Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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Biogen Inc. | Amevive | Alefacept; novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells | Psoriasis | Biogen said that 76% of 21 patients with psoriasis achieved "clear" or "almost-clear" results based on preliminary data (11/22) |
Serono SA | Rebif (FDA- | Interferon beta-1a | Multiple sclerosis | Clinical results showed that Rebif was more effective than Avonex in reducing relapses and active brain lesions in patients with relapsing remitting MS (11/26) |
Teva Pharmaceutical Industries Ltd. (Israel; TEVA) | Copaxone (FDA- | Oral formulation of | Primary progressive multiple | An interim analysis showed it was "improbable" that the study would reach statistical significance (11/7) |
CANCER | ||||
AltaRex Corp. | OvaRex | Immunotherapeutic; oregovomab; a fully foreign monoclonal anti- body that targets CA125 | Metastatic ovarian cancer | Clinical results showed that OvaRex MAb patients demonstrated a near doubling in time to disease relapse as compared with placebo patients (11/22) |
Aton Pharma | SAHA | An inhibitor of histone | Solid tumors, lymphomas and leukemias | Phase I results demonstrated that the oral formulation is readily bioavailable and results in prolongation of acetylated histone accumulation in peripheral blood mononuclear cells compared to an identical dose administered intravenously (11/21) |
Biomira Inc. | BLP25 | Synthetic MUC1 therapeutic vaccine consisting of the 25-amino-acid sequence of the MUC1 cancer mucin, encapsulated in liposomes | Non-small-cell lung cancer | Company completed enrollment of 168 patients in its Phase IIb trial (11/13) |
Celgene Corp. | Revimid | Orally available agent; immunomodulatory drug | Multiple | Phase I/II results showed that 17 of 24 patients, or 71%, experienced at least a 25% reduction in paraprotein (11/1) |
Cell Therapeutics | Trisenox | Arsenic trioxide | Myelodysplasia and chronic myeloid leukemia | Clinical trial results showed an overall objective response rate of 67% (11/8) |
Cell Therapeutics | Xyotax | Links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer | Ovarian | Company plans to conduct a Phase III trial of Xyotax in frontline treatment of ovarian cancer (11/5); Phase II data show that Xyotax may have fewer and less-severe side effects when compared to paclitaxel (11/14) |
Cell Therapeutics | Xyotax | Links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer | Non-small-cell lung cancer | Company began Phase III studies (11/22) |
Cell Therapeutics | Xyotax | Links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer | Solid tumors | Phase I data showed that 11 of 13 evaluable patients achieved durable disease control, with five patients achieving a partial remission and six patients with stable disease (11/25) |
EntreMed Inc. | ENMD | A derivative of thalidomide | Multiple | Company began a Phase I study (11/13) |
Essential Therapeutics | ETRX | A small molecule designed to restore lowered blood cell counts due to myelosuppression | Cancer complications, such as mucositis | Company initiated a Phase I trial (11/7) |
Eximias Pharmaceutical Corp.* | Thymitaq | Nolatrexed | Hepatocellular carcinoma | Company said that 223 patients were enrolled in a Phase III trial, achieving 50% recruitment (11/7) |
FeRx Inc.* | -- | Hepatic intra-arterial delivery of doxorubicin hydrochloride absorbed to magnetic targeted carriers | Hepatocellular carcinoma | Phase I/II data showed that in 21 lesions on 19 patients there was one complete response, two partial responses, seven minor responses, seven patients with stable disease and four patients with progressive disease (11/20) |
Genta Inc. | Genasense | Antisense compound geared toward blocking the production of Bcl-2 | Colorectal cancer and solid tumors | Companies are initiating two trials of Genasense in combination with platinum-based chemotherapy (11/6) |
Genta Inc. | Genasense | Antisense compound geared toward blocking the production of Bcl-2 | Small-cell lung cancer | Clinical data showed Genasense was well tolerated when used with standard doses of carboplatin/etoposide; 10 out of 12 patients achieved a major anti-tumor response (11/22) |
GenVec Inc. | TNFerade | Delivers the human tumor necrosis factor-alpha gene to tumors, using GenVec's adenovector gene delivery technology | Esophageal | Phase Ib results showed 73% of patients had objective tumor shrinkage (11/11); company began a Phase II trial in non-metastatic esophageal cancer (11/14) |
