Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


CANCER

Abraxis BioScience Inc. (ABBI)

Abraxane (FDA-approved)

Paclitaxel protein-bound particles for injectable suspension

Metastatic breast cancer

Phase II showed 150mg/m2 of Abraxane administered weekly and 300 mg/m2 every three weeks resulted in longer progression-free survival and an overall improved toxicity profile compared to 100 mg/m2 of Taxotere every three weeks (6/4)

Abraxis BioScience Inc. (ABBI)

Nab-paclitaxel

Albumin-bound paclitaxel

Non-squamous non-small-cell lung cancer and platinum-sensitive, recurrent ovarian, peritoneal and fallopian tube cancer

Phase II studies of nab-paclitaxel in combination with Avastin and carboplatin showed that 31.3% of 36 patients had a partial response and 52.1% had stable disease (6/5)

Adherex Technologies Inc. (AMEX:ADH)

ADH-1

Single-agent therapy

N-cadherin positive solid tumors

Phase II showed it was well tolerated and prolonged stable disease (6/4)

AEterna Zentaris Inc. (AEZS)

AEZS-108

Targeted cytotoxic luteinizing hormone-releasing hormone analogue

Cancers expressing LHRH receptors

Phase I showed evidence of antitumor activity (6/4)

Agennix Inc.*

Talactoferrin alfa

Oral immunomodulatory protein

Refractory non-small-cell lung cancer

Phase II met its primary endpoint of a statistically significant improvement in overall survival (6/4)

Alexion Pharmaceuticals Inc. (ALXN)

Soliris (FDA-approved)

Eculizumab

Paroxysmal nocturnal hemo-globinuria in patients with aplastic anemia or myelodysplastic syndromes

Phase III showed it significantly reduced red blood cell destruction, decreased blood transfusion requirements, improved fatigue and quality-of-life outcomes, and reduced thrombotic events (6/4)

Antisoma plc (UK; LSE:ASM)

ASA404

A small-molecule vascular disrupting agent

Hormone-refractory prostate cancer

Phase II showed a response rate of 59% for ASA404 plus docetaxel vs. 37% for docetaxel alone (6/4)

Ariad Pharmaceuticals Inc. (ARIA)

AP23573

mTOR inhibitor

Metastatic endometrial cancer

Phase II demonstrated efficacy (6/4)

ArQule Inc. (ARQL)

ARQ197

Selective inhibitor of the c-Met receptor tyrosine kinase

Cancer

Phase I data showed it was well tolerated over extended dosing periods (6/4)

Biogen Idec Inc. (BIIB)

Zevalin (FDA-approved)

Ibritumomab tiuxetan radioimmunotherapy

Follicular lymphoma

Phase II showed it doubled the rate of complete response compared to standard treatment (6/4)

Celator Pharmaceuticals Inc.*

CPX-1

Irinotecan HCl: Floxouridine

Advanced solid tumors

Phase I showed safety and 73% of patients had a clinical benefit (6/4)

Celgene Corp. (CELG)

Revlimid (FDA-approved)

Lenalidomide

Multiple myeloma

Phase III data showed using Revlimid with a reduced dose of dexamethasone resulted in a 98% survival rate in patients younger than 65 compared to 90% with Revlimid and high-dose dexamethasone (6/5)

Celtic Pharma* and Neurobiological Technologies Inc. (NTII)

Xerecept

Corticorelin acetate injection

Peritumoral edema

Phase III data showed that long-term therapy appears safe and well tolerated, and is associated with reduced exposure to dexamethasone overall, resolution or improvement in associated steroid side effects and neurological stability or improvement (6/5)

Cell Genesys Inc. (CEGE) and Medarex Inc. (MEDX)

GVAX and MDX-010

Immunotherapy and a fully human anti-CTLA-4 antibody

Advanced prostate cancer

Phase I demonstrated antitumor activity in five patients (6/4)

Cell Genesys Inc. (CEGE)

GVAX

Immunotherapy

Pancreatic cancer

Phase II data show a median disease-free survival of about 16 months (6/4)

Cell Therapeutics Inc. (CTIC)

