Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Berlex Inc.
(unit of
Schering AG)

Betaseron (FDA-approved)

Interferon beta-1b

Multiple sclerosis

Monitors recommended continuation of the BEYOND trial after the first interim analysis; the trial is designed for more than 2,000 patients (11/22)

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

Tysabri (formerly Antegren, natalizumab)

Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class

Multiple sclerosis

Phase III AFFIRM trial in 942 patients with relapsing, remitting MS showed a statistically significant 66% reduction in relapses vs. placebo after one year (11/8)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Rheumatoid arthritis

University of Leeds researchers published data showing drug was able to reverse RA symptoms in newly diagnosed patients (11/5)

Centocor Inc.
(unit of Johnson
& Johnson)

Remicade (FDA-approved)

Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha

Crohn's disease

Subanalysis from ACCENT I trial showed a three-dose injection produced a significantly greater reduction in pain than one dose (11/2)

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

Rheumatoid arthritis

Phase IIb DANCER trial met its primary endpoint vs. placebo on the number of patients achieving an ACR 20 response at week 24 (11/2)

CANCER

Adherex
Technologies
Inc.
(Canada;
TSE:AHX)

Exherin

Cadherin antagonist; small- peptide, tumor/ vascular-targeting agent

Cancers

Updated Phase I data on 14 patients showed the agent generally was well tolerated and produced antitumor activity in three patients (11/8)

Advanced Viral
Research Corp.
(OTC BB:ADVR)

AVR118

Peptide-nucleic acid complex with immunomodulatory properties

Advanced malignancies

Filed IND for Phase II trial to examine safety, tolerability and efficacy in patients with advanced cancer (11/29)

Adventrx
Pharmaceuticals
Inc.
(AMEX:ANX)

CoFactor

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

Metastatic colorectal cancer

Got FDA approval to begin second stage of Phase II trial, allowing for recruitment of another 25 patients (11/2)

Alteris
Therapeutics
Inc.*

--

Vaccine based on peptide technology targeting EGFRvIII, a tumor-specific splice variant of the receptor

Malignant glioma

Phase I study in 16 patients showed a doubling of time to disease progression and an increase in survival vs. historical controls (11/19)

Amgen Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa, a recombinant erythropoietic protein

Anemia from
chemotherapy

Head-to-head trials including 312 patients showed drug dosed once every two weeks was as effective as 40,000 U of epoetin alfa dosed weekly in boosting hemoglobin and reducing the need for blood transfusions (11/24)

Amgen Inc.
(AMGN) and
Abgenix Inc.
(ABGX)

Panitumumab (formerly ABX-EGF)

Fully human monoclonal antibody that targets the epidermal growth factor receptor

Metastatic colorectal cancer

Interim data from 19 patients in a Phase II trial showed nine patients had objective responses six weeks after first-line therapy (11/1)

BioCryst
Pharmaceuticals
Inc.
(BCRX)

Forodesine
hydrochloride
(BCX-1777)

Oral purine nucleoside phosphorylase inhibitor; blocks T-cell synthesis

Leukemias and lymphomas

Presented data showing activity in a Phase I trial in refractory cutaneous T- ell lymphoma and a Phase I/II trial in B- cell acute lymphoblastic leukemia (11/15)

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

L-BLP25

Synthetic MUC1 peptide vaccine that incorporates a sequence of the MUC1 cancer mucin, in a liposomal formulation

Non-small-cell lung cancer

Presented data from a Phase IIb trial in patients with Stage IIIb and IV disease showing a survival advantage of 4.4 months vs standard therapy (11/1)

Bioniche Life
Sciences Inc.
(Canada; TSE:BNC)

Urocidin

Mycobacterial cell wall-DNA complex

Bladder cancer

Presented data showing the induction of urinary cytokines and apoptotic markers in patients (11/18)

ChemGenex
Pharmaceuticals
Ltd.
(Australia;
ASX:CXS)

