| Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
|
Abbott Laboratories (NYSE:ABT) |
Humira (FDA-approved) | Adalimumab; fully human antibody designed to block TNF-alpha | Moderate to severe psoriasis | Phase III data demonstrated the efficacy of Humira both on a short-term and sustained basis (2/2) |
|
BioMS Medical Corp. (Canada; TSX:MS) |
MBP8298 | Synthetic peptide | Secondary progressive multiple sclerosis | Began the open-label, follow-on portion to its MAESTRO-01 pivotal Phase II/III trial (2/27) |
|
Centocor Inc. (unit of Johnson & Johnson) |
Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor alpha | Moderate to severe plaque psoriasis | Phase III data demonstrated statistically significant improvements in productivity, which correlated with improvements in health- related quality of life (2/2) |
|
Centocor Inc. (unit of Johnson & Johnson) |
CNTO 1275 | IL-12/23 mAb; subcutaneous injections | Severe plaque psoriasis | Phase II data showed patients experienced significant clearance of skin disease and signifcant improvements in quality of life (2/8) |
|
Human Genome Sciences Inc. (HGSI) and GlaxoSmithKline plc (UK) |
LymphoStat-B stimulator | Belimumab; human monoclonal antibody that inhibits activity of B-lymphocyte | Systemic lupus erythematosus | Started the first of two pivotal Phase III trials with about 810 patients (2/13) |
|
La Jolla Pharmaceutical Co. (LJPC) |
Riquent | Abetimus sodium; B-cell toleragen; designed toreduce levels of antibodies to double-stranded DNA | Lupus renal disease | Company is changing its ongoing Phase III trial, increasing the number of patients from 600 to 730, focusing on higher doses and combining data from the Phase II pharmacology study with the Phase III study (2/1) |
| Lux Biosciences Inc.* |
LX211 | A next-generation calcineurin inhibitor | Active Uveitis | Began pivotal testing (2/20) |
|
Opexa Therapeutics Inc. (OPXA) |
T-cell vaccine technology | Rheumatoid arthritis | Data from a 15-patient trial demonstrated that the technology was well tolerated and induced T cell regulatory immune responses, which correlated with substantial clinical improvements (2/6) | |
|
Targeted Genetics Corp. (TGEN) |
tgAAC94 | Product using an adeno-associated viral vector to deliver a soluble TNF- alpha receptor protein | Inflammatory arthritis | Phase I/II data support the safety and tolerability of a single and repeated intra-articular injection of tgAAC94 to affected joints (2/12) |
| CANCER | ||||
| Adnexus Therapeutics Inc.* |
CT-322 | Anti-angiogenic biologic based on AdNectin protein that blocks vascular endothelial growth factorreceptor-2 | Advanced cancer | Phase I data demonstrated promising evidence of biological activity within four hours of administration, as shown by elevated plasma levels of biomarkers of VEGFR-2 pathway (2/2) |
|
Algeta ASA* (Norway) |
Alpharadin | Radiotherapy based on radium-223 | Hormone-refractory prostate cancer | Phase II data showed patients survived on median nearly 25 weeks (53%) longer than those receiving placebo (2/26) |
|
Antisoma plc (UK; LSE:ASM) |
AS1404 | Small molecule derived from xanthenone acetic acid; vascular disrupting agent | Hormone-refractory prostate cancer | Interim Phase II data showed that men receiving AS1404 plus standard docetaxel chemotherapy had a substantially higher PSA response rate than men receiving chemotherapy alone (2/23) |
|
Biogen Idec Inc. (BIIB) |
Lumiliximab | Primatized anti-CD23 monoclonal antibody in combination with the chemotherapies, fluarabine and cyclophos- phamide plus the antibody Rituxan | Chronic lymphocytic leukemia | Company began a pivotal cancer trial (2/7) |
|
Biomira Inc. (Canada; BIOM; TSX:BRA) and Merck KGaA (Germany) |
Stimuvax | Liposomal vaccine encapsulating a sequence of the MUC1 cancer mucin | Non-small-cell lung cancer | Enrolled the first patient in a Phase III trial (2/26) |
|
Callisto Pharmaceuticals Inc. (AMEX:KAL) |
