Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
Advitech Inc. |
XP-828L |
Oral bioactive complex derived from milk proteins |
Psoriasis |
Four of seven patients in open-label extension study had further improvements in PASI scores; seven of 11 patients improved in initial eight-week study (8/31) |
Astralis Ltd. |
Psoraxine |
Protein-based immuno- |
Plaque psoriasis |
Phase I trial showed drug generally was well tolerated; some signs of efficacy were seen (8/5) |
La Jolla |
Riquent (abetimus sodium) |
B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
Reached agreement with FDA on Phase IV trial to assess time to renal flare over 12 months in 500 to 600 patients (8/2) |
MedImmune |
Vitaxin |
Monoclonal antibody that targets the alpha-v beta-3 integrin |
Rheumatoid arthritis and psoriasis |
Terminated Phase II testing based on preliminary data suggesting lack of clinical benefit; no safety concerns were noted, and trials in cancer continue (8/30) |
Protein Design |
Nuvion |
Humanized antibody directed at CD3 antigen on activated T cells |
Ulcerative colitis |
Resumed enrollment in optional re-reatment arm of Phase I/II trial in patients with severe disease that is refractory to intravenous steroids (8/9) |
TolerRx Inc.* |
TRX4 |
Humanized monoclonal antibody that binds to the CD3 receptor found on all mature T cells |
Psoriasis |
Began Phase I trial in 30 psoriasis patients to assess safety, pharmacokinetics and pharmacodynamics (8/2) |
CANCER | ||||
Cell Genesys |
CG7870 |
Oncolytic virus therapy |
Prostate cancer |
Began Phase I/II trial in combination with Taxotere in up to 70 patients with metastatic, hormone-refractory disease who have not had prior chemotherapy (8/18) |
Celsion Corp. |
ThermoDox |
Liposome-encapsulated |
Liver cancer |
The National Institutes of Health began a Phase I trial to test the product in combination with radiofrequency ablation (8/31) |
Conforma |
CNF1010 |
Small-molecule inhibitor of heat-shock protein 90 containing a form of the geldanamycin derivative 17-AAG |
Advanced solid tumors/chronic myelogenous leukemia |
Began Phase I trials in each indication to assess safety, tolerability, pharmacokinetics and pharmaco-dynamics (8/2) |
Cytogen Corp. |
Quadramet (FDA-approved) |
Samarium-153 bound to a small-molecule, bone-seeking phosphonate |
Hormone-refractory prostate cancer |
Began trial to evaluate safety, tolerability and efficacy in combination with docetaxel in patients whose cancer progressed after hormonal therapy (8/5) |
Erimos |
EM-1421 |
Small molecule designed to temporarily prevent cell division and to induce cell death in tumor cells |
Refractory head and neck cancer |
Phase I trial produced tumor necrosis in five of six patients and appeared to be well tolerated (8/12) |
Genmab A/S |
HuMax-CD4 |
Human antibody that targets the CD4 receptor on T lymphocytes |
Non-cutaneous T-cell lymphoma |
Began Phase II trial in 20 patients with relapsed or refractory disease that will measure tumor response at 18 weeks (8/13) |
Genmab A/S |
HuMax-CD4 |
Human antibody that targets the CD4 receptor on T lymphocytes |
Cutaneous T-cell lymphoma |
Presented Phase II data on 38 CTCL patients with mycosis fungoides, 42% of whom achieved at least a partial response (8/11) |
Human |
HGS-TR2J |
Agonistic human monoclonal antibody to TRAIL Receptor 2 |
Advanced solid tumors |
Began Phase I trial in Canada in up to 48 patients to assess safety and tolerability, as well as pharmacokinetics and disease response (8/24) |
Introgen |
Advexin |
Adenoviral vector containing the p53 tumor-suppressor gene |
Head and neck cancer |
Investigator presented data from Phase II trial showing clinical activity and a positive safety profile (8/10) |
Keryx |
KRX-0401 (perifosine) |
Oral AKT inhibitor |
Solid tumors |
Began trial to evaluate safety and tolerability of the drug in combination with gemcitabine in patients who failed gemcitabine treatment (8/4) |
Lorus |
GTI-2040 |
Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase |
