Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
AlphaRx Inc. |
Indaflex |
Topical non-steroidal anti-inflammatory drug; formulation of indomethacin |
Arthritis |
Starting a Phase I trial to assess safety, tolerability and bioavailability in healthy subjects (2/16) |
Amgen Inc. |
Enbrel |
Etanercept; anti-tumor necrosis factor-alpha antibody |
Psoriasis |
At three months, nearly 30% of 311 patients with moderate to severe psoriasis reported they were "not at all" bothered by their psoriasis (2/18) |
Biogen Idec |
Amevive |
Alefacept; targets the |
Psoriasis |
Two multiple-course efficacy and safety analyses from Phase III trials showed additional treatment may provide incremental benefit (2/18) |
Biogen Idec |
Amevive (FDA-approved) |
Alefacept; targets the CD45RO+ subset of T cells |
Psoriatic arthritis |
54% of patients in a trial with methotrexate who received drug for 12 weeks achieved an ACR 20 response at 24 weeks (2/18) |
Biogen Idec |
Tysabri (FDA-approved) |
Natalizumab (formerly Antegren); humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Multiple sclerosis |
Companies suspended marketing of the drug and ongoing trials based on reports of serious adverse events seen in trials in combination with Avonex (2/28) |
Biogen Idec |
Tysabri (FDA-approved) |
Natalizumab (formerly Antegren); humanized monoclonal antibody that inhibits adhesion molecules on immune cells |
Multiple sclerosis |
Phase III AFFIRM monotherapy trial achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of MS (2/17) |
Genentech |
Raptiva (FDA-approved) |
Efalizumab; humanized antibody designed to block T cells implicated in psoriasis |
Psoriasis |
Data from long-term Phase III trial showed sustained improvement in psoriasis symptoms throughout three years of treatment (2/18) |
Renovis Inc. |
REN-850 |
Inhibitor of leukocyte trafficking |
Multiple sclerosis |
Began Phase Ia trial to assess safety, tolerability and pharmacokinetics in about 45 healthy volunteers (2/14) |
CANCER | ||||
Advanced Life |
ALS-357 |
Natural product derived from birch bark that has shown antitumor activity |
Melanoma |
Starting a trial to evaluate safety and tolerability of the topical application in patients with intransit metastatic disease involving the skin (2/1) |
Alfacell Corp. |
Onconase |
Ranpirnase; cytotoxic ribonuclease |
Non-small-cell lung cancer |
Began a Phase I/II trial to evaluate the drug in patients with refractory disease (2/8) |
American |
Abraxane (FDA-approved) |
Paclitaxel protein-bound particles for injection; albuminound |
Metastatic breast cancer |
Pivotal Phase III trial in 460 patients demonstrated a statistically significant improvement in survival vs. Taxol in second-line patients, but not in both first- and second-line treatment (2/25) |
Amgen Inc. |
Neulasta (FDA-approved) |
Pegfilgrastim; white-blood-cell stimulator |
Neutropenia |
Phase III trial in 928 breast cancer patients showed early and subsequent administration reduced febrile neutropenia by more than 90% (2/25) |
Aphton Corp. |
Insegia (G17DT) |
Immunotherapy vaccine designed to induce antibodies to both gastrin 17 and glygastrin 17 |
Pancreatic cancer |
Phase III trial with chemotherapy did not meet primary endpoint of improving overall survival; data were encouraging for those who achieved an antibody response (2/15) |
Australian |
GPI-0100 |
Vaccine adjuvant; semi- synthetic compound derived from saponins |
Relapsed prostate cancer |
Phase I trial showed use of GPI- 0100 appeared to be safe and to stimulate a strong immune response (2/23) |
Celgene |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Myelodysplastic syndromes |
Published Phase I/II trial data showed 24 of 36 patients achieved an erythroid response (2/10) |
Celsion Corp. |
ThermoDox |
Liposome-encapsulated formulation of doxorubicin |
Liver cancer |
Began Phase I trial with radio- frequency ablation to evaluate the maximum tolerated dose and pharmacokinetic profile (2/16) |
