Company* |
Product |
Description |
Indication |
Status (Date) |
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CANCER |
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Abgenix Inc. |
ABX-EGF |
A human monoclonal antibody that targets the epidermal growth factor receptor |
Colorectal cancer |
Company initiated the third Phase II trial this year (12/28) |
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AEterna |
Neovastat |
Antiangiogenic product |
Renal cell carcinoma |
Company completed patient recruitment in a Phase III trial (12/18) |
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Amgen Inc. |
Epratuzumab |
A humanized, nonradioactive antibody targeting the CD22 receptor of NHL |
Non-Hodgkin's lymphoma |
Interim Phase II data suggest it may have a beneficial effect when used in combination with rituximab and does not seem to affect rituximab's safety profile (12/11) |
|
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Amgen Inc. |
Neupogen |
Filgrastim; a white blood cell booster |
Breast cancer |
Data suggests the benefits of identifying subgroups of breast cancer patients at high risk for hospitalization due to febrile neutropenia so that Neupogen might be administered to help decrease the incidence of side effects (12/11) |
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Amgen Inc. |
Pegfilgrastim |
A polyethylene glcyol molecule unit added to enlarge the Filgrastim molecule |
Non-Hodgkin's lymphoma |
Phase II data showed the duration of severe neutropenia in cycle 1 appeared to be no different for patients in the pegfilgrastim and filgrastim groups (12/11) |
|
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AVI BioPharma |
Avicine |
Nontoxic therapeutic cancer vaccine, which elicits a specific immune response to human chorionic gonadotropin |
Pancreatic cancer |
Phase II results showed that one-year survival data was similar to Gemzar, but that patients had no significant vaccine-related side effects in contrast to those side effects associated with Gemzar (12/7) |
|
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Biomira Inc. |
Theratope |
Vaccine; synthetic carbohydrate-based vaccine; mimic of cancer antigen sialyl-Tn plus carrier molecule KLH |
Metastatic breast cancer |
Company said an independent data safety monitoring board reviewed data from a Phase III and recommended the company continue with its study (12/3) |
|
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BioTransplant |
MEDI-507 with the AlloMune System |
MEDI-507 was used in combination with nonmyeloblative allogeneic bone marrow transplantation |
End-stage refractory lymphoma |
Phase I/II data demonstrated encouraging antitumor results (12/27) |
|
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BioTransplant |
MEDI-507 |
T-cell depleting monoclonal antibody |
Large B-cell lymphoma |
Company reported that a mild course of chemotherapy, including in some cases MEDI-507 followed by bone marrow transplantation, was found to positively affect the treatment of large B-cell lymphoma in patients (12/10) |
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Celgene Corp. |
Revimid |
Immunomodulatory drug to treat solid tumors |
Multiple myeloma |
Phase I/II data demonstrated antitumor activity; Revimid was generally well tolerated (12/11) |
|
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Cell Genesys |
CG7870 |
Oncolytic virus engineered to target and destroy prostate cancer cells |
Prostate cancer |
Phase I/II results demonstrated stabilization of prostate-specific antigen levels in six of 23 patients for a median duration of four months after a single intravenous injection in patients (10/14) |
|
|
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Cell Genesys |
GVAX |
Cancer vaccine; immunotherapeutic comprising irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor |
Refractory or relapsed acute myelogenous leukemia and pre-leukemia |
Phase I trial demonstrated clinical safety and the induction of antitumor immunity following GVAX vaccination (12/10) |
|
|
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Cell Genesys |
GVAX |
Cancer vaccine; immunotherapeutic comprising irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor |
Lung cancer |
Phase I/II data demonstrated a complete tumor response rate of 12% and a median response duration of greater than 11 months (12/17) |
|
|
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Cell Pathways |
Aptosyn and Taxotere |
Exisulind and weekly docetaxel |
Non-small-cell lung cancer |
FDA lifted the clinical hold to new patient accrual for the company's Phase III study (12/7) |
