Company* |
Product |
Description |
Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Amgen |
Enbrel (FDA-approved) |
Etanercept; fully |
Rheumatoid arthritis; psoriatic arthritis and ankylosing spondylitis |
Amgen presended data at ACR from the TEMPO trial showing 37% of RA patients taking Enbrel and methotrexate achieved clinical remission at one year, and 80% of patients had no progression of joint damage (10/24); other studies showed Psoriatic patients improved after one year, and that 57% of ankylosing spondylitis patients reported a 20% improvement at six months (10/24) |
Aspreva Pharmaceuticals Corp.* |
CellCept |
Mycophenolate |
Lupus nephritis |
Lupus Foundation presented 24-week data at ACR from 140 patients showing it had equivalent efficacy to cyclophosphamide with potentially fewer side effects (10/27) |
AtheroGenics Inc. (AGIX) |
AGIX-4207 |
Modulator of TNF-alpha-induced inflammatory genes |
Rheumatoid |
Company began a Phase II trial named OSCAR in which 220 patients will be given one of three doses or placebo (10/21) |
Centocor Inc. |
Remicade |
Infliximab; antibody |
Ankylosing |
Results of the ASSERT trial showed Remicade reduced signs and symptoms of the disease (10/25); another study showed the drug increased quality of life and decreased disease burden (10/28) |
Biogen Inc. (BGEN) |
Amevive (FDA-approved) |
Alefacept; targets the CD45RO+ subset of T cells |
Rheumatoid |
Study combining Amevive and methotrexate in 36 patients showed disease improvement (10/26) |
Genentech Inc. (NYSE:DNA) and IDEC Pharmaceuticals |
Rituxan |
Rituximab; antibody |
Rheumatoid |
Follow-up results from the Phase II trial presented at ACR showed a short course of treatment improved symptoms at 48 weeks when compared to methotrexate alone (10/26) |
Human Genome Sciences Inc. (HGSI) |
LymphoStat-B |
Human antibody to B-lymphocyte |
Systemic lupus erythematosus |
Company said clinical and pre- clinical results to date support continued development (10/28) |
Peptimmune Inc.* |
PI-0824 |
Synthetic peptide |
Pemphigus |
Company began a Phase I trial to test safety (10/7) |
NPS Pharmaceuticals |
ALX-0600 |
Teduglutide; derivative of protein that regulates gastrointestinal processes |
Crohn's |
NPS began a proof-of concept study examining dosing and efficacy in 100 patients (10/7) |
Regeneron Pharmaceuticals |
IL-1 Trap |
Designed to block interleukin-1 |
Rheumatoid |
Phase II trial in 200 patients missed primary endpoint of ACR-20 responses, though company said it demonstrated some evidence of efficacy (10/7) |
CANCER | ||||
Antigenics Inc. (AGEN) |
Oncophage (HSPPC-96) |
Personalized cancer vaccine |
Cancer |
Immunological Phase II data published in The Journal Of Immunology showed a cancer-specific response (10/1) |
Aton |
SAHA |
Histone |
Multiple |
Enrollment began in Phase I trial that will assess safety and dosing, as well as anticancer effects and activity (10/13) |
Bioenvision Inc. (AMEX:BIV) |
Clofarabine |
Purine nucleoside antimetabolite |
Leukemia |
Company said Phase I data published in Blood showed a 32% response rate in pediatric patients with advanced disease (10/29) |
Bioenvision Inc. (AMEX:BIV) |
Gossypol |
Isoform of the cancer agent |
Cancer |
Company said it will begin Phase I testing to determine dosin (10/8) |
Celgene Corp. (CELG) |
CC-8490 |
Cancer compound |
Brain cancer |
Celgene and the National Cancer Institute began clinical testing of the drug, which is being developed under a CRADA (10/31) |
Celgene Corp. (CELG) |
Actimid (CC-4047) |
Immunomodulatory |
Prostate cancer |
