Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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AltaRex Corp. | OvaRex | Oregovomab; a fully foreign monoclonal antibody that targets CA 125 | Advanced ovarian cancer | Clinical data demonstrated a 41% reduced risk of relapse for OvaRex-treated patients compared to placebo, a result that is statistically significant; all studies to date demonstrate a benign safety profile (3/15); company saw positive primary results of its 20-patient chemo-immunotherapy study of OvaRex, showing T-cell responders demonstrated a statistically significant benefit over nonresponders in time to progression and survival (3/18) |
AltaRex Corp. (Canada; TSE:AXO) CA 125 | OvaRex | Oregovomab; a fully foreign monoclonal antibody that targets | Cancer | Company began a pharmacokinetic study with the treatment in the first three patients (3/5) |
Coley Pharma- | CpG 7909 | Synthetic oligonucleotide sequences that activate different immunologic functions | Non-Hodgkin's lymphoma | Company initiated a Phase I study of its compound in combination with Rituxan (3/27) |
CollaGenex Pharmaceuticals | COL-3 | Anti-angiogenesis compound | AIDS-related Kaposi's sarcoma | Phase I results showed eight of 18 patients responded to treatment with tumor regression (3/7) |
Dynavax | ISS and Rituxan (FDA-approved) | Immunostimulatory DNA sequence and monoclonal antibody therapy, rituximab | B-cell non-Hodgkin's lymphoma | Company initiated a Phase I study (3/25) |
Hybridon Inc. | GEM 231 | Second-generation anti-sense product | Solid tumors | Company initiated a Phase I/II trial of GEM 231 and irinotecan (CPT-11, Camptosar) (3/4) |
MGI Pharma | Irofulven | Anticancer compound; hydroxymethylacylfulvene | Cancer | Company initiated a Phase I trial of irofulven in combination with the antitumor agent cisplatin (3/19) |
Northwest Biotherapeutics | DCVax- | Dendritic cell-based immunotherapy | Prostate cancer | Phase I/II results showed overall stabilization of disease in 55% of patients (3/5) |
SangStat | Thymoglobulin (FDA- | Anti-thymocyte globulin (rabbit) | Leukemia | Thymoglobulin improved both nonrelapse mortality and overall survival of leukemia patients undergoing unrelated donor bone marrow transplant (3/21) |
Seattle Genetics | SGN-30 | Monoclonal antibody | Hematologic malignancies | Company initiated its first Phase I trial of SGN-30 (3/21) |
SuperGen Inc. | Orathecin | Rubitecan; oral chemotherapy compound | Pancreatic cancer | Company completed a Phase III trial and gave the product the name Orathecin (3/7) |
Viragen Inc. | - | Natural interferon | Melanoma | Viragen said 158 patients in a Phase II/III trial showed no statistically significant increase in overall survival, but they tolerated the treatment well and the chance of relapse-free survival after five years was more than doubled in the treated patients (3/20) |
Wilex AG | WX-UK1 | Small-molecule anti-metastatic drug; urokinase inhibitor | Cancer | Phase Ia data were positive, showing the drug was safe and well tolerated (3/20**) |
Xcyte Thera- | Xcellerated T cells and are injected into the patient | Patient blood is collected and the T cells are stimulated to increase 100-fold cancer | Hormone- | Company initiated a Phase I/II trial (3/29) |
CARDIOVASCULAR | ||||
Collateral Therapeutics Inc. (CLTX), Schering AG (Germany) and Berlex Laboratories Inc. | Ad5FGF-4 | Angiogenic gene therapy product | Angina | Phase II results demonstrated that Ad5FGF-4 showed improvement in myocardial perfusion (3/20) |
CENTRAL NERVOUS SYSTEM | ||||
Amrad Corp- | Emfilermin by certain human cells | Leukemia inhibitory factor; a protein growth factor naturally produced | To reduce nerve damage | Company is abandoning development due to poor Phase II results (3/27**) |
Boston Life Sciences Inc. (BLSI) | Altropane | Radioimaging agent that targets the dopamine transporter | Attention deficit hyperactivity disorder | Company initiated a Phase II study (3/18) |
Celltech Pharma- | Metadate CD (FDA- | Methylphenidate HCl, USP; extended-release capsules | Attention deficit hyperactivity disorder | Phase III results demonstrated that Metadate, when administered daily before school, controlled ADHD during the school day without the need for a second dose (3/6) |
Nastech Pharma- | Interferon beta-1a | Nasally delivered | Multiple sclerosis | Phase I interim results demonstrated the successful nasal delivery of interferon beta-1a (3/21) |
NeoTherapeutics | Neotrofin | Small-molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors | Alzheimer's disease | Company completed patient dosing in its pivotal trial (3/15) |
ReGen Thera- | Colostrinin | Proline-rich polypeptide complex isolated from ovine colostrum | Alzheimer's disease | Phase IIa data showed the rate of deterioration was slower than in the placebo group, but it did not achieve statistical significance (3/27**) |
DIABETES | ||||
Amylin Pharma- | AC2993 | Synthetic exendin-4 | Type II diabetes | Company began the third of three Phase III pivotal trials (3/14) |
