Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Alba
Therapeutics
Corp.*

AT-1001

Oral zonulin receptor antagonist

Celiac disease

Company said it successfully completed a Phase I trial (10/26)

 

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

Tysabri

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

Crohn's disease and rheumatoid arthritis 

Safety evaluation from trials in CD and RA resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (10/17) 

 

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha  

Crohn's disease

Nearly 90% of pediatric patients who previously responded inadequately achieved clinical response at week 10(10/25)

 

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade
(FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Ulcerative colitis

Phase III trial demonstrated  mucosal healing and remission,  as well as other benefits (10/19)

 

Human Genome
Sciences Inc.
(HGSI)

LymphoStat-B

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

Lupus

Phase II trial in 449 patients showed significance in seropositive subgroup but did not meet overall primary efficacy endpoints (10/5)

 

Merrimack
Pharmaceuticals
Inc.*

MM-093

Recombinant version of human alpha-fetoprotein; an immunomodulator

Plaque soriasis

Began pilot Phase IIa trial to test safety and efficacy in 40 patients with moderate to severe disease (10/13)

 

Pharma-
Frontiers Corp.
(OTC BB:PFTR)

Tovaxin

Trivalent formulation of attenuated myelin-peptide reactive T cells

Multiple sclerosis

Phase I/II trial demonstrated safety, tolerability and depletion of myelin- peptide reactive T cells (10/3); is starting a Phase IIb trial to evaluate efficacy, safety and tolerability in 150 patients (10/31)

 

Targeted
Genetics Corp.
(TGEN)

tgAAC94

Product using an adeno-associated viral vector to deliver a soluble TNF-alpha receptor protein

Inflammatory arthritis

Began Phase I trial in up to 40 patients already receiving anti-TNF-alpha therapies (10/11); additional data from initial Phase I trial showed improvements in swelling and tenderness (10/31)

 

The Immune
Response Corp.
(IMNR)

NeuroVax

T-cell receptor peptide vaccine

Multiple sclerosis

Phase I/II trial showed restoration to normal levels of FOXP3 and regulatory T cells, as well as increased IL-10 secretion (10/3)

 

Vertex
Pharmaceuticals
Inc.
(VRTX)

VX-765

Interleukin-1 beta converting enzyme inhibitor

Psoriasis

The company said it was minimizing investment in the drug to  focus on more promising opportunities; it is in Phase II (10/6)

 

CANCER

AmpliMed
Corp.*

Amplimexon

Imexon injection; a cyanoaziridine compound believed to disrupt mitochondria

Refractory cancers

Began Phase I trial that will evaluate drug with docetaxel in 30 patients (10/19)

 

Antigenics
Inc.
(AGEN)

Aroplatin

Third-generation, liposome- ncapsulated platinum compound

Advanced cancers

Began Phase I trial to evaluate safety, dosing and pharmacokinetics in up to 28 patients (10/25)

 

Antigenics
Inc.
(AGEN)

Oncophage

Personalized cancer vaccine based on heat-shock protein technology

Metastatic melanoma

Phase III trial in Stage IV M1a patients showed better than 50% improvement in median survival vs. standard treatments (10/10)

 

Biomira Inc.
(Canada; BIOM)
and Merck KGaA
(Germany)

BLP25

Liposomal vaccine encapsulating a sequence of the MUC1 cancer mucin

Statge IIIB non-small-cell lung cancer

Phase IIb trial showed median surival of 30.6 months vs. 13.3 months for the unvaccinated group (10/27)

 

CancerVax
Corp.
(CNVX)

Canvaxin

Therapeutic whole-cell vaccine that expresses more than 20 antigens

Stage III melanoma

Phase III trial was discontinued after monitors determined a survival benefit was unlikely to be seen (10/3)

 

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

CHIR-12.12

Fully human, antagonist antibody that targets the CD40 antigen

Multiple myeloma

Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in up to 40 patients (10/13)

 

Cytogen
Corp.
(CYTO)

Quadramet (FDA-approved)

