Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Acorda
Therapeutics Inc.*

Fampridine-SR

Selective neuronal potassium channel blocker

Multiple sclerosis

Began pivotal Phase III trial under FDA SPA to evaluate safety and improved walking in 240 MS patients (6/30)

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

Tysabri

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

Crohn's disease

Phase III ENCORE trial met its primary endpoint of clinical response and all secondary endpoints; the 510 patients had been dosed prior to trials and sales being voluntarily suspended (6/30)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Psoriatic arthritis

New Phase III data showed significantly greater inhibition of structural damage than placebo (6/9); long-term data showed sustained efficacy (6/10)

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

Rituxan (FDA-approved)

Rituximab; antibody that that targets and selectively depletes CD20-positive B cells

Rheumatoid arthritis

Phase IIb trial in 465 patients who weren't responding to methotrexate showed improved response rates vs. placebo (6/9)

Immunomedics
Inc.
(IMMU)

Epratuzumab

Humanized anti-CD22 antibody labeled with yttrium-90

Sjogren's syndrome

Phase I/II trial in 15 patients produced improvements in disease signs and symptoms (6/10)

Immunomedics
Inc.
(IMMU)

Epratuzumab

Humanized anti-CD22 antibody labeled with yttrium-90

Lupus

Began pivotal Phase III ALLEVIATE A and B trials that will assess disease activity (6/1)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Monoclonal antibody that binds to alpha 4 beta 7, a T-cell integrin

Ulcerative colitis

Phase II trial demonstrated statistically significant improvements in remission rates vs. placebo (6/16)

Pharma-
Frontiers Corp.
(OTC BB:PFTR)

Tovaxin

Trivalent formulation of
attenuated myelin-peptide
reactive T cells

Multiple
sclerosis

Interim data from six patients in Phase I/II trial showed reduced peripheral blood MRTC levels and improved disability scores (6/3)

QuatRx
Pharmaceuticals
Co.*

Becocalcidiol

Topical vitamin D analogue

Psoriasis

Phase IIb trial in 185 patients demonstrated a statistically significant improvement vs. vehicle in physicians' assessment (6/14)

Regeneron
Pharmaceuticals
Inc.
(REGN)

IL-1 Trap

Agent designed to attach to and neutralize interleukin-1

CIAS1-associated periodic syndrome

All four patients in a pilot study experienced positive responses to loading and subsequent doses (6/10)

Renovis Inc.
(RNVS)

REN-850

Inhibitor of leukocyte trafficking

Multiple sclerosis

Stopped Phase Ia trial and further development after seeing unexpected pharmacokinetics (6/13)

The Immune
Response Corp.
(IMNR)

NeuroVax

T-cell receptor peptide vaccine

Multiple sclerosis

Data from ongoing trial demonstrated a significant increase in FOXP3, a gene marker that tracks regulatory T cells (6/21)

Vertex
Pharmaceuticals
Inc.
(VRTX)

VX-702

Oral p38 MAP kinase inhibitor

Rheumatoid arthritis

Began Phase II trial to evaluate safety, tolerability and activity in 300 patients with moderate to severe RA (6/10)

CANCER

Adventrx
Pharmaceuticals
Inc.
(AMEX:ANX)

CoFactor

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

Metastatic colorectal cancer

31 of 48 patients in Phase II trial with 5-FU achieved clinical benefit; 18 patients responded to treatment (6/20)

Ariad
Pharmaceuticals
Inc.
(ARIA)

AP23573

Oral form of agent designed to inhibit cell-signaling protein mTOR

Endometrial cancer

Began Phase II single-agent trial to evaluate clinical benefit in up to 45 patients (6/30)

Astex Ltd.*
(UK)

AT7519

Cell-cycle inhibitor that targets cyclin-dependent kinases

Refractory solid tumors

Starting a Phase I trial in the U.S. and UK in patients (6/27)

Biogen Idec
Inc.
(BIIB)

Galiximab

Primatized monoclonal antibody that targets CD80 on the surface of B cells

Relapsed/ refractory follicular non-Hodgkin's lymphoma

Phase II trial in 73 patients showed combination with Rituxan may extend event-free survival vs. Rituxan alone; an overall response rate of 64% was achieved (6/14)

Biogen Idec
Inc.
(BIIB)

Zevalin (FDA-approved)

Ibritumomab tiuxetan; monoclonal antibody targeting CD20 combined with radioisotope