L-Annamycin | Liposomal annamycin | Pediatric refractory or relapsed acute lymphocytic leukemia or acute myelogenous leukemia | Started a Phase I trial (2/22) |
|
Cell Genesys Inc. (CEGE) and Medarex Inc. (MEDX) |
GVAX | Immunotherapy administered with Medarex's anti-CTLA-4 antibody, ipilimumab (MDX-010) | Prostate cancer | Phase I follow-up data showed that five of six patients treated in the two highest dose groups exhibited antitumor activity including significant declines in prostate-specific antigen (2/22) |
|
Cell Therapeutics Inc. (CTIC) |
Xyotax | Paclitaxel poliglumex | Prostate cancer | Phase II data demonstrated a major response rate of 24% with a median overall survival of 8.5 months and a median time to progression of 3.5months (2/26) |
|
ChemGenex Pharmaceuticals Ltd. (Australia; CXSP) |
Ceflatonin | sHHT; homoharringtonine apoptosis inducer | Chronic myeloid leukemia | Phase I/II data showed that all five patients that received the therapy at the highest dose and were evaluable achieved a complete hematological response, including those resistant to Gleevec (2/14) |
|
Ciphergen Biosystems Inc. (CIPH) |
In vitro diagnostic test | To diagnose ovarian cancer | Started a trial to evaluate the triage test to differentiate women with ovarian cancer from women with benign pelvic masses (2/13) | |
| Cougar Biotechnology Inc.* |
CB7630 | Abiraterone acetate; oral inhibitor of the steroidal enzyme 17 alpha-hydroxy-lase/C17,20 lyase | Prostate cancer | Phase I/II data showed the drug was well tolerated at doses as high as 2,000 mg/day in the 15 patients tested, with no dose-limiting toxicity observed (2/26) |
|
Cytogen Corp. (CYTO) |
Prostascint | Brachytherapy; monoclonal antibody that targets prostate-specific membrane antigen, conjugated with indium-111 | Prostate cancer | Data showed that the cure rate was 90.6% for patients whose fused Prostascint scan showed local disease vs. 66.1% for patients with distant disease(2/8) |
|
Cytogen Corp. (CYTO) |
CYT-500 | Radiolabeled monoclonal antibody targeted to prostate-specific membrane antigen | Prostate cancer | Began the first clinical study of CYT-500 (2/27) |
|
Favrille Inc. (FVRL) |
FavId | Patient-specific immunotherapy | Non-Hodgkin's lymphoma | Treatment followed by high- dose chemotherapy and autologous stem cell transplantation resulted in nine of 15 patients remaining in complete remission for up to 61 months (2/12) |
|
Genentech Inc. (NYSE:DNA) |
Avastin (FDA-approved) | Bevacizumab; antibody designed to inhibit vascular endothelial growth factor | Non-small-cell lung cancer | Phase III data showed that the 7.5 mg/kg and 15 mg/kg doses of Avastin produced a similar treatment effect (2/23) |
|
Generex Biotechnology Corp. (Canada; GNBT) |
AE37 | Peptide vaccine developed by Generex's Antigen Express division in the U.S. | Breast cancer | Entered a Phase II trial (2/1) |
|
Genta Inc. (GNTA) |
Genasense | Oblimersen sodium injection | Relapsed or refractory chronic lymphocytic leukemia | Phase III data showed it achieved its primary endpoint, an increase over chemotherapy in those who had a complete or nodular partial response (2/14) |
|
Genta Inc. (GNTA) |
Genasense | Oblimersen sodium injection | Advanced prostate cancer | Preliminary Phase II data showed that in patients given Genasense plus docetaxel, vs. docetaxel alone, response rates proved similar (2/26) |
| Gloucester Pharmaceuticals Inc.* |
Romidepsin | Depsipeptide; histone deacetylase inhibitor | Relapsed or refractory multiple myeloma | First patient has been treated in a Phase I/II study of romidepsin in combination with bortezomib (2/6) |
|
Tx Inc. (GTXI) |
Acapodene | Toremifene citrate; small-molecule non-steroidal selective estrogen receptor modulator | For side effects of androgen deprivation therapy and to prevent prostate cancer in men with high-grade prostatic intraepithelial neoplasia | An independent data safety monitoring board recommended that the company continue its two pivotal Phase III trials (2/2); Phase III interim data showed that oral, once-daily Acapodene 80 mg increased bone mineral density and lowered cholesterol (2/23) |