Quinamed

Amonafide dihydrochloride; topoisomerase II inhibitor

Prostate cancer

Starting a Phase II trial that will use a genotyping-based regimen in patients with hormone-refractory disease who have failed docetaxel therapy (11/1)

Gamida-Cell
Ltd.*
(Israel)

StemEx

Ex vivo expanded cord blood stem/progenitor cells with non-expanded cells from the same unit

Leukemia

Phase I/II trial showed treatment significantly reduced the occurrence of GvHD and shortened the time to platelet engraftment (11/15)

GammaCan
International
Inc.
(Israel;
OTC BB:GCAN)

GCAN 101

Therapy based on intravenous immunoglobulin

Cancers

Plans to begin a Phase II trial; the approach involves periodical treatments in the years following initial treatment (11/9)

Gemin X
Biotechnologies
Inc.*
(Canada)

GX15-070

Small-molecule inhibitor of bcl-2 proteins

Solid tumors

Began Phase I trial to evaluate safety and tolerability of multiple doses in solid tumors (11/4)

Genentech
Inc.
(NYSE:DNA)

Avastin (FDA-approved)

Bevacizumab; antibody designed to inhibit vascular endothelial growth factor

Metastatic colorectal cancer

Phase III trial in 829 patients showed drug plus FOLFOX regimen improved overall survival vs. the regimen alone (11/29)

Genitope
Corp.
(GTOP)

MyVax Personalized Immunotherapy

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

Follicular non- Hodgkin's lymphoma

Monitors recommended a pivotal Phase III trial continue after reviewing safety data on more than 100 patients (11/16)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced multiple myeloma

Phase III trial failed to meet its primary endpoint of increasing the time to development of progressive disease (11/26)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Relapsed or refractory chronic lymphocytic leukemia

Phase III trial met primary endpoint on remissions vs chemotherapy alone, but failed to meet secondary endpoints related to time to progression and overall survival (11/8)

Geron Corp.
(GERN)

--

Telomerase vaccine

Prostate cancer

Phase I/II trial showed improved cellular immune responses in those who received a modified version of the hTERT antigen (11/8)

Guilford
Pharmaceuticals
Inc.
(GLFD)

Gliadel Wafer (FDA-approved)

Wafer comprised of a biodegradable polymer incorporating carmustine

Metastatic brain cancer

Three-year prospective data from 30 patients in PROLONG registry showed nine patient deaths and disease progression in eight patients after a median 27-week follow-up (11/22)

Hybridon Inc.
(AMEX:HBY)

IMOxine
(HYB2055)

Immunomodulatory oligo-nucleotide; TLR9 agonist

Refractory solid tumors

Phase I trial in 23 patients showed drug was well tolerated, and provided preliminary evidence of dose response (11/22)

Isis
Pharmaceuticals
Inc.
(ISIS) and
Eli Lilly and Co.

LY2181308

Antisense agent that targets survivin

Cancers

Lilly began a Phase I trial in cancer patients (11/17)

Kosan
Biosciences
Inc.
(KOSN)

KOS-862

Epothilone D, a
polyketide

Non-small-cell
lung cancer

Stopped a Phase II trial when it failed to meet the objective of tumor response in the first stage of a two-stage trial design; trials of the drug continue in other cancers (11/23)

Kosan
Biosciences
Inc.
(KOSN)

KOS-953

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

Relapsed/refractory myeloma

Began a Phase Ib trial to test the agent with Millennium Pharmaceuticals Inc.'s approved drug Velcade (11/8)

Micromet AG*
(Germany)

MT201

Fully human antibody targeting the EpCAM antigen

Metastatic breast cancer

Got FDA OK for a Phase II trial in the U.S. (11/23)

NeoPharm
Inc.
(NEOL)

IL13-PE38QQR

Tumor-targeting agent designed to deliver bacterial cytotoxic PE38

Malignant glioma

Phase I/II trial assessed catheter placement on drug distribution using a surrogate imaging tracer (11/22)

