Company (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Corixa Corp. (CRXA) and Genesis Research and Development Corp. Ltd. (Australia; ASX:GEN)

PVAC

Immunotherapeutic based on a process an formulation derived from heat-killed Mycobacterium vaccae

Psoriasis

Companies discontinue development after Phase II trial failed to demonstrate a reduction in psoriasis compared to placebo; the product also did not improve treatmen with standard ultraviolet light therapy (12/22)

Genmab A/S
(Denmark; CSE:GEN)

HuMax-CD4

Human antibody that targets the CD4 receptor on T lymphocytes

Psoriasis

Company said Phase IIb trial in 118 patients did not achieve statistical significance company is ending development in psoriasis (12/12)

Genzyme
Corp.
(GENZ)

Genz-29155

Small molecule designed to inhibit some activities of tumor necrosis factor

Multiple sclerosis

Company started a Phase I trial to test safety in up to 56 healthy volunteers (12/12)

MedImmune
Inc.
(MEDI)

Vitaxin

Monoclonal antibody that targets the alpha-v beta-3 integrin

Psoriasis

MedImmune began a Phase II trial in 180 patients with plaque psorisis, comparing safety and activity of Vitaxin to placebo (12/17)

Millennium Pharmaceuticals
Inc.
(MLNM) and
Aventis SA (France)

MLN3897 (AVE-9897)

Small molecule designed to block CCR1, a chemokine receptor

Inflammatory disease

Companies started a Phase I trial to evaluate safety, tolerability and pharmacokinetics and to get preliminary information on receptor-binding properties (12/22)

Protein Design
Labs Inc.
(PDLI)

Nuvion (visilizumab)

Humanized monoclonal antibody directed at CD3 antigen on activated T cells

Ulcerative colitis

PDL started open-label Phase I/II trial in patients with severe disease who had not responded to intravenous steroids (12/11)

Tularik
Inc.
(TLRK)

T487

Product binds to CXCR3, a receptor found on the surface of lymphocytes

Psoriasis

Tularik began a Phase II safety and efficacy trial comparing the drug to placebo in about 40 patients (12/10)

CANCER

Aastrom Biosciences
Inc.
(ASTM)

--

Vaccine produced by loading tumor-associate peptide antigens onto patient's blood-derived dendritic cells

Gastrointestinal cancers

Phase I trial started to examine the safety, feasibility, immune outcome and efficacy (12/11)

AEterna Laboratories Inc. (Canada; AELA)

Neovastat

Anti-angiogenic drug

Non-small-cell lung cancer and renal-cell carcinoma

AEterna said it will continue the Phase III lung cancer trial but is ending development of the drug in kidney cancer (12/17)

Amgen
Inc.
(AMGN)

Palifermin

Recombinant human keratinocyte growth factor

Oral mucositis in cancer patients

Additional data from Phase III trial in 212 patients showed drug was associated with a statistically significant improvement in mouth and throat soreness (12/8)

Amgen
Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa, a recombinant erythropoietic protein

Anemia of cancer

Interim analysis of trial's first 150 patients with nonmyeloid malignancy showed improvement vs. control in mean change in hemoglobin levels (12/6); a head-to-head study showed Aranesp dosed every two weeks provided similar results to epoetin alfa dosed once weekly in boosting hemoglobin and reducing the need for blood transfusions (12/7)

American
BioSciences
Inc.*

Abraxane

Paclitaxel delivered via albumin-bound nanoparticle

Metastatic breast cancer

Company said researchers reported Phase III data showing drug produced higher response rates and longer time to tumor progression than Taxol (12/5)

AnorMED Inc.
(Canada; TSE:AOM)

AMD3100

Drug designed to block receptor triggering movement of stem cells out of bone marrow

Stem cell transplantation in cancer patients

Phase II data showed drug used with G-CSF improved generation of stem cells vs. G-CSF alone (12/7)

Antigenics
Inc.
(AGEN)