Diffuse large B-cell lymphoma

Data were presented showing drug is as effective as a second- line treatment in patients not eligible for stem cell transplantation (6/13)

BioVex Ltd.*
(UK)

OncoVEX

Oncolytic virus that delivers the gene for GM-CSF

Malignant melanoma

Got OK from the FDA to begin Phase II trials (6/6)

Celgene Corp.
(CELG)

Revlimid

Lenalidomide; derivative of Thalomid (thalidomide)

Myelodysplastic syndromes

Data from ongoing Phase II (MDS-002) trial showed 51% of patients responded to treatment; 33% became transfusion independent (6/6)

Cell
Genesys
Inc.
(CEGE)

GVAX

Vaccine comprises non-patient-specific tumor cells modifiedto secrete GM-CSF

Cancers

Company is ending development in lung cancer and myeloma as part of move to save money by focusing on the most promising indications (6/7)

Chiron Corp.
(CHIR)

CHIR-258

Orally available tyrosine kinase inhibitor

Multiple myeloma

Chiron and the Multiple Myeloma Research Consortium began a Phase I trial to assess safety, tolerability and pharmacokinetics in patients (6/2)

Cytogen
Corp.
(CYTO)

Quadramet (FDA-approved)

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

Cancers

Positive data were reported from studies in prostate cancer and bone metastases (6/21)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Non-Hodgkin's lymphoma

Trial with rituximab in 35 relapsed/ refractory patients showed an overall response rate of 42% (6/13)

Genentech
Inc.
(NYSE:DNA)
and Curis
Inc.
(CRIS)

--

Topical antagonist of the Hedgehog signaling pathway

Basal-cell carcinoma

Began Phase I trial to evaluate safety and tolerability of a multi-dose regimen in patients (6/8)

Genmab A/S
(Denmark;
CSE:GEN)

HuMax-CD20

Human antibody that binds to the CD20 antigen

Follicular non- Hodgkin's lymphoma

Objective response rates of up to 63% were seen in relapsed/refractory patients still in follow-up from Phase I/II safety trial (6/10)

Human Genome
Sciences Inc.
(HGSI)

HGS-ETR1

Mapatumumab; agonistic human monoclonal antibody to TRAIL receptor 1

Advanced non- Hodgkin's lymphoma

Interim data from Phase II trial in 40 patients demonstrated tolerability and signs of clinical activity (6/13)

ImClone
Systems Inc.
(IMCL) and
Bristol-Myers
Squibb Co.

Erbitux
(FDA-approved)

Cetuximab; antibody that blocks the epidermal growth factor receptor

Head and neck cancer

Analysis of Phase III IMCL-9815 trial with radiation in first-line treatment confirmed it met its primary endpoint of locoregional control vs. radiation alone (6/8)

ImmunoGen
Inc.
(IMGN)

huC242-DM4

Tumor-activated prodrug targeting the CanAg antigen

Cancers

Began Phase I trial in patients to evaluate safety, pharmacokinetics and dosing(6/24)

Introgen
Therapeutics
Inc.
(INGN)

Advexin

Adenoviral vector containing the p53 tumor-suppressor gene

Various cancers

Presented data showing potential applications of the drug alone and in combination therapies in several cancers (6/2)

Kosan
Biosciences
Inc.
(KOSN)

KOS-1022 (DMAG)

Second-generation heat- shock protein 90 inhibitor

Hematologic malignancies

Began a Phase I trial to assess safety and pharmacokinetics of escalating doses in patients with leukemias (6/6)

Kosan
Biosciences
Inc.
(KOSN)

KOS-953

17-AAG; designed to inhibit heat-shock protein 90

Multiple myeloma

Preliminary Phase I single-agent data and data from a Phase Ib combination trial both showed signs of anticancer activity(6/3)

MediciNova
Inc.
(OSE:
4875)

MN-029

Vascular-targeting agent

Solid tumors

The company began a second Phase I trial of the drug (6/17)

MediGene AG
(Germany; FSE:
MDG)

G207

Herpes simplex virus engineered to replicate in and kill cancer cells

Malignant melanoma

Began Phase I trial to evaluate safety, tolerability, efficacy trends and synergies with radiation therapy in about 20 patients (6/9)

MediGene AG
(Germany; FSE:
MDG)

Polyphenon E Ointment

Product from green tea leaves designed to block virus binding to cells

Actinic keratosis

Phase II trial in 62 patients showed a reduction in visible skin lesions vs. placebo (6/30)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade
(FDA-approved)