NeoPharm
Inc.
(NEOL)

LErafAON

Liposome-entrapped c-raf antisense oligonucleotide

Advanced cancers

Began a Phase I trial to determine dose-limiting toxicity and tolerability, as well as pharmacokinetics and treatment effects (11/18)

NeoPharm
Inc.
(NEOL)

LEP-ETU

Liposomal formulation of paclitaxel

Cancers

Phase I dose-escalation trial demonstrated preliminary evidence of safety and tolerability in patients (11/2)

Onyx
Pharmaceuticals
Inc.
(ONXX) and
Bayer Pharmaceuticals
Corp.

BAY 43-9006

RAF kinase and VEGF inhibitor

Cancers

Phase I trials showed the drug could be combined with other cancer drugs, and showed no unexpected treatment- related adverse events (11/2)

Pharmacyclics
Inc.
(PCYC)

Xcytrin

Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis

Glioblastoma multiforme

Two Phase I trials showed drug plus cranial irradiation in 55 patients demonstrated tolerability and an apparent survival advantage vs. radiation alone (11/19)

Pharmacyclics
Inc.
(PCYC)

Xcytrin

Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis

Advanced tumors

Interim Phase I data showed drug and Taxotere produced partial responses in five of nine evaluable patients; also, began Phase I trial with Taxotere and cisplatin in the first-line treatment of non-small-cell lung cancer (11/1)

PharmaMar
SA
(Spain;
subsidiary of
Zeltia Group)

Yondelis

Trabectedin; ET-743; derived from the sea squirt Ecteinascidia turbinata

Solid tumors

Trials showed combination of drug with Doxil was safe and feasible; trial of drug and carboplatin showed preliminary antitumor activity (11/2)

PharmaMar
SA
(Spain;
subsidiary of
Zeltia Group)

Aplidin

Antitumor agent derived from the marine tunicate Aplidium albicans

Advanced melanoma

Phase II study of Aplidin as a second-line therapy demonstrated an acceptable safety profile (11/2)

Point
Therapeutics
Inc.
(POTP)

Talabostat
(PT-100)

Small molecule designed to stimulate proliferation of hematopoietic progenitor cells

Non-small-cell lung cancer

First stage of Phase II trial with Taxotere in Stage IIIB/IV disease met tumor-response criteria, allowing continuation into the second stage of the study (11/30)

Point
Therapeutics
Inc.
(POTP)

Talabostat (PT-100)

Small molecule designed to stimulate proliferation of hematopoietic progenitor cells

Cancers

Phase I data on healthy volunteers suggested drug generally was well tolerated and sustained inhibition of a target enzyme, dipeptidyl peptidase IV (11/4)

Raven
Biotechnologies
Inc.*

RAV12

High-affinity IgG1 chimeric antibody

Advanced adenocarcinoma

Filed IND for a Phase I trial to test safety and tolerability in cancer patients (11/16)

Spectrum
Pharmaceuticals
Inc.
(SPPI)

EOquin

Bioreductive prodrug

Superficial bladder cancer

Phase II trial in recurrent, refractory disease showed 18 of 28 patients achieved a complete response after six weekly treatments (11/11)

Vical Inc.
(VICL)

Allovectin-7

DNA plasmid/lipid complex containing the DNA sequences encoding HLA-7 and ß2 microglobulin

Metastatic melanoma

Updated data from high-dose Phase II trial showed increases in response duration and survival, and no safety concerns (11/5)

CARDIOVASCULAR

Alexion
Pharmaceuticals
Inc.
(ALXN)

Pexelizumab

Monoclonal antibody; terminal complement inhibitor

Coronary artery bypass graft surgery

Additional data from Phase III PRIMO-CABG trial showed the drug reduced the composite endpoint of death or myocardial infarction in each of seven pre-specified risk-factor patient groups; the same result was seen with four other pre-specified baseline risk factors (11/10)