GenVec Inc. | TNFerade | Delivers the human tumor necrosis factor-alpha gene to tumors, using GenVec's adenovector gene delivery technology | Soft tissue | Phase I data showed the product was well tolerated with no dose-limiting toxicities (11/25) |
Genzyme | -- | Vaccine made from combining the patient's own cancer cells with immune- stimulating cells to fight the disease | Kidney | Company began a Phase I/II trial with 20 patients (11/6) |
Immuno-Designed Molecules SA* (France) | Uvidem | Vaccine; cell drug containing dendritic cells that have been generated using IDM's technology in the presence of interleukin-13 | Melanoma | Company launched a Phase II trial (11/4) |
ImmunoGen | huN901- | Monoclonal antibody-based chemotherapy agent | Small-cell lung cancer | Companies completed the Phase I portion of the Phase I/II study (11/22) |
Kosan | KOS-862 | Epothilone D; a polyketide natural product | Cancer | Phase I data showed no apparent myelosuppression (11/20) |
Maxim Pharmaceuticals Inc. (MAXM) | Ceplene | Histamine dihydrochloride | Advanced metastatic melanoma | Phase II results demonstrated that combination therapy with Ceplene and interleukin-2 induced significant and measurable increases in the number and function of key activated immune cells that are known to target cancer cells (11/11) |
Millennium Pharmaceuticals Inc. (MLNM) and BZL Biologics LLC* | MLN2704 | Designed to deliver the maytansanoid chemotherapeutic agent DM1 directly to prostate cancer cells through the MLN691 delivery mechanism, a targeting monoclonal antibody vehicle that binds specifically to the prostate-specific membrane antigen | Prostate | Companies initiated a Phase I trial (11/21) |
NeoPharm Inc. | IL13-PE38 | Tumor-targeting agent | Malignant | Phase I/II data indicated that it was well tolerated, and that evidence of tumor necrosis and prolonged patient survival was observed (11/26) |
NeoPharm Inc. | LE-SN38 | NeoLipid liposomal formulation of SN38, the active metabolite of the cancer drug CPT-11 | Colorectal | Company initiated a Phase I/II trial of LE-SN38 (11/18) |
NewBiotics | Thymectacin | Derived from NewBiotics' Enzyme Catalyzed Therapeutic Activation technology | Colon | Phase I data showed the drug was well tolerated at all dose levels tested (11/20) |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer Corp. | BAY | A small-molecule Raf kinase inhibitor | Hepatocellular carcinoma | Phase I data showed that 27 out of 114 patients treated at higher doses remained on the drug with no disease progression after more than six months, and seven patients had been treated for more than one year with no disease progression (11/20) |
Pharmagenesis | PG490- | A derivative of a compound from an herb widely used in Chinese medicine | Advanced | Company began Phase I trials (11/6) |
Progen Industries (Australia; PGLAF) | PI-88 | Semi-synthetic sulfated oligosaccharide that has several modes of action | Cancer | Phase I/II data showed PI-88 was well tolerated and demonstrated encouraging anticancer activity in some patients with advanced cancer (11/25) |
Telik Inc. | TLK286 | A small-molecule antitumor drug that is activated by GST P1-1 | Colorectal | Phase II data showed a median time to tumor progression of 2.9 months, an increase over both oxaliplatin and 5-FU/LV; the drug also showed an improvement in median survival time (11/20) |
Telik Inc. | TLK286 | A small-molecule antitumor drug that is activated by GST P1-1 | Ovarian | A Phase II trial in 36 patients had not reached median survival yet, but median survival exceeds 16 months; 63% of patients were still alive (11/20) |
Telik Inc. | TLK286 | A small-molecule antitumor drug that is activated by GST P1-1 | Non-small-cell lung cancer | Phase II data showed the product prolonged expected survival and had significant single-agent activity in patients with highly resistant disease; median survival was nine months, with 38% of patients alive at one year (11/20) |
Transgene SA (France; TRGNY) | MVA-Muc1- interleukin-2 vaccine | Uses the highly attenuated MVA vaccinia virus vector to express the Muc1 tumor- associated antigen and the cytokine interleukin-2 (IL-2) in order to stimulate specific T-cell responses | Metastatic | Company initiated a Phase II trial (11/5) |
CARDIOVASCULAR | ||||