Coley Pharmaceutical |
ProMune (CPG 7909) |
Toll-like receptor 9 agonist |
Non-small-cell lung cancer |
Positive results were seen in a Phase II study in combination with chemotherapy; final data will be reported later in 2005 (2/3) |
CuraGen Corp. |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Advanced multiple myeloma |
Began Phase II trial to evaluate efficacy and safety as a single agent and in combination with dexamethasone in 50 patients (2/1) |
Dendreon |
Provenge |
Immunotherapy that uses a recombinant form of the prostatic acid phosphatase antigen |
Relapsed prostate cancer |
Phase II trial with Avastin in 22 patients showed a 90% increase in PSA doubling time (2/19) |
Dendreon |
Provenge |
Immunotherapy that uses a recombinant form of the prostatic acid phosphatase antigen |
Advanced prostate cancer |
Three-year data from Phase III Study D9901 showed a 4.5-month improvement in median survival and more than a threefold increase in survival at 36 months vs. placebo (2/17) |
Enzon |
Pegamotecan |
PEGylated cytotoxic drug in the topoisomerase I inhibitor class |
Gastric cancers |
Company stopped development of the drug following analysis of a Phase IIb trial (2/3) |
Genmab A/S |
HuMax-CD4 |
Human antibody that targets the CD4 receptor on T lymphocytes |
Mycosis fungoides |
Additional data from Phase II trial showed median response dura- tion of more than 45 weeks (2/18) |
GenVec |
TNFerade |
Adenovector with TNF-alpha gene and a radiation- responsive promoter |
Advanced pancreatic cancer |
Got FDA OK to begin 74-patient Phase II trial to test drug plus 5-FU and radiation followed by gemcitabine vs. that regimen alone (2/11) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Hormone-refractory prostate cancer |
Published data from 50-patient trial showed a statistically significant doubling in progression-free survival (2/28) |
Hana |
PT-523 |
Nonclassical antifolate; analogue of aminopterin |
Non-small-cell lung cancer |
Began a Phase I/II single-agent trial that initially will evaluate dosing, safety, tolerability and preliminary efficacy in relapsed disease (2/1) |
ImmunoGen |
Bivatuzumab mertansine |
BI's anti-CD44v6 antibody with ImmunoGen's DM1 cytotoxic agent |
Advanced carcinomas |
BI stopped development after seeing skin toxicity in a Phase I trial (2/9) |
Kosan |
KOS-862 |
Epothilone D, a polyketide |
Prostate cancer |
Began Phase II trial to evaluate the safety and efficacy of the drug as monotherapy in 20 to 50 hormone-refractory patients (2/14) |
Lorus |
Virulizin |
Immunotherapy agent |
Pancreatic cancer |
Monitors recommended Phase III trial continue without modification, after reviewing preliminary data (2/8) |
Millennium |
MLN2704 |
Monoclonal antibody (MLN591) directed at PSA conjugated to DM1 |
Hormone- refractory prostate cancer |
Final Phase I data showed the drug was well tolerated and produced sustained antitumor activity (2/20) |
Millennium |
Velcade (FDA-approved) |
Bortezomib; proteasome inhibitor |
Hormone-refractory prostate cancer |
Encouraging data were seen from a Phase I/II trial with docetaxel and a Phase II study with and without steroids (2/20) |
Millennium |
Velcade (FDA-approved) |
Bortezomib; proteasome inhibitor |
Non-Hodgkin's lymphoma |
Published data from two Phase II trials demonstrated positive response rates in patients with various forms of NHL (2/1) |
NeoRx Corp. |
Skeletal Targeted Radiotherapy |
Bone-targeting molecule DOTMP with radioactive substance holmium-166 |
Advanced breast cancer |
Investigator-sponsored Phase I trial in six Stage IV patients demonstrated encouraging progression and survival data (2/14) |
Oncolytics |
Reolysin |
Formulation of the human reovirus |
Recurrent malignant gliomas |
Got OK for Phase I/II trial in 30 patients to evaluate safety, dosing, toxicity and antitumor activity (2/28) |
OSI |
OSI-930 |