|
IDM Pharma Inc. (IDMI) |
Uvidem | Vaccine consisting of mature dendritic cells loaded with lysates of tumor cell lines | Melanoma | Completed patient enrollment in two Phase II studies (2/28) |
|
Infinity Pharmaceuticals Inc. (INFI) and MedImmune Inc. (MEDI) |
IPI-504 | Heat-shock protein inhibitor | Advanced non-small-cell lung cancer | Started a Phase I/II trial (2/14) |
|
Innate Pharma SA (France; FSE:IDD) and Novo Nordisk A/S (Denmark) |
IPH 2101 | A fully human monoclonal antibody | Acute myeloid leukemia | IPH 2101 was administered into humans in a Phase I trial (2/14)** |
|
Kosan Biosciences Inc. (KOSN) and F. Hoffmann- La Roche Ltd. (Switzerland) |
R1492 (KOS-862)/R1645 (KOS-584) | Epothilone compounds | Solid tumors | Discontinued development of R1492 in favor of a second- generation version called R1645, which is moving into Phase II (2/27) |
| Light Sciences Oncology Inc.* |
Light Infusion Therapy (Litx) | Uses light-emitting diodesto activate LS11 (talaporfin sodium) | Glioma | Treated the first patient in its Phase II trial (2/14) |
|
Northwest Biotherapeutics Inc. (OTC BB:NWBT) |
DCVax-Brain | Therapy that uses a patient's own tumor, surgically removed, to prepare a mix of their personal cancer bio-markers that are loaded into the patient's dendritic cells and injected back into the patient intradermally | Glioblastoma multiforme | The first two patients have undergone surgery in the Phase II trial (2/13) |
|
Novacea Inc. (NOVC) |
DN-101 | Asentar; oral, intermittent, high-dose of calcitriol designed to activate the vitamin D receptor | Androgen-independent prostate cancer | Phase II data show that DN-101 might help advanced prostate cancer patients live longer while experiencing fewer chemotherapy-related side effects (2/20) |
|
Onyx Pharmaceuticals Inc. (ONXX) |
Nexavar (FDA- approved) | Sorafenib tablets; oral RAF kinase and VEGF inhibitor | Liver cancer | Phase III data showed the study met its primary endpoint earlier than expected, demonstrating superior overall survival com- pared to placebo (2/12) |
|
Pharmion Corp. (PHRM), GPC Biotech AG (Germany; GPCB) and Spectrum Pharmaceuticals Inc. (SPPI) |
Satraplatin cancer | A platinum-based agent; oral | Hormone-refractory prostate | Phase III data showed satraplatin significantly reduced the risk of disease progression (2/23) |
|
Rigel Pharmaceuticals Inc. (RIGL) |
R763 | An oral, multi-Aurora kinase inhibitor | Hematological malignancies | Partner Merck Serono started enrolling patients in a Phase I study (2/13) |
|
Spectrum Pharmaceuticals Inc. (SPPI) |
EOquin | Apaziquone for intravesical instillation | Non-invasive bladder cancer | Completed patient acrrual in a pilot safety study with 20 patients (2/6) |
|
Threshold Pharmaceuticals Inc. (THLD) |
Glufosfamide | Small molecule targeting abnormal glucose metabolism | Recurrent, sensitive small-cell lung cancer | Began enrolling patients in a Phase II trial (2/6) |
|
Threshold Pharmaceuticals Inc. (THLD) |
Glufosfamide | Small molecule targeting abnormal glucose metabolism | Pancreatic cancer | Phase III data showed glufosfamide missed statistical significance on its primary endpoint on improvement of overall survival compared to best supportive care in patients with metastatic disease who had relapsed after chemotherapy (2/27) |
|
Ziopharm Oncology Inc. (ZIOP) |
ZIO-101 | Organic arsenic | Relapsing multiple myeloma | Phase I study showed 43% of patients achieved stable disease (2/12) |
| CARDIOVASCULAR | ||||
|
ActivBiotics Inc. (BE:AF9) |
Rifalazil | Anti-chlamydial antibiotic | Atherosclerotic changes in the carotid artery | Began patient enrollment in a Phase II study (2/15) |
|
BioMarin Pharmaceutical Inc. (BMRN) |
6R-BH4 | Tetrahydrobiopterin; enzyme cofactor that plays a role in the production of nitric oxide | Hypertension | Phase IIa data failed to show any benefit compared to placebo (2/20) |
