Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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Biogen Inc. | Avonex (FDA- | Interferon beta-1a | Multiple | Clinical data showed early treatment with Avonex can reduce the rate at which individuals at particularly high risk for the disease develop clinically definite multiple sclerosis (6/26) |
Cambridge Anti- | D2E7 | Fully human antibody; adalimumab | Rheumatoid arthritis | Phase III data showed positive results in safety and efficacy (6/14) |
CollaGenex Pharmaceuticals Inc. (CGPI) | Periostat (FDA- | Doxycycline 20mg tablets; oral adjunctive therapy to scaling and root planing | Meibomianitis | Company initiated a study with 70 patients (6/17) |
Corixa Corp. | PVAC | Immunotherapeutic based on a process and formulation derived from heat-killed Mycobacterium vaccae | Plaque psoriasis | Company began an additional U.S. clinical study (6/6) |
EluSys Therapeutics Inc. | ETI-104 | Heteropolymer | Systemic lupus erythematosus | ETI-104 showed safety and activity in humans (6/6) |
IDEC Pharmaceuticals Corp. (IDPH), | Rituxan (FDA- | Rituximab; monoclonal antibody therapy | Rheumatoid arthritis | Phase II results were positive (6/19) |
IDEC Pharmaceuticals Corp. (IDPH) | IDEC-131 | Humanized anti-CD154 monoclonal antibody | Crohn's disease | Company stopped Phase II trials after a patient developed a blood clot in the lower leg (6/11) |
Immunex Corp. | Enbrel (FDA- | Etanercept; tumor necrosis factor inhibitor | Rheumatoid arthritis | Clinical data showed patients with early disease experienced a 56% reduction in health assessment questionnaire scores compared to a 35% improvement in patients with longstanding disease; Enbrel was generally well tolerated over five years (6/14) |
Isotechnika Inc. (Canada; VSE:ISA) | ISATX247 | Immunosuppressive agent based on cyclosporine | Moderate to severe psoriasis | Company enrolled 200 patients in a Phase II trial (6/26) |
Medinox Inc.* | MX-1094 | A non-steroidal anti-inflammatory prodrug | Arthritis | Company began a Phase I trial (6/5) |
Praecis Pharmaceuticals | Plenaxis | Gonadotropin-releasing hormone agonist | Endometriosis | Phase II/III data showed 95.7% of patients treated with Plenaxis experienced menstrual relief (6/19) |
Protein Design | SMART anti-IL-12 | Humanized antibody | Autoimmune diseases | Company started a Phase I trial (6/27) |
Theratechnologies Inc. (Canada; | TH9507 | ThGRF peptide | Immune dysfunctions | Company completed a Phase II trial, which demonstrated a positive impact on cell-mediated immune response (6/6) |
Vertex Pharmaceuticals | VX-702 | Orally administered inhibitor of p38 mitogen- activated protein kinase | Inflammatory diseases | Company began a Phase I trial (6/12) |
CANCER | ||||
Antigenics | Oncophage | Cancer vaccine; uses heat shock proteins to activate cellular immune responses | Metastatic kidney cancer | Clinical data showed the quality of life of patients remained stable or improved throughout the course of treatment and a four-week follow-up period (6/4) |
Antisoma plc | Dmxaa | Vascular targeting agent | Cancer | Phase I results showed the drug to be well tolerated as a monotherapy at doses that reduced tumor blood flow and increased the production of serotonin (6/17) |
Aphton Corp. | G17DT | Used in combination with chemotherapy | Metastatic stomach cancer | Clinical results of 58 patients showed that 28 had either a partial or a complete tumor response for an overall response rate of 48.3% (6/12) |
Axcan Pharma | Photofrin (FDA- | Photodynamic therapy porfimer sodium; produces toxic oxygen compound when light-activated | High-grade dysplasia associated with Barrett's esophagus | Phase III results confirm that Photofrin has the potential to be used to prevent esophageal cancer (6/19) |
Celgene Corp. | Revimid | Orally available agent; immunomodulatory drug | Hematological and solid tumor cancers | Company started five additional trials (6/25) |
Cell Genesys | GVAX | Lung 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 median survival of 8 months, as compared to the reported 5.7 to 7 months for docetaxel (6/27) |