Bortezomib; proteasome inhibitor

Various lymphomas

Positive data were reported from

a Phase II trial with rituximab in indolent lymphoma (6/13)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade
(FDA-approved)

Bortezomib; proteasome inhibitor

Multiple myeloma

Published data from single-agent and combination Phase II trials showed overall response rates ranging from 88% to 95% (6/8); Phase III APEX trial showed superiorty to dexamethasone in patients with relapsed MM (6/16)

NeoPharm
Inc.
(NEOL)

IL13-PE38QQR

Tumor-targeting agent designed to deliver bacterial cytotoxic PE38

Glioblastoma multiforme

Monitors recommended Phase III PRECISE trial continue as planned, following an interim analysis (6/27)

Northwest
Biotherapeutics
Inc.
(OTC BB:NWBT)

DCVax-Brain

Dendritic cell-based immunotherapy made from patients' cells

Brain cancer

Starting a Phase II trial in 150 newly diagnosed glioblastoma multiforme patients (6/1)

Peregrine
Pharmaceuticals
Inc.
(PPHM)

Cotara

Chimeric tumor-necrosis therapy antibody attached to iodine-131

Brain cancer

51-patient study validated the use of convection-enhanced delivery for administering Cotara (6/1)

Point
Therapeutics
Inc.
(POTP)

Talabostat

Small molecule designed to stimulate proliferation of hematopoietic progenitor cells

Metastatic pancreatic cancer

Began Phase II trial in up to 60 patients to evaluate six-month survival and other endpoints in combination with gemcitabine (6/23)

TransMolecular
Inc.*

131I-TM-601

Radiopharmaceutical containing a synthetic version of chlorotoxin (TM-601), which is derived from scorpion venom

Recurrent high-grade glioma

Began Phase II trial; initially, dosing will be tested in 12 patients; then safety and efficacy will be evaluated in 54 patients (6/1)

Vertex
Pharmaceuticals
Inc.
(VRTX) and
Merck & Co. Inc.

VX-680

Small-molecule inhibitor of Aurora kinases

Hematologic cancers

They began an additional Phase I trial to evaluate safety and tolerability in patients with hematologic malignancies (6/17)

CARDIOVASCULAR

Affymax Inc.*

Hematide

Peptide-based erythropoiesis- stimulating agent

Anemia

Phase I trial in healthy volunteers demonstrated safety and a sustained effect on red blood cell production (6/7)

Alexion
Pharmaceuticals
Inc.
(ALXN)

Eculizumab

Humanized monoclonal antibody designed to block complement protein C5

Paroxysmal nocturnal hemoglobinuria

Follow-up data from a pilot trial showed drug maintained statistically significant reductions in red blood cell destruction and blood transfusions (6/28)

Alteon Inc.
(AMEX:ALT)

Alagebrium

A.G.E. crosslink breaker

Systolic hypertension

Discontinued Phase IIb SPECTRA trial after interim evaluation indicated the drug had not demonstrated efficacy (6/9)

Arginox
Pharmaceuticals
Inc.*

Tilarginine
acetate

Agent designed to inhibit the production of nitric oxide

Cardiogenic shock

Began pivotal Phase III TRIUMPH trial that will evaluate reduced mortality vs. placebo in 650 patients (6/28)

CardioVascular
BioTherapeutics
Inc.
(OTC BB:CVBT)

Cardio Vascu-Grow

Agent designed to facilitate the growth of new blood vessels

Coronary heart disease

Monitors who reviewed data from four patients in a Phase I trial concluded it was safe to continue (6/15)

CoTherix Inc.
(CTRX)

Ventavis (FDA-approved)

Inhaled formulation of iloprost, a prostacyclin analogue

Pulmonary hypertension

Began Phase II ACTIVE trial to assess safety and efficacy in 50 patients with PH associated with idiopathic pulmonary fibrosis (6/1)

Dyax Corp.
(DYAX) and
Genzyme
Corp.
(GENZ)

DX-88

Recombinant small protein designed to inhibit human plasma kallikrein

Hereditary angioedema

Phase I data will allow for subcutaneous rather than intravenous delivery; also, reported positive interim data from the first 120 HAE attacks in a Phase II trial (6/30)

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 301012

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

Cholesterol management

Phase I trial in 36 volunteers showed rapid and prolonged reductions in ApoB- 00, along with reductions in lipoprotein and total cholesterol levels (6/9)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Integrilin (FDA-approved)