Initiated open-label Phase II trial in 19 patients to study safety and efficacy as a single agent for hormone-refractory disease (10/30) |
Cell Therapeutics Inc. (CTIC) |
Xyotax |
Paclitaxel linked to biodegradable polyglutamate |
Non-small-cell |
Company is reducing the dose in its pivotal STELLAR 4 trial follow-recommendation from a data monitoring committee due to toxicities (10/20) |
Cerus Corp. (CERS) |
ACIT |
Allogeneic cellular immune therapy |
Use in stem cell tranplants |
Product to improve transplant outcomes in patients with hema- tologic malignancies will be tested in Phase Ib trial involving three doses and up to 42 patients (10/23) |
Endo Pharmaceuticals |
EN3247 |
0.1% triclosan |
Oral mucositis resulting from chemotherapy |
The Phase III trial in 355 patients failed to demonstrate efficacy (10/24) |
GlycoGenesys |
GCS-100 |
Cancer compound |
Advanced solid |
Phase I results in 12 patients showed it was well tolerated with no dose-limiting toxicity; five patients achieved stable disease (10/22) |
Hybridon Inc. (OTC BB: HYBN) |
GEN231 |
Antisense |
Cancer |
Data from 14-patient safety study were published in Clinical Cancer Research; a dose was selected for Phase II study (10/2) |
Genentech Inc. (NYSE:DNA) and OSI Pharmaceuticals Inc. (OSIP) |
Tarceva |
Erlotinib; small-molecule EGFR inhibitor |
Metastatic non-small-cell |
Data from two Phase III studies of Tarceva and standard chemotherapy showed drug did not meet primary endpoint of improving overall survival (10/1) |
ILEX Oncology |
ILX-651 |
Synthetic analogue of dolastatin; targets tubulin |
Recurrent or |
ILEX began a Phase II study to measure efficacy and tolerability at 19 sites in the U.S. (10/7) |
Millennium Pharmaceuticals |
MLN2704 |
Targeted antibody delivering maytansinoid chemotherapeutic agent DM1 |
Metastatic androgen- |
Millennium began an escalating-dose Phase I/II study in about 46 patients (10/9) |
Novuspharma SpA (Italy; Nuovo Mercato:NOV) |
Pixantrone (BBR 2778) |
Anthracycline agent |
Aggressive non-Hodgkin's lymphom |
Company began a Phase II trial, expected to include 75 patients, to test Pixantrone as part of a chemotherapy salvage regimen (10/22) |
Onyx Pharmaceuticals |
BAY 43-9006 |
Signal transduction inhibitor designed to block the Ras/MEK/ERK pathway |
Advanced |
Companies initiated international Phase III trial in more than 800 patients who failed prior therapy; they also signed a special protocol agreement with the FDA (10/25) |
OSI |
OSI-7904L |
Liposomal thymidylate synthase inhibitor |
Advanced gastric cancer |
OSI began a Phase II study in 50 reviously untreated patients; the primary endpoint is response rate (10/24) |
Progen Industries Ltd. (Australia; PGLAF) |
PI-88 |
Anti-angiogenesis |
Advanced cancers |
Progen presented early data from Phase I/II trial highlighting some encouraging results (10/8**) |
Telik |
Telcyta (TLK286) |
Small-molecule |
Refractory or resistant ovarian cancer |
Telik reported positive interim results from Phase I/IIa trial of Telcyta in combination therapy (10/21) |
Telik |
Telcyta (TLK286) |
Small-molecule |
Non-small-cell |
Telik reached agreement with FDA on special protocol assessment for Phase III trial of Telcyta; the ASSIST-2 study will include about 500 third-line patients (10/1) |
CARDIOVASCULAR | ||||
AryX Therapeutics Inc.* |
ATI-2042 |
Amiodarone |
Atrial fibrillation |
Company initiated first clinical study of drug, a Phase I trial to evaluate safety and pharmaco-kinetic profile (10/22) |
Avant Immunotherapeutics Inc. (AVAN) |
CETi-1 |
Vaccine for |
Cholesterol maintenance |