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

Advanced osteosarcoma

Eight of 14 patients in trial with  gemcitabine had objective radiographic responses(10/7)

 

Cytogen
Corp.
(CYTO)

Quadramet (FDA-approved)

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

Hormone- refractory prostate cancer

Phase II TAXSAM1 trial with docetaxel showed PSA declines of more than 50% in 34% of the 29 patients (10/3)

 

Dendreon
Corp.
(DNDN)

Provenge

Immunotherapy that uses a recombinant form of the prostatic acid phosphatase antigen 

Metastatic prostate cancer

Final data from Phase III D9902A trial showed a 19-month median survival vs. 15.7 months for the placebo group (10/31)

 

Expression
Genetics Inc.*

EGEN-001

Interleukin-12 gene expression plasmid and a biocompatible delivery polymer

Recurrent epithelial ovarian cancer

Began Phase I trial in 18 patients that primarily will evalaute safety (10/17)

 

Genentech Inc.
(NYSE:DNA)

Herceptin
(FDA-pproved)

Trastuzumab; monoclonal antibody against HER2/neu protein

Early stage breast cancer

Pivotal Phase II trials showed addition of drug to chemotherapy significantly reduced the risk of recurrence vs. chemotherapy alone (10/19)

 

Genentech
Inc.
(NYSE:DNA)

Tarceva
(FDA-approved)

Erlotinib HCl; small- molecule HER1/EGFR inhibitor

Metastatic renal cell carcinoma

Phase II trial with Avastin showed progression-free survival and response rates similar to those achieved with Avastin alone (10/18)

 

Halozyme
Therapeutics
Inc.
(AMEX:HTI)

Chemophase

Recombinant agent designed to enhance the delivery of chemotherapy

Superficial bladder cancer

Began a Phase I trial with mitomycin to evaluate safety, tolerability and pharmacokinetics in at least five patients(10/27)

 

Idera
Pharmaceuticals
Inc.
(AMEX:IDP)

HYB2055

Toll-like receptor 9 agonist (also known as IMO-2055 or IMOxine)

Solid tumors

Began Phase I/II trial with gemcitabine and carboplatin to evaluate safety and efficacy, initially in 12 to 18 refractory patients (10/26)

 

Innovive
Pharmaceuticals
Inc.*

INNO-105

Naturally occurring peptide that interacts with the OGFr receptor

Advanced solid tumors

Got OK to start Phase I trial that will evaluate safety and antitumor  effects (10/4)

 

Inovio
Biomedical
Corp.
(AMEX:INO)

SECTA
therapy

Electroporation device used with a chemotherapeutic agent

Breast cancer

Began Phase I trial to test the agent for recurrent cancer after a mastectomy or partial mastectomy in up to 24 patients (10/20)

 

IRX
Therapeutics
Inc.*

IRX-2

Agent designed to stimulate cellular immune responses

Head and neck cancer

Began Phase II trial that will evaluate responses in 25 patients with late-stage disease (10/17)

 

Kosan
Biosciences
Inc.
(KOSN)

KOS-862

Epothilone D, a polyketide

Hormone- refractory prostate cancer

Phase II trial failed to meet end- point on number of patients with a response to therapy (10/18)

 

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

Virulizin

Immunotherapy agent designed to stimulate the immune system

Pancreatic cancer

Phase III trial with gemcitabine in first-line treatment showed promising trends vs. placebo but did not reach statistical significance (10/18)

 

Marshall
Edwards Inc.
(MSHL)

Phenoxodiol

Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP

Ovarian cancer and cervical cancer

Interim data from trial in 43 refractory patients showed improved survival with paclitaxel or cisplatin vs. either agent alone; trial in cervical cancer also showed benefit (10/24)

 

Millennium
Pharmaceuticals
Inc.
(MLNM)

MLN518

Small molecule designed to inhibit type III receptor tyrosine kinases

Acute myelogenous leukemia

Began Phase I/II trial with standard induction therapy to evaluate safety, tolerability and initial response rates in up to 24 patients, and MLN518 alone as a remission maintenance therapy (10/17)

