Company* |
Product |
Description |
Indication |
Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Alexion |
Eculizumab |
A humanized monoclonal |
Rheumatoid arthritis |
Phase IIb study met primary endpoint in the monthly dosing arm; biweekly dosing arm did not improve ACR20 scores (1/28) |
|
||||
Biogen Idec Inc. |
Antegren (natalizumab) |
Humanized monoclonal antibody; alpha-4 antagonist from the selective adhesion molecule inhibitor class |
Crohn's disease |
Phase III ENACT-2 trial met primary endpoint of response maintenance at six months; the trial followed 428 ENACT-1 patients (1/29) |
|
||||
Celltech Group |
CDP870 |
Product that uses pegylated antibody fragment technology to target TNF-alpha |
Crohn's disease |
Company began first of two Phase III trials, named PRECISE-1; the trials are expected to include 1,300 patients at sites around the world (1/6) |
|
||||
ChemoCentryx Inc.* |
Traficet-EN |
Small molecule that binds to a chemokine receptor involved in trafficking lymphocytes to the bowel |
Inflammatory bowel disease |
Company started two Phase I trials in 72 healthy volunteers in the UK to assess safety and pharmacokinetics (1/13) |
|
||||
Human Genome |
LymphoStat-B |
Human antibody to B- |
Rheumatoid arthritis |
Company began Phase II trial in about 230 patients who have failed prior therapy (1/8) |
|
||||
Isis Pharmaceuticals |
ISIS 104838 |
Antisense TNF-alpha inhibitor |
Rheumatoid arthritis |
Phase II trial in 157 RA patients showed a statistically significant decrease in disease activity (1/5) |
|
||||
Targeted Genetics |
tgAAC94 |
Product designed to use adeno-associated viral vector |
Rheumatoid arthritis |
Company got approval in U.S. and Canada for Phase I trial expected to be conducted in up to 32 adult subjects who will get a single injection in the affected joint (1/20) |
|
||||
CANCER | ||||
Abgenix Inc. |
ABX-EGF |
Fully human monoclonal antibody that targets the epidermal growth factor receptor |
Colorectal cancer |
Amgen began a pivotal trial of the drug as a third-line monotherapy; a second trial is being started outside the U.S. (1/20) |
|
||||
Allos Therapeutics |
RSR13 (efaproxiral) |
Radiation sensitizer; small molecule designed to decrease hemoglobin-oxygen binding affinity |
Non-small-cell lung cancer |
Allos began a Phase I trial of drug and supplemental oxygen with concurrent chemoradiation therapy in 22 patients with advanced disease (1/28) |
|
||||
Celsion |
ThermoDox |
Temperature-sensitive liposomal formulation of doxorubicin |
Liver cancer |
Company began a Phase I study of the product in combination with radiofrequency ablation (1/8) |
|
||||
Cytokinetics Inc.* |
SB-715992 |
Small molecule directed against kinesin spindle protein, a cytoskeletal protein needed for DNA division |
Various tumor types |
Partner GlaxoSmithKline plc began a broad Phase II program encompassing various regimens and cancers (1/14) |
|
||||
Dendreon |
Provenge |
Immunotherapy |
Prostate cancer |
Updated data from Phase III trial showed an 89% increase in survival compared to placebo in patients with Gleason scores of 7 or less (1/12) |
|
||||
FeRx Inc.* |
-- |
Magnetic target |
Non-small-cell lung cancer |
Company got approval for Phase I/II trial in up to 50 patients who no longer respond to conventional treatments (1/9) |
|
||||
GenVec |
TNFerade |
Contains TNF-alpha gene and a radiation-responsive promoter |
Pancreatic cancer |
Data showed product was well tolerated when administered by endoscopic ultrasound or percutaneous injection directly into the tumor; dose-related benefits were seen (1/23) |
|
||||
ILEX Oncology Inc. (ILXO) |
Eflornithine (DFMO) |
Orally delivered difluoro- methylornithine; selective irreversible inhibitor of ornithine decarboxylase |
Superficial bladder cancer |
ILEX stopped a Phase III trial conducted with the National Cancer Institute, after the drug failed to beat placebo (1/15) |
|
||||
Immunomedics |
Labetuzumab |
Humanized monoclonal antibody against carcino- embryonic antigen, labeled with iodine-131 |
Colorectal cancer |
Phase II data showed median survival of 54.2 months in 19 patients who had their liver metastases from colorectal cancer surgically removed; the drug was given after surgery (1/26) |
|
||||
Introgen Therapeutics |
Advexin |
Adenoviral vector containing the p53 tumor-suppressor gene |