Xyotax

Paclitaxel poliglumex

Advanced non-small-cell lung cancer

Cooperative group data showed E2 levels in serum are prognostic in men and women, showing those with higher levels have shorter survival (6/4)

Celldex Therapeutics Inc. (BE:C4W)

CDX-1307

Intrademerally administered

Cancer

Phase I suggests CDX-1307 resulted in localization of the beta subunit of human chorionic gonadotropin in antigen-presenting cells of the skin (6/4)

Celldex Therapeutics Inc. (BE:C4W)

CDX-110

Immunotherapy that targets EGFRvIII

Glioblastoma multiforme

Phase II data shows a median survival time of 126.1 weeks, and a median time to progression of 64.5 weeks vs. a control's median of 28.52 weeks (6/4)

ChemGenex Pharmaceuticals Ltd. (Australia; ASX:CXS)

Quinamed

Amonafide dihydrochloride

Solid tumors

Phase I/IIa data showed the dose level could be optimized and the drug was well tolerated (6/4)

Cougar Biotechnology Inc. (OTC BB:CGRB)

CB7630

Abiraterone acetate

Prostate cancer

Interim Phase I/II data showed 65% of patients had a decline in PSA levels of greater than 50% (6/4)

Cyclacel Pharmaceuticals Inc. (CYCC)

CYC682

Sapacitabine; an oral nucleoside analogue

Acute myelogenous leukemia and myelodysplastic syndromes

Phase I data showed 11 of 21 patients had a decrease of more than 50% in bone marrow blasts (6/4)

Cytogen Corp. (CYTO)

Quadramet (FDA-approved)

Samarium Sm-153 lexidronam injection

Prostate cancer

Phase I showed it can be safely administered (6/4)

Cytokinetics Inc. (CYTK)

Ispinesib

Kinesin spindle protein inhibitor

Advanced kidney cancer

Phase II showed the dose of 7 mg/m2 on days one, eight and 15 every 28 days does not lead to objective responses but is well tolerated (6/4)

Cytokinetics Inc. (CYTK)

SB-743921

Small-molecule kinesin spindle protein inhibitor

Cancer

Phase I data showed it is well tolerated (6/4)

Diatos SA* (France)

DTS-201

Doxorubicin prodrug

Cancer

Phase I demonstrated safety, tolerability and the ability to deliver high doses (6/4)

Eli Lilly & Co.

Altima

Pemetrexed for injection

Non-small-cell lung cancer

Phase III of Altima plus carbo-platin showed comparable quality of life benefit along with reduced toxicity vs. Gemzar plus carboplatin (6/4)

EntreMed Inc. (ENMD)

Panzem

2-methoxyestradiol

Multiple myeloma; glioblastoma multiforme

Phase II demonstrated prolonged stable disease and minor responses (6/4); Phase II resulted in one partial response and seven stable diseases (6/5)

Exelixis Inc. (EXEL)

XL999

Tyrosine kinase inhibitor

Non-small-cell lung cancer, renal cell carcinoma, metastatic colorectal cancer, recurrent ovarian cancer, acute myelogenous leukemia and multiple myeloma

Six Phase II trials showed preliminary antitumor activity in patients with lung cancer and AML, as well as a cardiovascular adverse event profile consistent with previously reported data (5/4)

Exelixis Inc. (EXEL)

XL880

A small molecule that inhibits MET and VEGFR2

Cancer

Phase I data showed it produced five partial responses and prolonged stable disease of more than three months (6/4)

Favrille Inc. (FVRL)

Favid

Patient-specific immunotherapy

Indolent B-cell non-Hodgkin's lymphoma

Phase II of FavId in combination with maintenance Rituxan showed it is feasible and well tolerated (6/4)

Genentech Inc. (NYSE:DNA)

Avastin (FDA-approved)

Bevacizumab; antibody drug

Advanced non-small-cell lung cancer

A 1,044-patient study demonstrated that Avastin significantly increased progression-free survival at two doses in combination with chemotherapy, but the lesser dose showed a greater improvement (6/4)

Genentech Inc. (NYSE:DNA)

Avastin (FDA-approved)

Bevacizumab; antibody drug

Metastatic renal cell carcinoma

Phase III of the drug in combination with interferon alpha-2a showed positive results in progression-free survival (6/4)

