Company* |
Product |
Description |
Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Antisense |
ATL1102 |
Antisense drug that |
Multiple |
Companies began a Phase I trial (8/27) |
|
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Astralis Ltd. |
Psoraxine |
A protein to stimulate |
Plaque |
Company began |
|
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Berlex |
Leukine |
Sargramostim |
Crohn's disease |
Company will begin a Phase III trial (8/28) |
|
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Celltech Group |
CDP 571 |
An anti-TNF-alpha |
Crohn's disease |
Company decided to end development of CDP 571, a year after it failed to reach the primary endpoint in Phase III trials (8/27**) |
|
||||
ILEX Oncology |
Campath |
Alemtuzumab; humanized monoclonal antibody directed against the CD52 antigen prevalent on leukemia and lymphoma cells |
Relapsing and |
An independent data safety monitoring board recommended the Phase II study continue; enrollment is more than half complete (8/25) |
|
||||
CANCER | ||||
Allos Therapeutics |
RSR13 |
Efaproxiral; synthetic |
Non-small-cell lung cancer |
Phase II data showed that median survival was 20.6 months in patients taking RSR13, compared to 14.6 months for patients in the sequential chemoradiotherapy arm and 17 months for patients in the concurrent chemoradiotherapy arm (8/12) |
|
||||
Antigenics Inc. |
Oncophage |
Vaccine; uses heat-shock proteins to activate |
Metastatic colorectal cancer |
Phase II data showed that more than half of the 29 patients demonstrated significant immunological response (8/19) |
|
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Antisoma plc |
AS1403 (formerly TheraFab) |
A fragment of the |
Non-small-cell lung cancer |
Company decided to discontinue development after a Phase I trial showed unacceptable levels of toxicity (8/22) |
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Genentech Inc. (NYSE:DNA) and |
Tarceva |
Erlotinib; epidermal growth factor receptor |
Malignant glioma |
Companies began a Phase II trial (8/8) |
|
||||
IGI Inc. |
PTH |
Topical drug encapsulated |
Chemotherapy- induced alopecia in breast cancer patients |
Company began Phase I/II trials (8/20) |
|
||||
Kosan |
17-AAG |
17-allylamino- |
Cancer |
Company began several Phase Ib trials of 17-AAG in combination with other cancer agents (8/7) |
|
||||
KuDOS Pharmaceuticals |
Patrin |
4-bromothenylguanine; inhibits the enzyme alkylguanine alkyltransferase |
Metastatic colorectal cancer |
Company began a Phase II trial (8/18) |
|
||||
Ligand Pharmaceuticals Inc. (LGND) |
Targretin (FDA-approved) |
Bexarotene capsules |
Non-small-cell lung cancer |
Company exceeded a 600-patient enrollment goal in the first of two pivotal Phase III studies of Targretin (8/15) |
|
||||
Lorus |
GTI-2040 |
Antisense drug |
Metastatic breast cancer |
Company will begin a Phase II trial of GTI-2040 in combination with capecitabine; the National Cancer Institute is sponsoring the trial (8/12) |
|
||||
Novacea Inc.* |
DN-101 |
Contains high amounts of calcitrol, a naturally occurring hormone and biologically active form |
Advanced non-small-cell lung cancer |
Patient enrollment began in a Phase I/II trial of DN-101 in combination with Taxotere (8/18) |
|
||||
Nymox |
NX-1207 |
Prospective drug to |
Benign prostatic hyperplasia |
Phase I data showed initial patients treated with NX-1207 have not shown clinically signficant toxic effects from the drug (8/19) |
|
||||
Seattle Genetics |
SGN-15 |
cBR96-doxorubicin immunoconjugate |
Non-small-cell lung cancer |
Phase II data showed a median survival of 11.4 months for patients receiving SGN-15 plus Taxotere compared to 5.1 months for patients receiving Taxotere alone (8/12) |
|
||||
SuperGen Inc. |
Dacogen |
Decitabine; inhibitor of |
Advanced melanoma and renal cell cancer |
Company initiated patient enrollment in a Phase I study of Dacogen for injection in combination with Chiron Corp.'s Proleukin (8/27) |
|
||||
Telik Inc. |
Telcyta |
A small-molecule antitumor drug that is activated by GST-P1-1 |
Non-small-cell lung cancer |
Phase II data showed an 11% objective response rate in the 19 evaluable patients; the overall disease stabilization rate was 69% (8/14) |
|
||||
Titan Pharmaceuticals Inc. (AMEX:TTP) |
Pivanex |
Acts by inhibiting enzymes called histone deacetylases |
Non-small-cell lung cancer |
Clinical data showed no dose-limiting toxicity at any level and showed that the combination was generally well tolerated (8/12) |
|
||||
CARDIOVASCULAR | ||||
Alexion Pharmaceuticals Inc. (ALXN) |
Pexelizumab |
Short-acting, single-chain antibody C5 complement inhibitor |
To reduce death and myocardial infarction in patients undergoing coronary artery bypass graft surgery |
Phase III data showed the compound narrowly missed its primary endpoint (8/5) |
|
||||
AtheroGenics Inc. (AGIX) |
AGI-1067 |
V-protectant drug; oral anti-inflammatory agent |
Atherosclerosis and post-angioplasty restenosis |
Company completed enrollment in a Phase IIb trial (8/6) |
|
||||
AVI BioPharma Inc. (AVII) |
Resten-NG |
Antisense drug to be delivered using AVI's microbubble delivery |
Patients undergoingangioplasty and stent placement |
Company began a Phase II study of Resten-NG (8/19) |
|
||||
Cardiome Pharma Corp. (Canada; TSE:COM) |