Dual c-kit/VEGFR inhibitor; tyrosine kinase inhibitor |
Cancers |
Began Phase I trial to evaluate safety and tolerability in up to 35 healthy volunteers (2/28) |
PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Prostate cancer |
Began Phase II trial in 46 patients with androgen-independent, relapsing disease (2/17) |
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Metastatic melanoma |
First stage of single-agent Phase II trial demonstrated the desired level of tumor response, allowing for move into second stage (2/15) |
Transave Inc.* |
SLIT Cisplatin |
Inhaled, sustained-release liposome formulation of cisplatin |
Osteosarcoma metastatic to the lung |
Began a Phase II trial (2/28) |
Xcyte |
Xcellerated T Cells |
T cells from patient stimulated to carry out immune functions |
Indolent non- Hodgkin's lymphoma |
Phase II trial in refractory disease showed one complete response and 13 patients with stable disease among 16 treated patients (2/14) |
CARDIOVASCULAR | ||||
Angiogenix |
Acclaim |
Organic nitrate combined with L-arginine |
Nitrate tolerance in chronic angina patients |
Product did not meet primary endpoint of increased treadmill walking time in a Phase II trial; positive trends were seen in other endpoints (1/31) |
Cardiome |
Oxypurinol |
Xanthine oxidase inhibitor that is the active metabolite of allopurinol |
Congestive heart failure |
Physician-sponsored La Plata trial in 60 patients showed a statistically significant improvement in left ventricle ejection fraction (2/11) |
Critical |
CTI-01 |
Ethyl pyruvate; small molecule believed to inhibit release of cytokines |
Prevention of organ damage |
Began Phase II trial in up to 150 patients to evaulate safety and efficacy in patients undergoing major cardiac surgery involving the use of cardiopulmonary bypass (2/15) |
Encysive |
Thelin |
Sitaxsentan; small molecule designed to block endothelin |
Pulmonary arterial hypertension |
Phase III STRIDE-2 trial in 246 patients met its primary endpoint of improved six-minute walk distance in the 100-mg dose (2/14) |
Forbes |
FM-VP4 |
Amphipathic analogue of phytostanols; a cholesterol absorption inhibitor |
Cholesterol management |
Began 90-day toxicity study to support a Phase II trial expected to start later in 2005 (2/1) |
Genzyme |
-- |
Gene therapy using Ad2/HIF- alpha, an engineered form of the HIF-1 alpha gene |
Peripheral arterial disease |
Began Phase II trial in up to 300 patients with severe intermittent claudication to assess safety and effectiveness vs. placebo (2/24) |
Icagen |
ICA-17043 |
Ion channel blocker |
Sickle cell disease |
Began pivotal Phase III ASSERT trial that will measure vasoocclusive crisis rates vs. placebo in 300 patients (2/22) |
ParinGenix |
PGX-100 |
Nearly nonanticoagulant heparin derivative |
Myocardial infarction |
Began the first of three Phase I trials, which will examine safety, pharmacokinetics and dosing in 100 healthy volunteers (2/9) |
Speedel Group* |
SPP630 and SPP635 |
Renin inhibitors |
Hypertension |
Microdosing studies in humans demonstrated positive properties (2/3) |
ZymoGenetis |
rhThrombin |
Recombinant human thrombin |
For use in intraoperative bleeding |
Phase II trials in 130 patients showed the agent appeared safe and well tolerated (2/9) |
CENTRAL NERVOUS SYSTEM | ||||
Cephalon |
Nuvigil |
Armodafinil; single isomer of the active ingredient in Provigil (modafinil) |
Excessive sleepiness |
Phase III trials in 1,000 patients showed significantly improved wakefulness and overall clinical condition; the primary endpoint was hit in all four studies (2/10) |
Depomed |
Gabapentin ER |
Extended-release formulation of the approved agent |
Postherpetic neuralgia |
Began a Phase II trial in 150 patients to evaluate safety and efficacy vs. placebo (2/14) |
DOV |
DOV 102,677 |
Agent believed to be an inhibitor of serotonin, norepinephrine and dopamine reuptake |
Depression |