 

NeoPharm
Inc.
(NEOL)

IL13-PE38QQR

Cintredekin besudotox; agent designed to deliver bacterial cytotoxic PE38

Malignant glioma

Phase I trial in 12 patients provided preliminary support to the feasibility of use in multimodality therapy (10/10)

 

Oxford
Biomedica plc
(UK; LSE:OXB)

TroVax

Vaccine that delivers an antigen (5T4) using a poxvirus vector

Renal cell carcinoma

Preliminary data from Phase II trial showed safety and tolerability, and an immune response against the antigen (10/6)

 

OxiGene Inc.
(OXGN)

Combrestatin
A4 Prodrug

Vascular-targeting agent designed to block the flow of blood to a tumor

Non-small-cell lung cancer

Updated Phase Ib/II trial data with radiotherapy showed a statistic- ally significant 40% percent reduction in tumor blood volume (10/5)

 

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Tarvacin Anti-Cancer

Chimeric monoclonal antibody that binds to the phospholipid phosphatidylserine

Advanced solid tumors

Began Phase I trial that will assess safety, tolerability and pharmacokinetics in up to 28 patients (10/21)

 

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 drug with docetaxel vs. docetaxel with placebo in 400 patients (10/13)

 

Procyon
Biopharma Inc.
(Canada; TSE:PBP)

PCK3145

Synthetic peptide analogue of prostate secretory protein

Advanced prostate cancer

Results to date in dose-finding trial indicate agent is well tolerated and has an impact on MMP-9 plasma levels (10/25)

 

Pro-
Pharmaceuticals
Inc.
(AMEX:PRW)

Davanat

Carbohydrate compound designed for targeted delivery

Cancers

Phase I trial showed 5-FU remained in the bloodstream significantly longer when given with Davant; increased activity also was seen (10/6)

 

Reata
Pharmaceuticals Inc.*

RTA 401
(CDDO)

Synthetic triterpenoid; targeted anticancer agent

Relapsed leukemias

Began trial to evaluate safety, dosing, side effects and efficacy  in 401 patients (10/12)

 

RxKinetix Inc.*

RK-0202

The antioxidant N- acetylcysteine in a polymer matrix

Oral mucositis in cancer patients

Monitors recommended stopping enrollment in Phase II trial in order to expedite development, after reviewing data on 114 of planned 130 patients (10/18)

 

Telik Inc.
(TELK)

Telintra
(TLK199)

Glutathione analogue inhibitor of GST P1-1

Myelodysplastic syndromes

Got OK to begin initial trial of  an oral formulation of the drug in patients (10/6)

 

Xanthus Life
Sciences Inc.*

Xanafide

Salt formulation of the cancer compound amonafide

Secondary acute myeloid leukemia

Began Phase II trial with ara-C to evaluate remissions and survival in up to 60 patients(10/20)

 

YM
BioSciences Inc.
(Canada; TSE:YM)

Tesmilifene (DPEE)

Small molecule designed to augment the activity of chemotherapy agents

Hormone-refractory prostate cancer

Phase II trial with mixantrone/ prednisone showed PSA decreases, reduced symptoms and a two-year survival rate of 21% (10/13)

 

CARDIOVASCULAR

ActivBiotics
Inc.*

Rifalazil

Anti-chlamydial agent

Peripheral arterial disease

Said it is starting a 160-patient Phase III trial named PROVI- DENCE-1 that will assess symptom improvement (10/6)

 

Cardiome
Pharma Corp.
(Canada; CRME)

RSD1235

Formulation of drug designed to selectively block ion channels in the heart

Atrial arrhythmia

Began open-label ACT 4 trial to evaluate the safety of intravenous RSD1235 in 120 patients (10/19)

 

CardioVascular
BioTherapeutics
Inc.
(OTC BB:CVBT)

Cardio Vascu-Grow

Stimulator of angiogenesis

Heart conditions

Monitors reviewing safety data in Phase I trial OK'd move into the final dosing group (10/4)

 

Centocor Inc.
(unit of Johnson
& Johnson) and
Eli Lilly and Co.