Oncophage

Personalized cancer vaccine based on heat- shock protein technology

Renal-cell carcinoma

Data monitoring committee said trial should continue as planned, following interim analysis of 650-patient Phase III trial (12/22)

Antigenics
Inc.
(AGEN)

Oncophage

Personalized cancer vaccine based on heat-shock protein technology

Non-Hodgkin's lymphoma

Lead investigator from Phase II study reported clinical activity in eight out of 14 evaluable patients who has newly diagnosed or relapsed low-grade, indolent disease (12/9)

Antigenics
Inc.
(AGEN)

HSPPC-70

Personalized cancer vaccine based on heat- shock protein technology

Chronic myelogenous leukemia

Preliminary data from a Phase I trial in combination with Gleevec showed immunological response in 11 of 17 patients (12/9)

Aton Pharma
Inc.*

SAHA

Oral suberoylanilide hydroxamic acid, a histone deacetylase inhibitor

Cancers

Aton presented data from various studies in blood cancers, including encouraging results from Phase II trial in cutaneous T- cell lymphoma (12/9)

BioCryst
Pharmaceutials
Inc. (BCRX)

BCX-1777

Inhibitor of the enzyme purine nucleoside phosphorylase

T-cell malignancies

Four of five patients in Phase I trial showed a decrease in malignant cell counts (12/8)

Biogen Idec
Inc.
(BIIB)

Zevalin (FDA-approved)

Ibritumomab tiuxetan; monoclonal antibody targeting CD20 combined with radioisotope

Non-Hodgkin's lymphoma

Data supported Zevalin's ability to induce long-term, durable remissions in relapsed, refractory or transformed indolent B-cell disease; other data indicated drug has promise in mantle-cell lymphoma (12/6)

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

Theratope

Vaccine combining mimic of cancer antigen sialyl-Tn and carrier molecule KLH

Metastatic breast cancer

Companies released final results from Phase III trial that failed; new analysis showed possible survival benefit in subset of women who received hormonal treatment following chemotherapy (12/8)

Celgene
Corp
. (CELG)

Actimid (CC-4047)

Immunomodulatory drug

Multiple myeloma

Data from Phase I/II trial showed more than 90% of 44 patients achieved stabilization of disease or better (12/9)

Celgene
Corp.
(CELG)

Revimid (CC-5013)

Immunomodulatory drug

Multiple myeloma

Phase II data showed 73 of 91 evaluable patients with progressive disease had a reduction or stabilization in their para-protein levels (12/9)

Cell Genesys
Inc.
(CEGE)

GVAX

Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF

Leukemia

Preliminary findings of Phase II trial indicated vaccine was well tolerated and may reduce residual leukemic cells, as indicated by decreased levels of WT-1, a genetic marker (12/6)

Cell Therapeutics
Inc.
(CTIC)

Trisenox (FDA-approved)

Arsenic trioxide

Acute promyelocytic leukemia

Data from two studies of drug and all-trans retinoic acid showed complete response rates in excess of 90% (12/9)

Cel-Sci Corp. (AMEX:CVM)

Multikine

Mixture of human cytokines designed to stimulate an immune response

Head and neck cancer

Data from Phase I/II trial in 54 patients with advance disease showed the drug rendered the majority of cancer cells susceptible to radiation therapy (12/8)

Centocor Inc. (unit of Johnson & Johnson)

CNTO 95

Fully human antibody targeting the integrin receptors implicated in angiogenesis

Cancers

Centocor started a Phase I trial of the product generated with Medarix Inc. technology (12/11)

Corixa Corp.
(CRXA) and GlaxoSmithKline
plc (UK)

Bexxar

Tositumomab and I-131 tositumomab; radiolabeled monoclonal antibody that binds to CD20 antigen

Lymphomas

Various studies showed the drug was active in a number of patients with difficult-to-treat lymphomas (12/8)

Cytogen
Corp.
(CYTO)

Quadramet

Samarium-153 lexidrona injection; skeletal-targeting radiopharmaceutical

Bone pain in multiple myeloma

Data from a pilot study showed Quadramet in combination with zoledronic acid provided significant pain relief in elderly patients resistant to chemotherapy (12/8)