RSD1235 |
Atrial antiarrhythmic |
Atrial fibrillation |
Company began patient dosing in its first of three Phase III studies (8/6) |
|
||||
Encysive Pharmaceuticals Inc. (ENCY) |
Argatroban (FDA-approved) |
A direct thrombin |
Blood clots |
Clinical data showed Argatroban significantly reduced thrombosis and deaths due to clots without increasing the risk of bleeding (8/12) |
|
||||
Endomatrix |
Provasca |
An endothelial |
Cardiovascular disease |
Company began a clinical trial (8/27) |
|
||||
ISTA Pharmaceuticals Inc. (ISTA) |
Vitrase |
Ovine hyaluronidase |
Vitreous hemorrhage |
Phase III data demonstrated a statistically significant reduction in vitreous hemorrhage density as early as one month and through three months following a single intravitreous injection of Vitrase when compared to a single injection of saline solution (8/21) |
|
||||
SuperGen Inc. (SUPG) |
Dacogen |
Decitabine; inhibitor of |
Sickle cell anemia |
Phase I/II data showed Dacogen was well tolerated, with the only significant toxicity being neutropenia (8/20) |
|
||||
CENTRAL NERVOUS SYSTEM | ||||
Myriad Genetics Inc. (MYGN) |
MPC-7869 |
R-flurbiprofen |
Alzheimer's disease |
Clinical data showed MPC-7869 reduces levels of Abeta42 more effectively than any other compound tested (8/5) |
|
||||
DIABETES | ||||
Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. |
Exenatide |
Synthetic exendin-4 |
Type II diabetes |
Phase III data showed the product hit its primary endpoint (8/7); results from another Phase III study showed that 44% of patients who completed 24 weeks of treatment achieved glucose level averages in the American Diabetes Association's target range (8/25) |
|
||||
ConjuChem Inc. (Canada; TSE:CJC) |
DAC-GLP-1 |
An insulinotropic hormone that is a naturally occurring 30-amino-acid peptide; |
Type II diabetes |
Phase I/II data showed primary endpoints were met; the compound also was well tolerated (8/22) |
|
||||
DepoMed Inc. (AMEX:DMI) and Biovail Corp. (Canada) |
Metformin GR |
Once-daily, controlled- release formulation of metformin based on DepoMed's once-daily gastric retention technology |
Type II diabetes |
Phase III data showed Metformin GR controlled glucose levels after 48 weeks (8/6) |
|
||||
INFECTION | ||||
AVI BioPharma Inc. (AVII) |
AVI-4020 |
Neugene drug |
West Nile virus |
Company initiated a Phase Ib trial in patients hospitalized with West Nile virus (8/4) |
|
||||
Genome Therapeutics |
Ramoplanin |
Naturally occurring |
Vancomycin-resistant enterococci |
Company expanded its program, enrolling up to 50 patients, to investigate whether Ramoplanin can reduce the transmission of VRE by decreasing skin contamination through gastrointestinal decolonization (8/5) |
|
||||
Gilead |
Viread and Emtriva (FDA-approved) |
Tenofovir disoproxil |
HIV |
Company began enrollment in a Phase III trial of Viread and Emtriva used in combination with efavirenz vs. a regimen of Combivir and efavirenz (8/12) |
|
||||
MISCELLANEOUS | ||||
Arriva-ProMetic Inc. (joint venture of ProMetic Life Sciences Inc., Canada, TSE:PLI; and Arriva Pharma- ceuticals Inc.) |
-- |
Recombinant alpha-1- antitrypsin topical gel |
Atopic dermatitis |
Company completed a Phase I trial showing the gel was well tolerated (8/12) |
|
||||
BCY Life-Sciences Inc. (Canada; VSE:BCY) |
DCF 987 |
Low-molecular-weight dextran |
Cystic fibrosis |
Company completed enrollment in a Phase II trial (8/8) |
|
||||
Bioniche Life Sciences Inc. (Canada; TSE:BNC) |
Cystistat |
Sodium hyaluronate |
Interstitial cystitis |
Company missed its primary endpoint in a pivotal trial (8/18) |
|
||||
Cellegy Pharmaceuticals Inc. (CLGY) |
Cellegesic |
Nitroglycerin ointment |
Chronic anal fissures |
Company is enrolling a confirmatory Phase III trial (8/6) |
|
||||
Genaera Corp. (GENR) |
Squalamine |
Anti-angiogenic drug that blocks a number of angiogenic growth factors, including vascular |
Choroidal neovascularization associated with age-related macular degeneration |
Phase I/II data showed that Squalamine improved vision in patients with wet AMD (8/4) |
|
||||
Genentech Inc. (NYSE:DNA) |
Lucentis (formerly called rhuFab V2) |
Ranibizumab; a humanized therapeutic antibody |
Wet form of age-related macular degeneration |
Phase Ib/II data showed that of 40 patients treated for six months who completed the study through day 210, 97.5% had stable or improved vision and 45% improved 15 letters or more on the Early Treatment Diabetic Retinopathy Study chart (8/19) |
|
||||
Inspire Pharmaceuticals Inc. (ISPH) |
Diquafosol |
Diquafosol tetrasodium ophthalmic solution |
Dry eye disease |
A Phase IIIb study showed diquafosol was well tolerated with the incidence of adverse events similar to placebo (8/13) |
|
||||
MacroChem |
Topiglan |
Combines alprostadil, a vasodilator, with SEPA, MacroChem's drug absorption enhancer; topical cream |
Erectile dysfunction |
Company is expanding a doubleblind Phase II trial of Topiglan in the U.S. (8/26) |
|
||||
Santarus Inc.* |
SAN-05 |
Oral, immediate-release omeprazole suspension |
Upper |
Phase III data showed |
|
||||
|
| ||||
Notes: | ||||
* Privately held | ||||
** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
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; VSE = Vancouver Stock Exchange. | ||||