ReoPro

Abciximab; an anticlotting agent

Acute ischemic stroke

Enrollment in Phase II AbESTT trial was temporarily suspended after monitors observed safety concerns (10/4); enrollment was permanently discontinued (10/28)

 

CoTherix Inc.
(CTRX)

Ventavis
(FDA-approved)

Inhaled formulation of iloprost, a prostacyclin analogue

Pulmonary arterial  hypertension

Phase II trial showed the addition of drug to Tracleer produced similar safety trends and improvements in secondary endpoints (10/31)

 

Forbes
Medi-Tech Inc.
(FMTI)

FM-VP4

Amphipathic analogue of phytostanols; a cholesterol absorption inhibitor

Cholesterol control

The company is starting a Phase II trial (10/3)

 

Icagen Inc.
(ICGN)

ICA-17043

Ion channel blocker

Sickle cell anemia

Open-label extension of Phase II trial provided further positive safety and tolerability data (10/19)

 

Lumen
Therapeutics
LLC*

LT-1951

Polymer of L-arginine, the substrate for production of nitric oxide

Prevention of graft failure

Phase I portion of Phase I/II trial demonstrated tolerability and safety in 20 patients (10/3)

 

Speedel
Holding Ltd.
(Switzerland;
SWX:SPPN

SPP635

Renin inhibitor

Hypertension

Began Phase I trial to evaluate safety, tolerability, pharmacokinetics and renin-angiotensin inhibition in healthy volunteers (10/13)

 

Surface
Logix Inc.*

SLx-2101

Selective, oral PDE-5 inhibitor

Cardiovascular diseases

Phase I trial indicated the product was safe, well tolerated and pharmacodynamicaly active (10/11)

 

Synthetic Blood
International
Inc.
(OTC BB:SYBD)

Oxycyte

Perfluorocarbon-based
blood substitute and therapeutic oxygen carrier

Blood substitute

Plans to begin Phase II trials in patients with traumatic brain injury and with sickle cell anemia; is suspending enrollment in Phase II trial in patients with hip-revision surgery (10/4)

 

The Medicines
Co.
(MDCO)

Clevelox
(clevidipine)

Intravenous L-calcium channel blocker

For use in cardiac surgery

Resumed Phase III trial after data review showed no safety concerns; studies were stopped in March due to possible increases in atrial fibrillation (10/19)

 

ZymoGenetics
Inc.
(ZGEN)

rhThrombin

Recombinant human thrombin

Controlling blood loss during surgery

Began pivotal Phase III trial to test efficacy vs. bovine-derived thrombin in at least 400 patients undergoing surgery (10/27)

 

CENTRAL NERVOUS SYSTEM

Aeolus
Pharmaceuticals
Inc.
(OTC BB:AOLS)

AEOL 10150

Small-molecule catalytic antioxidant

Amyotrophic lateral sclerosis

Began follow-on Phase I trial that will evaluate the agent in 18 patients (10/19)

 

AlgoRx
Pharmaceuticals Inc.*
and
Corgentech
Inc.
(CGTK)

ALGRX 3268

Anesthetic administered into the skin by Powderject system

Morton's neuroma

Phase II trial in 30 patients showed statistically significant   decreases in foot pain vs. placebo (10/18)

 

AlgoRx
Pharmaceuticals
Inc.*
and
Corgentech
Inc.
(CGTK)

ALGRX 3268

Anesthetic administered into the skin by Powderject system

Pain

Phase III trial in 574 pediatric patients demonstrated statistically significant less pain for drug group vs. placebo (10/5)

 

Cephalon
Inc.
(CEPH)

Sparlon

New formulation and dosage of modafinil, the active ingredient in the approved product Provigil