|
Cytori Therapeutics (CYTX) |
Adipose-derived stem and regenerative cells | Chronic myocardial ischemia | First patient has been treated in its randomized clinical trial (2/5) | |
| Ilypsa Inc.* | ILY101 | A phosphate-binding agent | Hyperphos-phatemia | Completed enrollment of its Phase II trial with 120 patients (2/6) |
|
Pharmacopeia Drug Discovery Inc. (PCOP) |
PS433540 | A dual-acting angiotensin and endothelin receptor antagonist | Hypertension and diabetic nephropathy | Started a Phase I trial (2/14) |
|
Scios Inc. (unit of Johnson & Johnson) |
Natrecor (FDA-approved) | Nesiritide; recombinant B-type natriuretic peptide | To prevent renal dysfunction after coronary artery bypass grafting | Phase II data showed that those taking Natrecor had improved outcomes after 180 days compared to patients receiving placebo (2/6) |
| Trigen Ltd.* (UK) | Flovagatran (formerly TGN 255) | An intravenous direct thrombin inhibitor | Thrombocytopenia | Completed an IND to begin a Phase III program (2/6) |
|
United Therapeutics Corp. (UTHR) |
Remodulin (FDA- approved) | Treprostinil sodium injection | Pulmonary arterial hypertension | Clinical data showed that rapid transition from intravenous epoprostenol to intravenous Remodulin in 12 patients was achieved with no serious adverse events, and baseline clinical status was maintained over 12 weeks (2/1) |
|
ViaCell Inc. (VIAC) |
CB001 | Ubilical cord blood transplant therapy | Blood transplants | Phase I data showed the product is generally well tolerated and its outcomes were comparable to standard transplants (2/6) |
| CENTRAL NERVOUS SYSTEM | ||||
|
Adolor Corp. (ADLR) |
ADL5859 | Oral Delta opioid agonist | Pain and other conditions | Started a Phase I trial (2/12) |
|
Avicena Group Inc. (OTC BB:AVGO) |
PD-02 | Agent that incorporates ultra-pure form of creatine | Parkinson's disease | The dose-escalating portion of a chronic toxicology study demonstrated it is safe and well tolerated; company plans to begin Phase III enrollment (2/5) |
|
Avigen Inc. (AVGN) |
AV411 | Ibudilast; oral therapy; small-molecule glial attenuator that suppresses pro- inflammatory cytokines | Neuropathic pain | Phase IIa results support a twice- daily dosing frequency (2/6) |
|
BioLineRx Ltd.* (Israel) |
BL-1020 | A GABA-enhanced antipsychotic; small- molecule neuro-transmission modulator | Schizophrenia | Completed Phase I trials showing the drug was well tolerated and demonstrated an improved safety profile (2/13) |
|
Debiopharm Group * (Switzerland) |
DEBIO-9902 SR implants | Monthly sustained-release acetylcholinesterase inhibitor | Alzheimer's disease | Began a Phase II study (2/27) |
|
Elite Pharmaceuticals Inc. (AMEX:ELI) |
ELI-216 | A combination of a narcotic agonist, oxycodone hydrochloride, in a sustained release formulation, and an antagonist, naltrexone hydrochloride | Drug abuse | Completed the first stage of a Phase II study, with results demonstrating its euphoria-blocking effect (2/15) |
|
Halozyme Therapeutics (AMEX:HTI) and Baxter Healthcare |
Hylenex | A liquid injectable formulation that includes recombinant human hyaluronidase | Pain | Phase IIIb data showed positive results for the subcutaneous administration of morphine with Hylenex recombinant; it accelerated the time to maximal blood levels of morphine by 33% (2/15) |
|
ISTA Pharmaceuticals Inc. (ISTA) |
Xibrom (FDA-approved) | Bromfenac sodium ophthalmic solution; once-daily formulation associated with cataract surgery | Post-operative ocular pain and inflammation | Phase III data showed statistically significant results; ISTA plans to file a supplemental NDA (2/8) |
|
Neurochem Inc. (Canada; NRMX; TSX:NRM) |
Alzhemed | Tramiprosate; small molecule designed to interfere with association between glycosamino- glycans and A-beta protein | Alzheimer's disease | Completed the 18-month North American Phase III trial with 1,052 patients (2/1) |
|
TorreyPines Therapeutics Inc. (TPTX) |