Results from 203-patient Phase II trial failed to demonstrate a statistically significant improvement over placebo in increasing HDL levels (10/22) |
Corentech Inc.* |
CGT003 |
EF2 decoy; oligonucleotide that inactivates E2F transcription factor |
Graft failure following |
Company completed enrollment in second Phase III trial, this one in 1,400-patient PREVENT study (10/2) |
CV Therapeutics Inc. (CVTX) |
CVT-3146 |
Selective A2A-adenosine |
Stress agent in cardiac perfusion imaging studies |
CV initiated a pivotal Phase III trial of drug, triggering $3M milestone from partner Fujisawa Healthcare Inc. (10/28) |
Medicure Inc. (Canada; TSE:MPH) |
MC-1 |
Cardioprotective |
For use in coronary artery bypass graft surgery |
Company filed for approval in Canada and the U.S. to begin Phase II trial in up to 900 patients to assess effects in patients undergoing high-risk CABG (10/15) |
United |
Remodulin (FDA-approved) |
Treprostinil sodium injection |
Pulmonary arterial hypertension |
Sixteen-month data on 19 patients showed the drug was effective on a long-term basis (10/2) |
XOMA Ltd. (XOMA) |
Neuprex |
Modified form of fragment of bactericidal/ |
Pediatric patients with abnormalties requiring open-heart surgery associated with cardio-pulmonary bypass |
XOMA said Children's Medical Center of Dallas started an open-label Phase I/II study (10/2) |
XOMA Ltd. (XOMA) and Millennium Pharmaceuticals |
MLN2201 |
Humanized |
Conditions related to inflammation of the heart and blood vessels |
XOMA said it was discontinuing development following a Phase I trial that failed to meet predetermined criteria (10/10) |
CENTRAL NERVOUS SYSTEM | ||||
Cortex Pharmaceuticals |
Ampakine CX516 |
Compound designed |
Excessive daytime sleepiness |
Preiminary results of Phase I trial in 10 healthy men showed positive dose-related responses (10/21) |
Cypress Bioscience Inc. (CYPB) |
Milnacipran |
Norepinephrine |
Fibromylasia syndrome |
Data presented at meeting from Phase II trial showed drug improved syndrome in multiple measures of clinical pain (10/28) |
Cypress Bioscience Inc. (CYPB) |
Milnacipran |
Norepinephrine |
Fibromylasia syndrome |
Cypress began a Phase III program in the U.S. expected to take about two years (10/21) |
Guilford Pharmaceuticals Inc. (GLFD) |
GPI 1485 |
Neuroimmunophilin ligand |
Parkinson's |
Company completed enrollment of 212 patients in Phase II trial (10/14) |
Durect Corp. (DRRX) |
Chronogesic pain product |
Osmotic implant that delivers sufentanil |
Chronic pain |
Durect said data from a preclinical model indicated a potential problem with the delivery mechanism, a result expected to delay the restart of the Phase III program (10/16) |
Ligand Pharmaceuticals |
Avinza (FDA-approved) |
Extended-release morphine |
Chronic back pain |
Company said product provided stable analgesia for one year without an increase in dose or use of rescue medicines; data were from open-label extension study in 128 patients (10/14) |
NeorogesX Inc.* |
NGX-410 |
Capsaicin dermal delivery system |
Neuropathic pain associated with HIV and AIDS |
NeurogesX began a Phase II/III study comparing analgesic effect compared with low-dose capsaicinin in up to 300 patients (10/8) |
Neurobiological Technologies Inc. (NTII) and Forest Laboratories Inc. |
Namenda |
Memantine; NMDA receptor antagonist |
Neuropathic pain |
Forest said it would continue to study the drug after analyzing Phase III results that did not demonstrate efficacy in treating nocturnal pain (10/22) |
Pain Therapeutics Inc. (PTIE) |
Oxytrex |
Small-molecule |