|
|
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Cell Thera- |
Trisenox |
Arsenic trioxide injection |
Blood cell cancers |
Clinical data from more than 600 patients showed no deaths and few side effects, indicating the injection can be used to safely treat patients (12/10) |
|
|
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Coley Pharma- |
CpG 7909 |
Immunostimulatory oligonucleotide |
Non-Hodgkin's lymphoma |
Phase I results show that CpG 7909 infusions were well tolerated and produced positive stimulation of the immunological responses measured in the study (12/10) |
|
|
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Corixa Corp. |
Bexxar |
Radioimmunotherapy antibody conjugated to iodine-131 |
Non-Hodgkin's lymphoma |
Studies showed Bexxar may offer a new treatment option for NHL patients whose prognosis is very poor (12/11) |
|
|
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Genaera |
Squalamine |
An angiogenesis inhibitor |
Advanced cancer |
Phase I results demonstrated transient tumor responses (12/27) |
|
|
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Genta Inc. |
Genasense |
Antisense compound geared toward blocking the production Bcl-2 |
Chronic lymphocytic leukemia |
Phase I data reaffirmed that 3 mg/kg/day was appropriate for extended study of the drug as a single agent (12/11) |
|
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Genzyme |
|
Vaccines |
Melanoma and breast cancer |
Phase I/II results showed the melanoma vaccine was well tolerated by the 20 patients, with 14 showing immunologic or clinical responses; one patient administered the breast cancer vaccine has shown a complete clinical response as well as an immunologic response to the tumor (12/11) |
|
|
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Human |
Repifermin |
Systemically administered treatment |
Cancer therapy-induced mucositis |
Phase IIa trial results demonstrated the safety of systemically administered repifermin (12/7) |
|
|
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ILEX |
Clofarex |
Clofarabine |
Acute refractory leukemias |
Phase II results showed adults with myelogenous leukemia achieved a 45% clinical response rate and acute lymphocytic leukemia patients achieved a 20% response rate (12/10) |
|
|
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Immuno- |
Epratuzumab |
Yttrium-90-radiolabeled anti-CD22 humanized antibody (90Y-epratuzumab) |
Non-Hodgkin's lymphoma |
Data showed that the antibody could be given repeatedly without any adverse immunological effects (12/10) |
|
|
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Introgen |
INGN 241 |
Mda-7 gene drug candidate |
Breast cancer |
Company said the drug in combination with Herceptin, demonstrated supra-additive effects of the gene therapy in breast cancer (12/18) |
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|
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Large Scale Biology Corp. |
|
Cancer vaccines produced by Geneware plant viral vector technology |
Non-Hodgkin's lymphoma |
Phase I data showed the vaccines have excellent safety (12/11) |
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Ligand Pharm- |
Targretin and Ontak |
Bexarotene and denileukin diftitox |
Cutaneous T-cell lymphoma |
Phase I data showed Targretin boosted the activity of Ontak and increased patient response rates (12/12) |
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|
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Matrix Pharm- |
Tezacitabine |
Nucleoside analogue that is an inhibitor of ribonucleotide reductase and a DNA chain terminator |
Acute myeloid leukemia and acute lymphocytic leukemia |
Phase I data indicated a maximum tolerated dose of 7.5 mg/m2 (12/11) |
|
|
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MediGene |
G207 |
Modified herpes simplex virus that has been genetically engineered to selectively multiply in tumor cells and cause cancer cell death without harm to healthy tissue |
Recurrent malignant brain tumors |
Company began a Phase Ib/II trial (12/13) |
|
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MGI Pharma |
Irofulven |
Anticancer compound |
Unresectable hepatocellular carcinoma |
Company expanded its ongoing Phase II trial (12/13) |
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|
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Millennium |
LDP-341 |
Small-molecule protease inhibitor |
Multiple myeloma |
Phase II data showed that LDP-341 halted the progression of the disease in nearly all study participants while reducing a primary marker of cancer severity in a significant number of patients (12/10) |