NGX426 | Prodrug of tezampanel; an AMPA/kainite receptor antagonist | Pain | Started a second Phase I trial to determine the maximum tolerated dose (2/26) |
| DIABETES | ||||
|
Metabasis Therapeutics Inc. (MBRX) |
CS-917 | Inhibits gluconeogenesis | Type II diabetes | Completed enrollment in the Phase IIb trial with 392 patients (2/1) |
| INFECTION | ||||
|
Amarillo Biosciences Inc. (OTC BB:AMAR) |
Low-dose interferon-alpha lozenges | HIV-positive subjects with oral warts | Began enrolling patients in a Phase II trial (2/8) | |
| Antipodean Pharmaceuticals Inc.* |
MitoQ | Mitoquinone; antioxidants delivered by targeted lipophilic cations | To reduce liver damage in patients with raised liver enzymes associated with hepatitis C virus | Started a Phase II trial with 36 patients (2/5) |
| Argos Therapeutics Inc.* |
AGS-004 | A personalized RNA- loaded dendritic cell-based immunotherapy designed to stimulate the immune system | HIV | Began a Phase I/II trial (2/9) |
|
AspenBio Pharma Inc. (OTC BB:APNB) |
Human appendicitis blood test | To detect appendicitis | Clinical data shows the test can identify patients with appendicitis at a very high sensitivity level of 94% to 97%, compared to significantly lower diagnostic success rates for CT scans (2/22) | |
|
Dynavax Technologies Corp. (DVAX) |
Tolamba | Dynavax's ISS molecule linked to Amb a 1, the major allergen of ragweed | Ragweed allergy | Interim data from the first year of a two-year trial showed a therapeutic benefit in the Midwest (2/23) |
|
GeoVax Labs Inc. (OTC BB:GOVX) |
Vaccine | AIDS prevention | Phase I data indicate a good safety profile of a one-tenth dose of the vaccine, which also showed it stimulates potential protective anti-HIV-1 immune responses in the majority of recipients; a full-dose also indicated a good safety profile (2/5) | |
|
Gilead Sciences Inc. (GILD) and Achillion Pharmaceuticals Inc. (ACHN) |
GS 9132 | Small-molecule inhibitor of hepatitis C virus replication | Hepatitis C | Companies stopped development and plan to pursue a backup compound (2/9) |
|
Gilead Sciences Inc. (GILD) |
GS 9137 | Oral HIV integrase inhibitor | HIV | Completed a Phase II trial (2/26) |
|
Human Genome Sciences Inc. (HGSI) |
Albuferon | Albinterferon alfa-2b; long-acting form of interferon alpha, created with albumin fusion technology | Chronic hepatitis C virus genotypes 2 and 3 | Started dosing in a Phase III trial of Albuferon in combination with ribavirin in treatment-naive patients (2/28) |
|
MedImmune Inc. (MEDI) |
FluMist | Influenza virus vaccine live, intranasal | Influenza | Pivotal Phase III data showed 55% fewer cases of flu in children younger than 5 who were immunized with FluMist, compared with children who received the flu shot (2/15) |
| NanoBio Corp.* | NB-001 | Topical emulsion comprised of water/oil droplets coated with an antiviral surfactant | Herpes labialis | Started enrolling patients in a Phase IIb study (2/15) |
|
Panacos Pharmaceuticals Inc. (PANC) |
PA-040 | Maturation inhibitor | HIV | Started a Phase I trial (2/27) |
|
Peregrine Pharmaceuticals Inc. (PPHM) |
Bavituximab (formerly Tarvacin) | Anti-phosphotidylserine immunotherapeutic | Chronic hepatitis C virus | Phase Ib data showed it generally was safe and well tolerated and had dose-dependent antiviral activity (2/15) |
| Pharmasset Inc.* | R7128 | Polymerase inhibitor; prodrug of the agent PSI-6130 | Hepatitis C virus genotype 1 | Started the multiple-ascending dose portion of an ongoing Phase I trial of R7128 in up to 40 patients chronically infected (2/28) |
|
SciClone Pharmaceuticals Inc. (SCLN) |
SCV-07 | Oral form of synthetic dipeptide; immuno-modulatory agent | Viral infectious diseases | Started a Phase II dose-ranging study (2/5) |
|
SIGA Technologies Inc. (SIGA) |
SIGA-246 | Orally active antiviral agent | Smallpox | Launched a multiple-dose Phase I trial (2/13) |
|
Targeted Genetics Corp. (TGEN) |