Attention deficit/ hyperactivity disorder

Data from three pivotal Phase III  trials in a total of 600 children aged 6 to 17 showed significant improvements vs. placebo (10/21)

 

Durect Corp.
(DRRX) and
Voyager
Pharmaceutical
Corp.*

Memryte

Durin implant technology with leuprolide acetate

Alzheimer's disease

Began pivotal Phase III trial to test product as an adjunctive therapy with acetyl cholinesterase inhibitors in about 1,100 patients with mild to moderate disease (10/14)

 

Endo
Pharmaceuticals
Inc.
(ENDP)

Lidoderm

Lidocaine patch 5%

Pain from carpal tunnel syndrome

Open-label pilot study showed  drug compared favorably with those treated with a cortico-steroid injection (10/27)

 

Endo
Pharmaceuticals
Inc.
(ENDP)

Oxymorphone ER

Extended-release formulation of oxymorphone

Pain

Second Phase III trial in 142 patients with chronic low-back pain showed a statistically significant improvement vs. placebo (10/3)

 

Javelin
Pharmaceuticals
Inc.
(OTC BB:JVPH)

Rylomine

Intranasal morphine

Pain

Phase II trial in 187 post-bunionectomy patients showed statistically significant pain relief vs. placebo (10/12)

 

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 following a safety review on 1,042 patients (10/5)

 

Repligen Corp.
(RGEN)

RG1068

Synthetic human secretin

Schizophrenia

Began follow-on trial in 30 patients to assess the impact on a marker for a cognitive deficit characteristic of schizophrenia patients (10/6)

 

Sepracor
Inc.
(SEPR)

SEP-225289

Triple reuptake inhibitor

Major depressive disorder

Began Phase I trial to evaluate safety, tolerability and pharmacokinetics (10/19)

 

StemCells Inc.
(STEM)

HuCNS-SC

Human neural stem cells

Batten disease

Got OK from FDA to begin Phase I trial to evaluate safety and preliminary efficacy in children (10/20)

 

DIABETES

Advanced Viral
Research Corp.
(OTC BB:ADVR)

AVR118

Peptide-nucleic acid complex with immuno-modulatory properties

Type II diabetes

Began Phase I trial to evaluate safety and effect on blood glucose in 30 patients (10/3)

 

INFECTION

Antigenics
Inc.
(AGEN)

AG-707

Recombinant heat-shock protein 70 polyvalent peptide complex

Genital herpes

Began Phase I trial to evaluate safety and immune responses in 84 patients with HSV-2 (10/18)

 

Biolex
Therapeutics
Inc.*

BLX-883

Form of alfa interferon manufactured using firm's LEX System

Hepatitis C

Phase I trial in 24 healthy volunteers supported continued development (10/26)

 

Cerexa Inc.*

PPI-0903

Broad-spectrum cephalosporin antibiotic

Complicated skin and skin structure infections 

Began Phase II trial to evaluate efficacy and safety vs. standard therapy in 100 patients (10/19)

 

Chiron Corp.
(CHIR)

--

Cell culture-derived influenza vaccine

Influenza

Began a Phase I/II trial of the vaccine (10/25)

 

Chiron Corp.
(CHIR) and
Nektar
Therapeutics
(NKTR)

TIP

Tobramycin inhalation powder

Lung infections caused by P. aeruginosa

Began Phase III ASPIRE I trial to test efficacy and safety for lung infections in patients with cystic fibrosis (10/5)

 

Elusys
Therapeutics
Inc.*

Anthim

Monoclonal antibody that targets the protective antigen component of anthrax

Anthrax infection

Began Phase I trial to test safety, tolerability and pharmacokinetics of a single dose in healthy volunteers (10/3)

 

Koronis
Pharmaceuticals
Inc.*

KP-1461

Agent that targets HIV mutation to force the production of a nonfunctional virus

HIV

Began Phase Ib trial to evaluate safety, toxicity, pharmacokinetics and initial clinical activity in 40 patients who failed HAART regimens (10/12)

 

Medarex Inc.
(MEDX)