Genentech Inc. (NYSE:DNA)

Herceptin (FDA-approved)

Trastuzumab

HER2-positive breast cancer

Phase III showed the addition of Herceptin to standard adjuvant therapy significantly improved overall survival (6/4)

Genentech Inc. (NYSE:DNA)

Pertuzumab

A monoclonal antibody designed to bind to the HER2 receptor

Platinum-resistant ovarian, fallopian tube or primary peritoneal cancers

Phase II demonstrated an increase in overall progression-free survival by 52% when combined with gemcitabine (6/4)

Genentech Inc. (NYSE:DNA)

Pertuzumab

A monoclonal antibody designed to bind to the HER2 receptor

Metastatic breast cancer

Phase II showed encouraging results in objective response rates (6/4)

Genentech Inc. (NYSE:DNA)

Apomab

Human DR5 agonist antibody

Solid tumors or non-Hodgkin's lymphoma

Phase I showed the product was well tolerated at the five dose levels tested (6/4)

Genta Inc. (GNTA)

Ganite (FDA-approved)

Gallium nitrate

Non-Hodgkin's lymphoma

Phase II of Ganite plus Rituxan and dexamethasone produced a major objective response in 41% of patients (6/4)

GlaxoSmithKline plc (UK)

Tykerb

Oral small-molecule HER2 kinase inhibitor

Advanced breast cancer

Three studies were positive: one with paclitaxel, one with heavily pretreated patients with CNS metastases and one with cape-citabine (6/4)

GlaxoSmithKline plc (UK) and Antigenics Inc. (AGEN)

MAGE-A3 ASCI

A purified recombinant MAGE-A3 protein combined with GSK's adjuvant system containing the QS-21 Stimulon adjuvant from Antigenics

Lung cancer

Opening patient recruitment in a Phase III study (6/5)

Gloucester Pharmaceuticals Inc.*

Romidepsin

A histone deaceytlase inhibitor

Cutaneous and peripheral T-cell lymphoma

Interim Phase II data showed four of 70 patients achieved a complete response (6/5)

GPC Biotech AG (GPCB), Pharmion Corp. (PHRM) and Spectrum Pharmaceuticals Inc. (SPPI)

Satraplatin

Platinum-based drug; oral compound

Hormone-refractory prostate cancer

Phase III data show it reduces disease progression by 33% compared to control (6/4)

GPC Biotech AG (Germany; GPCB), Pharmion Corp. (PHRM) and IDM Pharma Inc. (IDMI)

Uvidem

Melanoma vaccine

Melanoma

Phase II data showed it was well tolerated, and had evidence of efficacy and induction of immune response (6/5)

IDM Pharma Inc. (IDMI)

EP-2101

Vaccine

Non-small-cell lung cancer

Phase II showed it is well tolerated and suggested a survival benefit (6/4)

ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co.

Erbitux (FDA-approved)

IgG1 monoclonal antibody

Colorectal cancer (untreated)

Data showed the drug slightly prolonged survival from 8 months to 8.9 months (6/4)

ImClone Systems Inc. (IMCL)

IMC-A12

A monoclonal antibody targeted to IGF-1R (insulin-like growth factor type 1 receptor)

Advanced solid tumors

First-in-human results showed it was well tolerated and had activity in patients (6/5)

ImmunoGen Inc. (IMGN)

huN901-DM1

Tumor-Activated Prodrug; trastuzumab

Small-cell lung cancer

Four of 10 patients had an objective response in a Phase I (6/4)

Immunomedics Inc. (IMGN)

Epratuzumab

Humanized anti-CD20 monoclonal antibody

Non-Hodgkin's lymphoma

Phase I/II showed it was active at a low dose; the overall objective response was 45% (6/4)

Infinity Pharmaceuticals Inc. (INFI) and MedImmune Inc.(LSE:MDI)

IPI-504

A heat-shock protein 90 inhibitor

Gastrointestinal stromal tumors and other advanced soft-tissue sarcomas

Phase I showed 81% of treated patients achieved stable disease or better (6/5)

Innovive Pharmaceuticals Inc. (OTC BB:IVPH)