tgAAC09 | Preventive vaccine based on HIV subtype C; uses a recombinant adeno-associated viral vector | HIV | Phase I data in 80 healthy volunteers show that a single intra- muscular injection appears to be safe and well tolerated and stimulated a modest immune response against gag, the principal HIV protein encoded by tgAAC09 (2/28) |
|
The Immune Response Corp. (OTC BB:IMRP) |
Remune and IR103 |
First- and second-generation HIV vaccine candidates; IR103 is a co- formulation of Remune and Amplivax, a TLR-9 agonist adjuvant | HIV | Phase II data suggested that both Remune and IR103 stabilize CD4+ T-cell counts compared to placebo in HIV patients who have not started antiretroviral therapy (2/15) |
|
Tibotec Pharmaceuticals Ltd. (Belgium; unit of Johnson & Johnson) and Medivir AB (Sweden; SSE:MVIRB) |
NS3/4A protease inhibitor | Hepatitis C virus | Started a Phase I trial (2/8) | |
| MISCELLANEOUS | ||||
|
Aastrom Biosciences Inc. (ASTM) |
Tissue Repair Cells | A mixture of stem and progenitor cells derived from the patient's bone marrow | Severe long bone fractures | Company said 90% of patients who have completed the 12 months post-treatment follow-up of a Phase I/II trial have evidence of bone regeneration (2/14) |
| Advanced BioHealing Inc.* |
Celaderm | Next-generation bio-engineered tissue product | Venous leg ulcers | Enrolled the first patient in a pilot study (2/8) |
|
Amarin Corp. plc (UK; AMRN) |
Miraxion | Compound that inhibits certain enzymes, including phospholipases and caspases | Huntington's disease | Completed the treatment phase of the North American and the European Phase III trials (2/5) |
| Ambrx Inc.* | ARX201 | A next-generation human growth hormone candidate | Growth hormone deficiency | Started a Phase I/II trial (2/12) |
|
Arena Pharmaceuticals Inc. (ARNA) |
Lorcaserin hydrochloride
|
Obesity | Completed enrollment in the first of three planned Phase III trials (2/5) | |
|
Arpida Ltd. (Switzerland; SWX:ARPN) and obesity |
Iclaprim | Intravenous formulation of broad-spectrum antibiotic | Renal and hepatic impairment | Phase I data confirmed the drug was safe and well tolerated (2/8) |
|
Auxilium Pharmaceuticals Inc. (AUXL) |
AA4500 | Injectable enzyme product | Dupuytren's contracture | Phase III data demonstrated the drug reduced joint contracture in both the double-blind and open-label phases of the trial (2/20) |
|
Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) |
Alitretinoin | Naturally occurring vitamin A derivative | Severe and refractory chronic hand dermatitis | Phase III data showed that of the patients receiving 30 mg, 48% achieved the primary endpoint of clear or almost clear skin, compared to 28% in the 10 mg group and 17% in the placebo group (2/20) |
|
Ceragenix Pharmaceuticals Inc. (OTC BB:CGXB) |
EpiCeram | Mid-strength topical steroid | Moderate to severe atopic dermatitis | Completed the patient visit phase of a clinical study with 112 children (2/21) |
|
Columbia Laboratories Inc. (CBRX) |
Prochieve (FDA-approved) | Progesterone gel | Preterm birth | Failed to reduce the incidence of preterm birth in a Phase III study (2/5) |
| Dynogen Pharmaceuticals Inc.* |
DDP733 | An oral partial agonist of the serotonin Type 3 receptor | Irritable bowel syndrome | Phase II data showed the drug achieved a statistically significant overall clinical response rate of 54% in those receiving 1.4mg t.i.d. compared to 15% for the placebo group (2/13) |
|
Emisphere Technologies Inc. (EMIS), Novartis Pharma AG (Switzerland) and Nordic Bioscience (Denmark) |
Salmon calcitonin | Oral formulation that uses Emisphere's eligen-delivery technology | Osteoporosis | Novartis and Nordic started a Phase III trial (2/27) |
|
InSite Vision Inc. (AMEX:ISV) |
AzaSite Plus | ISV-502; a combination antibiotic/corticocosteroid product formulated in DuraSite | Inflammation and infection of the eye | Top-line Phase I data showed the product was well tolerated, with no serious adverse events reported (2/13) |
|
Intercytex plc (LSE:ICX) |
ICX-SKN | A skin graft substitute comprised of active, allogeneic, human dermal fibroblasts embedded in a human collagen matrix | For skin grafts | Started a Phase I trial (2/21)** |