EntreMed
Inc.
(ENMD)

Panzem

2-methoxyestradiol; naturall occurring metabolite of endogenous estrogen

Multiple myelom

Preliminary Phase II data demonstrated drug was well tolerated and stabilized disease in patients with plateau or relapsed multiple myeloma (12/7)

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

Rituxan (FDA-approved)

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

Non-Hodgkin's lymphoma

Patients in Phase II trial with indolent disease who received Rituxan maintenance therapy had 31 months of progression-free survival, compared to eight months for those re-treated with Rituxan at the time of disease progression (12/8)

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

Rituxan (FDA-approved)

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

Aggressive lymphomas

Phase III trial named MInT comparing drug plus chemotherapy to chemotherapy alone was stopped early by monitoring board after meeting efficacy endpoint of improving time to treatment failure (12/7)

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

Rituxan (FDA-approved)

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

Non-Hodgkin's lymphom with indolent disease showed

Phase III trial as a front-line and maintenance therapy in treating newly diagnosed, diffuse, large, B-cell or aggressive disease showed benefit in time to disease progression when combined with CHOP regimen vs. CHOP alone; another Phase III trial in untreated patients time to failure of 26 months for drug with CVP regimen vs. seven months for CVP alone (12/7)

Genentech Inc. (NYSE:DNA) and Hoffmann-La Roche
Inc.

Herceptin (FDA-approved)

Trastuzumab; monoclonal antibody against HER-2/neu protein

HER-2-positive metastatic breast cancer

Phase II trial showed adding Herceptin to docetaxel resulted in an increase in median survival of 51%; overall response rate in 188-patient study also was significantly higher (12/4)

Genitope
Corp.
(GTOP)

MyVax Personalized Immunotherapy

Patient- and tumor-specific cell-surface idiotype protein, combined with keyhole limpet hemocyanin

Agressive non-Hodgkin's lymphoma

Phase II trial in 27 patients showed patients treated with accelerated regimen may have more extended remissions (12/8)

Genmab A/S
(Denmark;
CSE:GEN)

HuMax-CD20

Human antibody that binds to the CD20 antigen

Relapsed follicular lymphoma

Genmab filed for approval in the U.S. and UK for dose-escalation Phase I/II trial in 40 patients (12/19)

Genmab A/S
(Denmark; CSE:GEN)

HuMax-CD4

Human antibody that targets the CD4 receptor

Cutaneous T-cell lymphoma

Interim results from two Phase II trials showed 55% of the early stage and 38% of the advanced-stage patients achieved at least a partial response (12/7)

Genta
Inc.
(GNTA)

Genasense

Oblimersen sodium, inhibits function of bcl-2 protein

Multiple myeloma

Genta reported presentation of several studies showing drug enhances the activity of many types of chemotherapy (12/9)

Genta
Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Non-Hodgkin's lymphoma

Investigators in several studies reported drug could be used synergistically to enhance the activity of Rituxan (12/9)

Genta
Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Acute myeloid leukemia

Presentations from studies in patients older than 60 showed safety and potentially enhanced activity when chemotherapy was combined with drug (12/8)

Geron
Corp.
(GERN)

--

Telomerase therapeutic vaccine

Metastatic prostate cancer

Additional Phase I/II data showed all but one of 24 patients had telomerase-specific cellular immune responses, and there were no adverse effects; three patients in high-dose group had stablization of serum PSA values (12/8)

Human
Genome
Sciences
Inc.
(HGSI)

LymphoRad-131

Radioiodinated form of B-lymphocyte stimulator protein

Non-Hodgkin's lymphoma

Interim results from ongoing Phase I trial showed the drug was well tolerated and biologically active (12/9)

ILEX Oncology
Inc.
(ILXO)

Campath (FDA-approved)

