type II diabetes

Is starting a Phase I/II trial to evaluate safety, tolerability, dosing and pharmacokinetics in up to 68 patients (2/27)

DiObex Inc.*

DIO-902

Cortisol synthesis inhibitor; 2S,4R ketoconazole

Type II diabetes

Began Phase II trial that will evaluate safety and pharmacokinetics (2/22)

Metabasis
Therapeutics
Inc.
(MBRX)

MB07803

Fructose 1,6 bisphosphatase inhibitor; from the same class as CS-917

Type II diabetes

Began a Phase I trial of the agent (2/14)

Metabasis
Therapeutics
Inc.
(MBRX)

CS-917

Fructose 1,6 bisphosphatase inhibitor

Type II diabetes

Partner Sankyo Co. Ltd. began a Phase IIb trial to evaluate safety and efficacy (2/1)

OSI
Pharmaceuticals Inc.
(OSIP)

PSN357

Glycogen phosphorylase inhibitor

Type II diabetes

Began Phase IIa trial to evaluate safety and pharmacokinetics in up to 30 patients (2/21)

OSI
Pharmaceuticals
Inc.
(OSIP)

PSN010

Glucokinase activator

Diabetes

Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in up to 80 healthy volunteers (2/15)

INFECTION

Acambis plc
(UK; ACAM)

Vaccine against Clostridium difficile

C. difficle infections

Phase I trial in 50 healthy volunteers demonstrated antibody responses and tolerability (2/15)

Anadys
Pharmaceuticals
Inc.
(ANDS) and
LG Life Sciences
Ltd. (South Korea)

ANA380
(LB80380)

Oral prodrug of the nucleotide analogue ANA317 (LB80317)

Hepatitis B

Phase II trial in 59 patients with lamivudine-resistant HBV showed significant reductions in viral load and in levels of alanine amino-transferase (2/14)

Arpida Ltd.
(Switzerland;
SWX:ARPN)

Iclaprim

Capsule formulation of broad- spectrum antibiotic

Infections

Phase I trial demonstrated the bioavailability of the oral formulation (2/13)

Avant Immuno-
therapeutics
Inc.
(AVAN)

Ty800

Vaccine against Salmonella typhi, the cause of typhoid fever

Typhoid fever

Began Phase I/II trial to evaluate safety and immunogenicity in 54 healthy volunteers (2/14)

Coley
Pharmaceutical
Group Inc.
(COLY)

Actilon (CPG 10101)

Agent designed to target and stimulate Toll-like receptor 9

Hepatitis C

Began Phase II trial in 90 patients who have failed previous therapy; drug will be given with pegylated interferon alpha and ribavirin (2/23)

Incyte Corp.
(INCY)

DFC

Nucleoside analogue reverse transcriptase inhibitor

HIV

Began Phase II Study 204 that will compare drug to 3TC in 250 treatment-experienced patients (2/16)

ISTA
Pharmaceuticals
Inc.
(ISTA)

Combination product containing tobramycin and prednisolone acetate

Ocular conditions with a risk of bacterial infection

Phase III trial achieved its primary endpoint of demonstrating bio- equivalence and achieved secondary endpoints (2/2)

Nabi Bio-
pharmaceuticals
(NABI)

S. epidermidis PS-1 vaccine and S. aureus Type 336 vaccine

Infections

Phase I trials in healthy volunteers showed the vaccines were well tolerated and produced significant increases in antibody levels (2/7)

Optimer
Pharmaceuticals
Inc.*

OPT-80/
PAR-101

Narrow-spectrum antibiotic agent

Clostridium difficile- associated diarrhea

Phase IIa trial showed clinical cures in 41 of 45 patients; the agent was well tolerated (2/7)

Panacos
Pharmaceuticals
Inc.
(PANC)

PA-457

Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein

HIV

Drug-interaction trial showed drug had no detectable effect on atazanavir-induced hyperbiliru- binemia; another study showed bioavailability of tablet formulation (2/15)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Tarvacin Anti-Viral