|
|
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Myriad |
Flurizan |
MPC-7869; it affects a drug target in a novel pathway that may be involved in the regulation of NFkB, a transcriptional activator implicated in cancer and inflammatory diseases |
Prostate cancer |
Company began a pivotal Phase IIb trial with 400 patients (12/20) |
|
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Novus- |
BBR 2778 |
Administered as a one-hour intravenous infusion |
Non-Hodgkin's lymphoma |
Data indicated that BBR 2778 is effective as a monotherapy (12/10) |
|
|
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Oncolytics |
Reolysin |
A human reovirus-based product |
RAS-activated cancers |
Phase I data showed that no patients have experienced any serious adverse events related to the virus; evidence of viral activity in tumors was observed (12/13) |
|
|
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Peregrine |
Cotara |
A monoclonal antibody that carries the radioactive isotope iodine-131 to the necrotic core of solid tumor cancers |
Recurrent glioblastoma multiforme |
Company plans to start a pivotal Phase III trial (12/13) |
|
|
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Pharmacyclics |
Xcytrin |
Motexafin gadolinium injection |
Brain metastases |
Xcytrin missed its primary endpoint in a Phase III trial (12/14) |
|
|
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PhotoCure |
Hexvix |
Diagnostic using fluorescence cystoscopy |
Detection of bladder cancer |
Company will start its final Phase III trial in the U.S. with Hexvix for fluorescence cytoscopic detection of bladder cancer (12/11) |
|
|
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Protein |
Remitogen |
SMART 1D10; |
Non-Hodgkin's lymphoma |
Phase II results indicated one partial response and no complete responses in 25 patients evaluated (12/10) |
|
|
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Protein |
Zamyl |
Humanized antibody that binds to the CD33 antigen on myeloid leukemia cells |
Acute myeloid leukemia |
Zamyl missed its primary endpoint in a Phase III trial and did not demonstrate a complete response in patients within 70 days of the initiation of therapy; it did, however, show an overall response rate of 43% when administered with chemotherapy, compared to a response rate of 26% in patients receiving chemotherapy alone (12/7) |
|
|
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Salmedix |
SDX-101 |
Oral drug; a component of a drug marketed for nononcology indications |
Chronic lymphocytic leukemia and other hematologic malignancies |
Company completed a Phase I trial; SDX-101 was found to be safe and well tolerated (12/4) |
|
|
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SuperGen |
Rubitecan |
Oral chemotherapy compound |
Chronic myelomonocytic leukemia and myelodysplastic syndromes |
Phase II data showed an objective response rate of 28%; hematological improvement was observed in 14%, leading to an overall response rate of 42% (12/11) |
|
|
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Vion Pharma- |
Triapine |
Inhibitor of the enzyme ribonucleotide reductase |
Advanced chronic and acute leukemias |
Company initiated a second Phase I trial (12/10) |
|
|
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CARDIOVASCULAR | ||||
|
|
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AtheroGenics |
AGI-1067 |
V-protectant drug |
Restenosis and atherosclerosis |
Company initiated a Phase IIb trial (12/20) |
|
|
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Corvas |
rNAPc2 |
Anticoagulant that blocks the Factor VIIa/Tissue Factor protease complex |
For patients undergoing percutaneous transluminal coronary angioplasty |
Phase IIa results show rNAPc2 is safe and well tolerated (12/5) |
|
|
||||
Esperion |
ETC-216 |
ApoA-1 Milano product |
Acute coronary syndrome |
Company initiated a Phase II study (12/4) |
|
|
||||
Genentech |
Rituxan |
Rituximab |
Immune thrombocytopenic purpura |
Clinical data indicate that 47% of patients have responded to treatment with 38% achieving a complete response (12/10) |
|
|
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CENTRAL NERVOUS SYSTEM |
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|
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Aderis Pharm- |
Rotigotine CDS |
A transdermal dopamine agonist |
Parkinson's disease |
Company entered Phase III trials with the product (12/31) |
|
|
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Biogen Inc. |
Antegren |
Natalizumab |
Multiple sclerosis and Crohn's disease |