Severe chronic pain |
Company said Phase II results in osteoarthritic patients demonstrated statistically significant results in primary endpoint of prospectively defined reduction in pain scores at three weeks; study also met secondary endpoints (10/16) |
Sepracor |
Estorra |
Eszopiclone; non-benzodiazepine agent |
Chronic insomnia |
Published Phase III data showed statistically significant improvement; drug is on file with FDA (10/21) |
Targacept Inc.* |
TC-1734 |
Neuronal nicotinic receptor agonist |
Cognitive and memory disorders |
Company said Phase I trial showed no safety concerns and a dose-specific effect on surrogate measures of disease (10/30) |
DIABETES | ||||
AmCyte Inc.* |
-- |
Replacement islets for transplantation |
Diabetes |
Company said a Phase I/II trial was initiated that will evaluate islet transplantion in three patients (10/30) |
Generex Biotechnology |
Oralin |
Oral insulin spray formulation |
Type II diabetes |
Generex presented results from studies pointing to efficacy (10/7) |
Keryx Biopharmaceuticals Inc. (KERX) |
KRX-101 |
Sulodexidel; oral heparinoid compound |
Diabetic nephropathy |
Keryx began the Phase II portion of its Phase II/III program; this portion of the study will include about 135 patients with Type II diabetes (10/21) |
INFECTION | ||||
Amarillo |
Interferon-alpha |
Low-dose version formulated in lozenge |
Oral warts in HIV patients |
Amarillo filed an IND for a pivotal Phase III study in 90 patients (10/14) |
AVI BioPharma |
AVI-420 |
Neugene |
West Nile virus |
AVI said it would being a second study in West Nile virus to allow expanded access of the drug (10/8) |
Biosynexus Inc.* |
BSYX-L210 |
Intranasal cream containing lysostaphin |
Eradication of S. aureus nasal carriage |
Company said Phase I/II trial met endpoints for safety and micro-biological activity, and data will be submitted for publication (10/14) |
Chiron |
Tifacogin |
Recombinant form of tissue factor pathway inhibitor |
Severe |
Chiron said it was initiating plans for a Phase III trial; it also said it acquired all of Pfizer Inc.'s interest in the drug (10/29) |
Genzyme Corp. (GENZ) |
-- |
Tolevamer sodium |
Clostridium difficile-associated diarrhea |
Genzyme presented preliminary data from a Phase II trial in 289 patients showing non-inferiority to vancomysin in time to diarrhea resolution (10/20) |
Gilead |
Hespera (FDA-approved) |
Adefovir dipivoxil; nucleoside analogue |
Hepatitis B |
Gilead presented data from open-label Study 460i showing drug was associated with sustained reduction of HBV through 144 weeks in lamivudine-resistant patients co-infected with HIV (10/28) |
Gilead |
Viread (FDA-approved) |
Tenofovir disoproxil fumarate; nucleotide analogue reverse transcriptase inhibitor |
HIV |
One presentation from extension of pivotal study showed low incidence of adverse events for up to four years; another, from the1,350- patient RECOVER study, suggested drug in place of stavudine may improve dyslipidemia (10/28) |
Human Genome Sciences Inc. (HGSI) |
Albuferon |
Long-acting form of interferon-alpha |
Hepatitis C |
Interim results from Phase I/II trial showed drug was well tolerated, had a prolonged half-life and was biologically active (10/28) |
Idenix Pharmaceuticals Inc.* |
Telbivudine (LdT) |
Antiviral agent |
Chronic hepatitis B |
52-week data from Phase IIb trial in 104 patients showed better suppresion of HBV and normalization of ALT when compared to lamivudine monotherapy (10/28) |
Idun Pharmaceuticals Inc.* |
IDN-6556 |
Inhibitor of caspase enzymes that mediate apoptosis |