Anti-phosphotidylserine immunotherapeutic

Hepatitis C

Phase I trial in 24 patients demonstrated the agent was well tolerated; no serious adverse events were reported (2/27)

The Immune
Response Corp.
(OTC BB:IMNR)

Whole-inactivated HIV-1 immunogen

HIV

Final data from Phase II trial in patients showed induction of HIV-specific immune responses (2/10)

VaxGen Inc.
(PK:VXGN)

LC16m8

Attenuated smallpox vaccine candidate

Smallpox infection

Phase II trial showed the vaccine was safe and well tolerated (2/15)

Vertex
Pharmaceuticals
Inc.
(VRTX)

VX-950

Oral hepatitis C virus protease inhibitor

Hepatitis C

Phase II trial in 12 treatment-naïve patients produced undetectable virus levels at 28 days in all patients (2/7)

Vical Inc.
(VICL)

Ebola vaccine administered using Vical's DNA delivery technology

Ebola virus

Phase I trial in healthy volunteers demonstrated safety, tolerability and both antibody and T-cell Ebola-specific responses (2/21)

Vical Inc.
(VICL)

DNA vaccine against cytomegalovirus

Cytomegalovirus infection

Began Phase II trial to evaluate the product in donors and patients undergoing stem cell transplants (2/1)

MISCELLANEOUS

Acuity
Pharmaceuticals
Inc.*

Cand5

Small interfering RNA therapeutic designed to shut down VEGF

Diabetic macular edema

Began a pilot Phase II trial to evaluate the product in patients (2/2)

Adolor Corp.
(ADLR) and
GlaxoSmithKline
plc (UK)

Entereg

Alvimopan capsules; mu opioid antagonist

Postoperative ileus

Phase III trial in 654 patients showed statistically significant recovery of gastrointestinal function, as well as secondary end-points, vs. placebo (2/7)

Advanced
Magnetics Inc.
(AMEX:AVM)

Ferumoxytol

Intravenously administered bioavailable iron

Iron replacement in anemic chronic kidney disease

Monitors reviewing safety data from Phase III trial recommended the study continue (2/21)

Alteon Inc.
(AMEX:ALT)

Alagebrium (ALT-711)

Alagebrium chloride; A.G.E. crosslink breaker

Erectile dysfunction

Discontinued development in that indication after the FDA said more preclinical data were needed prior to a Phase IIa trial (2/1)

Amgen Inc.
(AMGN)

Denosumab (AMG 162)

Agent designed to target RANK Ligand, a protein implicated in promoting bone removal

Bone loss

Phase II trial in 412 healthy post-menopausal women demonstrated significantly increased bone mineral density vs. placebo (2/22)

Amylin
Pharmaceuticals
Inc.
(AMLN)

Pramlintide (FDA-approved)

Synthetic analogue of human amylin

Obesity

Phase II trial in 408 obese subjects showed average weight losses of 8.4 to 13.4 pounds vs. 6.2 pounds for placebo (2/9)

Antares
Pharma Inc.
(AMEX:AIS)

Anturol

Transdermal gel formulation of oxybutynin

Overactive bladder

Phase II trial in 48 healthy subjects demonstrated positive tolerability and pharmacokinetic data (2/22)

Applied
Genetic
Technologies
Corp.*

AGTC-0106

Gene therapy using an adeno- associated virus to deliver the AAT gene

Alpha-1 antitrypsin deficiency

Began a Phase I trial to evaluate safety and dosing in 12 patients (2/23)

Bionovo Inc.
(OTC BB:BNVI)

MF101

Estrogen receptor beta selective modulator

Menopausal symptoms

Began a Phase II trial to evaluate the product (2/8)

Corgentech
Inc.
(CGTK)

Avrina

NF-kB Decoy; inhibitor of the NF- B transcription factor

Atopic dermatitis (eczema)

