Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
||||
Aastrom Biosciences Inc. (ASTM) | -- | CB-1 cord blood cell therapy | Adult leukemia | Company initiated patient enrollment in a clinical trial (2/27) |
Aphton Corp. (APHT) | Anti-gastrin vaccine | Vaccine that induces antibodies in patients that neutralize gastrin-17 | Advanced pancreatic cancer | Phase II results indicated a greater increase in survival in treated patients compared to increases in a prior trial; the study produced an overall median survival rate of 8.6 months after initiation of therapy (2/9) |
BioChem Pharma Inc. (Canada; BCHE) | Troxatyl | Troxacitabine | Leukemia | Phase I data published in the Journal of Clinical Oncology show that Troxatyl demonstrated broad antileukemic activity (2/2) |
Biomira Inc. (BIOM) | Theratope | Synthetic carbohydrate-based vaccine; mimic of cancer antigen si alyl-Tn plus carrier molecule KLH | Metastatic breast cancer | Company recruited 903 patients for its Phase III trial and the study will remain open until March (2/5) |
British Biotech plc (UK; BBIOY) | Marimastat | Matrix metalloproteinase inhibitor | Solid tumors | Marimastat failed in two Phase II trials and the company also decided to drop BB-3644, its second generation matrix metalloproteinase inhibitor meant to avoid the dose-limiting side effects of marimastat, because it caused the same musculoskeletal pain (2/13) |
Cell Therapeutics Inc. (CTIC) | PG-TXL | Paclitaxel/polyglutamate polymer therapeutic | Cancer | Preliminary data presented at the European Organization for ReSearch and Treatment of Cancer indicated PG-TXL is well tolerated at doses more than 150% greater than the current approved dose of Taxol (2/6) |
EntreMed Inc. (ENMD) | Panzem (2ME2) | 2-methoxyestradiol, an antiproliferative | Prostate cancer | Company started a Phase II trial (2/15) |
FeRx Inc.* | MTC-DOX | Doxorubicin released through Magnetic Target Carriers, microparticles, composed of elemental iron and activated carbon | Metastatic liver cancer | Company initiated a Phase I/II trial (2/20) |
Genta Inc. (GNTA) | Genasense | Antisense compound geared toward blocking the production of Bcl-2 | Advanced multiple myeloma | Genta entered a Phase III trial with Genasense (2/13) |
Genta Inc. (GNTA) | Genasense | Antisense compound geared toward blocking the production of Bcl-2 | Chronic lymphocytic leukemia | Company initiated a Phase III trial (2/28) |
GenVec Inc. (GNVC) | TNFerade | A compound to be used with radiation therapy | Cancer | Company initiated a Phase I trial of TNFerade intended for use in combination with radiation therapy (2/15) |
ImClone Systems Inc. (IMCL) | IMC-C225 | Monoclonal antibody designed to target and block the epidermal growth factor receptor | Non-small-cell lung cancer | Company commenced patient treatment in a Phase II trial (2/6) |
MGI Pharma Inc. (MOGN) | Irofulven | Hydroxymethylacylfulvene | Advanced-stage pancreatic cancer | MGI began dosing patients in its pivotal Phase III trial of irofulven (2/7) |
Progen Industries Ltd. (Australia; PGLAF) | PI-88 | Sulfated oligosaccharide | Cancer | Company concluded its Phase Ib trial and confirmed its plans to proceed with Phase II trials (2/2) |
Protein Design Labs Inc. (PDLI) | SMART 1D10 Antibody | Binds to an HLA-DR determinant found on many pre-B and B-cell lymphomas | Relapsed or refractory B-cell non-Hodgkin's lymphoma | Company began a Phase II trial (2/20) |
Ribozyme Pharmaceuticals Inc. (RZYM) and Chiron Corp. (CHIR) | Angiozyme | Antiangiogenic ribozyme targeting vascular endothelial growth factor | Breast cancer | Companies initiated a Phase II trial (2/8) |
SuperGen Inc. (SUPG) | Rubitecan | Oral chemotherapeutic in the camptothecin class | Pancreatic cancer | Company completed patient enrollment in a Phase III study (2/20) |
Telik Inc. (TELK) | TLK286 | Small-molecule candidate developed through the application of TRAP chemogenomics technology | Cancer | Company completed a Phase I trial (2/21) |
Therion Biologic Corp.* and the National Cancer Institute | CEA-Tricom | Vaccine that incorporates a triple dose of co-stimulatory molecules as well as the CEA tumor antigen | Cancer | Company initiated a Phase I trial (2/20) |
Valentis Inc. (VLTS) | Interleukin-2 | Gene medicine | Recurrent or refractory squamous cell carcinoma of the head and neck | Company completed enrollment of a randomized Phase IIb trial (2/15) |
Vical Inc. (VICL) | Allovectin-7 | DNA lipid complex containing the human gene encoding the HLA-B7 antigen | Late-stage metastatic melanoma and early stage cancer of the oral cavity and oropharynx | Company began Phase II trials in each indication (2/8) |