Alexion Pharmaceuticals Inc. (ALXN) | Pexelizumab | An anti-inflammatory C5 inhibitor monoclonal antibody fragment | Acute myocardial infarction | Phase II data showed the product missed endpoints of infarct size reduction measured at 72 hours, but the trials showed a reduction in 90-day mortality (11/18) |
Alteon Inc. | ALT-711 | A.G.E. crosslink breaker | Systolic hypertension | Company reached the targeted enrollment of 450 patients in a Phase IIb trial (11/12) |
CollaGenex Pharmaceuticals Inc. (CGPI) | Periostat | Doxycycline hyclate | Acute coronary syndrome | Pilot trial results showed Periostat significantly lowered levels of the inflammatory marker C-reactive protein among acute coronary syndrome patients (11/19) |
Corvas International | rNAPc2 | Recombinant nematode anticoagulant protein c2 | Acute coronary syndrome | Company began a Phase II trial to investigate the safety and efficacy of rNAPc2 (11/5) |
CV Therapeutics Inc. (CVTX) | CVT-3146 | Selective, short-acting A2A adenosine receptor agonist | For patients undergoing cardiac catheterization | Phase II results showed the drug produced a dose-dependent in- crease in coronary blood flow velocity (11/19) |
CV Therapeutics Inc. (CVTX) | Tecadenoson | Selective A1-adenosine receptor agonist | Paroxysmal supraventricular tachycardia | Phase III results showed all five dosing regimens converted back into a normal heart rhythm (11/20) |
GenVec Inc. | Biobypass | Angiogenic gene therapy that delivers vascular endothelial growth factor 121 | Coronary | Phase II data showed an improvement in total time to chest pain on the treadmill and total exercise time on a treadmill at both three and six months (11/20) |
Genzyme Biosurgery (division of Genzyme Corp.; GENZ) | -- | Autologous cell therapy that uses a transplant of a patient's own cells to stop or reverse damage | Heart | Clinical results showed an improvement in ejection fraction in the 10 patients treated (11/18) |
Millennium Pharmaceuticals Inc. (MLNM) | Integrilin | Eptifibatide; prevents reocclusion of the stented artery by blocking certain receptors, known as GP IIb-IIIa, on platelets responsible for thrombus development | Myocardial infarction | Company started a 6,000-patient Phase III trial of Integrilin (11/11) |
The Medicines Company Inc. (MDCO) | Angiomax | Bivalirudin; anticoagulant | Coronary angioplasty | Angiomax was found to be superior to heparin on its own, yielded similar clinical outcomes as com- pared to current standards of care and reduced bleeding and a need for transfusion; the company expects to submit a supplement to update product labeling for Angiomax (11/18) |
United | Remodulin | Treprostinil sodium; subcutaneous | Pulmonary arterial hypertension | Data showed that patients treated with Remodulin increased their survival rate to 69.8% at three years (11/20) |
Vasogen Inc. (Canada; AMEX: VSV; TSE:VAS) | -- | Immune modulation | Advanced chronic heart failure | Company plans to start a Phase III trial (11/19) |
CENTRAL NERVOUS SYSTEM | ||||
Aderis Pharmaceuticals Inc.* | Rotigotine | Constant delivery system; a once-a-day skin patch; a transdermal dopamine agonist | Restless legs syndrome | Phase II data showed the drug was well tolerated at all dose levels and induced a statistically significant reduction in symptoms (11/25) |
Avanir Pharmaceuticals Inc. (AMEX:AVN) | Neurodex | An orally administered combination of dextromethorphan and quinidine sulfate | Pseudobulbar affect | Phase II/III results showed Neurodex had statistically greater improvements in the primary end-point (11/19) |
CeNeS Pharmaceuticals | M6G | Morphine-6-glucuronide; a metabolite of morphine | Pain | Phase II data showed the compound has comparable analgesic effects, but with a better side-effect profile, than morphine; the company plans to enter Phase III trials (11/19) |
DOV Pharmaceutical | Ocinaplon | A chemically distinct molecule that differentially modulates specific subsets of GABA-A receptors | Generalized anxiety | Phase II results showed statistically significant reductions in anxiety as compared to placebo after 14 days of dosing (11/4) |
Guilford Pharmaceuticals Inc. (GLFD) | GPI 1485 | A neuroimmunophilin | Parkinson's disease | Company initiated a Phase II trial (11/6) |
Neurocrine Biosciences Inc. (NBIX) | Indiplon- | Capsules; acts on the | Insomnia | Phase III data demonstrated a statistically significant improvement in the latency to persistent sleep endpoint, and in the latency to sleep onset endpoint (11/14) |