Humanized monoclonal antibody that binds to CD52 on cell surfaces

B-cell chronic lymphocytic leukemia

Preliminary data from Phase III trial evaluating drug in front-line therapy vs. chlorambucin showed comparable safety, and monitors said trial shoud continue; other data showed drug cleared residual bone marrow disease in most of 29 patients (12/8)

ILEX Oncology
Inc.
(ILXO) and Bioenvision Inc. (AMEX:BIV)

Oral clofarabine

Next-generation purine nucleoside antimetabolite

Pediatric acute leukemia

Interim results from Phase II trials showed an overall response rate of 29% in studies involving 65 children (12/9)

ILEX Oncology
Inc.
(ILXO) and Bioenvision Inc. (AMEX:BIV)

Oral clofarabine

Next-generation purine nucleoside antimetabolite

Acute myeloid leukemia or myelodysplatic syndrome

Phase I/II data in adults with first-relapsed and primary-refractory disease showed 41% response rate in trial combining drug with ara-C (12/8)

ILEX Oncology
Inc.
(ILXO) and Bioenvision Inc. (AMEX:BIV)

Oral clofarabine

Next-generation purine nucleoside antimetabolite

Locally advanced or refractory solid tumors

ILEX started a Phase I trial to test safety and tolerability in 25 patients (12/3)

Immunomedic
Inc.
(IMMU)

LymphoCide

Epratuzumab; humanized anti-CD22 antibody labeled with yttrium-90

Non-Hodgkin's lymphoma

Studies with unlabeled epratuzu- mab showed it could be combined safely with rituximab and CHOP regimen; trial with rituximab in indolent NHL showed the combination to be active in certain lymphoma subtypes, but efficacy ad- vantage was not seen (12/8)

Inex
Pharmaceuticals
Corp.
(Canada;
TSE:IEX)

Onco TCS

Vincristine encapsulated in Inex's liposomal delivery technology

Lymphoma

Data from Phase II trial showed overall response rate of 33% in refractory Hodgkin's disease; Phase II study in refractory dif- fuse large B-cell lymphoma had response rate of 56% in trial with Rituxan (12/8)

Introgen
Therapeutics
Inc. (INGN)

INGN 241

MDA-7 therapeutic; designed to produce the therapeutic protein

Solid tumors

Company presented final Phase I data showing drug was safe and clinically active (12/15)

Introgen
Therapeutics
Inc. (INGN)

INGN 225

Product using Advexin to stimulate dendritic cells, which are then used as a therapeutic vaccine

Advanced breast cancer

Company began a Phase I/II trial testing the vaccine in combination with chemotherapy (12/5)

Ligand
Pharmaceuticals
Inc.
(LGND)

Ontak (FDA-approved)

Denileukin diftitox

Various cancers

Data presented showed drug may benefit patients with chronic lymphocytic leukemia, B- and T-cell non-Hodgkin's lymphoma, and graft-vs.-host disease resistant to steroids; final Phase II data from NHL study showed drug benefited 54% of 39 patients (12/8)

Kosan Biosciences
Inc.
(KOSN)

KOS-862

Epothilone D

Cancers

Kosan started Phase II monotherapy trials in three solid-tumor indications; Kosan and partner Roche also will study KOS-862 in various combination trials (12/8)

Medarex
Inc.
(MEDX)

MDX-060

Fully human antibody believed to target CD30 on activated lymphocytes

Hodgkin's disease and anaplastic large- cell lymphoma

Phase I/II results showed one complete and two partial responses, and nine cases of stable disease among 31 patients with refractory disease (12/9)

MedImmune
Inc.
(MEDI)

Vitaxin

Monoclonal antibody that targets the alpha-v beta-3 integrin

Prostate cancer

MedImmune began a Phase II trial in 165 patients with androgen- independent disease that has metastasized to bone; it will be used with chemotherapy (12/17)

Millennium Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Proteasome inhibitor

Multiple myeloma

Company stopped control arm of Phase III APEX trial after monitoring committee saw statistical signifance for drug in patients with relapsed or refractory disease (12/15)