INNO-406

A dual Bcr-Abl and Lynkinase inhibitor

Gleevec-resistant chronic myelogenous leukemia

Phase I showed it was well tolerated and generated hematologic, cytogenic and molecular responses (6/4)

Introgen Therapeutics Inc. (INGN)

Advexin

Adenoviral vector containing the p53 tumor suppressor gene

Recurrent squamous cell carcinoma of the head and neck

Phase II showed a significant correlation between abnormal p53, tumor responses and increased survival following Advexin (6/4)

Keryx Biopharmaceuticals Inc. (KERX) and AEterna Zentaris Inc. (AEZS)

Perifosine

Oral agent that modulates AKT and other signal transduction pathways

Advanced sarcoma

Phase I and II data showed an overall clinical benefit rate of 52% (6/4)

Kosan Biosciences Inc. (KOSN)

KOS-953

Tanespimycin; HSP90 inhibitor

Metastatic melanoma and multiple melanoma

Phase II demonstrated antitumor activity and tolerability; combined with bortezomib, it showed a high degree of antitumor activity

Kosan Biosciences Inc. (KOSN)

KOS-1584/R16545

An epothilone

Solid tumors

Phase I demonstrated activity in 13 of 41 evaluable patients

Kosan Biosciences Inc. (KOSN)

Alvespimycin

A second-generation Hsp90 inhibitor

Refractory Her2-positive metastatic breast cancer and refractory ovarian cancer

Phase I data showed promising antitumor activity and tolerability in combination with Herceptin (6/4)

Medarex Inc. (MEDX) and Bristol-Myers Squibb Co.

MDX-010

Ipilimumab; and antibody that binds to CTLA-4

Advanced melanoma

Multiple studies demonstrated an antitumor response, either as a monotherapy or in combination with other therapies (6/5)

MGI Pharma Inc. (MOGN)

Dacogen (FDA-approved)

Decitabine for injection; a hypomethylating agent

Acute myelogenous leukemia; acute lymphocytic leukemia

Data showed an overall response rate ranging from 50% to 57% across three clinical trials; Phase I data showed that two of seven patients had complete bone marrow response (6/5)

MGI Pharma Inc. (MOGN)

Aloxi (FDA-approved)

Palonosetron hydrochloride injection

Solid tumors

The drug in combination with dexamethasone and aprepitant demonstrated a complete response in 75% of patients on day one (6/5)

MGI Pharma Inc. (MOGN)

Irofulven

Hydroxymethylacylfulvene; compound from acylfulvenes family

Hormone-refractory prostate cancer

Phase II data demonstrated a trend toward increased survival (6/5)

Micromet Inc. (MITI)

MT201

Adecatumumab

Metastatic breast cancer

Phase II showed a significant prolongation of time to progression in the higher dose group compared to a lower dose (6/4)

Millenium Pharmaceuticals Inc. (MLNM)

Velcade (FDA-approved)

Bortezomib

Multiple myeloma

A regimen that employs Velcade, called Total Therapy 3, generated a complete response and near-complete response rate of 84% when used prior to and as maintenance following stem cell transplantation; other data showed the combination of Velcade and Doxil improves the probability of survival by 41% (6/4)

Millennium Pharmaceuticals Inc. (MLNM)

Velcade (FDA-approved)

Bortezomib

B-cell lymphoma and mantle cell lymphoma

The addition of Velcade to R-CHOP produced high complete response rates of 83%; (6/4)

Millennium Pharmaceuticals Inc. (MLNM)

MLN8054

Aurora A kinase inhibitor

Cancer

Phase I data showed six patients maintained stable disease for longer than eight months (6/4)

Novacea Inc. (NOVC)

Asentar

DN-101; oral, intermittent, high-dose of calcitriol designed to activate the vitamin D receptor

Non-small-cell lung cancer

Phase I/II showed tolerability; it did not reach the maximum tolerated dose (6/4)

OncoGenex Technologies Inc.*

OGX-011

Second-generation anti-sense drug designed to inhibit the production of clusterin, a cell-survival protein

Non-small-cell lung cancer

Phase I/II showed a median over-all survival of 14 months compared to eight to 11 months for chemotherapy alone and 12.3 months for Avastin plus chemo (6/4)

Onyx Pharmaceuticals Inc. (ONXX) and Bayer Healthcare Pharmaceuticals Inc.