Liver impairment caused by hepatitis C infection |
Dose-ranging study showed the drug normalized liver enzymes after two weeks of treatment; data are based on results from 41 patients (10/27) |
InterMune Inc. (ITMN) |
Infergen |
Interferon alfacon-1 |
Hepatitis C |
Company said an investigator-sponsored study showed drug with ribavarin produced positive results (10/29) |
MedImmune Inc. (MEDI) |
Numax |
Next-generation antibody |
Respiratory syncytial virus |
MedImmune submitted IND for first trial of Numax to assess safety and tolerability in healthy adult volunteers (10/1) |
MedImmune Inc. (MEDI) and Wyeth |
-- |
Intranasal, cold-adapted trivalent vaccine |
Influenza |
Companies presented encouraging data from five studies totaling 5,500 patients (10/13) |
Samaritan Pharmaceuticals Inc. (OTC BB:SPHC) |
-- |
Neuroimmuno- |
HIV |
Company submitted Phase II clinical report to FDA showing data demonstrating statistical significance for viral load and quality of life, and said it is developing a Phase III regimen (10/28) |
SciClone Pharmaceuticals Inc. (SCLN) |
Zadaxin |
Synthetic thymosin alpha-1 |
Hepatitis C |
Results from 23 patients in pilot trial showed triple therapy with ribavarin and pegylated interferon-alpha produced a 12-week early virologic response in 61% of non-responder patients (10/27) |
Trimeris Inc. (TRMS) and F. Hoffmann La-Roche Ltd. (Switzerland) |
Fuzeon (FDA-approved) |
Enfuvirtide; HIV fusion inhibitor |
HIV |
New data presented at AIDS conference showed Fuzeon as part of combination therapy provided virologic and immunologic benefit through 48 weeks in patients with less-advanced HIV (10/27) |
Vertex Pharmaceuticals |
Lexiva (FDA-approved) |
Fosamprenavir |
HIV infection |
Data from Phase III study showed HIV patients taking drug boosted with ritonavir had increased levels of HDL cholesterol at 48 weeks (10/28) |
Vertex Pharmaceuticals Inc. (VRTX) |
VX-497 |
Merimepodib; small- molecule inhibitor of the enzyme inosine guanosine triphosphate |
Hepatitis C |
Vertex said the drug met its primary endpoint of safety and tolerability in an interim analysis from a Phase II study in 31 patients; it also showed clinical activity (10/17) |
Vicuron Pharmaceuticals |
Dalbavancin |
Semi-synthetic glycopeptide |
Skin and |
Vicuron started a Phase III study comparing its drug to vancomycin in up to 150 patients (10/8) |
MISCELLANEOUS | ||||
Adolor |
Entereg |
Alvimopan; mu opioid antagonist |
Postoperative ileus |
Top-line results from 519-patient Phase III study showed the drug generally was well tolerated; other Phase III trials are ongoing (10/22) |
Altus Biologics Inc.* |
TheraCLEC |
Oral enzyme replacement therapy |
Malabsorption resulting from pancreatic insufficiency |
Altus said a Phase I trial demonstrated a favorable safety and clinical activity profile (10/22) |
Avanir Pharmaceuticals Inc. (AMEX:AVN) |
AVP 13358 |
Molecule designed to inhibit production of IgE |
Allergy and asthma |
Avanir said preliminary results show product was well tolerated at single rising doses in a Phase I trial (10/21) |
AVI BioPharma Inc. (AVII) |
AVI-4557 |
Neugene antisense drug |
To affect drug metabolism |
AVI initiated Phase I trial of oral drug (10/10) |
BioSante Pharmaceuticals Inc. (AMEX:BPA) |
LibiGel |
Gel formulation of testosterone |
Female sexual dysfunction |
BioSante said interim analysis of Phase II trial showed statistically significant improvement in sexual desire and activity (10/21) |
Corus Pharma Inc.* |
Corus 1020 |
Aztreonam formulated for inhalation |
Cystic fibrosis |