Eptifibide; glycoprotein IIb/IIIa inhibitor

Acute coronary syndromes

Began EARLY ACS trial to assess safety and efficacy vs. placebo in 10,500 patients with non-ST elevation ACS (6/28)

Myogen Inc.
(MYOG)

Enoximone

Small-molecule inhibitor of Type III phospho-diesterase

Chronic heart failure

Phase III ESSENTIAL I & II trials in patients with advanced CHF failed to demonstrate a statistically significant benefit in any of the three co-primary endpoints(6/26)

Sangamo
BioSciences
Inc.
(SGMO)
and Edwards
Lifesciences Corp.

EW-A-401

Agent encoding a zinc finger DNA-binding protein transcription factor designed to activate all isoforms of the VEGF-A gene

Critical limb ischemia

Began a Phase I trial in up to 16 patients to assess safety, as well as to gather efficacy data (6/23)

Surface
Logix Inc.*

SLx-2101

Selective, oral PDE-5 inhibitor

Cardiovascular diseases

Began a Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy male subjects (6/8)

V.I.
Technologies
Inc.
(VITX)

Inactine

Pathogen-reduction system

Blood substitute

The company is ending development of the product; enrollment was suspended in a Phase III trial in November 2004 after an adverse event was seen (6/30)

ZymoGenetics
Inc.
(ZGEN)

rhThrombin

Recombinant human thrombin

For use in intraoperative bleeding

Phase II trial showed the product may be a safe and effective tool to stop bleeding in vascular surgery (6/20)

CENTRAL NERVOUS SYSTEM

Acadia
Pharmaceuticals
Inc.
(ACAD)

ACP-103

Small-molecule, 5-HT2A inverse agonist

Parkinson's disease

An interim trend analysis from the first 30 patients in a Phase II trial showed improved reductions in psychotic symptoms vs. placebo (6/22)

Amarin Corp.
plc
(UK; AMRN)

Miraxion (LAX-101c)

Compound that inhibits certain enzymes, including phospholipases and caspases

Huntington's disease

Began Phase III trial to assess the drug's impact on signs and symptoms in 300 patients with mild to moderate HD (6/14)

Aradigm
Corp.
(ARDM)

Intraject system

Needle-free delivery system for a triptan

Migraine and cluster headaches

Self-injection study in healthy subjects achieved bioequivalent blood plasma levels to a marketed injected product (6/29)

Arena
Pharmaceuticals
Inc.
(ARNA)

APD125

Antagonist at the 5-HT2A serotonin receptor

Insomnia

Phase I trial demonstrated safety and a statistically significant increase in the amount of deep sleep, and positive signals in other sleep parameters (6/30)

Avanir
Pharmaceuticals
Inc.
(AMEX:AVN)

Neurodex

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Diabetic neuropathic pain

Began Phase III trial that will assess efficacy, safety and tolerability vs. placebo (6/23)

Cortex
Pharmaceuticals
Inc.
(AMEX:COR)

CX717

Ampakine analogue

Sleep deprivation

The Defense Advanced Research Projects Agency is sponsoring a trial using a simulated night shift work paradigm (6/21)

Myriad
Genetics Inc.
(MYGN)

Flurizan

Selective amyloid beta 42 lowering agent

Alzheimer's disease

Moderate AD patients given 800 mg twice daily demonstrated a 45% slowing of decline (p=0.059) in their performance of activities of daily living (6/20)

Neurochem
Inc.
(Canada;
NRMX)

Alzhemed

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

Alzheimer's disease

Monitors recommended continuation of Phase III trial after second interim review, including data from 742 patients (6/13)

Neurocrine
Biosciences
Inc.
(NBIX)

Indiplon

Capsule form of a non- benzodiazepine agent that targets the GABA-A receptor

Insomnia

Phase III trial in 358 elderly patients showed significant improvements in latency to sleep onset; another study in elderly patients demonstrated significant improvement in sleep maintenance vs. placebo (6/14)

NeurogesX
Inc.*

NGX-4010

High-concentration trans- capsaicin dermal patch

Postherpetic neuralgia

Began 300-patient Phase III trial to study pain reduction vs. a control patch (6/15)

Neurologix
Inc.
(OTC BB:NRGX)

--

Gene therapy entailing injection of a virus directly into the brain

Parkinson's disease

Preliminary data from Phase I trial in 12 patients suggested no safety concerns (6/8)