|
Kuros Biosurgery AG* (Switzerland) and Baxter Healthcare |
An injection that uses Kuros' technology for binding biologics within Baxter's fibrin-based biomatrix, TISSEEL Fibrin Sealant | Tibial plateau fractures | Started a Phase II trial (2/5) | |
|
Manhattan Pharmaceuticals Inc. (AMEX:MHA) |
Oleoylestrone | Oral therapy; synthetic formulation | Obesity | Completed patient enrollment in a Phase IIa study (2/21) |
| MAP Pharmaceuticals Inc.* |
MAP0010 | Nebulized formulation of budesonide for inhalation | Asthma | Phase II data showed it met its primary efficacy endpoints of asthma control as assessed by changes in morning asthma symptom scores compared to placebo (2/27) |
| Marinus Pharmaceuticals Inc.* |
Ganaxolone | Synthetic version of naturally occurring neuroactive steroids (epalons) that bind to gamma aminobutyric acid (GABA)-A receptors in brain | Infantile spasms | Dosed the first patient in an international, randomized Phase IIb study (2/28) |
|
Nymox Pharmaceutical Corp. (NYMX) |
NX-1207 | Investigational agent for BPH | Benign prostatic hyperplasia | Completed a long-term follow-up study of NX-1207 (2/28) |
|
OrthoLogic Corp. (OLGC) |
Chrysalin | A synthetic peptide that mimics certain attributes of the thrombin molecule | Unstable, displaced wrist fractures | Phase III data showed that a subset of female osteopenic subjects treated with 10 mcg of Chrysalin demonstrated a statistically significant benefit compared to placebo in the primary endpoint of time to removal of immobilization (2/19) |
|
Osiris Therapeutics Inc. (OSIR) |
Chondrogen | Adult stem cells formulated for direct injection | To regenerate cartilage in the knee | Six-month results from a Phase I/ II trial showed Chondrogen met its primary endpoint of safety, but did not show a statistically significant increase in the volume of meniscus as compared to placebo (2/13) |
|
OxiGene Inc. (OXGN) |
CA4P | Combretastatin A4 Phosphate; vascular disrupting agent | Myopic macular degeneration | Phase II data showed it met its primary efficacy endpoint of maintenance of visual acuity in 100% of patients, and safety results were favorable (2/15) |
|
Palatin Technologies Inc. (AMEX:PTN) and King Pharmaceuticals Inc. |
Bremelanotide | Melanocortin receptor agonist | Female sexual arousal disorder | Phase IIa data show that 73% of women receiving bremelano- tide reported an increased level of genital arousal vs. 23% on placebo (2/26) |
|
Pharmacopeia Drug Discovery Inc. (PCOP) and Schering-Plough Corp. |
PS522501 | A compound in development for metabolic disease | Metabolic diseases | Started a Phase I trial (2/20) |
|
Pharmaxis Ltd. (Australia; PXSL) |
Bronchitol | Mannitol formulation delivered via an inhalation device | Bronchiectasis | Company reached the recruitment target of 354 subjects in its Phase III trial (2/2) |
|
Regeneron Pharmaceuticals Inc. (REGN) |
IL-1 Trap | Interleukin-1 rilonacept | Cryopyrin-associated periodic syndromes | Product met its primary endpoint in the change of disease activity in a Phase III study (2/28) |
|
Quark Biotech Inc.* and SR Pharma plc (UK) |
RTP-801i | Small interfering RNA therapeutic | Age-related macular degeneration | Started a Phase I trial (2/5) |
| TargeGen Inc.* | TG100801 | Topical, small-molecule multitarget kinase inhibitor | Macular degeneration and other eye diseases | Completed a Phase I trial in 42 healthy volunteers (2/28) |
|
Zelos Therapeutics Inc. (ASX:ZCO) |
Ostabolin-C | A parathyroid hormone analogue | Osteoporosis | Top-line Phase II results showed that it demonstrated a statistically significant, dose response increase in mean lumbar spine bone mineral density that reached 5.2% at the highest dose tested (2/8) |
| Notes: | ||||
| * Privately held. Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
| AMEX = American Stock Exchange; BE = Berlin Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||