Phase I/II trial in 75 patients showed the lowest dose to be most efficacious (2/6)

Critical
Therapeutics
Inc.
(CRTX)

Intravenous zileuton; 5-lipoxygenase inhibitor

Asthma

Began Phase I/II trial to evaluate the I.V. formulation's safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients (2/15)

DUSA
Pharmaceuticals
Inc.
(DUSA)

Levulan (FDA-approved)

Aminolevulinic acid HCl; photodynamic therapy; used with light source

Photodamaged skin

Phase II trial in 80 patients demonstrated statistically significant improvements vs. vehicle and the same light source (2/24)

GenVec Inc.
(GNVC)

AdPEDF

Gene therapy using an adenovector to produce pigment epithelium- derived factor

Wet age-related macular degeneration

Phase I trial in 28 patients showed evidence of a halt in disease progression lasting six to 12 months; there were no serious adverse events (2/7)

Halozyme
Therapeutics Inc.
(AMEX:HTI)
and Baxter Healthcare Corp.

Hylenex
(FDA-approved)

Formulation of recombinant human hyaluronidase

For use in Sub-Q infusion

INFUSE-LR trial showed use of drug preceding Sub-Q infusion accelerated the flow rate by four-fold vs. infusion with placebo (2/8)

ISTA
Pharmaceuticals
Inc.
(ISTA)

Ecabet sodium

Eye drop formulation designed to increase production of mucin

Dry eye syndrome

Phase IIb trial demonstrated a a trend toward efficacy for the lower of two doses tested (2/21)

Microbia Inc.*

MD-1100

Peptide designed to act on guanylate cyclase-C, a receptor found on the surface of intestinal cells

Chronic idiopathic constipation

Began Phase II trial to evaluate the product in CIC (2/27)

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Investigational agent for BPH

Benign prostatic hyperplasia

Internal review of ongoing Phase II trial revealed no serious drug side effects (2/23)

OSI
Pharmaceuticals
Inc.
(OSIP)

Macugen (FDA-approved)

Pegaptanib sodium injection; pegylated anti- VEGF-aptamer

Age-related macular degeneration

VISION trials showed systemic safety was maintained over two years of treatment; preliminary data also showed safety over three years (2/24)

Palatin
Technologies
Inc.
(AMEX:PTN)

PT-141

Intranasally delivered melanocortin agonist

Female sexual arousal disorder

Began Phase IIb trial to evaluate safety and efficacy in 60 women (2/7)

Progenics
Pharmaceuticals
Inc.
(PGNX)

MNTX

Methylnaltrexone; agent designed to block peripheral opioid receptors

Opioid-induced constipation

Second pivotal Phase III trial met all primary and secondary end- points with statistical significance (2/15)

QLT Inc.
(Canada; QLTI)

Lemuteporfin

Photodynamic therapy

Benign prostatic hyperplasia

Phase II trial failed to meet its primary endpoints at three months (2/16)

QuatRx
Pharmaceuticals
Co.*

Fispemifene

Oral, non-testosterone agent

Andropause

Began Phase II trial to evaluate drug in treating low testosterone in about 100 older men (2/16)

QuatRx
Pharmaceuticals
Co.*

Ospemifene

Small-molecule, selective estrogen receptor modulator

Vaginal atrophy

Began Phase III trial expected to enroll 800 post-menopausal women (2/16)

Regeneron
Pharmaceuticals
Inc.
(REGN)

VEGF Trap

Intravenous product designed to block vascular endothelial growth factor

Wet age-related macular degeneration

Data from 18 patients in ongoing Phase I trial showed rapid and prolonged reductions in retinal thickness (2/2)

Zonagen Inc.
(ZONA)

Androxal

Small-molecule agent designed to restore normal testosterone production in males

Testosterone deficiency

Open-label trial in 13 men produced positive results (2/3)


Notes:

* Privately held.

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; 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; TSE = Toronto Stock Exchange.

No Comments