Cell Therapeutics | Xyotax | Polyglutamate paclitaxel; a new generation taxane | Ovarian cancer | Phase I results showed disease control was achieved in 10 of 12 patients, with five achieving a major objective response and five achieving stable disease (6/17); company completed enrollment in a Phase II trial and advanced the compound to Phase III trials (6/20) |
Coley Pharmaceutical Group Inc.* | CpG 7909 | Synthetic oligonucleotide sequences that activate different immunologic functions | Metastatic melanoma | Company began a Phase I/II trial (6/13) |
EpiTan Ltd. | Melanotan | A 13-amino-acid peptide that stimulates the production of melanin to produce normal tanning | Skin cancer | Phase I/II data showed the drug to be safe; the company said the drug, which triggers the natural tanning process, reduces the risk of skin cancer (6/19) |
Genta Inc. | Genasense | Antisense compound geared toward blocking the production Bcl-2 | Melanoma | Company is increasing the enrollment of the Phase III study, which will delay the NDA filing to mid-2003 (6/3) |
IntraBiotics Pharmaceuticals | Iseganan HCl | Hydrochloride oral solution | Oral mucositis resulting from chemotherapy | Company completed enrollment in a pivotal Phase III trial (6/6) |
Introgen Therapeutics | Advexin | p53 gene therapy | Cancer | Phase I and Phase II data showed the product selectively kills cancer cells in tumors (6/25) |
Introgen Therapeutics | INGN 241 | A modified adenoviral vector that carries the cancer-killing mda-7 gene | Solid tumors | Phase I results showed that up to 70% of tumor cells died via apoptosis after tumors were injected with a single dose of INGN 241 (6/10) |
Meditech | HyDOX | HyACT technology is achieved through the selective targeting of potent anticancer drugs, such as HyDOX (doxorubicin), directly to tumors, where it makes cancer cells more sensitive to the drug | Cancer | Phase I data showed the product, used in combination with doxorubicin, is safe in humans (6/27) |
MGI Pharma | Irofulven | Anticancer compound; hydroxymethylacylfulvene | Solid tumors | Company initiated a Phase I trial of irofulven in combination with the antitumor drug Xeloda (6/6) |
MGI Pharma | Palonosetron | A 5-HT3 receptor | Chemotherapy- induced nausea and vomiting | Phase III results showed palonosetron achieved statistical significance for both primary and secondary endpoints (6/26) |
Millennium Pharmaceuticals | Velcade (formerly called MLN341) | Bortezomib for injection | Multiple myeloma | Company initiated a Phase III trial (6/12) |
Oxigene Inc. | CA4P | Antitumor vascular targeting agent, combrestatin A4 prodrug | Advanced solid tumor cancers | Company initiated a Phase Ib combination trial to test CA4P with carboplatin for injection (6/5) |
Pharmexa A/S | AutoVaca HER-2 | DNA pharmaccine | Breast cancer | Phase I/II results showed immune responses in some patients at the low-dose level (6/6) |
QLT Inc. (Canada; | Tariquidar | A P-glycoprotein membrane inhibitor | Non-small-cell lung cancer | Company started two Phase III trials to explore the drug's use as an adjunct with first-line chemotherapy (6/28) |
Ribozyme Pharmaceuticals | Angiozyme | Ribozyme that targets the high-affinity receptor for vascular endothelial growth factor, designed as an angiogenesis inhibitor | Colorectal cancer | Phase II results of a combination therapy of Angiozyme with CPT-11, 5-FU and leucovirin showed that 12.5% of patients experienced disease progression by the 12th week, compared to 25% of patients taking chemo- therapy in a comparison study (6/10) |
TransMolecular | 131I-TM- | A radiopharmaceutical containing a synthetic version of a substance called chlorotoxin, which is derived from scorpions | Glioma brain cancer | Company will study the drug in 18 patients to evaluate the safety and tolerability, as well as overall tumor response rate (6/18) |
YM Biosciences | Tesmilifene | Combination therapy with doxorubicin | Metastatic hormone- refractory prostate cancer | Company completed recruitment in its North American Phase II pilot study (6/25) |
CARDIOVASCULAR | ||||
Actelion Ltd. (Switzerland; SWX:ATLN) | Tracleer (FDA- | Bosentan; orally active endothelin receptor antagonist | Pulmonary arterial hypertension | Company reported positive results from the Breathe-3 trial in pediatric patients (6/5) |