Sepracor
Inc.
(SEPR)

Lunesta (FDA-approved)

Eszopiclone tablets; a non- enzodiazepine agent

Insomnia

Positive data were presented from trials with Prozac in patients with major depressive disorder (6/21); statistically significant data were reported in two other patient populations (6/20)

Solstice
Neurosciences
Inc.*

Myobloc (FDA-approved)

Botulinum toxin type B

Cervical dystonia

Head-to-head trial in 111 toxin-naive subjects with CD showed drug to be clinically equivalent to Botox for efficacy (6/21)

Somaxon
Pharmaceuticals
Inc.*

Silenor

Low dose of the approved depression drug doxepin

Insomnia

Began a Phase III trial that will measure sleep maintenance, as well as sleep onset and duration (6/9)

TorreyPines
Therapeutics*

NGX267

Selective cholinergic muscarinic receptor agonist (M1 subtype)

Alzheimer's disease

Filed an IND to begin clinical testing of the product (6/7)

DIABETES

Agennix Inc.*

Talactoferrin

Topical talactoferrin alfa

Diabetic ulcers

Phase II trial in 55 patients met its primary endpoint of 75% or better healing at the end of 12-week dosing (6/13)

Alkermes
Inc.
(ALKS ) and
Eli Lilly and Co.

--

Inhaled insulin system based on Alkermes' AIR delivery technology

Type I diabetes

Phase II trial in 259 patients showed similar blood sugar levels to treatment with injected insulin (6/14)

Amylin
Pharmaceuticals
Inc.
(AMLN) and
Eli Lilly and Co.

Byetta (FDA-approved)

Exenatide; incretin mimetic

Type II diabetes

Long-term data from open-label extension of pivotal trial showed sustained improvements in glucose control and progressive weight reduction (6/10)

Amylin
Pharmaceuticals
Inc.
(AMLN)

Symlin (FDA-approved)

Pramlintide acetate; an analogue of human amylin

Type I and II diabetes

Phase II trial in 204 obese diabetics showed a statistically significant 3.6% weight loss vs. placebo (6/3)

Generex
Biotechnology
Corp.
(Canada;
GNBT)

Oral-lyn

Oral insulin spray formulation

Diabetes

Presented data from various studies showing glucodynamic profiles and metabolic effects (6/14)

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 113715

Antisense inhibitor of protein tyrosine phosphatase (PTP-1B)

Type II diabetes

Interim data from Phase II trial showed drug reduced HbA1C and plasma glucose after six weeks of dosing (6/14)

Keryx Bio-
pharmaceuticals
Inc.
(KERX)

KRX-101

Sulodexidel; oral heparinoid compound

Diabetic nephropathy

Began Phase III trial to test the drug against placebo in about 1,000 patients; also began Phase IV study in 2,200 patients (6/29)

MannKind
Corp.
(MNKD)

Technosphere Insulin

Dry-powder, inhaled insulin formulaiton

Type II diabetes

Data from two studies showed the benefit of use in conjunction with an oral diabetes medication (6/14); began pivotal Phase III trial to evaluate pulmonary safety (6/29)

Nektar
Therapeutics
Inc.
(NKTR)

Exubera

Dry-powder, inhaled insulin formulation

Type I and II diabetes

Two-year Phase III trials demonstrated effective, sustained glycemic control in Type II patients; trial in 226 Type I patients showed effectiveness in achieving tight glycemic control (6/14)

INFECTION

Barrier
Therapeutics
Inc.
(BTRX)

Hyphanox

Tablet formulation of itraconazole, an antifungal agent

Vaginal candidiasis

Phase III non-inferiority trial failed to meets its primary endpoint of therapeutic cure vs. fluconazole (6/29)

Cadence
Pharmaceuticals
Inc.*
and
Migenix Inc.*
(Canada)

CPI-226 (MX-226)

Omiganan pentahydro-
chloride; a topical antibiotic

Catheter-related infections

Starting a Phase III trial under an FDA SPA to evaluate efficacy vs. 10% povidone-iodine in about 1,250 patients (6/27)

Chemokine
Therapeutics
Corp.
(Canada;
TSE:CTI)

CTCE-0214

Stable peptide agonist of stromal cell-derived factor-1

Infections

Phase I trial in 24 subject demonstrated safety and efficacy results that warrant continued investigation (6/1)

Chiron Corp.
(CHIR)