Neurogen Corp. | NGD | Designed to selectively reduce the activity of the neurotransmitter gamma-aminobutyric acid in the memory centers of the brain | Alzheimer's disease | The drug failed to show a therapeutic effect in a Phase II study (11/12) |
NeuroSearch | NS2330 | Therapeutic compound that increases the | Alzheimer's disease | Company initiated a Phase IIb trial (11/4) |
Oxford GlycoSciences plc (UK; OGSI; LSE:OGS) | OGT 923 | N-butylgalactonorjirimycin; an iminosugar and an analogue of Zavesca | Nervous | Company began a Phase I study (11/5) |
Repligen Corp. | RG1068 | Human synthetic secretin | Autism | Results of a 12-patient trial showed that secretin is active in the central nervous system and potentiates activity in the amygdala (11/1) |
DIABETES |
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Theratechnologies Inc. (Canada; TSE:TH) | ThGRF | Induces the production of growth hormone in a natural and pulsatile fashion | Diabetes | Company completed the clinical part of its Phase II study (11/28) |
INFECTION | ||||
Acambis plc | ChimeriVax- DEN2 | Component of Acambis' ChimeriVax-Dengue vaccine | Dengue | Company completed a Phase I trial that showed the vaccine was well tolerated and there were no serious side effects (11/25) |
AuRx Inc.* | -- | Vaccine | Genital | Phase I/II data from the low-dose arm showed the recurrence rate was reduced 84% from the previous year and 37.5% of the treated patients had no recurrent episodes, or complete prevention of all symptoms (11/12) |
BioMarin Pharmaceutical Inc. (BMRN) and Genzyme General (GENZ) | Aldurazyme | Laronidase; enzyme replacement therapy | Mucopoly- | Phase III data showed that patients maintained improvements after 50 weeks of treatment (11/25) |
Gilead Sciences | Hepsera | A nucleotide analogue; adefovir dipivoxil | Lamivudine- resistant hepatitis B | Clinical results showed patients who switched to Hepsera monotherapy or added Hepsera to ongoing lamivudine therapy experienced virological, biochemical and serological improvements through 48 weeks (11/4) |
Hollis-Eden Pharmaceuticals Inc. (HEPH) | HE2000 | Immune-regulating hormone | Malaria | Phase II data showed that 20 of 21 patients reached the primary endpoint of the trial, and 15 of 21 patients cleared the parasites from the blood within seven days of treatment (11/21) |
Human Genome Sciences Inc. | Albuferon- | Created by fusing interferon alpha to albumin | Hepatitis C | Phase I results showed the product was well tolerated, had a prolonged half-life and was biologically active in adults with chronic hepatitis C (11/4) |
Idenix Pharmaceuticals Inc.* | Telbivudine | A nucleoside that exhibits marked and selective activity against HBV replication in laboratory assays | Hepatitis B | Phase IIb data showed an antiviral response coupled with improvement in ALT levels in patients receiving telbivudine, either alone or in combination with lamivudine (11/5) |
Immtech International Inc. (IMMT) | DB289 | Oral anti-infective; dicationic pharmaceutical compound | African | Company completed Phase IIa trials (11/13) |
Inspire Pharmaceuticals Inc. (ISPH) | INS365 Respiratory | An eye drop that works by activating the P2Y receptor | Chronic bronchitis | Company is discontinuing development of INS365 for chronic bronchitis (11/18) |
Inspire Pharmaceuticals Inc. (ISPH) | INS37217 | Intranasal; a P2Y2 agonist designed to enhance mucosal hydration and mucociliary clearance in airway tissues by activating receptors on the mucosal surface | Upper respiratory infections | Phase II results demonstrated statistically significant improvement compared to placebo in post-nasal drip and malaise (11/6) |
Inspire Pharmaceuticals Inc. (ISPH) | INS37217 | Intranasal; a P2Y2 agonist designed to enhance mucosal hydration and mucociliary clearance in airway tissues by activating receptors on the mucosal surface | Allergic | Company began a Phase III trial (11/21) |
Intercell AG* | -- | Vaccine | Hepatitis C | Company started a Phase II study (11/25) |
Isis Pharmaceuticals Inc. (ISIS) | ISIS 14803 | Antisense drug; | Hepatitis C | Phase II results showed the drug demonstrated antiviral activity by producing up to 3.8-log reductions in plasma virus levels in patients with chronic hepatitis C virus (11/5) |
Ribapharm Inc. (NYSE:RNA) | Viramidine | Antiviral drug; nucleoside analogue structurally related to ribavirin | Hepatitis C | Company plans to begin Phase II trials by the end of the year (11/4) |