Companies began Phase III trials (12/19) |
|
|
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DIABETES | ||||
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|
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Amylin Pharm- |
AC2993 |
Synthetic exendin-4 |
Type II diabetes |
Company began a Phase III trial (12/10) |
|
|
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MicroDose |
Human |
Pulmonary delivery of human insulin |
Type I and Type II diabetes |
Company completed a Phase I study evaluating the pulmonary delivery of human insulin (12/4) |
|
|
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INFECTION | ||||
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|
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Achillion |
ACH- |
Beta-L-Fd4C, an L-nucleoside analogue |
Hepatitis B and HIV |
Phase I data showed the product can be given once daily (12/17) |
|
|
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Amerimmune |
Cytolin |
Monoclonal antibody that blocks certain adhesion molecules |
HIV |
Phase Ia trial data showed the product was safe and well tolerated (12/11) |
|
|
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Dynavax |
HbsAG |
Hepatitis B surface antigen |
Hepatitis B |
Phase I/II results showed a co-administered dose of HbsAG and Dynavax's immunostimulatory DNA sequences produced protective antibody titers in 88% of subjects after a single immunization (12/18) |
|
|
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InSite Vision |
ISV-401 |
DuraSite formulation of a broad-spectrum antibiotic |
Bacterial conjunctivitis |
Company began a Phase II study (12/19) |
|
|
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InterMune |
Actimmune |
Interferon gamma-1b |
Cryptococcal meningitis |
Phase II results showed the addition of Actimmune to the standard regimen showed a strong trend toward more rapid clearance of cryptococcus fungus from cerebral spinal fluid (12/18) |
|
|
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IntraBiotics |
Iseganan hydrochloride |
Antibiotic; oral solution |
Ventilator- |
Phase IIa results showed iseganan was well tolerated and demonstrated significant reductions in the mean numbers of microorganisms in mechanically ventilated patients (12/18) |
|
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Maxim Pharm- |
Ceplene |
Histamine dihydrochloride |
Hepatitis C |
Company said investigators are treating patients in a Phase II trial of Ceplene in triple-drug combination therapy for patients who have failed to respond to prior therapy (12/18) |
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|
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MedImmune |
Synagis |
Palivizumab |
Respiratory syncytial virus |
Company completed enrollment in a Phase III clinical trial (12/27) |
|
|
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Ortho Bio- |
Procrit |
Epoetin alfa |
HIV |
An interim analysis showed that both once-weekly dosing of Procrit and three-times-weekly dosing were well tolerated (12/17) |
|
|
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Versicor Inc. |
Anidula- |
Antifungal agent; one of a new class called echinocandins |
Fungus infection |
Phase I results showed it is well tolerated and had no dose-limiting toxicities (12/17) |
|
|
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Versicor Inc. |
Dalbavancin |
Antibiotic |
Staphylococcal and other Gram-positive hospital infections |
Phase I results showed it is well tolerated and has promise as a potential once-weekly injectable antibiotic (12/17) |
|
|
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XTL Bio- |
XTL-001 |
Consists of two high-affinity human monoclonal antibodies that act at multiple sites on the HBV surface antigen |
Chronic hepatitis B |
Phase IIa interim results of XTL-001 in combination with lamivudine showed a significant lowering of viral DNA and antigen levels after only one week of treatment (12/10) |
|
|
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Zycos Inc.* |
ZYC101a |
DNA-based therapeutic that works by inducing T cells to attack cervical cells infected by HPV |
Human papillomavirus- |
Company completed enrollment in a Phase II trial (12/4) |
|
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MISCELLANEOUS | ||||
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Alexion Pharm- |
5G1.1 |
Humanized monoclonal antibody C5 complement inhibitor |
Dermatomyositis |
Company completed a Phase I trial that showed the drug was well tolerated and improved skin rash (12/20) |
|
|
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Alkermes |