PA-824

Tuberculosis drug candidate

Tuberculosis

The Global Alliance for TB Drug Development began Phase I trials (6/14)

Cubist
Pharmaceuticals
Inc.
(CBST)

Cubicin (FDA-approved)

Daptomycin for injection; a bactericidal antibiotic

Staphylococcus aureus

Phase III endocarditis and bacteremia trial met its primary end-points of non-inferiority; an sNDA filing is planned (6/27)

DOR
BioPharma
Inc.
(AMEX:DOR)

RiVax

Fragment of ricin toxin

Ricin vaccine

Early results from Phase I trial in volunteers showed the agent was safe and immunogenic (6/15)

Dynavax
Technologies
Corp.
(DVAX)

--

Vaccine combining immunostimulatory sequence with HBV surface antigen

Hepatitis B

Phase II/III trial in older population showed statistically significant superiority in protective antibody response and robustness of protective effect vs. Engerix-B (6/14) began pivotal Phase III trial to compare efficacy to Engerix-B in 400 older patients (6/23)

Gilead Sciences
Inc.
(GILD)

Hepsera (FDA-approved)

Adefovir dipivoxil; a nucleotide analogue

Hepatitis B

Phase III Study 438 in 185 patients supported the efficacy and tolerability of the drug at 144 weeks (6/30)

Gilead
Sciences Inc.
(GILD)

GS 9137 (JTK-303)

Oral HIV integrase inhibitor

HIV

Began Phase I/II trial to evaluate tolerability, safety and antiviral activity in HIV-positive patients (6/21)

Immtech
International
Inc.
(AMEX:IMM)

DB289

Oral, dicationic antiviral agent

African sleeping sickness

FDA agreed to SPA on pivotal Phase III trial that will evaluate efficacy vs. pentamidine in 250 patients in Africa (6/16)

MedImmune
Inc.
(MEDI)

CAIV-T

Trivalent vaccine; next generation of FluMist

Influenza

Phase III trial met its objective of producing similar immune responses to FluMist (6/16)

Oscient
Pharmaceuticals
Corp.
(OSCI)

Factive (FDA-approved)

Gemifloxacin mesylate; a fluoroquinolone antibiotic

Community- acquired pneumonia

Pivotal Phase III trial in 460 patients showed non-inferiority of five-day treatment vs. the approved seven-day treatment (6/6)

Protein
Sciences Corp.*

FluBIOk

Influenza vaccine derived from recombinant hemagglutinin

Influenza

Trial in 460 healthy subjects met its primary endpoints by showing safety and inducing strong titers against influenza (6/14)

SciClone
Pharmaceuticals
Inc.
(SCLN)

Zadaxin

Synthetic preparation of thymosin alpha-1

Hepatitis C

Six of 30 nonresponsive patients taking drug with pegylated interferon alpha and ribavirin achieved a sustained viral response (6/21)

TaiGen
Biotechnology
Co. Ltd.*
(Taiwan)

TG-873870

Novel quinolone antibiotic

Infections

Began a Phase Ib trial that will examine safety and dosing (6/18)

MISCELLANEOUS

Alteon Inc.
(AMEX:ALT)

Alagebrium

A.G.E. crosslink breaker

Erectile dysfunction in diabetics

The FDA put a hold on Phase IIa EMERALD trial pending submission of additional data on preclinical toxicity tests (6/9)

Altus
Pharmaceuticals
Inc.*

TheraCLEC

Oral enzyme-replacement therapy designed to replace digestive enzymes

Pancreatic insufficiency

Phase II trial in 125 patients with cystic fibrosis demonstrated a statistically significant improvement in fat absorption (6/20)

Altus
Pharmaceuticals
Inc.*

ALTU-238

Long-acting crystalline formulation of recombinant human growth hormone

Growth hormone deficiency

Successfully completed Phase I trial and said it plans to begin a Phase II trial in adults (6/6)

Arena
Pharmaceuticals
Inc.
(ARNA)

APD356

Small-molecule, selective 5HT2C serotonin receptor agonist

Obesity

Began Phase IIb trial to evaluate safety and weight loss over 12 weeks in 400 patients (6/23)

CollaGenex
Pharmaceuticals
Inc.
(CGPI)

Oracea

Non-antimicrobial tetracycline derivative

Rosacea

Two Phase III trials totaling 537 patients demonstrated statistical significance vs. placebo (6/6)

Genaera
Corp.
(GENR)