Metastatic kidney cancer |
Phase II trial demonstrated that GTI- 040 was well tolerated in combination with capecitabine (8/13) |
NeoPharm |
IL13-PE38QQR |
Tumor-targeting agent designed to deliver bacterial cytotoxic PE38 |
Malignant glioma |
Began Phase I trial to include 24 patients; delivery will follow tumor resection after initial diagnosis (8/4) |
Novacea Inc.* |
DN-101 |
Contains calcitriol, a naturally occurring hormone and the biologically active form of vitamin D |
Androgen-independent prostate cancer |
Will continue Phase II/III trial with Taxotere after reviewing six-month data from all 250 patients (8/4) |
Peplin Biotech |
PEP005 |
Topical formulation |
Actinic keratosis and non-melanoma skin cancers |
Partner Allergan Inc. began Phase I/II testing of the product (8/27) |
Point |
Talabostat (PT-100) |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
B-cell malignancies |
Data from ongoing Phase I trial showed drug could be safely administered in combination with rituximab; some activity also was seen (8/3) |
Spectrum |
Elsamitrucin |
Antibiotic designed to inhibit topoisomerase I and II |
Non-Hodgkin's lymphoma |
Presented preliminary Phase II data showing evidence of anti-tumor activity in advanced patients, as well as tolerability (8/11) |
CARDIOVASCULAR | ||||
Archemix Corp.* |
ARC183 |
Anti-thrombin aptamer |
Anticoagulant |
Began Phase I trial in 16 healthy volunteers to test safety, tolerability and anticoagulation activity, to be followed by testing in patients with coronary artery disease (8/9) |
CV |
Ranexa |
Partial inhibitor of fatty-acid oxidation |
Chronic angina |
Began trial under FDA SPA in 500 patients with chronic angina who remain symptomatic despite treatment with amlodipine (8/2) |
Encysive |
Thelin (sitaxsentan) |
Small molecule designed to block endothelin |
Pulmonary arterial hypertension |
12-patient study in combination with Viagra showed a minor pharmacokinetic drug-drug interaction (8/27); presented extension data from pivotal Phase IIb/III STRIDE-1 trial showing positive long-term data (8/31) |
Endovasc Inc. |
Liprostin |
Liposome-encapsulated |
Peripheral vascular disease |
Phase II trial in 73 patients demonstrated significant improvements in mean walking distance and painfree walking distance, the primary endpoints; patients monitored at one center had improved transcutaneous oxygen pressure (8/24) |
Guilford |
Aggrastat |
Glycoprotein IIb/IIIa receptor antagonist; tirofiban hydrochloride |
Acute coronary conditions |
Plans to begin two Phase III trials to determine the optimal regimen at the time of percutaneous coronary intervention; a 2,000-patient trial will compare drug to placebo in high-risk patients undergoing PCI with coronary stent placement; the TENACITY study in 8,000 patients will determine whether the 30-day efficacy is non-inferior to abciximab (8/12) |
Isis |
ISIS 301012 |
Second-generation antisense inhibitor of ApoB-100 |
Cardiovascular disease |
Preliminary Phase I data showed reductions of apoB-100 by up to 55%, and lowered cholesterol levels (8/11) |
Sangamo |
EW-A-401 |
Agent encoding a zinc finger DNA-binding protein transcription factor designed to activate all isoforms of the VEGF-A gene |
Intermittent claudication |
Edwards began a Phase I/II trial in 36 patients to test safety, as well as gather preliminary efficacy data (8/30) |
The Medicines |
Angiomax |
Bivalirudin; direct |
Anti-clotting agent |
Published data from REPLACE-2 angioplasty trial showed lowered one-year mortality in high-risk Angiomax patients vs. those treated with heparin plus GP IIb/IIIa blockade (8/10) |
CENTRAL NERVOUS SYSTEM | ||||
Amarin Corp. |
Miraxion (LAX-101) |
Compound that inhibits certain enzymes, including phospholipases and caspases |
Huntington's disease |
Gene-variant analysis from failed Phase III trial identified a group of patients with a specific variant that responded to treatment; the initial trial was conducted by Laxdale Ltd. (8/24) |
A.P. Pharma |
APF112 |