CDA-1
(MDX-066)

Fully human antibody believed to target and neutralize the effects of Toxin A

Clostridium difficile- associated diarrhea

Began Phase II trial to assess safety, tolerability and efficacy with standard care in up to 150 patients (10/11)

 

Nabi Bio-
pharmaceuticals
(NABI)

Altastaph

Staphylococcus aureus immune globulin

S. aureus infections

Phase I/II trial showed a shorter duration of bacteremia and fever vs. placebo, and shorter hospital stays (10/7)

 

Nabi Bio-
pharmaceuticals
(NABI)

StaphVAX

Staphylococcus aureus  polysaccharide conjugate vaccine

To prevent S. aureus infections

Successfully completed studies of  three commercial-scale lots of the vaccine in 354 healthy adults (10/12)

 

Oscient
Pharmaceuticals
Corp.
(OSCI)

Factive
(FDA-approved)

Gemifloxacin mesylate; a fluoroquinolone  antibiotic

Acute bacterial sinusitis

Meta-analysis of pooled Phase III studies showed drug was more effective than two others in ABS patients with allergic rhinitis (10/7)

 

Tanox Inc.
(TNOX)

TNX-355

Humanized anti-CD4 monoclonal antibody; designed to inhibit viral entry

HIV

Phase II trial with optimized background therapy produced a statistically significant reduction in viral load vs. therapy and placebo (10/26)

 

Vertex
Pharmaceuticals
Inc.
(VRTX)

Merimepodib (VX-497)

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

Hepatitis C

The company said it was minimizing investment in the drug to  focus on more promising opportunities; it is in Phase II (10/6)

 

Vertex
Pharmaceuticals
Inc.
(VRTX)

VX-950

Oral HCV protease inhibitor

Hepatitis C

14-day study showed serum ALT declines in patients with genotype 1 HCV infection (10/3)

 

Vical Inc.
(VICL)

--

Plasmid DNA vaccine that incorporates parts of four HIV genes

HIV

Began NIH-sponsored Phase II trial in which responses will be boosted afterward with a single dose of an adenoviral vector vaccine (10/11)

 

MISCELLANEOUS

Acuity
Pharmaceuticals
Inc.*

Cand5

Small interfering RNA therapeutic designed to shut down VEGF

Age-related macular degeneration

Began Phase II trial in 30 patients and reported that Phase I trial demonstrated safety and tolerability (10/14)

 

Arena
Pharmaceuticals
Inc.
(ARNA)

APD356

Stimulator of the 5-HT2C serotonin receptor

Obesity

Phase IIa trial demonstrated a statistically significant weight loss in patients taking the 15-mg dose (10/18)

 

Cobalis Corp.
(OTC BB:CLSC)

PreHistin

Agent designed to modulate levels of IgE, reducing the overproduction of histamines

Allergy

Phase III trial in 714 patients demonstrated statistically significant fewer allergy symptoms vs. placebo (10/27)

 

DUSA
Pharmaceuticals
Inc.
(DUSA)

Levulan
(FDA-approved)

Aminolevulinic acid HCl; photodynamic therapy

Photodamaged skin

Trial with intense pulsed light in 20 patients showed significant improvement vs. IPL alone (10/20)

 

Eyetech
Pharmaceuticals
Inc.
(EYET)

Macugen
(FDA- approved)

Pegaptanib sodium injection; pegylated anti-VEGF aptamer

Diabetic macular edema and diabetic retinopathy

Began Phase III trial to evaluate safety and efficacy in 900 patients treated over three years; the move followed a prospective analysis of the Phase II trial (10/17)

 

Eyetech
Pharmaceuticals
Inc.
(EYET)

Macugen
(FDA- approved)

Pegaptanib sodium injection; pegylated anti-VEGF aptamer

Wet age-related macular degeneration

Retrospective analysis showed drug may work better in patients with early stage neovascular AMD vs. overall study population (10/5)

 