Millennium Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Proteasome inhibitor

Advanced, refractory multiple myeloma

Preliminary Phase I/II results from investigative study showed drug combined with thalidomide produced a partial response in more than 50% of patients; separate study with liposomal doxorubicin also showed benefit (12/9)

Millennium Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Proteasome inhibitor

Non-Hodgkin's lymphoma

Results of a Phase II trial showed overall response rate of 50% for 20 of the 22 evaluable patients in the mantle-cell lymphoma group; separate Phase II in indolent NHL also showed benefit (12/8)

NeoRx
Corp.
(NERX)

Skeletal Targeted Radiotherapy

Small-molecule carrier of the radionucleotide holmium-166

Multiple myeloma

Long-term follow-up from Phase I/II trial showed three-year survival rate of 90% of the 10 patients treated with the dose planned for Phase III (12/8)

Novuspharma SpA
(Italy; Nuovo Mercato: NOV)

Pixantrone

Anthracycline agent

Non-Hodgkin's lymphoma

Data from Phase I study in which drug was used as part of CHOP regimen showed a major objective response rate of 77% among 22 patients (12/9)

Pharmacyclics
Inc.
(PCYC)

Xcytrin

Motexafin gadolinium; small-molecule texaphyrin designed to inhibit apoptosis

Relapsed chronic lymphocytic leukemia

Company started a Phase II trial of the drug as a single agent in up to 30 patients (12/11)

Seattle Genetics
Inc.
(SGEN)

SGN-30

Monoclonal antibody

Hematologic malignancies

Phase I study in 24 patients with relapsed or refractory CD30-positive disease produced one compplete response and stable disease in six patients; drug was well tolerated (12/8)

SuperGen
Inc.
(SUPG)

Nipent (FDA-approved)

Pentostatin for injection

Chronic lymphocytic leukemia

Company presented data from five different trials showing the activity of the drug as part of combination therapy (12/8)

SuperGen
Inc.
(SUPG)

Nipent (FDA-approved)

Pentostatin for injection

Non-Hodgkin's lymphoma

Phase II study in combination with rituximab showed response rate of 60%; pilot combination study showed response rate of 83% in 24 patients, with nine complete responses (12/8)

VasGene
Therapeutics
Inc.*

Veglin

Antisense oligonucleotide that binds VEGF

Cancers

Phase I data on 26 refractory patients showed the drug was safe at various doses and demonstrated evidence of activity in some patients (12/8)

Xycte
Therapies Inc.*

Xcellerated T Cells

Activated T cells from patient designed to enhance natural immune responses

Chronic lyphocytic leukemia and multiple myeloma

Company presented data from Phase I/II trials that showed reduction of enlarged lymph nodes and spleens in CLL and recovery of lymphocytes and T cells in multiple myeloma (12/10)

CARDIOVASCULAR

Angiogenix
Inc.*

Acclaim

Organic nitrate combined with L-arginine

Chronic angina

Company began a 170-patient Phase II study in eight countries (12/8)

Celgene
Corp.
(CELG)

Revimid (CC-5013)

Immunomodulatory drug

Refractory anemias due to myelodysplastic syndromes

Phase II data showed 24 of 36 evaluable patients experienced an erythroid response to Revimid (12/8)

Cell Therapeutics
Inc.
(CTIC)

Trisenox (FDA-approved)

Arsenic trioxide

Myelodysplasia

Preliminary data from two Phase II trials showed 28 of 120 patients experienced a major or minor hematologic response (12/7)

Dyax
Corp.
(DYAX)

DX-88

Recombinant small protein designed to inhibit human plasma kallikrein

Bleeding control

Phase I trial in patients undergo- ing cardiopulmonary bypass in the course of coronary artery bypass graft surgery met pharmacokinetic and safety endpoints (12/26)

Esperion
Therapeutics
Inc.
(ESPR)

ETC-642

Complex of a 22-amino-acid peptide and phospholipids designed to mimic HDL

Acute coronary syndromes

Phase I trial showed agent was safe and well tolerated at all dose levels (12/16)