The anesthetic mepivacaine in a polymer-based drug delivery |
Pain following inguinal hernia repair |
Phase II trial in 90 patients produced no significant difference in efficacy between two formulations of APF112 and bupivacaine (8/12) |
Avanir |
Neurodex |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Pseudobulbar affect |
Pivotal Phase III trial in 150 PBA patients with multiple sclerosis demonstrated a statistically significant benefit for the drug vs. placebo on primary and secondary endpoints (8/24) |
Avigen Inc. |
AV201 |
Delivers gene for aromatic L-mino acid decarboxylase to allow lower doses of levodopa |
Parkinson's disease |
Got FDA authorization to begin Phase I/II trial (8/12) |
Cephalon Inc. (CEPH) |
Modafinil (FDA-approved as Provigil) |
Once-daily dosage form of the drug |
Attention deficit hyperactivity disorder |
Three nine-week trials involving a total of 600 children each showed a statistically significant improvement vs. placebo on the primary endpoint of teacher ratings; an NDA filing is planned for 4Q:04 (8/19) |
DarPharma Inc.* |
DAR-0100 |
Dopamine D1 receptor agonist |
Schizophrenia |
Began Phase I trial in patients to evaluate the effect on brain activation (8/24) |
NeuroSearch |
ABT-894 |
Nicotinic acetylcholine modulator |
Neuropathic pain |
Abbott began Phase I trials of the product candidate (8/5) |
INFECTION | ||||
AVI BioPharma |
AVI-4020 |
Neugene antisense drug; designed to block function of the target gene or virus |
West Nile virus |
Began trial in 50 patients with presumptive acute WNV neuroinvasive disease to test safety and disease progression and resolution (8/31) |
BioPort Corp.* |
BioThrax (FDA-approved) |
FDA-licensed anthrax vaccine |
Anthrax infection |
Got FDA OK for proof-of-concept studies in humans in which an immune-stimulating molecule will be added to the vaccine (8/18) |
Cubist |
Cubicin (FDA-approved) |
Daptomycin for injection |
Infective endocarditis and bacteremia caused by S. aureus |
Monitors recommended Phase III trial continue, following a third safety review involving more than 100 patients (8/4) |
Enanta Pharmaceuticals Inc.* |
EP-013420 |
A bridged bicyclic ketolide |
Infections |
Began Phase I trial to evaluate pharmacokinetics, safety and tol- erability in healthy volunteers (8/31) |
ID Biomedical |
StreptAvax |
Vaccine that targets 26 serotypes of group A streptococci with a mixture of four proteins |
Group A streptococci |
Preliminary data from expanded Phase II trial showed the vaccine induced high titers of antibodies to all 26 serotypes and was well tolerated (8/10) |
Gilead |
Viread and Emtriva (FDA- approved as Truvada) |
Nucleotide and nucleoside reverse transcriptase inhibitors, respectively |
HIV |
24-week data from Phase III Study 934 in 500 treatment-naive patients showed a statistically significant benefit for drugs plus efavirenz vs. Combivir and efavirenz (8/26) |
Metabasis |
Remofovir mesylate |
Prodrug of the approved HBV drug adefovir (Gilead Sciences Inc.'s Hepsera) |
Hepatitis B |
Began 48-week Phase II trial in 220 patients with compensated HBV, at sites in the U.S. and Asia (8/3) |
Oscient |
Factive (FDA-approved) |
Gemifloxacin mesylate; a fluoroquinolone antibiotic |
Community-acquired pneumonia |
Published data in CAP and in acute bacterial exacerbations of chronic bronchitis showed positive data in both indications (8/11) |
Oscient |
Ramoplanin |
Naturally occurring antibiotic |
Clostridium difficile-associated diarrhea |
Phase II trial failed to show non-inferiority due to lower response rates than expected; company still plans to move into Phase III (8/10) |
Vicuron Pharmaceuticals Inc. (MICU) |
Dalbavancin |
Glycopeptide agent from the same class as vancomycin |
Skin and soft-tissue infections |
Three pivotal Phase III trials in more than 1,500 patients all met the primary endpoint of non-inferiority; company said an NDA filing is planned in 2004 (8/12) |
MISCELLANEOUS | ||||
Acuity |
Cand5 |
Small interfering RNA therapeutic designed to shut down VEGF |