Amgen Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa; recombinant erythropoietic protein

Anemia

Began TREAT trial to test the impact of treating anemia on cardiovascular outcomes in 4,000 patients with chronic kidney disease and Type II diabetes (11/1)

AtheroGenics
Inc.
(AGIX)

AGI-1067

Oral agent designed to inhibit the production of VCAM-1 and other molecules in the inflammatory process

Atherosclerosis

Phase IIb CART-2 trial showed the drug reduced plaque volume by 2.3% vs. standard care, a statistically significant amount, but less than was seen in interim data reported in September (11/22)

AVI
BioPharma
Inc.
(AVII)

Resten-NG

Antisense agent that targets the transcription factor c-myc

Cardiovascular restenosis

Phase II AVAIL trial showed a statistically significant effect in preventing restenosis vs. the control arm and the sub-therapeutic dose arm (11/10)

Cardiome
Pharma Corp.
(Canada; CRME)

RSD1235

Oral formulation of drug designed to selectively block ion channels in the heart

Atrial fibrillation

Began Phase Ib trial after selecting a controlled-release formulation in a Phase Ia trial (11/29)

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

DX-88

Recombinant small protein designed to inhibit human plasma kallikrein

Hereditary angioedema

Final results from Phase II EDEMA1 trial showed statistical significance for the primary endpoint of improving HAE symptoms (11/15)

FibroGen Inc.*

FG-2216

Small-molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase

Anemia

Phase I trial in healthy volunteers showed the agent was safe, well tolerated and significantly increased production of endogenous erythropoietin (11/1)

GenVec Inc.
(GNVC)

--

Transplantation of autologous myoblast cells

Congestive heart failure

Follow-up data from three trials demonstrated the feasibility and safety of the treatment (11/8)

Guilford
Pharmaceuticals
Inc.
(GLFD)

Aggrastat (FDA-approved)

Tirofiban hydrochloride; glycoprotein IIb/IIIa receptor antagonist

For use in coronary stent procedures

The STRATEGY trial demonstrated that use with a drug-eluting stent resulted in a significantly lower rate of death, MI, stroke and binary restenosis at six months vs. abciximab and a bare metal stent; also, began Phase III TENACITY trial to evaluate if dose retains at least 50% of the benefit of abciximab in patients undergoing PCI with coronary stent placement, and to evaluate safety and efficacy vs. heparin with tirofiban or abciximab (11/12)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Integrilin (FDA-approved)

Eptifibide; glycoprotein IIb/IIIa inhibitor

Cardiac conditions

The CLEAR Platelets trial showed that adding Integrilin to a common regimen provided better platelet inhibition and prevention of heart muscle damage associated with elective coronary stenting in low to moderate risk patients (11/8); Integrilin did not beat bivalirudin in the PROTECT trial on the primary endpoint of coronary flow reserve, but did in improving myocardial perfusion (11/6)

NitroMed
Inc.
(NTMD)

BiDiL

Nitric oxide-enhancing agent consisting of isosorbide dinitrate and hydralazin

Heart failure

Phase III A-HeFT trial in African-Americans showed a 43% improvement in survival with standard therapy vs. standard therapy and placebo (11/8)

Sanguine
Corp.
(OTC BB: SGNC)

PHER-O2

Synthetic red blood cell product

Blood substitute

Virginia Commonwealth University is conducting a trial for the U.S. Navy for the oxygenation treatment of the bends (11/1)

Valentis Inc.
(VLTS)

Deltavasc

Del-1 angiogenesis gene plus VLTS 934 (PINC polymer)

Peripheral arterial disease

Presented further Phase II results showing Deltavasc and VLTS 934 groups both demonstrated statistically significant improvements in exercise tolerance and ankle brachial index vs. baseline (11/8)

V.I.
Technologies Inc.
(VITX)