Amylin Pharmaceuticals | AC3056 | Antioxidant that inhibits vascular cell adhesion molecule expression in human vascular cells | Atherosclerosis | Phase I results showed dose- dependent increases in blood levels, and absorption following oral administration (6/11) |
Esperion Therapeutics | LUV (ETC-588) | Large unilamellar vesicles | Vascular disease | Company initiated a Phase II trial (6/27) |
MediGene AG (Germany; Neuer Markt:MDG) | Etomoxir | Inhibitor of carnitine- palmitoyl-transferase-1 | Congestive heart failure | Phase II data indicated that Etomoxir did not have the expected efficacy in the treatment of congestive heart failure (6/19**) |
SuperGen Inc. | Decitabine | Inhibits DNA methyltransferase activity | Sickle-cell anemia | Clinical results showed it significantly elevated fetal hemoglobin levels in 100% of patients taking part in the study (6/6) |
CENTRAL NERVOUS SYSTEM |
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Acorda | Fampridine- | 4-aminopyridine; designed to improve conduction in damaged nerves | Chronic spinal cord injury | Company initiated two Phase III trials (6/28) |
Avanir Pharmaceuticals | Neurodex | Orally administered combination of dextromethorphan and an enzyme inhibitor | Pseudobulbar affect (emotional lability) in patients with amyotrophic lateral sclerosis | Phase II/III results showed the effect was statistically significant in favor of Neurodex when compared to dextromethorphan and an enzyme inhibitor (6/21) |
Neurocrine Biosciences Inc. (NBIX) | Indiplon | Acts on the GABA-A receptor | Insomnia | Company kicked off a fifth Phase III trial, this time with a modified-release version (6/4); Phase II results were positive with Indiplon demonstrating statistically significant improvement in sleep efficiency relative to placebo (6/24); company began a sixth Phase III trial with indiplon-IR, an immediate-release version, and indiplon-MR, a modified-release formulation (6/25) |
DIABETES | ||||
Aerogen Inc. | Aerodose | Ipratropium inhaler; uses AeroGen's aerosol generator technology to aerosolize liquids | Type II diabetes | Phase II results showed patients are able to control their glucose levels with insulin as effectively with the Aerodose inhaler as with subcutaneous injection (6/17) |
Amylin Pharmaceuticals | AC2993 | Synthetic exendin-4; a 39-amino-acid peptide | Type II diabetes | Phase II data showed significant sustained reductions in post-meal glucose concentrates compared to placebo at 28 days (6/17); company began another Phase II study with the goal of developing a once-a-month injection of AC2993 (6/25) |
Aradigm Corp. | AERx | Insulin diabetes management system that is electronic and inhaled | Type II diabetes | Data showed the system achieved a level of glycemic control in Type II diabetes (6/18) |
Inhale Therapeutic Systems Inc. | Exubera | Inhaled insulin product using Inhale's inhaleable technology | Type II diabetes | Phase III results showed patients who failed to meet recommended blood glucose levels with combination oral therapy achieved better glycemic control with Exubera than patients who received only oral agents (6/17) |
Insmed Inc. | INS-1 | Orally active insulin | Type II diabetes | Phase II results showed INS-1 improved lipid profiles in patients, especially those receiving statin therapy (6/17) |
Keryx Bio- pharmaceuticals | KRX-101 | Sulodexide; an oral drug | Diabetic kidney disease | Phase II data demonstrated a statistically significant, dose- related reduction in albumin excretion in both Type I and Type II diabetic patients (6/18) |
Neurocrine Biosciences Inc. (NBIX) | NBI-6024 | Vaccine with potential to stop the destruction of insulin-secreting beta islet cells | Type I diabetes | Phase I/II results showed the overall safety profile and incidence of adverse events for all dosing cohorts was similar to that of placebo (6/14) |
Regeneron Pharmaceuticals | Axokine | Genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor | Type II diabetes mellitus | Company began a clinical trial to assess the safety and efficacy of Axokine in overweight and obese individuals (6/13) |
INFECTION | ||||
Arpida Ltd.* (Switzerland) | AR-100 | An antibacterial compound | Antibiotic- resistant Staphylococci and respiratory- tract pathogens | Phase I results showed that intravenously administered doses of up to 300 mg per day are safe and well tolerated (6/27) |