Wet age-related macular degeneration |
Filed IND to begin a Phase I trial (8/10) |
Amgen Inc. |
AMG 162 |
Fully human monoclonal antibody that binds to and inhibits RANK ligand |
Postmenopausal osteoporosis and treatment-induced bone loss |
Began two pivotal Phase III trials to test the effect of the drug on protecting against bone loss (8/10) |
Amicus |
AT1001 |
Small molecule designed to enhance alpha-galactosidase A activity |
Fabry's disease |
Began Phase I trial in healthy volunteers to evaluate safety and pharmacokinetics (8/5) |
BioMarin Pharmaceutical Inc. (BMRN) |
Vibrilase |
Topical agent containing the enzyme vibriolysin, which preferentially digests burned skin |
Serious burns |
Phase Ib trial in 19 patients suggested the product generally was safe and well tolerated, and effectively debrided partial-thickness burns (8/25) |
Columbia |
Striant |
Testosterone buccal system |
Testosterone replacement |
Published Phase III data showed Striant was a safe and effective treatment in hypogonadal men (8/3) |
Genetronics |
Medpulser DNA Delivery System |
Electroporation-mediated method for delivering DNA- ased therapies |
Various conditions |
Pilot study in healthy volunteers showed the delivery method was safe and tolerable (8/2) |
Indevus |
Sanctura |
Trospium chloride; anti-cholinergic compound; muscarinic receptor antagonist |
Overactive bladder |
Trial data showed drug reduced micturitions and urge urinary incontinence episodes; separate trial showed safety and tolerability in hepatically impaired patients; presented data showing drug did not produce daytime sleepiness (8/26) |
InKine |
Visicol (FDA- approved) |
Tablet form of sodium phosphate |
Constipation |
Phase IV study supported additional trials to seek an expansion of the label to include constipation (8/23) |
Jerini AG* |
Icatibant |
Bradykinin B2 receptor antagonist |
Hereditary angioedema |
Phase II proof-of-concept study had positive results, with no efficacy difference between intravenous and subcutaneous formulations (8/26) |
MacroChem |
Opterone |
Testosterone in cream form delivered with SEPA technology |
Testosterone |
Pharmacokinetics study in 32 patients demonstrated estosterone delivery to the bloodstream (8/3) |
MedImmune |
-- |
Anti-interleukin-9 monoclonal antibody |
Asthma |
Began Phase I trial in 24 healthy adult volunteers to evaluate safety, tolerability, pharmacokinetics and immunogenicity (8/18) |
Miravant |
SnET2 |
Photodynamic therapy that uses a light-activated drug to destroy abnormal blood vessels |
Macular degeneration |
Presented subgroup analyses from Phase III trial showing stat- istically significant vision benefit in both predominantly occult and pure occult AMD lesions (8/17) |
Peptimmune Inc.* |
GT389-255 |
Lipase inhibitor conjugated to a fat-binding polymer, designed to prevent fat digestion |
Obesity |
Began Phase I trial to evaluate the safety, tolerability and pharmacokinetics in 48 healthy male volunteers (8/9) |
Rigel |
R112 |
Intranasal agent designed to interrupt the signal from the IgE receptor |
Allergic rhinitis |
Phase II “Park“ study in 319 patients demonstrated statistical significance in reducing symptoms (8/2) |
Santarus Inc. |
Zegerid |
Immediate-release capsule formulation of the proton pump inhibitor omeprazole |
Gastrointestinal conditions |
Began pivotal trial to evaluate pharmacokinetics; a powder form of the drug is approved as Rapimnex (8/25) |
Theratechnologies Inc. (Canada; TSE:TH) |
ThGRF |
Analogue of growth hormone-releasing factor |
HIV-associated lipodystrophy |
Said it will present Phase II data, first reported in April, showing agent is safe and could represent a new treatment option (8/26) |
XOMA Ltd. |
XMP.629 |
Gel formulation of synthetic |
Acne |
Phase II trial in 253 patients did not demonstrate efficacy vs. vehicle gel; there was no discernable dose response, and the vehicle response was higher than anticipated (8/16) |
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; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