Inactine

Pathogen-reduction system

Blood substitute

Suspended enrollment in Phase III surgical study after identification of an immune response in one patient (11/23)

CENTRAL NERVOUS SYSTEM

Aeolus
Pharmaceuticals
Inc.
(OTC BB:AOLS)

AEOL 10150

Small-molecule catalytic antioxidant

Amyotrophic lateral sclerosis

Began a Phase I trial in 30 patients to evaluate safety, tolerability and pharmacokinetics (11/15)

Avanir
Pharmaceuticals
Inc.
(AMEX:AVN)

Neurodex

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Diabetic neuropathy

Phase II trial in 36 adults with the condition demonstrated the drug was well tolerated and produced significantly decreased pain intensity vs. baseline (11/12)

DOV
Pharmaceuticals
Inc.
(DOVP)

Ocinaplon

Agent that modulates a subset of GABA-A receptors

Anxiety

Began a pivotal Phase III trial to test the agent against placebo in 375 patients (11/23)

Endo
Pharmaceuticals
Inc.
(ENDP)

Oxymorphone ER

Extended-release formulation of oxymorphone

Pain

Began Phase III trial after getting final approval under an FDA SPA (11/22)

NeuroSearch
A/S
(Denmark;
CSE:NEUR)

NS2359

Agent designed to enhance the function of dopamine, noradrenaline and serotonin

Attention deficit hyperactivity disorder

Phase II trial in 126 adult patients did not meet its primary efficacy endpoint, although it did improve certain parameters (11/8)

Pharmos
Corp.
(PARS)

Dexanabinol

A tricyclic dextro-
cannabinoid; synthetic analogue of marijuana

Cognitive impairment in CABG patients

Phase II trial in coronary artery bypass graft patients showed efficacy on one measure but no benefit on another vs. placebo (11/22)

TransForm
Pharmaceuticals
Inc.*

TPI-926

Reformulation of an existing marketed product

Undisclosed CNS disorder

Began a Phase II trial in patients suffering from a disease of the CNS (11/15)

Vernalis plc
(UK; VNLS)

Frova (FDA-approved)

Frovatriptan; 5HT 1B/1D agonist

Menstrually related migraine

Began a confirmatory Phase IIItrial in 600 patients whose migraines were not adequately treated with acute therapies (11/23)

XenoPort
Inc.*

XP13512

Transported produg of the approved agent gabapentin (Pfizer Inc.'s Neurontin)

Neuropathic pain

Phase I trial demonstrated safety, tolerability and dose-proportional pharmacokinetics (11/4)

DIABETES

Amylin
Pharmaceuticals
Inc.
(AMLN) and
Alkermes Inc.
(ALKS)

Exenatide LAR

Long-acting formulaiton of an incretin mimetic

Type II diabetes

Phase II trial showed safety, tolerability and sustained release; the companies and Eli Lilly and Co. will move the product into a multiple-dose Phase II trial (11/2)

Generex
Biotechnology
Corp.
(Canada;
GNBT)

Oralyn

Oral insulin spray formulation

Diabetes

Presented various positive data from studies of Ora-lyn and the company's RapidMist Diabetes Management System (11/1)

INFECTION

ActivBiotics
Inc.*

Rifalazil

Anti-chlamydial agent

Acute non-gonococcal urethritis

Phase II trial in 170 men with NGU met all primary endpoints; it demonstrated a statistically significant dose response on clinical cure rates (11/1)

Aerogen Inc.
(AEGN)

--

Aerozolized formulation of amikacin

Ventilator-associated pneumonia

Filed IND to begin a Phase II trial with more than 100 patients to define the effective dose and monitor clinical responses (11/8)

AEterna
Zentaris Inc.
(Canada; TSE: AEZ)

Impavido

Oral miltefosine

Recurrent visceral leishmaniasis

Compassionate-use progam in 39 HIV patients who had failed other agent showed the drug generally was well tolerated and produced positive responses (11/15)