Corus initiated Phase II trial to evaluate safety, tolerability and efficacy (10/15) |
ICOS Corp. (ICOS) and Eli Lilly and Co. |
Cialis |
Talafidil; PDE 5 inhibitor dysfunction |
Erectile Phase III data showing efficacy |
Companies' joint venture reported of Cialis in men who have undergone a form of prostatectomy (10/10) |
Genaera Corp. (GENR) |
Lomucin |
Talniflumate; an anti- inflammatory drug |
Cystic fibrosis |
Genaera and Cystic Fibrosis Foundation Therapeutics presented Phase II data showing safety and maintenance of existing lung function in CF patients (10/16) |
Genaera Corp. (GENR) |
Squalamine |
Anti-angiogenic drug |
Choroidal neo-vascularization related to age- related macular degeneration |
Company said updated Phase II results in 40 patients were positive (10/7) |
Idun Pharmaceuticals Inc.* |
IDN-6556 |
Designed to protect liver cells from apoptosis |
Liver damage in transplantation |
Twelve transplant centers are expected to participate in the 100-patient Phase II study (10/8) |
Indevus Pharmaceuticals Inc. (IDEV) |
Trospium |
Muscarinic receptor antagonist |
Overactive bladder |
Indevus presented data showing that early patient response was an accurate predictor of long-term therapeutic success (10/14) |
Indevus Pharmaceuticals Inc. (IDEV) |
Trospium |
Muscarinic receptor antagonist |
Urgency severity, a symptom of overactive bladder |
Indevus presented data from controlled, 523-patient study showing reduced urgency severity (10/7) |
Neurotech SA* (France) |
NT-501 |
Intraocular polymer containing cells modified to secrete ciliary neurotrophic factor |
Retinitis |
Company initiated Phase I trial in 10 patients with late-stage disease; trial will be conducted at U.S. National Eye Institute (10/8) |
NexMed Inc. |
Femprox |
Alprostadil cream arousal disorder |
Female sexual showed positive dose-related |
Phase II data published in journal (NEXM) trends (10/7) |
NPS Pharmaceuticals Inc. (NPSP) |
Preos |
Recombinant, full-length parathyroid hormone |
Osteoporosis |
NPS completed enrollment of 2,700 women in Phase III TOP trial (10/7) |
Progenics Pharmaceuticals Inc. (PGNX) |
Methylnaltrexone |
Opioid-receptor antagonist |
Opioid-induced urinary retention |
Company said Phase II data showed drug relieved condition without reversing CNS effects of the opiod (10/10) |
RegeneRx Biopharmaceuticals Inc. (OTC BB:RGRX) |
Thymosin beta-4 |
Naturally occurring peptide |
Wound healing |
RegeneRx completed Phase I trial in 15 volunteers, showing it was well tolerated (10/8) |
Theratechnologies Inc. (Canada; TSE:TH) |
ThGRF |
Growth hormone-releasing factor analogue |
Chronic wasting |
Preliminary results from Phase II study in patients with disease secondary to chronic obstructive pulmonary disease suggested improvement in condition (10/21) |
Xenova Group plc (UK; XNVA) |
TA-CD |
Therapeutic vaccine designed to produce anti-cocaine antibodies |
Cocaine addiction |
Xenova initiated Phase IIb trial in up to 132 methadone-dependent addicts who will be given drug or placebo; trial is expected to last two years (10/24) |
Xenova Group plc (UK; XNVA) |
TA-NIC |
Therapeutic vaccine |
Smoking cessation |
Xenova began a second Phase I trial to further establish safety and tolerability, and to determine dosing (10/8) |
| | ||||
Notes: | ||||
* Privately held. | ||||
** Date item was published in BioWorld International. | ||||
ACR = American College of Rheumatology meeting | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; | ||||
TSE = Toronto Stock Exchange. | ||||
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