Vivtrex |
Injectable sustained-release formulation of naltrexone |
Alcoholism |
Phase II results show that on average people treated with Vivtrex plus psychosocial therapy experienced a 50% reduction in heavy drinking days; Vivtrex was well tolerated (12/10) |
|
|
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Antex |
Activax |
Vaccine |
Travelers' diseases |
Company began a Phase I trial (12/18) |
|
|
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Aradigm |
AERx Pain Management System |
Delivers morphine via the AERx pulmonary drug delivery technology |
Pain |
Company completed Phase IIb trials (12/19) |
|
|
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AVI Bio- |
AVI-4126 |
Third-generation anti-sense drug |
Polycystic kidney disease |
Company initiated a Phase I/II study (12/12) |
|
|
||||
Genmab A/S |
HuMax- |
Monoclonal antibody |
Rheumatoid arthritis |
Company began a Phase III trial (12/12) |
|
|
||||
Inflazyme |
IPL576,092 |
Lead compound from a class of anti-inflammatory compounds known as LSAIDs |
Asthma |
Company completed patient enrollment in a Phase II trial (12/11) |
|
|
||||
Interneuron |
Pagoclone |
Gamma amino butyric acid receptor agonist |
Anxiety disorder |
Company said patients experienced a statistically significant improvement in symptoms in a trial involving 200 patients (12/18) |
|
|
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IntraBiotics |
Iseganan |
Antibiotic; oral solution |
Oral mucositis |
Company completed enrollment of 544 patients in the second of three planned pivotal Phase III trials (12/6) |
|
|
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KS Biomedix |
KSB301 |
Super-high affinity monoclonal antibody |
Osteoarthritis |
Company discontinued development of KSB301 after an inconclusive Phase IIb trial (12/12**) |
|
|
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Ligand Pharma- |
Ontak |
Denileukin diftitox |
Severe psoriasis |
Company said 47% of patients treated with a low-dose regimen had a clinically meaningful response and fewer, less severe side effects than patients in previous studies (12/21) |
|
|
||||
MedImmune |
|
Siplizumab |
Psoriasis |
Company completed enrollment in a Phase II clinical trial (12/27) |
|
|
||||
Nastech |
|
Nasally administered apomorphine formulation |
Erectile dysfunction |
Phase II results in 184 men demonstrated efficacy and tolerance (12/13) |
|
|
||||
Neurocrine |
NBI-34060 |
A nonbenzodiazepine that acts on a specific site of the GABA-A receptor |
Insomnia |
Phase II results showed a statistically significant effect on latency to persistent sleep relative to placebo with up to 61% improvement (12/14) |
|
|
||||
Neurogen |
NGD 91-3 |
Works through selective modulation of the neuro- transmitter system known as GABA (gamma amino-butyric acid) |
Anxiety disorder |
The drug failed to meet Phase IIa trial endpoints (12/20) |
|
|
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NPS Pharma- |
AMG 073 |
A calcimimetic |
Secondary hyperparathyroidism |
Companies began a Phase III trial (12/21) |
|
|
||||
Pain Thera- |
PTI-801 |
Narcotic painkiller; version of oxycodone |
Pain |
Trial results indicate that PTI-801 is a viable drug candidate that is well tolerated (12/11) |
|
|
||||
Phytopharm |
P57 |
Appetite suppressant |
Obesity and related conditions |
Preliminary clinical data suggest a statistically significant reduction in the average daily calorie intake of the P57 group compared with the placebo group (12/5) |
|
|
||||
Stressgen |
HspE7 |
Immunotherapeutic to treat diseases caused by the human papillomavirus |
Anal dysplasia |
Phase II data showed that 67% of those who received a high dose showed improvement after three months (12/18) |
|
|
||||
SuperGen |
Nipent |
Pentostatin |
Refractory chronic graft-vs.-host disease |
Phase II data showed a 60% overall response rate in treating patients, with five receiving complete resonses and one receiving a partial response (12/10) |
|
|
||||
Synsorb |
Synsorb Cd |
Product that binds to toxins secreted by bacteria in the gastrointestinal tract |
Clostridium difficile-associated diarrhea |
Company decided to stop development due to high dropout rates and inadequate enrollment in the Phase III trial (12/11) |
| |
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| Notes: |
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| * Privately held |
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| ** Denotes the date the item ran in BioWorld International. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OSE = Oslo Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange | ||||