Xenova Group plc (UK; XNVA) | XR9576 | A P-glycoprotein modulator | To prevent multidrug resistance in cancer | Phase IIa results were positive; company plans to move compound into Phase III (2/28**) |
Xenova Group plc (UK; XNVA) | XR5000 | Topoisomerase inhibitor | Ovarian, glioblastoma and non-small-cell lung cancers | Company decided to discontinue development after the drug failed to show significant responses in three Phase II trials (2/28**) |
CARDIOVASCULAR |
||||
Actelion Ltd. (Switzerland; SWX: ATLN) and Genentech Inc. (NYSE:DNA) | Tezosentan | Intravenous dual endothelin receptor antagonist | Heart failure | Phase III data showed the compound demonstrated positive hemodynamic results (2/13) |
The Medicines Co. (MDCO) | Angiomax | Bivalirudin | Angioplasty | Company reached its enrollment target of 1,000 patients in a Phase IIIb randomized trial (2/26) |
United Therapeutics Corp. (UTHR) | Beraprost | Oral therapeutic; form of prostacyclin, which is produced in blood vessels to keep them dilated and free of platelet aggregation | Pulmonary hypertension | Company completed enrollment in its Phase III study of oral beraprost (2/26) |
CENTRAL NERVOUS SYSTEM |
||||
Pain Therapeutics Inc. (PTIE) | PTI-601 | Opioid treatment | Moderate pain | Company completed patient enrollment for an additional Phase II trial (2/23) |
Pozen Inc. (POZN) | MT 100 | Pain-relief formulation that combines a fast-release metoclopramide and an extended-release naproxen sodium | Migraine | MT 100 met its final Phase III trial primary endpoints (2/21) |
Scios Inc. (SCIO) | SCIO-469 | Oral p38 kinase inhibitor | Rheumatoid arthritis | Company initiated a Phase Ib trial (2/7) |
INFECTION |
||||
Acambis plc (UK; ACAM; LSE:ACM) | ChimeriVax | Vaccine derived from the live, attenuated 17D strain of the yellow fever virus | Japanese encephalitis | Phase I/II trial results showed the vaccine was safe, well tolerated and highly immunogenic after a single dose (2/14**) |
Access Pharmaceuticals Inc. (AMEX:AKC) | OraDisc | An amlexanox formulation in a polymer disc designed to adhere to the disease site | Canker sore | Initial data from a 400-patient trial showed evaluable patients reached the primary clinical end-point, complete healing, by day five (2/8) |
Enzo Biochem Inc. (NYSE:ENZ) | HGTV43 | Stem cell gene therapy that contains three Enzo-developed antisense genes designed to intefere with the functioning of two HIV-1 genes | HIV | Phase I results presented at the 8th Conference on Retroviruses and Opportunistic Infections showed the anti-HIV-1 genes could be successfully put into the stem cells, which survived, grew and developed into CD4+ cells for a minimum of six months (2/6) |
Gilead Sciences Inc. (GILD) | Tenofovir DF | Tenofovir disoproxil fumarate | HIV | Preliminary Phase III results show the compound met its primary endpoint, mainly a reduction in viral load (2/20) |
IntraBiotics Pharmaceuticals Inc. (IBPI) |
Protegrin IB-367 | A rinse; synthetically derived analogue of naturally occurring protegrins | Ventilator-associated pneumonia | Phase I data indicated the drug safely reduces bacterial levels in the mouths of patients at risk of experiencing ventilator-associated pneumonia (2/14) |
Serono Inc. (unit of Serona SA; Switzerland; NYSE:SRA; SWX:SEO) | Serostim | Somatropin, rDNA origin for injection; a recombinant human growth hormone | HIV-associated adipose redistribution syndrome | Company initiated a double-blind placebo-controlled study involving 200 patients (2/20) |
Tibotec Group NV (Belgium)* | TMC120 | A non-nucleoside reverse transcriptase inhibitor | HIV | Phase II data showed TMC120 to be highly potent (2/9) |
Triangle Pharmaceuticals Inc. (VIRS) | Coviracil | Nucleoside reverse transcriptase inhibitor | HIV | Preliminary Phase III data indicate that 61% of patients in the Coviracil group and 64% of patients in the lamivudine group had fewer than 50 copies/ml at week 48; data were presented at the 8th Conference on Retroviruses and Opportunistic Infections (2/5) |
Triangle Pharmaceuticals Inc. (VIRS) | DAPD | Dioxolane guanosine reverse transcriptase inhibitor | HIV | Phase I/II data indicates the compound has a positive pharmacokinetics profile and is well tolerated (2/6) |
VaxGen Inc. (VXGN) | AIDSVAX | Bivalent vaccine composed of recombinant gp120 (envelope protein) from two strains of HIV-1 that are prevalent in Southeast Asia and the Pacific Rim | AIDS | Phase I/II data indicated that an adjuvant in development significantly reduces the amount of vaccine material required to induce an immune response (2/9) |