INFECTION | ||||
Advanced Viral Research Corp. (OTC BB:ADVR) | Product R | Nontoxic peptide nucleic acid-type immuno-modulator | Genital warts caused by infection | Phase I results showed the product was safe and well tolerated (3/11) |
Atrix Laboratories Inc. (ATRX) | - | Oral interferon-alpha product | Oral warts caused by human papillomavirus in HIV-infected patients | Company began Phase II trials (3/20) |
BioCryst Pharmaceuticals Inc. (BCRX) | Peramivir (RWJ-270201) | Orally administered; neuraminidase inhibitor | Influenza | Company completed patient enrollment in the first Phase III trial (3/25) |
Crucell NV (CRXL; the Netherlands) and Merck & Co. Inc. | - | Vaccine based on a recombinant adenovirus; it is produced on Crucell's PER.C6 cell technology platform | HIV | Phase I data showed the vaccine was generally well tolerated and generated a substantial and prolonged specific T-cell response (3/5) |
DepoMed Inc. | Ciprofloxacin GR | Once-daily extended-release dosage form | Urinary tract infection | Company completed enrollment in a Phase II trial comparing the extended-release form with the immediate-release ciprofloxacin HCl formulation, Cipro (3/5) |
Hemispherx | Ampligen | Immunotherapeutic; double-stranded synthetic RNA compound poly 1; poly C124 | HIV | Clinical results showed no patients relapsed while on Ampligen within the first 30 days, compared to 86% of a control group of 21 patients, resulting in a statistically significant difference (3/18) |
HepaSense Ltd. (joint venture of Isis Pharmaceuticals Inc., ISIP; and Elan Corp. plc, Ireland) | ISIS 14803 | Antisense drug; 20-base phosphorothioate oligonucleotide | Chronic hepatitis C | Company initiated a Phase II trial (3/21) |
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ID Biomedical Corp. (Canada; TSE:IDB) | StreptAVAX | A multivalent alum-adjuvanted vaccine containing recombinant proteins representing coverage for 26 significant serotypes of group A streptococci | To prevent diseases caused by group A streptococci | Phase I results showed the desired immune response endpoints were achieved and no safety concerns were apparent (3/20) |
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Keryx Bio- | KRX-101 | Sulodexide | HIV-associated nephropathy in AIDS patients | Company began initial dosing of patients in a Phase II trial (3/14) |
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Progenics | PRO 542 | Fusion protein that incorporates HIV binding region of human cell surface receptor (CD4) into a human antibody molecule that binds to GP120 | HIV | Company said the drug produced an antiviral response in HIV-infected individuals who were no longer responding to currently available antiretroviral medications (3/18) |
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The Medicines | CTV-05 | A strain of human Lactobacillus | Bacterial | Company said a Phase II trial of CTV-05, as an adjunct to antibiotic treatment, did not improve clinical cure rates at 30 days, the primary endpoint of the trial (3/27) |
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Versicor Inc. | Dalbavancin | Antibiotic; a novel second-generation glycopeptide agent | Bloodstream infections that are catheter-related | Company started a Phase II trial (3/12) |
INFLAMMATION | ||||
Isis Pharma- | ISIS 104838 | Antisense inhibitor of tumor necrosis factor-alpha | Rheumatoid arthritis | Company initiated a Phase II trial (3/13) |
MISCELLANEOUS | ||||
Actelion Ltd. | Tracleer | Orally available dual endothelin receptor antagonist | Digital ulcers | Company initiated a clinical trials program to expand the use of Tracleer (3/27) |
Amrad | AM336 | Synthetic version of the molecule CVID, originally isolated from the venom of a fish-eating species of cone snail from Australia's Great Barrier Reef | Chronic severe pain | Phase I/II results were positive (3/6**) |
Aradigm Corp. | AERx | Pain management system; aerosolized morphine delivered via the AERx pulmonary drug delivery technology | Pain | Phase IIb results showed faster onset of pain relief when compared to immediate-release oral morphine solution and intravenous morphine (3/18) |
AtheroGenics | AG1-1096 | Oral treatment; an antioxidant and selective anti-inflammatory agent derived from AtheroGenics' v-protectant technology platform | To prevent organ transplant rejection | Company began a Phase I trial (3/5) |
Atrix Labora- | Atrisone | Dapsone topical gel in SMP technology | Acne | Phase III results showed Atrisone was statistically superior to vehicle on all four primary efficacy endpoints (3/28) |
Biopure Corp. | Hemopure | Blood oxygenator; hemoglobin glutamer-250 (bovine) | Orthopedic surgery | Phase III results showed an avoidance of red blood cell transfusion in 59.4% of the Hemopure-treated patients at 42 days post-surgery, 70.3% at one week following surgery and 96.3% on the day of surgery itself (3/20) |
Biovitrum AB | BVT.933 | Appetite suppressant | Obesity | Phase IIa results were positive with subjects achieving a statistically significant and clinically relevant weight reduction compared to placebo (3/6**) |