FoldRx
Pharmaceuticals
Inc.*

Fx-1006A

Small-molecule compound designed to inhibit the formation of amyloid deposits

Certain genetic disorders

Began Phase I trial to evaluate safety, tolerability and pharmacologic properties in 55 healthy volunteers (10/12)

 

Genaera
Corp.
(GENR)

Evizon (squalamine)

Anti-angiogenesis agent; vascular endothelial growth factor inhibitor

Wet age-related macular degeneration

Phase II trial with Visudyne in 45 subjects met its primary goal of demonstrating safety; a slight increase in mean visual acuity was seen (10/11)

 

Hollis-Eden
Pharmaceuticals
Inc.
(HEPH)

Neumune

Immune-regulating hormone

Acute radiation syndrome

Preliminary Phase I data demonstrated safety and tolerability and an increase in neutrophils and platelets; trial was in healthy volunteers (10/18)

 

ICOS Corp.
(ICOS) and Eli
Lilly and Co
.

Tadalafil
(FDA-approved)

Cialis; oral PDE5 inhibitor

Benign prostatic hyperplasia 

Phase II trial demonstrated statistically significant improvement in the severity of symptoms (10/12)

 

Inspire
Pharmaceuticals
Inc.
(ISPH)

Denufosol
tetrasodium

P2Y2 receptor agonist

Cystic fibrosis

Completed Phase II safety trial that will help with design of  Phase III program (10/13)

 

ISTA
Pharmaceuticals
Inc.
(ISTA)

Vitrase
(FDA-approved)

Ovine hyaluronidase formulation

Vitreous hemorrhage

Pooled, subset analysis of Phase III trials showed a three-line improvement on an eye chart vs. a saline control (10/20)

 

Kemia Inc.*

KC706

Agent designed to inhibit the activity of p38 MAP kinase

Inflammatory diseases

Began a Phase I trial to test safety in healthy volunteers (10/6)

 

Microbia Inc.*

MD-1100

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

Irritable bowel syndrome

Phase I trial in healthy volunteers showed the drug was well tolerated (10/31)

 

Miravant
Medical
Technologies
Inc.
(OTC BB:MRVT)

Photrex (SnET2)

Photodynamic therapy that uses a light-activated drug to destroy abnormal blood vessels

Wet age-related macular degeneration

Began Phase III trial in 650 patients to fulfill requirements set out in September 2004 approvable letter from the FDA (10/10)

 

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Investigational agent for BPH

Benign prostatic hyperplasia

Second interim analysis of Phase II trial revealed no serious drug side effects (10/12)

 

Osiris
Therapeutics
Inc.*

Prochymal

Intravenous formulation of mesenchymal stem cells

Graft-vs.-host disease

Is starting a Phase II trial to test safety and efficacy in patients  with treatment-refractory disease (10/12)

 

Savient
Pharmaceuticals
Inc.
(SVNTE)

Puricase

Polyethylene glycol conjugate of uricase

Gout

Phase II trial demonstrated sustained lowering of plasma urate levels in the majority of patients (10/3)

 

Sirna
Therapeutics
Inc.
(RNAI)

Sirna-027

Chemically modified short interfering RNA targeting vascular endothelial  growth factor receptor-1

Age-related macular  degeneration

Data from 22 patients in Phase I trial showed all patients had acuity stabilization and 23% had improved visual acuity (10/19)

 

Symbollon
Pharmaceuticals
Inc.
(OTC BB:SYMBA)

IoGen

Iodine-based oral drug

Proliferative benign breast disease

Is starting a trial to evaluate the clinical effects of agent in about 20 women (10/20)

 

Urigen Inc.*
(Canada)

U101

Intravesical formulation of FDA-approved components

Interstitial cystitis

Is starting a Phase IIb trial to evaluate safety and efficacy (10/3)

 

XenoPort
Inc.
(XNPT)

XP19986

Transported prodrug of R-baclofen

Gastro-esophageal reflux disease

Began Phase IIa trial to evaluate safety, tolerability and efficacy (10/26)


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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.