Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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Alexion Pharmaceuticals | Eculizumab | C5 complement | Paroxysmal nocturnal hemoglobinuria | Phase Ib data showed that eculizumab administration for three months was associated with a 68% reduction in the need for blood transfusions, and an 81% reduction in biochemical parameters of hemolysis (12/9) |
Cypress | Milnacipran | The first of a new class | Fibromyalgia syndrome | Phase II data showed that 87% of those treated with milnacipran reported overall improvement, compared with 33% in the placebo group (12/10) |
Endo | MorphiDex | Morphine and the N-methyl-D-aspartate receptor antagonist | Osteoarthritis | Phase III data showed the pro- duct did not meet its primary endpoint to reduce the daily morphine requirement and maintain the same degree of pain control over three months in patients with moderate to severe pain from osteoarthritis (12/20) |
Inhale Therapeu- | CDP 870 | A humanized PEGylated antibody fragment | Rheumatoid | Companies moved the product into a Phase III trial (12/16) |
La Jolla | Riquent | Arrests the production | Lupus renal | Company completed a Phase III trial; based on 313 patient samples analyzed to date, 94% had high-affinity antibodies to Riquent (12/17) |
Medarex Inc. | -- | Fully human antibody product candidate developed using Medarex's UltiMAb Human Antibody Development System | Autoimmune | Companies began Phase I trials (12/3) |
Millennium Pharmaceuticals | MLN1202 | Humanized monoclonal antibody that blocks the CCR2 chemokine receptor | Rheumatoid | Company began a Phase I trial (12/16) |
Vertex Pharmaceuticals | VX-148 | Second-generation, orally administered inhibitor of inosine monophosphate dehydrogenase immune response and proliferation of specific cell types | Psoriasis | Company initiated enrollment for a Phase II trial (12/19) |
CANCER |
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AnorMED | AMD-3100 | A potential agent in stem cell transplant by enhancing the effect of Neupogen | Cancer | Company began a Phase II trial to evaluate the potential of AMD-3100 in stem cell transplantation (12/15) |
Antigenics | AG-858 | Personalized heat-shock protein 70 product | Chronic | Results from a pilot study of AG-858 in combination with Novartis AG's Gleevec showed objective clinical response in all five patients evaluated; two patients had complete molecular responses (12/17) |
AVI BioPharma | Neugene | Antisense technology that targets cytochrome P450 3A4 | Cancer | Phase I data showed the drug can block cytochrome P450, and is safe and effective in humans (12/12) |
Bioenvision | Clofarabine | A second-generation nucleoside analogue | Acute myeloid leukemia | Phase II data showed an overall response rate of 55% (12/18) |
CancerVax | Canvaxin | Therapeutic cancer vaccine; allogeneic, whole-cell vaccine that expresses more than 20 antigens | Stage III | Clinical data showed the vaccine increased overall survival in patients with Stage III melanoma (12/9) |
Celgene | Revimid | Orally available agent; immunomodulatory drug | Multiple | Phase II data showed that 39 of 46 evaluable patients with progressive disease experienced a reduction or stabilization in their paraprotein levels (12/9) |
Celgene | Revimid | Orally available agent; immunomodulatory drug | Myelodysplastic syndrome | Clinical results showed that nine of 16 patients responded to the therapy (12/10) |
Celgene | Thalomid | Thalidomide; modulates levels of tumor necrosis factor alpha | Advanced multiple | Clinical results showed that 62 patients (52%) using combination therapy of thalidomide plus dexamethasone achieved a greater than 50% reduction in myeloma protein levels, compared to 54 patients (45%) receiving chemotherapy (12/11) |
Cell Genesys | CG7870 | Oncolytic virus engineered to target and destroy prostate cancer cells | Prostate | Phase I/II data showed antitumor activity in 75% of patients with elevated prostate-specific antigen levels at baseline; treatment was well tolerated (12/13) |
Cell Genesys | GVAX | A patient-specific vaccine made directly from patient tumor biopsies | Lung cancer | Phase I/II data showed that three of 33 patients achieved a com- plete response with a median duration of 17.8 months (12/16) |
Cell | Trisenox | Arsenic trioxide | Multiple | Clinical data of the drug alone or in combination with vitamin C or chemotherapy showed it was well tolerated with manageable side effects and produced clinically relevant responses in the majority of patients; disease control was observed in almost all evaluable patients (12/9) |
Cell | Trisenox | Arsenic trioxide | Myelodysplastic syndrome | Phase II data showed the drug was well tolerated; there were 11 patients with objective responses and 12 with stable disease out of 32 patients total (12/10) |
Collgard Bio- | Tempostatin | Halofuginone hydrobromide | Bladder | Company is enrolling patients in a Phase II trial (12/10) |