Non-small-cell lung cancer |
Phase II study combining drug and radiation therapy showed 60% of primary tumors regressed or disappeared at three months after treatment (1/26) |
|
||||
Lorus Therapeutics |
GTI-2040 |
Antisense drug that targets |
Advanced, end- stage renal- cell cancer |
Interim results from Phase II trial in combination with capecitabine showed more than half of 21 pat- ients had disease stabilization (1/12) |
|
||||
Millennium |
Velcade (FDA-approved) |
Bortezomib; proteasome |
Refractory, metastatic colorectal cancer |
Company stopped further accrual in Phase II trial after interim data failed to meet predefined efficacy criteria (1/6) |
|
||||
Pharmacyclics |
Xcytrin (motexafin gadolinium) |
Small-molecule, tumor- |
Malignant gliomas |
Company started a Phase I trial of the drug in combination with Temodar in 25 patients (1/28) |
|
||||
Progen Industries Ltd. (Australia; ASX:PGL) |
PI-88 |
Anti-angiogenesis |
Melanoma |
Company started a Phase II study in Australia and the U.S. in patients with advanced disease (1/20) |
|
||||
Pro-Pharmaceuticals |
Davant |
Carbohydrate compound that targets sugar-specific binding sites on cancer cells |
Refractory colorectal cancer |
Company started a Phase II trial of drug in combination with 5-FU as a third-line therapy (1/8) |
|
||||
Seattle Genetics |
SGN-30 |
Monoclonal antibody that targets CD30+ hematologic malignancies |
Hodgkin's disease and anaplastic large- cell lymphoma |
Company began a Phase II trial of the drug as a single agent in up to 40 patients in each indication who have relapsed or are refractory to prior therapies (1/22) |
|
||||
Vion |
Triapine |
Inhibitor of ribonucleotide reductase |
Hematologic malignancies |
Trials began in collaboration with the National Cancer Institute; the first is a Phase I study with fludarabine in relapsed and refractory disease (1/20) |
|
||||
YM BioSciences Inc. (Canada; TSE: YM) |
Tesmilifene (DPEE) |
Small molecule designed to augment the activity of chemotherapy agents |
Metastatic breast cancer |
Published Phase III data showed tesmilifene plus doxorubicin was statistically superior to doxorubicin alone in terms of overall survival (1/29) |
|
||||
CARDIOVASCULAR | ||||
Curacyte |
PHP |
Pyridoxalated hemoglobin polyoxyethylene |
Distributive shock |
Phase IIc data confirmed tolerability and showed favorable trends in future primary endpoints (1/21) |
|
||||
Myogen |
Ambrisentan |
Type-A selective endothelin receptor antagonist |
Pulmonary arterial hypertension |
Company began pivotal Phase III program that will include the ARIES I and II trials; each will enroll 186 patients and test different doses; the primary endpoint is exercise capacity (1/8) |
|
||||
Schering |
Ad5FGF-4 (Generx) |
Angiogenic gene therapy product acquired from Collateral Therapeutics Inc. |
Stable exertional angina |
Schering stopped Phase IIb/III trial after interim look led to conclusion efficacy was not going to be reached (1/30) |
|
||||
SuperGen |
Nipent |
Pentostatin for injection |
Myelodysplatic syndrome |
Published data showed a regimen including Nipent provided benefit in allogeneic bone marrow transplant patients (1/23) |
|
||||
Synthetic Blood International |
Oxycyte |
Perfluorocarbon- |
Blood substitute |
Phase I trial showed the product had a good safety profile (1/27) |
|
||||
United |
Remodulin (FDA-approved) |
Intravenous formulation of treprostinil sodium |
Pulmonary arterial hypertension |
Study in normal volunteers demonstrated bioequivalence of drug delivered intravenously as compared to subcutaneously (1/26) |
|
||||
CENTRAL NERVOUS SYSTEM | ||||
Cephalon |
R-modafinil |
Single-isomer version of the active ingredient in Provigil |
Narcolepsy and obstructive sleep apnea/hypopnea syndrome |
Company began Phase III program, with two trials in OSA/HS and one in narcolepsy; enrollment is expected to total 800 (1/13) |
|
||||
GB |
GT 1061 |
Compound that mimics certain activities of nitric oxide |
Alzheimer's disease |
Company began a Phase I trial to test safety in aged healthy volunteers (1/6) |
|
||||
ExonHit |
Ikomio |
Compound believed to |
Amyotrophic lateral sclerosis |
Monitors recommended a 400-patient trial in which the drug is used with Rilutek continue, after an interim analysis showed no safety concerns (1/26) |
|
||||
Labopharm Inc. |