Began a Phase I trial to evaluate safety, pharmacokinetics and dosing in healthy volunteers (2/24) |
Durect Corp. |
-- |
Transdur-based transdermal sufentanil product |
Pain |
Began Phase II trial to evaluate pharmacokinetics, efficacy and safety in chronic patients (2/16) |
Memory |
MEM 3454 |
Partial agonist of the nicotinic alpha-7 receptor |
Central nervous system disorders |
Began a Phase I trial to evaluate the safety, tolerability and pharmacokinetics of ascending doses (2/25) |
Neurocrine |
Indiplon MR |
Modified-release form of a non-benzodiazapine agent that targets the GABA-A receptor |
Insomnia |
Phase III trial in 248 adult patients with chronic insomnia demonstrated statistically significant improvement for all primary and secondary endpoints (2/16) |
NovaDel |
-- |
Lingual spray version of zolpidem tartrate (Sanofi- Aventis Group's Ambien) |
Insomnia |
Pilot trial demonstrated ability to deliver drug with the technology and achieve similar blood levels faster than the oral tablet (2/14) |
Pozen Inc. |
Trexima (MT400) |
Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen |
Migraine |
First of two pivotal Phase III trials demonstrated superior pain-free response vs. the individual components, and met other endpoints (2/28) |
Repligen |
Secretin |
Synthetic human secretin |
Schizophrenia |
Phase II trial failed to demonstrate improvements in patient symptoms, but did show a trend in improving mood (2/4) |
Vasogen Inc. |
VP025 |
Agent designed to target chronic inflammation in the brain |
Neurological diseases |
Began Phase I trial to examine safety and tolerability of various doses in up to 24 healthy volunteers (2/3) |
XenoPort |
XP13512 |
Transported prodrug of gabapentin (Pfizer Inc.'s Neurontin) |
Restless legs syndrome |
Began Phase IIb trial to evaluate efficacy of two doses vs. placebo (2/10) |
DIABETES | ||||
Generex |
Orallyn |
Oral insulin spray formulation |
Type II diabetes |
Phase IIb trial showed drug produced pharmacokinetic and lucodynamic profiles comparable to that produced by injected regular human insulin (2/2) |
INFECTION | ||||
Cubist |
Cubicin (FDA-approved) |
Daptomycin for injection; a bactericidal antibiotic |
Infective endocarditis and bacteremia due to S. aureus |
Monitors completed fifth safety review; no decision was needed since all patients have completed the treatment phase (2/22) |
DOR |
RiVax |
Genetically engineered vaccine against ricin |
Ricin infection |
Began Phase I trial in 15 volunteers to evaluate safety at doses that produce neutralizing antibodies (2/7) |
Elusys |
Anthim |
Monoclonal antibody against anthrax infection |
Anthrax infection |
Filed IND for a Phase I trial to test safety, tolerability and pharmacokinetics in healthy volunteers (2/28) |
Gilead |
Viread |
Nucleotide reverse |
HIV |
48-week data from the RAVE trial comparing regimens with drug or abacavir showed increases in limb fat in both groups, but not a significant difference between study arms (2/28) |
Gilead |
Viread and Emtriva (FDA- approved as Truvada) |
Nucleotide and nucleoside reverse transcriptase inhibitors, respectively |
HIV |
48-week data from Study 934 showed combination plus Sustiva performed better than Combivir and Sustiva in treatment-naïve patients (2/3) |
Indevus |
PRO 2000 |
Topical vaginal microbicide |
HIV and herpes simplex virus |
Presented data from trial in 20 HIV-infected women showing activity against HIV and HSV following intravaginal administration (2/24) |
Indevus |
PRO 2000 |
Topical vaginal microbicide |
HIV prevention |
The National Institute of Allergy and Infectious Diseases began a pivotal trial in 3,220 women that will include PRO 2000 (2/11) |
Maxim |
Ceplene |
Histamine dihydrochloride in combination with interleukin-2 |
Hepatitis C |
Phase II trial with PEG-Intron and Rebetol in unresponsive patients did not improve virological response vs. those agents alone (2/8) |
NexMed Inc. |
NM10060 |
Nail lacquer treatment |