Anadys
Pharmaceuticals
Inc.
(ANDS)

Isatoribine (ANA245)

Agent designed to regulate innate immunity by interacting with toll-like receptor 7

Hepatitis C

Phase Ib trial showed the drug was safe, well tolerated and bio- logically active, and reduced viral load (11/3)

Anadys
Pharmaceuticals
Inc.
(ANDS)

ANA380 (LB80380)

Oral prodrug of the nucleotide analogue ANA317 (LB80317)

Hepatitis B

Phase I/II trial showed a reduction in viral load of more than 99.9% in patients receiving 60 mg or more for four weeks (11/1)

Basilea
Pharmaceutica
AG
(Switzerland;
SWX:BSLN)

BAL5788

Ceftobiprole; broad-spectrum cephalosporin antibiotic

Complicated skin and skin-structure infections

Began international Phase III STRAUSS trial to study efficacy vs. vancomycin in 700 patients (11/4)

Chiron Corp.
(CHIR)

Menjugate

A conjugate vaccine against Neisseria meningitidis serogroup C

To prevent meningococcal C disease

Company completed Phase III trial and said it would not be filing for approval of the product (11/12)

Cubist
Pharmaceuticals
Inc.
(CBST) and
XTL Bio-pharmaceuticals Ltd.
(Israel;LSE:XTL)

HepeX-B

Combination of two fully human monoclonal antibodies, libivirumab and exbivirumab

Hepatitis C

Monitors in a Phase II trial recommended the trial continue after reviewing data on the first 15 patients (11/23)

DOR
BioPharma
Inc.
(AMEX:DOR)

RiVax

Genetically engineered vaccine against ricin

Ricin infection

The University of Texas Southwestern Medical Center began a Phase I trial to assess safety and immunogenicity in human volunteers (11/30)

Dynavax
Technologies
Corp.
(DVAX)

--

Prophylactic vaccine based on immunostimulatory sequences

Hepatitis B

Phase II trial showed faster protective antibody responses and that they were maintained longer than with GlaxoSmithKline plc's Engerix-B (11/1)

Gilead Sciences
Inc.
(GILD)

Hepsera (FDA-approved)

Adefovir dipivoxil; a nucleotide analogue

Hepatitis B

144-week data from Study 437 demonstrated continued inhibition of viral replication and normal-ization of liver enzymes (11/2)

Human Genome
Sciences Inc.
(HGSI)

Albuferon

Albumin interferon-alpha; long-acting form of interferon-alpha

Hepatitis C

Began Phase II trial in combination with ribavirin to evaluate safety, tolerability and efficacy in patients with chronic disease (11/30)

Human Genome
Sciences Inc.
(HGSI)

Albuferon of interferon-alpha

Albumin interferon-alpha; long-acting form

Hepatitis C

Phase I/II trial in 122 patients showed drug was well tolerated, biologically active and reduced viral load in dose-dependent manner (11/2)

Idenix
Pharmaceuticals
Inc.
(IDIX)

NM 283

Oral nucleoside analogue

Hepatitis C

Presented positive data from a Phase I trial and an ongoing Phase IIa trial (11/1)

Idenix
Pharmaceuticals
Inc.
(IDIX)

Telbivudine

Oral nucleoside agent

Hepatitis B

Viral dynamics analysis from a Phase IIb trial showed faster and more profound viral clearance than with lamivudine alone (11/1)

Idenix
Pharmaceuticals
Inc.
(IDIX)

Valtorcitabine

Agent that specifically targets HBV DNA polymerase

Hepatitis B

Phase I trial demonstrated safety and reductions in viral load (11/1)

Inhibitex Inc.
(INHX)

Aurexis

Humanized monoclonal antibody based on MSCRAMM protein platform technology

S. aureus infections

Phase I trial in healthy volunteers showed the agent generally was safe and well tolerated; also, monitors said a Phase II trial should continue after looking at data from 40 patients (11/1)