Dendreon | Provenge | Therapeutic vaccine that appears to delay tumor progression | Prostate | Company intends to amend the protocol for a Phase III trial to enroll only advanced hormone- resistant prostate cancer patients with a Gleason score of 7 or less (12/5); Phase III data indicated that the product delayed the onset of disease-related pain (12/11) |
Dendreon | APC8024 | Vaccine designed to | Advanced | Phase I data showed the vaccine was safe and showed signs of clinical benefit (12/12) |
Genentech Inc. | Herceptin | Trastuzumab; monoclonal antibody developed | Breast | Phase III results of Herceptin showed that the addition of carboplatin to Herceptin and paclitaxel resulted in a six-month improvement in time to progression (12/12) |
Genentech Inc. | Rituxan | MabThera/rituximab; | Non-Hodgkin's | Clinical data showed that extended single-agent Rituxan therapy reduced the risk of disease pro- progression or relapse by 55% for responding patients and nearly doubled event-free survival for chemotherapy-naive indolent NHL patients (12/10) |
Genitope | GTOP-99 | A personalized vaccine- like immunotherapy | Follicular | The company initiated a trial using patients already registered with the Phase III trial (12/4) |
Genta Inc. | Genasense | Oblimersen sodium; | Chronic | Phase II data showed that two patients who had failed four or more prior treatment regimens achieved a partial response; 11 patients achieved stablization of their disease; eight of 19 patients achieved greater than 50% decrease in the size of enlarged lymph nodes; eight of 16 patients achieved greater than 50% decrease in the size of enlarged liver or spleen (12/9) |
Genzyme | -- | Vaccine using cell fusion technology in which cancer cells surgically removed from the patient are chemically combined with dendritic cells | Breast | Phase I/II data showed that two of 10 patients had measurable tumor regressions following therapy; a third patient showed stable disease (12/10) |
Genzyme | -- | Vaccine made from electrically combining a patient's cancer cells with immune-stimulating cells | Kidney | Company is enrolling patients in a Phase I/II trial (12/12) |
Hybridon | GEM231 | Second-generation antisense compound targeted to the RI(alpha) regulatory subunit for protein kinase A | Solid tumors | Phase I results showed a decrease in serum extracellular PKA in the range of 45% to 87% in 43 paired measurements obtained across dose levels before and after a five-day continuous intravenous infusion (12/19) |
ILEX Oncology | Campath | Humanized monoclonal antibody directed against the CD52 antigen that is prevalent on leukemia and lymphoma cells | Non-Hodgkin's lymphoma | Company began a Phase I/II trial with up to 60 patients (12/19) |
ImmunoGen | huN901- | Monoclonal antibody- | Small-cell | Company started the Phase II portion of the Phase I/II study (12/5) |
Immunomedics | Epratuzumab | A humanized, nonradioactive antibody targeting the CD22 receptor of NHL | Non-Hodgkin's lymphoma | Phase I/II data showed that 18% of patients with indolent NHL had an objective response, while 43% of follicular patients showed an objective response (12/9) |
Inex | Onco TCS | Liposomal version of the widely used agent vincristine | Non-Hodgkin's lymphoma | Phase II/III data showed the overall response rate to be 24% (12/3); Phase II results of Onco TCS used in combination therapy showed that 97% of patients completely responded and had all tumors eliminated (12/9) |
Introgen Therapeutics | Advexin | p53 gene therapy | Advanced | Phase I data showed it was safe and well tolerated (12/16) |
Isis | ISIS 2503 | An inhibitor of H-ras, a molecule known to be involved in human cancers | Pancreatic | Phase II data showed that ISIS 2503 in combination with gemcitabine demonstrated a median survival time of more than six months, exceeding the primary endpoint of the study (12/18) |
Millennium Pharmaceuticals | Velcade | Bortezomib; an injectable drug; a small molecule designed to inhibit proteasome | Relapsed and refractory multiple myeloma | Phase II data showed a 35% response rate in patients who were progressing on their last therapy (12/9) |
Millennium Pharmaceuticals | Velcade | Bortezomib; an injectable drug; a small molecule designed to inhibit proteasome | Colorectal | Company began a Phase II trial (12/30) |
Nastech Pharmaceutical Company Inc. (NSTK) | -- | Intranasal morphine gluconate | Pain in opioid-tolerant cancer patients | Phase II data showed the product was rapidly absorbed and produced meaningful pain relief (12/10) |
NeoRx Corp. | Skeletal Targeted Radiotherapy | Small-molecule carrier of the radionucleotide holmium-166 | Multiple | Phase I/II data of STR with high-dose chemotherapy and stem cell transplantation showed that STR is an active agent and provided a high complete-response rate (12/10) |
Neurocrine Biosciences Inc. (NBIX) | NBI-3001 | IL-4 fusion toxin; | Glioblastoma | Clinical results of 32 patients showed median survival was greater than six months; results indicated a safe and well-tolerated dose (12/23) |