Romark Laboratories* | Nitazoxanide | A nitrothiazole compound | Crypto- | Clinical results showed nitazoxanide significantly reduced the duration of diarrhea and the rate of death in malnourished children (11/4) |
SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Thymalfasin, thymosin | Hepatitis C | Clinical results showed Zadaxin in combination with pegylated interferon alpha increased the early virologic response rates up to 36% in hepatitis C patients who had failed prior therapy (11/4) |
Trimeris Inc. | Fuzeon | Enfuvirtide; a fusion inhibitor | HIV | Phase III data showed Fuzeon, in combination with other antiretrovirals, provided benefit to treatment-experienced HIV patients at 24 weeks regardless of patient demographics, base- line disease stage or treatment history (11/18) |
Vertex Pharmaceuticals Inc. (VRTX) | GW433908 | Protease inhibitor; calcium phosphate ester prodrug of amprenavir | HIV | Clinical results showed that 68% of HIV-positive patients achieved undetectable viral load with the compound boosted with ritonavir, compared to 65% of patients taking a comparator regimen (11/21) |
MISCELLANEOUS | ||||
Adolor Corp. | Alvimopan | Small-molecule opioid | Opioid bowel dysfunction | Phase III results showed 43% of patients receiving alvimopan 0.5 mg and 55% of those receiving alvimopan 1 mg had at least one bowel movement within eight hours of each dose, as compared to 29% of those taking placebo (11/11) |
Alexion Pharmaceuticals Inc. (ALXN) | Eculizumab | C5 complement | Membranous nephritis | The drug did not reach its primary clinical efficacy endpoint of proteinuria reduction after four months of therapy, but the remission rate was 27% for the 55 evaluable patients who were treated with eculizumab for six months or longer (11/4) |
Amgen Inc. | Aranesp | Darbepoetin alfa; a recombinant erythropoietic protein | Anemia in chronic kidney disease | Clinical results showed 96% of patients receiving Aranesp reached and maintained target hemoglobin levels (11/4) |
AnorMED Inc. | Fosrenol | Lanthanum carbonate; | Renal disease | Fosrenol was shown to be effective in reducing high phosphate levels associated with end-stage renal disease (11/4) |
AVI BioPharma | AVI-4126 | Neugene antisense drug | Polycystic kidney disease | The drug was safe in adult patients (11/21) |
Exhale Therapeutics Inc.* | ETX-100 | A pulmonary therapeutic | Genetic emphysema | Company initiated Phase I trials (11/21) |
Galileo Laboratories Inc.* | GLI-8545 | Targets C-reactive protein reduction | End-stage | Clinical results showed a 52% reduction in serum CRP when orally administered to patients diagnosed with dialysis-dependent end-stage renal disease (11/18) |
GenVec Inc. | AdPEDF | A modified adenovirus, | Age-related macular degeneration | Company began a Phase I trial (11/26) |
Hemosol Inc. (Canada; HMSL TSE:HML) | Hemolink | Hemoglobin raffimer; oxygen therapeutic | For patients having orthopedic surgery | Company will begin a Phase II trial (11/20) |
Inflazyme Pharmaceuticals Ltd. (Canada; TSE: IZP) and Aventis Pharma AG (Germany) | IPL512,602 | Leukocyte-suppressing anti-inflammatory drug | Asthma | Phase Ia and Ib results showed IPL512,602 was safe and well tolerated (11/8) |
Isis Pharmaceuticals Inc. (ISIS) | ISIS 2302 | Alicaforsen; an antisense inhibitor of intercellular | Ulcerative | Company initiated a Phase II trial (11/21) |
Novactyl Inc.* | PCL-016 | A member of a class of | Acne | Company began enrolling patients in a Phase IIa trial (11/26) |
SR Pharma plc | SRP299 | A killed Mycobacterium | Dermatitis | Companies began a Phase II trial (11/25) |
Sucampo Pharmaceuticals Inc.* | RU-0211 | Part of a class of functional | Occasional constipation | Phase III results showed the agent was effective in treating occasional constipation (11/12) |
Transkaryotic Therapies Inc. (TKTX) | Replagal | Agalsidase alfa; enzyme replacement therapy | Fabry's | Phase III data showed no statistical difference between the treatment and placebo in the primary endpoint of renal function (11/27) |
Vivus Inc. | TA-1790 | Phosphodiesterase Type 5 inhibitor | Erectile dysfunction | Clinical results showed that peak efficacy response was comparable to or greater than that observed with Viagra (11/7) |
Vivus Inc. | VI-0162 | Oral product | Premature ejaculation | Company initiated a trial to evaluate VI-0162 (11/20) |
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Notes: | ||||
* Privately held |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange |
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