-- |
Once-daily formulation |
Pain |
Phase III MDT3-002 trial met primary endpoints but Phase III trial named MDT3-003 did not; company plans an NDA filing (1/28) |
|
||||
Neurobiological Technologies |
Namenda (FDA-approved) |
Memantine; NMDA |
Mild to moderate Alzheimer's disease |
Phase III results of drug as monotherapy were positive, and Forest plans to seek approval based on the results (1/7) |
|
||||
Neurochem |
Alzhemed |
Small molecule designed to interfere with association |
Alzheimer's disease |
Company reported positive interim data from 30 patients in Phase II study who had mild to moderate disease (1/22) |
|
||||
Repligen |
RG1068 |
Synthetic human secretin |
Autism |
Phase III trial involving 132 children failed to hit either of two primary endpoints related to symptoms of autism vs. placebo (1/5) |
|
||||
XenoPort Inc.* |
XP13512 |
Transported produg of the approved agent gabapentin |
Neuropathic disorders |
Phase I results showed the drug was well tolerated at all doses and was rapidly absorbed (1/12) |
|
||||
DIABETES | ||||
Emisphere |
-- |
Oral insulin tablet developed with company's eligen technology |
Type II diabetes |
Study in 13 patients showed drug was not associated with hypoglycemic events and improved glucose control (1/29) |
|
||||
Tularik |
T131 |
An oral, selective modulator of peroxisome proliferator-activated receptor gamma |
Type II diabetes |
Company began a Phase II trial in 60 patients whose blood glucose has not been controlled with diet and exercise (1/7) |
|
||||
INFECTION | ||||
Chiron |
-- |
Vaccine designed to prime immune response by DNA immunization and then boosting with |
HIV |
Company started a Phase I trial to evaluate the safety and immuno- genicity of the vaccine, a study expected to last two years and in- clude 168 participants (1/15) |
|
||||
Coley |
Actilon (CPG 10101) |
Synthetic Toll-like receptor- 9 agonist |
Hepatitis C |
Company began two Phase I trials to assess safety, tolerability and immunological, and antiviral activity; the first study will be in healthy volunteers and the second in HCV patients (1/13) |
|
||||
Corixa Corp. (CRXA) |
-- |
Vaccine combining a |
Tuberculosis |
The FDA OK'd Phase I study to evaluate the safety and immunogenicity of the prophylactic vaccine in 20 volunteers (1/14) |
|
||||
CytRx Corp. (CYTR) and Advanced BioScience Laboratory Inc.* |
-- |
HIV vaccine incorporating |
HIV |
Company said an IND was filed for Phase I trial of the HIV vaccine formulation (1/29) |
|
||||
Enzo Biochem Inc. (NYSE:ENZ) |
HGTV43 |
Gene construct for |
HIV |
Phase I/II study of the gene therapy was initiated to assess the increase in engineered cells containing anti-HIV-1 antisense RNA genes (1/14) |
|
||||
GenoMed Inc. (OTC BB:GMED) |
-- |
Angiotensin II blocker |
Common cold |
GenoMed launched a trial available to anyone with the common cold (1/26) |
|
||||
Gilead Sciences |
GS 9005 (GS 4338) |
HIV protease inhibitor |
HIV |
Company plans Phase I trial in patients and healthy volunteers to assess oral bioavailability, pharmacokinetics, safety and efficacy (1/12) |
|
||||
InterMune |
Actimmune |
Interferon gamma-1b |
Advanced liver fibrosis (cirrhosis) |
Phase II study in patients who failed standard antiviral therapy did not meet its primary endpoint of reversing liver fibrosis (1/21) |
|
||||
Peninsula Pharmaceuticals |
Doripenem |
Inhaled version of the drug, which is from the carbapenem class of antibacterials |
Lung infections |
Company started a Phase I trial to evaluate safety and tolerability in healthy volunteers (1/15) |
|
||||
Rigel Pharmaceuticals Inc. (RIGL) |
R803 |
Small-molecule non- |
Hepatitis C |
Phase I trial showed the drug was safe and well tolerated at doses that will be moved forward (1/26) |
|
||||
Trimeris Inc. (TRMS) |
T-1249 |
HIV fusion inhibitor |
HIV |
Companies put a hold on further development of Phase I product due to formulation problem of the drug (1/5) |
|
||||
Vertex |
Lexiva (GW433908; FDA-approved) |
Fosamprenavir calcium; |
HIV |
Final 48-week results from the NEAT trial were published and showed an advantage for the drug compared to nelfinavir in combination regimens (1/20) |
|
||||
Vicuron |
Dalbavancin |
Glycopeptide agent |
Gram-positive catheter-related bloodstream infections |