Cellegy Pharma- | Tostrelle | Testosterone gel | Sexual dysfunction | Company began a Phase II/III trial (3/26) |
Celltech Group | CDP 870 | Antibody drug administered by monthly injection | Crohn's disease | Phase II results demonstrated the drug was effective and safe, but the study did not reach statistical significance because of a very high placebo response rate (3/6**) |
Centocor Inc. | Remicade | Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood | Spondylo- | Clinical results found that patients treated with Remicade monotherapy experienced median improvements in disease activity of 73% and 78% as determined by validated patient and physician global assessment measuring tools (3/11) |
Durect Corp. (DRRX) | Chronogesic | Pain therapy system; a three-month continuous infusion subcutaneous implant | Chronic pain | Phase III results showed no evidence of patient overdose at any point; the median reduction in opioid consumption other than from the Chronogesic product was 72%; 78% of patients reported either an improvement or no change in their pain scores (3/18) |
Dynavax Technologies Corp.* | AIC | Anti-allergy immunotherapy made of ragweed allergen, Amb a 1, linked to Dynavax's 1018 immunostimulatory DNA sequence | Allergies | Company announced positive preliminary results from a Phase II trial (3/4) |
GenStar Therapeutics | MAX AD Factor VIII | Factor VIII gene therapy | Hemophilia A | Phase I results showed that after eight months patients sustained an expression level of Factor VIII of 1% (3/27) |
Hemosol Inc. (Canada; HMSL; TSE:HML) | Hemolink | Oxygen therapeutic | Chemotherapy-induced anemia | Company began a Phase II trial (3/26) |
InSite Vision Inc. (AMEX:ISV) | ISV-205 | Uses the DuraSite drug delivery technology; intended to block steroid-induced intraocular pressure elevation | Glaucoma | Phase II results showed ISV-205 prevented maximum elevation of the intraocular pressure compared with placebo; it also significantly lowered intraocular pressure compared to the control vehicle (3/12) |
Inspire Pharma- | INS37217 | Intranasal spray; second-generation P2Y(2) agonist | Upper respiratory disorders | Company completed a Phase I trial (3/6) |
Interneuron | Dersalazine | Orally administered; combines activity against TNF-alpha and other inflammatory cytokines with 4-ASA | Inflammatory bowel disease | Company began a Phase I trial (3/7) |
ISTA Pharma- | Vitrase | Injectable enzyme; hyaluronidase | Vitreous hemorrhage | Vitrase failed to meet its primary endpoint in a Phase III trial (3/26) |
Karo Bio AB (Sweden; SSE:KARO) and Bristol-Myers Squibb Co. | - | A thyroid hormone receptor modulator | Obesity | Companies dropped development following toxic metabolites found in animals from a preclinical study; the compound was in Phase I development (3/27) |
Neurocrine Biosciences Inc. (NBIX) | NBI-34060 | Modified-release tablets | Insomnia | Company began a Phase III trial that will include 3,500 patients (3/19) |
Neurogen Corp. (NRGN) and Pfizer Inc. | NGD 96-3 | Modulates receptors of the GABAA neurotransmitter system | Insomnia | Companies began Phase I trials (3/11) |
NeuroSearch A/S (Denmark)* and Glaxo-SmithKline plc (UK) | NS2389 | Neurotransmitter reuptake inhibitor of serotonin, noradrenaline and dopamine | Depression | Companies decided to discontinue development of NS2389, which had been in Phase II trials (3/13**) |
NeuroSearch | NS2710 | A modulator of gamma amino buytric acid | Anxiety disorder | Companies are stopping development due to skin rashes that occurred in the Phase II trials (3/22) |
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Novavax Inc. | Estrasorb | Estradiol topical emulsion | Menopause | Phase III data showed patients experienced an 85% reduction in the total number of hot flashes during the trial (3/22) |
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NPS Pharma- | Preos | A full-length human parathyroid hormone | Osteoporosis | Company completed patient enrollment in a Phase III study (3/27) |
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Protein Design | Nuvion | Visilizumab; humanized monoclonal antibody directed at the CD3 antigen | Steroid-resistant, acute graft-vs.-host disease | Company initiated a Phase II study (3/11) |
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Protein Design | Zenapax | Humanized antibody | Psoriasis | Zenapax did not prolong the time to recurrence in a Phase II trial, prompting the company to discontinue further development (3/21) |
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Vasogen Inc. | - | Immune modulation therapy | Psoriasis | Company said its open-label clinical trial in moderate to severe psoriasis achieved its objective of identifying an optimal treatment schedule (3/14) |
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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. | ||||
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