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 301012

Second-generation antisense inhibitor of ApoB-100

Cardiovascular disease

Isis began a Phase I study in 40 healthy volunteers with elevated cholesterol to assess safety, toler- ability and pharmacokinetics (12/29)

Northfield Laboratories
Inc.
(NFLD)

PolyHeme

Oxygen-carrying blood substitute derived from human blood

Blood loss

Company received clearance to begin enrollment in pivotal Phase III urban ambulance trial testing product against saline solution (12/22)

Novacea Inc.*

DN-101

Contains calcitriol, a naturally occurring hormone and the biologically active form of vitamin D

Myelodysplatic syndromes

Company stopped enrollment in single-agent trial after only two of first 15 patients achieved a response (12/22)

XOMA Ltd. (XOMA) and Millennium Pharmaceuticals Inc. (MLNM)

MLN2222 (CAB-2)

Recombinant protein complement inhibitor

Heart attack

Companies started Phase I trial in healthy volunteers to assess safety and other endpoints; drug is being developed for use with cardiopulmonary bypass (12/18)

ZymoGenetic
Inc.
(ZGEN)

rhThrombin

Recombinant human thrombin

Control of bleeding

ZymoGenetics plans to begin a Phase I/II dose-escalation study to assess safety and efficacy in spinal surgery (12/3)

CENTRAL NERVOUS SYSTEM

ExonHit Therapeutics SA* (France)

EHT 0202

Neuron protective agent

Neuro-degenerative disorders

ExonHit began a Phase I trial to assess safety in healthy volunteers (12/4)

Axonyx
Inc.
(AXYX)

Phenserine

Inhibitor of acetylcholin- esterase and beta-amyloid precursor protein

Alzheimer's disease

Company broadened Phase IIb trial to include a sub-study that will use brain scans to assess disease progression (12/19)

Cypress Bioscience Corp. (CYPD)

Milnacipran

Agent that acts on norepinephrine and serotonin

Fibromyalgia syndrome

Phase II data in 125 patients showed drug provided superior pain relief vs. placebo (12/11)

Icagen Inc.*

ICA-69673

Compound that targets an ion channel expressed primarily in the central nervous system

Epilepsy

Company started a Phase I trial in healthy male volunteers (12/23)

Neurochem Inc. (Canada; NRMX)

Alzhemed

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

Alzheimer's disease

Interim results in 23 patients in Phase II extension study showed benefit (12/9)

Neurocrine Inc. (NBIX)

Indiplon

Non-benzodiazapine that acts on specific subtype of GABA-A receptors

Insomnia

Preliminary results from Phase I/II trial showed statistically sig- nificant improvement in patients who wake up in the middle of the night (12/9)

NPS Pharmaceuticals
Inc.
(NPSP)

Isovaleramide (NPS 1776)

Broad-spectrum neuromodulator

Migraine

NPS began a Phase IIa trial in 200 patients, testing its effectiveness against placebo (12/16)

Phytopharm plc (UK; LSE:PYM)

PYM50018

Product based on Asian plant extract believed to have neuroprotective effects

Amyotrophic lateral sclerosis

Company got approval for Phase I trial in eight healthy adult subjects (12/3)

Repligen Corp. (RGEN)

RG1068

Synthetic human secretin

Refractory schizophrenia

Company initiated a Phase II trial to include 45 patients (12/10)

DIABETES

Depomed Inc. (AMEX:DMI) and Biovail Corp.
(Canada)

Metformin GR

Extended-release formulation of diabetes drug metformin

Type II diabetes

Companies reported second Phase III trial hit endpoint of controlling glucose levels; trial compared product and glyburide to glyburide alone (12/10)

INFECTION

Anadys Pharmaceuticals Inc.*

Isatoribine (ANA245)

Nucleoside analogue believed to act on Toll-like receptor 7

Chronic hepatitis C

Results from Phase Ib trial showed drug was safe and well tolerated, and appeared biologically active in HCV patients (12/5); another presentation showed a decrease in viral load (12/17)