Phase II data in 67 patients showed the drug was superior to vancomycin in combined clinical and microbiological response (1/12) |
|
||||
MISCELLANEOUS | ||||
Aastrom |
Tissue Repair Cell |
Stem and progenitor cells produced from samples of a patient's own bone marrow |
Non-union fractures |
Company began trial expected to enroll up to 20 patients to assess use of the cells to generate bone in severe leg fractures (1/14) |
|
||||
Adolor |
Entereg (alvimopan) |
Mu opioid antagonist |
Postoperative ileus |
Data from a fourth Phase III trial missed the primary endpoint, but Adolor and partner GlaxoSmithKline plc still plan to seek regultory approval (1/13) |
|
||||
Alizyme plc (UK; LSE:AZM) |
Renzapride |
HT4 receptor agonist/ |
Irritable bowel syndrome |
Product produced statistically significant enhancement of colonic motility in constipation-predominant IBS patients treated in a U.S. trial (1/12) |
|
||||
Atrix Laboratories Inc. (ATRX) |
Atrisone |
Dapsone formulated with Atrix's SMP technology |
Acne |
Company said it successfully completed two Phase III trials and expects to submit an NDA in July (1/6) |
|
||||
Cellegy Pharmaceuticals Inc. (CLGY) |
Cellegesic |
Nitroglycerin ointment |
Pain from anal fissures |
Product produced a statistically significant reduction in pain vs. placebo at 21 days in the 187- patient Phase III trial (1/27) |
|
||||
Cytheris SA* (France) |
CYT 99 007 |
Recombinant human |
Immune reconstitution |
Company started a Phase I trial in cooperation with the National Cancer Institute to assess safety, immune effects and various surrogate markers (1/12) |
|
||||
FemmePharma Inc.* and KV Pharmaceutical Co. |
-- |
Product using Femme's |
Endometriosis |
Companies said a Phase II study was completed and Phase III trials have begun (1/29) |
|
||||
FemmePharma Inc.* |
FP1096 |
Investigational drug |
Endometriosis |
Phase II study in 30 patients demonstrated that FP1096 reduced painful symptoms of disease with minimal side effects (1/19) |
|
||||
ISTA Pharmaceuticals Inc. (ISTA) |
Vitrase |
Ovine hyaluronidase |
Vitreous hemorrhage |
Integrated data from two Phase III studies showed diabetic subset had a reduction in hemorrhage density; an NDA has been filed (1/30) |
|
||||
Nastech Pharmaceutical Co. Inc. (NSTK) |
PYY3-36 |
Nasal-spray formulation |
Obesity |
Company started a dose-finding study in 12 overweight adults and will assess appetite and food intake, as well as safety and other endpoints (1/20) |
|
||||
Neurochem Inc. (Canada; NRMX) |
Fibrillex |
Oral agent designed to |
Amyloid A amyloidosis |
Monitors reviewing safety data from 183 patients recommended the pivotal Phase II/III trial continue (1/14) |
|
||||
Neurogen Corp. (NRGN) |
NGD 2000-1 |
Oral C5a antagonist |
Asthma |
NGD 2000-1 did not demonstrate a therapeutic benefit in a Phase IIa trial in 142 patients (1/13) |
|
||||
NiCox SA (France; Nouveau Marche: NICOX) |
AZD3582 |
COX-inhibiting nitric |
Osteoarthritis |
Advisory panel reviewing Phase II program recommended development be continued (1/27) |
|
||||
Nymox Pharmaceutical Corp. (NYMX) |
NX-1207 |
Investigational drug for BPH |
Benign prostatic hyperplasia |
Phase I and I/II trials confirmed safety and showed most patients had statistically significant symptom improvement (1/26) |
|
||||
Progenics Pharmaceuticals Inc. (PGNX) |
Methylnaltrexone (MNTX) |
Agent designed to |
Opioid-induced constipation |
Company started a second pivotal Phase III trial that will measure the ability of MNTX to induce laxation within four hours (1/13) |
|
||||
Sucampo Pharmaceuticals Inc. (operating company of Sucampo Group) |
SPI-0211 |
Chloride channel |
Constipation |
Company completed the second of two Phase IIIpivotal studies, involving 237 patients, and said it demonstrated statistical significance (1/12) |
|
||||
Vertex Pharmaceuticals Inc. (VRTX) |
Pralnacasan |
Oral inhibitor of |
Osteoarthritis |
Data from Phase II trial in 522 patients with OA of the knee showed benefit but not statistically significant improvement; Vertex and partner Aventis SA will decide on next steps (1/12) |
|
||||
XOMA Ltd. (XOMA) |
XMP.629 |
Synthetic peptide derived |
Acne |
XOMA started a Phase II trial in 240 people with mild to moderate acne (1/22) |
|
||||
| | ||||
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
NDA = New drug application. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