Onychomycosis (nail fungal infection) |
Began Phase I trial to evaluate pharmacokinetics, safety and tolerability in 45 patients (2/2) |
Panacos |
PA-457 |
Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein |
HIV |
Phase I/II trial showed the drug was well tolerated and had antiviral activity (2/28) |
Vicuron |
Anidulafungin |
Broad-spectrum agent from the echinocandin class |
Invasive candidiasis/ |
Phase III trial demonstrated superiority to fluconazole in the primary endpoint of global response, and non-inferiority in secondary endpoints (2/7) |
ViroPharma |
HCV-796 |
Polymerase inhibitor |
Hepatitis C |
Began Phase Ia trial to evaluate safety, tolerability and pharmacokinetics in healthy adult volunteers (2/14) |
VirXsys Corp.* |
VRX496 |
T cells are removed from the patient, treated with an HIV lentiviral vector, then reintroduced to patient |
HIV |
Phase I trial in five patients demonstrated safety and a decrease in viral load (2/28) |
MISCELLANEOUS | ||||
Aastrom |
Tissue Repair Cell |
Stem and progenitor cells produced from a patient's own bone marrow |
Long-bone, severe fractures |
Trial in bone graft indications met the safety endpoints, allowing for expansion into a broader range of fracture indications (2/1) |
Alteon Inc. |
Alagebrium (ALT-711) |
A.G.E. crosslink breaker |
Various indications |
Alteon suspended enrollment in ongoing trials pending further review of toxicity data seen in a rat study (2/24) |
Genaera |
Evizon (squalamine) |
Anti-angiogenesis agent; vascular endothelial growth factor inhibitor |
Wet age-related macular degeneration |
Updated Phase II data on six patients showed preserved or improved vision through four months (2/25) |
GenVec Inc. |
AdPEDF |
Product that uses an adenovector to produce pigment epithelium-derived factor |
Wet age-related macular degeneration |
Began Phase Ib trial that will test safety, tolerability, dosing and effects on vision in 20 patients (2/22) |
GTx Inc. |
Ostarine |
Selective androgen receptor modulator |
Conditions associated with aging |
Began a Phase I trial to evaluate safety, tolerability and pharmaco- kinetics in healthy volunteers (2/1) |
InKine |
INKP-102 |
New-generation sodium phosphate purgative tablet |
Bowel cleansing prior to colonoscopy |
Phase III trial in 706 adults demonstrated non- inferiority of both INKP-102 doses vs. InKine's approved agent Visicol (2/22) |
Inspire |
Diquafosol tetrasodium |
Ophthalmic solution |
Dry eye |
Phase III trial with 640 patients failed to demonstrate statistical significance vs. placebo in corneal clearing; secondary endpoints were met (2/9) |
Isolagen Inc. |
Isolagen Process |
Autologous cellular therapy |
Facial contour deformities |
12-month follow-up data from Phase III trial showed sustained positive effects (2/18) |
Palatin |
PT-141 |
Intranasally delivered melanocortin agonist |
Female sexual dysfunction |
Phase IIa trial in pre-menopausal women showed increased sexual desire and genital arousal vs. placebo (2/8) |
RegeneRx Bio-pharmaceuticals |
Thymosin beta 4 |
Naturally occurring peptide that regulates actin, a cell-building protein |
Epidermolysis bullosa |
Plans to start a Phase II trial in a limited number of patients (2/28) |
Visient |
Litx |
Photo-reactive agent LS11 (talaporfin sodium) activated by light-infusion device |
Advanced age-related macular degeneration |
Began a Phase I trial in which LS11 will be administered intra- venously, then selectively activated (2/24) |
Zonagen Inc. |
Progenta |
Agent designed to block progesterone without blocking adrenal hormones |
Uterine fibroids |
Two doses of the drug, as well as the positive control Lucrin, demonstrated statistically significant reduction in mean fibroid size after three months (2/24) |
| | ||||
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; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board. | ||||
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