OncoGenex Technologies Inc.* (Canada) and Isis Pharmaceuticals Inc. (ISIS) | OGX-011 | An antisense drug | Prostate | Companies initiated a Phase I trial (12/16) |
Oncolytics | Reolysin | A human, reovirus-based product | Recurrent malignant | Phase I data showed it was well tolerated when surgically delivered into the brain during the treatment of the first six patients (12/23) |
Oxigene Inc. | CA4P | Combretastatin A4 Prodrug; vascular targeting agent; a tumor-starving compound | Thyroid | Company started a Phase II trial (12/23) |
Pharmacyclics | Xcytrin | Injection; motexafin gadolinium | Lung cancer | Company began a pivotal Phase III trial with 550 patients (12/19) |
Pharmexa A/S | AutoVac | Therapeutic DNA | Breast | Phase I/II data showed the pro- duct was safe and well tolerated at all three dose levels examined (12/12) |
PSMA Development Co. LLC (joint venture of Cytogen Corp., CYTO; and Progenics Pharmaceuticals Inc., PGNX) | -- | Vaccine that combines prostate-specific membrane antigen with an immune stimulant to induce an immune response against prostate cancer cells | Prostate | Company began a Phase I trial (12/19) |
SuperGen Inc. | Decitabine | Inhibits DNA methyltransferase | High-risk myelodysplastic syndrome | Phase II results showed an overall response rate of 68%, and a significant increase in platelets were observed in 42% of the patients after one cycle of therapy, and 63% after two cycles (12/6) |
SuperGen Inc. | Nipent | Pentostatin; chemotherapeutic that inhibits adenosine deaminase | Leukemias and lymphomas | Phase II data in allogeneic bone marrow transplant patients who were given a regimen of photopheresis, radiation and Nipent two days before a transplant showed that 94% experienced full bone marrow engraftment within 60 days; about 77% of Nipent patients achieved remission (12/9) |
Telik Inc. | TLK286 | A small-molecule antitumor drug that is activated by GST-P1-1 | Ovarian | Company began two clinical trials, one to evaluate the combination of TLK286 and Doxil in patients who have failed platinum-based chemotherapy, and the second to evaluate TLK286 in combination with carboplatin in patients who have recurrent, platinum-sensitive ovarian cancer (12/9) |
Titan | CeaVac | Monoclonal antibody that induces an immune response to the carcino-embryonic antigen | Metastatic colorectal | Phase III data showed a trend toward overall survival, but the product failed to meet the primary endpoint (12/11) |
US Oncology* | Paraplatin | Carboplatin for | Breast | Clinical results showed that Paraplatin in combination with Taxol and Herceptin enhanced the effectiveness of treatment for HER2-positive advanced breast cancer patients (12/11) |
Vion | Triapine | An inhibitor of ribonucleotide | Advanced hematologic malignancies | Phase I results showed Triapine was well tolerated; about 60% of patients had a greater than 80% reduction in the number of circulating leukemia cells, and about 40% had a greater than 95% temporary reduction (12/10) |
CARDIOVASCULAR |
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Esperion Therapeutics | ETC-588 | Large unilamellar vesicles product candidate | Acute coronary syndrome | Company began a Phase II trial (12/12) |
Millennium Pharmaceuticals | MLN1021 | Orally administered inhibitor of Factor Xa | Thrombotic | Company initiated a Phase I trial (12/20) |
Scios Inc. | Natrecor | Nesiritide; recombinant | Congestive | Clinical results published in the American Heart Journal showed Natrecor is safe and effective as a short-term treatment for patients with acutely decompensated congestive heart failure, particularly those with pre- existing arrhythmias (12/19) |
CENTRAL NERVOUS SYSTEM |
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ConjuChem | DAC:Opioid (CJC-1008) | Compound derived from the naturally occurring opioid hormone in man, Dynorphin A | To prevent pain following hysterectomy surgery | Phase II data was not statistically significant, but showed efficacy trends at all time points during the patients' hospitalization period (12/16) |
DOV Pharmaceutical | Bicifadine pain | Non-narcotic analgesic; a chemically distinct molecule that enhances and prolongs the actions of norepinephrine and serotonin | Moderate to severe post-surgical dental | Company began a Phase III trial (12/20) |
Forest Laboratories Inc. (NYSE:FRX), Neurobiological Technologies Inc. (NTII) and Merz Pharmaceuticals GmbH (Germany) | Memantine | Orally available neuroprotective agent that appears to restore dam- aged nerve cells and block excitatory signals by modulating the N- methyl D-aspartate re- ceptor on cell membranes | Alzheimer's | Clinical results showed that patients receiving a combination of memantine and donepezil performed significantly better than patients receiving alternate therapy; patients also showed significantly less decline in activities of daily living (12/10) |
Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Immunotherapeutic; double-stranded synthetic RNA compound poly 1; poly C124 | Chronic fatigue syndrome | Company said its pivotal Phase III study is fully enrolled (12/9) |
Indevus Pharmaceuticals | IP 751 | An anti-inflammatory and analgesic synthetic cannabinoid compound | Neuropathic | Phase II data showed the degree of pain decreased significantly during treatment periods (12/3) |
Teva | Copaxone | Glatiramer acetate | Multiple | Clinical results showed patients taking interferon therapy experienced increased frequency of headache compared to those taking Copaxone (12/9) |
Titan | Spheramine | Cell therapy product that uses human retinal pigmented epithelial cells that secrete dopamine | Parkinson's disease | Company initiated a study with 68 patients (12/19) |
DIABETES |
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Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. | AC2993 | Synthetic exendin-4; a 39-amino acid peptide | Type II | Patients in a clinical study showed progressive reductions in HbA1c, achieving a mean reduction of 1.5% at 12 weeks (12/19) |
INFECTION |
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Antex Biologics Inc. (AMEX:ANX) | -- | Vaccine | Shigella sonnei | Phase I data showed the vaccine was well tolerated, with no serious adverse events reported (12/16) |
Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Immunotherapeutic; double-stranded synthetic RNA compound poly 1; poly C124 | HIV | Phase IIb data suggested a prolongation of time off highly active antiretroviral therapy without significant viral rebound when taking Ampligen vs. control (12/17) |
ICOS Corp. | Pafase | Recombinant human serum protein that inactivates platelet-activating factor | Sepsis | ICOS dropped development of Pafase in sepsis because the product did not reduce 28-day all-cause mortality in a Phase III trial (12/19) |
ID Biomedical | FluINsure | Intranasally delivered trivalent influenza vaccine | Influenza | Phase II data showed favorable safety and tolerability with no serious adverse events and only mild and transient nasal stuffiness and/or runny nose being associated with the active vaccine when compared to a placebo nasal spray (12/3) |
NeuTec Pharma | Mycograb | Antibody-based | Invasive | Company completed recruitment in a Phase II trial with 21 patients (12/11**) |
Therion | TBC-MVA | Preventive smallpox vaccine derived from modified vaccinia Ankara | Smallpox | Company initiated a Phase I trial (12/20) |
Versicor Inc. | Dalbavancin | A next-generation glycopeptide agent that belongs to the same class as vancomycin | Skin and soft tissue infections | Company began a pair of Phase III trials with about 550 hospitalized patients each (12/17) |
MISCELLANEOUS |
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Acologix Inc.* | Dentonin | Human-derived small peptide that has demonstrated potent bone and dental tissue formation activities. | Osteoporosis | Company initiated a Phase I trial (12/20) |
Adolor Corp. | Alvimopan | Small-molecule opioid receptor antagonist | Postoperative | Company completed enrollment in the first of three Phase III trials (12/5) |
GTC | -- | Recombinant human antithrombin III | A hereditary deficiency of the antithrombin blood protein | GTC began a safety and efficacy study in at least 12 patients in high-risk situations to develop thromboses (12/6) |
ICOS Corp. | Cialis | Tadalafil; a PDE5 | Erectile dysfunction | Clinical data showed improved erections by 84% of men taking 10 mg Cialis and 80% of men taking 5 mg Cialis, compared with 28% of men taking placebo (12/3) |
NexMed Inc. | Alprox-TD | Incorporates alprostadil with the company's Nex-ACT transdermal delivery technology | Erectile dysfunction | Phase II data showed that up to 83% of patients reported satisfaction with their treatment (12/5); company completed testing of about 1,400 patients in two pivotal Phase III studies (12/16) |
Oculex | Posurdex | Biodegradable microsized drug delivery system designed to provide continuous drug therapy for about one month inside the eye | Persistent macular | Company completed enrollment of more than 300 patients in a Phase II trial (12/4) |
Progenics Pharmaceuticals | MNTX | Methylnaltrexone; designed to reverse the side effects of opioids without interfering with pain relief | Opioid-induced constipation | Company began a pivotal Phase III trial with 150 patients (12/20) |
QLT Inc. (QLTI) | Visudyne | Verteporfin therapy | Minimally classic wet age-related macular degeneration | Clinical results of 117 patients showed that the mean change in visual acuity scores of patients in Visudyne treatment arms were statistically significant compared to placebo (12/17) |
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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. |
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AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange |
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