AVI BioPharma
Inc.
(AVII)

AVI-4020

Neugene antisense drug

West Nile virus

Phase I/II data in 10 patients demonstrated no safety concerns (12/30)

ID
Biomedical Corp.
(Canada; IDBE)

FluINsure

Trivalent influenza vaccine for intranasal administration

Influenza

ID said analysis of data from challenge study in humans showed efficacy vs. placebo (12/5)

InterMune Inc. (ITMN)

Actimmune (FDA-approved)

Interferon gamma-1b

Idiopathic pulmonary fibrosis

Company began pivotal Phase III INSPIRE trial, a study in 600 patients with mild to moderate lung function impairment; the endpoint is survival (12/16)

InterMune
Inc.
(ITMN)

Infergen and Actimmune (both FDA-approved)

Interferon alfacon-1 and interferon gamma-1b

Hepatitis C

Retrospective analysis of 32 non-responders treated with drugcombination showed 65% had at least a 2-log decline in viral load (12/16)

Peninsula Pharmaceuticals Inc.*

Doripenem (S-4661)

Member of the carbapenem class of antibacterials

Urinary tract infections

Company said product met Phase II study endpoints of micro biological efficacy, clinical efficacy and safety (12/10); company began Phase III trial in up to 450 patients at 50 centers in the U.S., Europe and South America (12/23)

Vertex Pharmaceuticals Inc. (VRTX)

Merimepodib (VX-497)

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

Hepatitis C

Phase II data of drug with pegylated interferon and ribavirin in nonresponders showed statistically significant decrease in viral levels (12/17)

VirXsys Corp.*

VRX496

Process under which T cells are removed from HIV patient, treated with HIV lentiviral vector, and then reintroduced to patient

HIV/AIDS

A third patient will be treated in a Phase I trial following safety analysis from first two patients (12/18)

MISCELLANEOUS

Alkermes Inc. (ALKS)

Vivitrex

Extended-release injectable formulation of naltrexone

Alcohol dependence

Phase III study demonstrated a statistically significant decrease in heavy drinking over six-month study; however, overall men benefitted and women did not (12/8)

Esperion Therapeutics Inc. (ESPR)

ETC-1001

Small-molecule lipid- regulating agent

Lipid disorders

Phase I results showed the drug was safe and well tolerated in healthy volunteers (12/4)

FibroGen Inc.*

FG-3019

Fully human antibody directed against connective tissue growth factor

Idiopathic pulmonary fibrosis

FibroGen started a Phase I trial in up to 27 patients to assess safety, tolerability, pharmacokinetics and immunogenecity (12/18)

Jerini
AG*
(Germany)

Icatibant

B2 bradykinin receptor antagonist

Refractory ascites in liver cirrhosis

Jerini said Phase IIa study demonstrated positive results, and it will pursue development (12/2)

Rigel Pharmaceutical
Inc.
(RIGL)

R112

Agent designed to interrupt the signal from the IgE receptor

Allergic rhinitis

Phase I trial showed R112 was safe and well tolerated at three diferent doses (12/11)

Theratechnologies Inc. (Canada; TSE:TH)

ThGRF

Analogue of growth hormone-releasing factor

Recovery in hip fracture

Product did not demonstrate improvement in functional recovery following hip fracture surgery in eldery patients in Phase II trial (12/9)

Theravance Inc.*
and GlaxoSmithKline plc (UK)

GSK 159797

Long-acting, beta-2 agonist

Respiratory diseases

Companies said early Phase II trials in 38 patients with mild asthma showed product was well tolerated and improved forced expiratory volume (12/3)

ViaCell Inc.*

CB001

Stem cells isolated from umbilical cord blood and multiplied by company

Reconstitution of blood and immune system

Company started a Phase I/II trial to assess safety and reconstitution in adult patients with advanced stages of hematologic cancers (12/4)


Notes:

* Privately held

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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange.

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