InterMune
Inc.
(ITMN)

Infergen (FDA-approved)

Interferon alfacon-1

Hepatitis C

Investigators presented data from trials with ribavirin showing safety and efficacy in various HCV settings (11/2)

InterMune
Inc.
(ITMN)

Infergen and Actimmune (both FDA-approved)

Interferon alfacon-1 and interferon gamma-1b

Hepatitis C

Retrospective analysis involving PEG nonresponders showed 23 of 50 patients taking combination had undetectable viral loads after 24 weeks (11/1)

MedImmune
Inc.
(MEDI)

Numax

Third-generation variant of the anti-RSV antibody Synagis

Respiratory syncytial virus

Began a Phase III trial to evaluate safety and efficacy in reducing RSV disease in healthy, full-term Native American infants (11/15)

MedImmune
Inc.
(MEDI)

Numax

Third-generation variant of the anti-RSV antibody Synagis

Respiratory syncytial virus

Began a Phase III trial in 5,750 high-risk infants to compare safety and efficacy to Synagis, MedImmune's approved drug (11/1)

MedImmune
Inc.
(MEDI)

FluMist (FDA-approved)

Influenza vaccine delivered as a nasal mist

Influenza

Began a Phase I/II trial to compare safety and efficacy to the injectable influenza vaccine in children with HIV (11/1)

Nabi Bio-pharmaceuticals
(NABI)

Altastaph

Staphylococcus aureus immune globulin (human); polyclonal antibody

S. aureus infections in neonates

Phase II trial in 200 premature, low-birth-weight neonates demonstrated safety, but failed to show efficacy because only three patients each in the placebo and drug arms became infected (11/18)

Panacos
Pharmaceuticals
Inc.*

PA-457

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

HIV

Patients taking the higher doses in a Phase I/II trial experienced reductions in viral load (11/23)

Pharmasset
Inc.*

Racivir

Nucleoside analogue

HIV

Began Phase II RCV-201 trial to assess safety, tolerability and antiviral effect of substituting Racivir for lamivudine in treat- ment-experienced patients (11/10)

Rigel
Pharmaceuticals
Inc.
(RIGL)

R803

Small-molecule non-nucleoside HCV polymerase inhibitor

Hepatitic C

A lack of bioavailability was cited in the product failing to reduce viral levels in a statistically significant manner (11/22)

StressGen
Biotechnologies
Corp.
(Canada;
TSE:SSB)

HspE7

Fusion product consisting of heat-shock protein fused to human pappilomavirus antigen

High-grade cervical dysplasia

21-patient Phase II trial showed a 40% response rate (11/17)

Tanox Inc.
(TNOX)

TNX-355

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

HIV

Presented Phase Ib data showing the agent appeared to be safe and well tolerated, and produced a transient reduction in viral load (11/9)

Theravance
Inc.
(THRX)

Telavancin (TD-6424)

Lipoglycopeptide antibiotic believed to have multiple mechanisms of action

Skin and skin-structure infections

Phase II FAST trial in 167 patients showed similar efficacy and adverse events as standard therapy, with an efficacy advantage in a patient subset (11/2)

Vertex
Pharmaceuticals
Inc.
(VRTX)

VX-950

Oral protease inhibitor

Hepatitis C

Phase Ia trial showed the agent was well tolerated and had favor- able pharmacokinetic properties in healthy volunteers (11/1); began 60-subject Phase Ib trial that will include both healthy volunteers and chronic HCV patients (11/8)

MISCELLANEOUS

Alexion
Pharmaceuticals
Inc.
(ALXN)

Eculizumab

Humanized monoclonal antibody designed to block complement protein C5

Paroxysmal nocturnal hemoglobinuria

Began pivotal Phase III TRIUMPH trial under an FDA SPA that will include about 75 patients (11/1)

Amgen Inc.
(AMGN)

Sensipar (FDA-approved)