Evizon (squalamine)

Anti-angiogenesis agent; vascular endothelial growth factor inhibitor

Wet age-related macular degeneration

Reached agreement with FDA on SPA for pivotal trials (6/27); began first of two trials under the SPA, a trial to demonstrate safety and benefit on visual acuity at one year (6/30)

Halozyme
Therapeutics
Inc.
(AMEX:HTI)

Cumulase

Ex vivo formulation of recombinant human PH20 hyaluronidase

Treatment of oocytes

Drug-treated oocytes demonstrated significantly increased fertilization rates in a trial vs. the standard bovine-derived hyaluronidase extract (6/22)

Halozyme
Therapeutics
Inc.
(AMEX:HTI)

rHuPH20

Recombinant human hyaluronidase

For use in breaking down hyaluronan

Phase I trial in 100 volunteers showed no allergic reactions to the product (6/21)

Indevus
Pharmaceuticals
Inc.
(IDEV)

Sanctura
XR

Once-daily version of FDA-approved trospium chloride agent

Overactive bladder

Pilot Phase II trial demonstrated similar efficacy to the approved twice-daily drug (6/15)

Isolagen Inc.
(AMEX:ILE)

Isolagen Process

Autologous cellular therapy

Interdental papillary insufficiency

Phase II trial demonstrated statistical superiority to placebo at four months after treatment (6/30)

Neurochem
Inc.
(Canada;
NRMX)

Fibrillex

Glycosaminoglycan mimetic with anti- myloid properties

Amyloid A amyloidosis

Further analyses from Phase II/III trial showed reductions in the risk of renal decline or all-cause mortality (6/5); another analysis showed early clinical effect (6/9)

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Investigational drug for BPH

Benign prostatic hyperplasia

Follow-up data from 18-23 months in Phase I and II trials showed statistically significant symptomatic improvements (6/8)

Sucampo
Pharmaceuticals
Inc.*

Tacrolimus

Eye-drop formulation of tacrolimus

Dry-eye syndrome

Company voluntarily suspended development program after safety concerns were seen in another product containing tacrolimus (6/24)

Symbollon
Pharmaceuticals
Inc.
(OTC BB:SYMBA)

IoGen

Iodine-based oral drug

Breast pain associated with fibrocystic breast disease

Began first Phase III pivotal trial of drug to evaluate clinical effects in about 175 women (6/14)

Santarus Inc.
(SNTS)

Zegerid

Immediate-release capsule formulation of the proton pump inhibitor omeprazole

Gastrointestinal conditions

Trial in 36 patients showed significantly reduced gastric acidity throughout the night vs. Protonix (6/14)

Tercica Inc.
(TRCA)

Increlex

Mecasermin injection; recombinant human insulin-like growth factor-1

Short stature caused by IGF deficiency

Presented pharmacokinetic and safety data from various studies (6/6 and 6/7)

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

GSK159797

Inhaled, longer-acting Beta2 agonist

For use as a bronchodilator

Phase II trial showed clinically significant increases in bronchodilation over 24 hours with little impact on heart rate (6/27)

Theravance
Inc.
(THRX)

GSK656398 (formerly TD-5742)

Inhaled, long-acting muscarinic antagonist; bronchodilator

Chronic obstructive pulmonary disease

Partner GlaxoSmithKline plc began Phase I trial to assess safety, tolerability and pharmaco-kinetics (6/13)

Threshold
Pharmaceuticals
Inc.
(THLD)

TH-070

lonidamine; an indazole- 3-carboxylic acid

Benign prostatic hyperplasia

Began Phase II trial to evaluate dosing, safety and activity in about 200 patients (6/27)

Transkaryotic
Therapies Inc.
(TKTX)

Iduronate-2- sulfatase

Enzyme-replacement therapy

Hunter syndrome (MPS II)

Pivotal Phase III AIM trial showed a statistically significant improvement in forced vital capacity and six-minute walk test, the primary endpoints (6/20)

Vernalis plc
(UK; VNLS)

Frova (FDA-approved)

Frovatriptan; 5HT 1B/1D agonist

Menstrually related migraine

Six-month data from Phase III trial indicate the drug is well tolerated; no serious adverse events were reported (6/27)

Vivus Inc.
(VVUS)

Avanafil

Oral phosphodiesterase type-5 inhibitor

Erectile dysfunction

Phase II trial in 284 patients demonstrated statistical significance vs. placebo (6/23)


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.

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