BioCryst Pharmaceuticals | Peramivir | Orally administered neuraminidase inhibitor | Influenza | Company stopped development after Phase III data did not demonstrate a statistically significant difference in the primary effic- acy endpoint, as compared to placebo (6/25) |
BioMarin Pharmaceuticals | Aldurazyme | Laronidase; an enzyme replacement therapy | Mucopolysac- charidosis I | Phase III data showed Aldurazyme patients gained a 5.3% mean increase in pulmonary function and did better enduring a six-minute walk test, compared to placebo patients (6/24) |
BioMarin Pharmaceuticals | Aryplase | Recombinant human arylsulfatase B; enzyme replacement therapy | Mucopolysac- charidosis VI | Phase I data showed that Aryplase continued to be well tolerated at both dose levels by the five patients who received treatment for 48 weeks (6/25) |
Epimmune Inc. | EP HIV-1090 | Multi-epitope vaccine | HIV-1 | Company began a Phase I/II trial (6/13) |
SciClone Pharmaceuticals | Zadaxin | Immune system booster; thymalfasin; thymosin | Hepatitis C and hepatitis B | Company is starting Phase III hepatitis C trials in the U.S. and Phase III hepatitis B trials in Japan (6/14) |
XTL Biopharma- ceuticals Ltd. | XTL-002 | Human monoclonal | Hepatitis C | Company began a Phase Ib trial (6/11) |
MISCELLANEOUS | ||||
AnorMED Inc. | Fosrenol | Lanthanum carbonate | Hyperphos- | Fosrenol did not cause adverse effects over 12 months of therapy in a Phase III study of 98 patients who were starting renal dialysis for the first time (6/7) |
Aradigm Corp. (ARDM) | AERx system | A pulmonary drug delivery platform used to deliver testosterone | Testosterone deficiency | Data on 12 postmenopausal women showed the delivery was safe, with rapid absorption (6/25) |
Connetics Corp. | Actiza | A formulation of 1% clindamycin in the company's foam delivery system | Acne | Company initiated a Phase III trial (6/26) |
Connetics Corp. | Extina | A formulation of 2% ketoconazole in the company's foam delivery system | Seborrheic dermatitis | Company initiated a Phase III trial (6/14) |
Genzyme Corp. | Renagel (FDA- | Sevelamer hydrochloride; calcium-free, metal-free phosphate binder | End-stage renal disease | Clinical results suggest that the calcium-based phosphate binders may contribute to the progression of cardiac calcification, which was greater in patients who took the binders than in patients who took Renagel (6/27) |
Idun Pharma- | IDN-6556 | Caspase inhibitor | Hepatic | Phase I results in 76 adults with mild liver impairment showed the drug was safe and well tolerated (6/11) |
Indevus Pharma- | Trospium | Trospium chloride | Overactive bladder | Company completed enrollment in a Phase III trial (6/19) |
Inspire Pharma- | INS365 | An eye drop that works by activating the P2Y receptor | Chronic | Company said a second Phase III study is completed with a statistically significant improvement over placebo for the primary objective endpoint of corneal staining (6/18) |
Nabi Biopharma- | NicVAX | Nicotine conjugate vaccine; helps the body develop antibodies that bind to nicotine and block it from reaching the brain | Nicotine addiction | Company began Phase I testing (6/12) |
Novogen Ltd. (Australia; NVGN) | NV-07a | Synthetic dermatological compound | To reverse the damaging effects of sun exposure on the skin | Company began a second clinical trial (6/13) |
Santarus Inc.* | Acitrel | Combines omepazole with | Upper gastrointestinal bleeding | Company began a Phase III trial (6/26) |
Transkaryotic Therapies Inc. (TKTX) | Iduronate-2- sulfatase | Enzyme replacement | Hunter | Phase I/II results showed patients demonstrated reductions in levels of glycosaminoglycan, as well as reductions in liver and spleen size (6/12) |
Xenova Group | TA-NIC | Anti-nicotine vaccine administered by intramuscular injection | Nicotine dependence | Phase I data showed TA-NIC to be well tolerated both systemically and locally (6/14) |
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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. | ||||
AIM = Alternative Investment Market of the London Stock Exchange; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange; VSE = Vancouver Stock Exchange | ||||
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