Cinacalcet HCl; oral calcium calcimimetic

Secondary hyperparathyroidism

Data from one-year trial confirmed the benefits of the drug independent of the vitamin D dose (11/1)

APT
Pharmaceuticals
LLC*

AHCQ

Aerosolized hydroxy-chloroquine, a disease-modifying antirheumatic drug

Various conditions

Phase I trial showed a favorable safety profile and pharmacokinetics, and tolerable taste (11/19)

Arena
Pharmaceuticals
Inc.
(ARNA)

APD356

Small-molecule, selective 5HT2C serotonin receptor agonist

Obesity

Phase Ib trial showed the agent was well tolerated and supported a move into Phase II trials (11/30)

Auxilium
Pharmaceuticals
Inc.
(AUXL)

Testim

Topical 1% testosterone gel

Hypogonadism

Trial in 48 patients with HIV demonstrated a statistically significant improvement in sex-related endpoints vs. AndroGel (11/17)

BioBalance Corp. (OTC BB: BBAL)

Probactrix

Strain of E. coli in a BioBalance formulation

Irritable bowel syndrome

Began a trial in 210 patients to test the ability of the agent to reduce symptoms of IBS and improve quality of life (11/16)

BioMarin
Pharmaceutical
Inc.
(BMRN)

Phenoptin

Sapropterin hydrochloride; form of the enzyme cofactor 6R-BH4

Phenylketonuria

Following talk with the FDA, said it would begin a Phase III trial in 1Q:05 to test changes in blood phenylalanine levels vs. placebo (11/30)

BioSante
Pharmaceuticals
Inc.
(AMEX:BPA)

LibiGel

Transdermal testosterone gel

Female sexual dysfunction

Phase II trial in 46 surgically menopausal women demonstrated statistically significant benefits vs. baseline and placebo (11/1)

Connetics
Corp.
(CNCT)

Extina

2% ketoconazole formulated with Connetics' foam delivery vehicle

Seborrheic dermatitis

The FDA issued a non-approvable letter, saying the product was not superior to placebo foam (11/23)

CuraGen Corp.
(CRGN) and
Abgenix Inc.
(ABGX)

CR002

Fully human antibody against platelet-derived growth factor-D

Kidney inflammation

The product was moved into a Phase I trial to evaluate safety, tolerability and pharmacokinetics (11/18)

Hemispherx
Biopharma
Inc.
(AMEX:HEB)

Ampligen

RNA drug with potential action as an immuno-modulator and antiviral

Chronic fatigue syndrome

Presented new data from positive pivotal Phase III trial showing increased exercise capacity vs. placebo (11/1)

Microbia Inc.*

MD-1100

Superagonist of the guanylate cyclase-C receptor

Irritable bowel syndrome

Began Phase I trial to evaluate safety and pharmacokinetics in healthy volunteers (11/1)

OxiGene Inc.
(OXGN)

CA4P

Combretastatin A4 prodrug; a vascular targeting agent

Myopic macular degeneration

Began a Phase II trial to assess safety and efficacy in patients with active choroidal neovascularization associated with MMD (11/19)

RegeneRx Bio-
pharmaceuticals
Inc.
(OTC BB: RGRX)

Thymosin beta-4

Naturally occurring peptide with multiple mechanisms of action

Chronic pressure ulcers

Began a Phase II trial to evaluate several doses vs. placebo in patients (11/2)

Sirna
Therapeutics
Inc.
(RNAI)

Sirna-027

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

Wet age-related macular degeneration

Began Phase I trial to evaluate safety, tolerability and biological activity following a single intra-vitreal injection (11/23)

ZymoGenetics
Inc.
(ZGEN)

TACI-Ig

Antagonist protein that binds to the TNF cytokines BLyS and APRIL

B-cell malignancies and autoimmune diseases

A trial in 23 healthy volunteers showed the agent was safe and well tolerated at all dose levels tested (11/8)


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

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