Vertex Pharmaceuticals Inc. (VRTX) | VX-175 | Amprenavir HIV protease inhibitor prodrug | HIV | Preliminary Phase II results indicated the drug in combination with abacavir and lamivudine produced a median decrease in HIV-1 RNA of about 2.0 log10 from baseline and a median increase of about 100 CD4+ cells (2/7) |
MISCELLANEOUS |
||||
Access Pharmaceuticals Inc. (AMEX:AKC) | OraRinse | 0.5% mucoadhesive solution of amlexanox | Mucositis | Compound did not show a statistically significant difference in the two arms of the study (2/20) |
Alkermes Inc. (ALKS) and Janssen Pharmaceutica NV (Belgium; unit of Johnson & Johnson; NYSE:JNJ) | Risperdal | Intramuscular injectable sustained-release formulation of Risperdal, based on Alkermes' Medisorb injectable drug-delivery system | Psychosis | Companies completed two Phase III trials and are preparing for an NDA filing (2/20) |
Avant Immunotherapeutics Inc. (AVAN) | CETi-1 | Therapeutic vaccine against endogenous cholesterylester transfer protein (CETP) | Low levels of high-density lipoprotein cholesterol | Preliminary Phase I results indicated the vaccine produced an antibody response as early as a week after administration and for as long as 10 weeks in patients subjected to the highest dose level of 250 micrograms (2/21) |
Corixa Corp. (CRXA) | PVAC | Immunotherapeutic based on a process and formulationderived from heat-killed Mycobacterium vaccae | Psoriasis | PVAC failed to meet the primary endpoint, at least a 50% reduction in Psoriasis Area and Severity Index score, in a Phase II trial (2/15) |
DrugAbuse Sciences Inc.* | Naltrel | Depot naltrexone | Heroine addiction | Preliminary Phase II data showed the drug blocks opiate effects in a statistically significant manner (2/7) |
Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Double-stranded synthetic RNA compound poly 1; poly C12U | Chronic fatigue syndrome | Preliminary findings in 13 patients suggest an increase in quality of life after 24 weeks of treatment (2/7) |
Insmed Inc. (INSM) | INS-1 | Oral insulin sensitizer used in combination with sulfonylurea | Polycystic ovarian syndrome; dyslipidemia | Phase II results showed statistically significant efficacy in trials for each indication (2/27) |
InterMune Pharmaceuticals Inc. (ITMN) | Actimmune | Interferon gamma-1b | Cystic fibrosis | Company commenced enrollment in a Phase II trial (2/28) |
MacroChem Corp. (MCHM) | Topiglan | Topical drug; 1% alprostadil and 5% Sepatopical formulation | Erectile dysfunction | The February issue of Urology carries a paper detailing a successful Phase II study demonstrating the safety and efficacy of Topiglan (2/20) |
Millennium Pharmaceuticals Inc. (MLNM) | LDP-02 | Humanized monoclonal antibody against alpha-4 beta-7, an integrin on inflammatory cells that causes the cells to adhere to the gastrointestinal tract | Ulcerative colitis | Company initiated a Phase II trial (2/9) |
Neurocrine Biosciences Inc. (NBIX) | NBI-34060 | Type 1 GABA-a receptor agonist; chemically distinct from benzodiazepines | Insomnia | Clinical results demonstrated the product works as a sedative-hypnotic (2/15) |
Palatin Technologies Inc. (AMEX:PTN) | PT-141 | Synthetic modification of PT-14, an analogue of a naturally occurring peptide hormone called alpha M.S.H. | Erectile dysfunction | Company began enrolling patients in a Phase I study of PT-141 (2/1) |
QLT Inc. (QLTI) | Visudyne | Injected intravenously into a patient's arm; a nonthermal laser light is shined into the patient's eye to activate the drug | Wet age-related macular degeneration in patients with occult subfoveal choroidal neovascularization | Phase IIIb results show Visudyne is effective in reducing the risk of vision loss and probably prevents progression of occult CNV (2/8) |
Theratechnologies Inc. (Canada; TSE:TH) | ThGRF 1-44 | Growth hormone-releasing factor analogue | Sleep disorders | Company began the first of two Phase II trials |
United Therapeutics Corp. (UTHR) | Beraprost | Oral therapeutic; form of prostacyclin, which is produced in blood vessels to keep them dilated and free of platelet aggregation | Intermittent claudication | Company completed enrollment in a Phase III study (2/20) |
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. |
||||
AEX = Australian Stock Exchange; AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange |
||||
BLA = Biologics License Application; NDA = New Drug Application |
||||
ND = Not disclosed |