Nexavar (FDA-approved)

Sorafenib; oral multi-kinase inhibitor

Liver cancer

Phase III data showed the drug improves survival; median over-all survival was 10.7 months vs. 7.9 months in the placebo group (6/4)

OSI Pharmaceuticals Inc. (OSIP)

Tarceva (FDA-approved)

Erlotinib; small-molecule HER1/EGFR inhibitor

Non-small-cell lung cancer

Phase I established a maximum tolerated dose of 300 mg per day; Phase II data suggested a correlation between skin rash development and severity and treatment outcome in patients with Stage IIIb and Stage IV NSCLC (6/5)

Oxford BioMedica plc (UK; LSE:OXB) and Sanofi-aventis (France)

Trovax

Immunotherapy

Metastatic renal cell cancer

Phase II on 48 evaluable patients showed it was well tolerated and induced anti-5T4 antibody responses in 91% of patients (6/4)

Pfizer Inc.

Sutent (FDA-approved)

Sunitinib malate; a multi-kinase inhibitor

Advanced renal cell carcinoma

Phase III data showed prolonged progression-free survival across all patient risk groups (6/4)

Pharmacyclics Inc. (PCYC)

Xcytrin

Motexafin gadolinium

Metastatic non-small-cell lung cancer

Phase II showed comparable response rates and survival to approved second-line therapies (6/4)

Pharmion Corp. (PHRM)

Amrubicin

A third-generation synthetic anthracycline

Platinum-sensitive small-cell lung cancer

Phase II showed that 40% of 15 patients had an objective tumor response (6/4)

Pharmion Corp. (PHRM)

Thalidomide

Revlimid is a derivative of Thalomid (thalidomide)

Multiple myeloma

Phase III data shows it improves overall survival by 17.6 months (6/4)

Pharmion Corp. (PHRM)

Vidaza (FDA-approved)

Azacitidine

Hematologic malignancies and advanced solid tumors

61% of myelodysplastic syndrome patients experienced hematologic improvement and combining it with valproic acid is safe and active in advanced solid tumors (6/4)

Pharmion Corp. (PHRM) and MethylGene Inc. (Canada; TSX:MYG)

MGCD0103

Isotype selective histone deacetylase inhibitor

Hodgkin's lymphoma, myelodysplastic syndromes and acute myelogenous leukemia

Phase II and I/II data showed significant antitumor activity (6/4)

Poniard Pharmaceuticals Inc. (PARD)

Picoplatin

New-generation platinum therapy

Recurrent small-cell lung cancer

Phase II demonstrated a survival benefit (6/4)

PTC Therapeutics Inc.*

PTC299

A VEGF inhibitor

Cancer

Phase I showed it was well tolerated (6/4)

Regeneron Pharmaceuticals Inc. (REGN)

VEGF Trap

Aflibercept; an angiogenic agent

Ovarian cancer

Phase II data showed an 8% partial response rate and 77% achievement of stable disease in heavily pretreated patients who have failed multiple other treatments (6/4)

SciClone Pharmaceuticals Inc. (SCLN) and Sigma-Tau SpA

Zadaxin

Thymosin alpha 1

Stage IV malignant melanoma

Phase II achieved its primary endpoint; in combination with dacarbazine, it tripled the overall response rate and extended over-all survival by nearly three months (6/4)

Synta Pharmaceuticals Corp. (SNTA)

STA-4783

Small molecule

Metastatic melanoma

Phase IIb data of STA-4783 in combination with paclitaxel showed a median survival of 12 months compared to 7.8 months for those who initially received paclitaxel alone (6/5)

Tapestry Pharmaceuticals Inc. (TPPH)

TPI 287

Next-generation taxane agent

Cancer

Two Phase I studies showed it was safe and well tolerated (6/4)

Transave Inc.*

Cisplatin

Sustained-release liposomal inhalation-targeting agent

Relapsed/progressive osteosarcoma

Phase Ib/IIa showed it was safe and well tolerated, and responses suggestive of antitumor activity were observed (6/4)

Vical Inc. (VICL)

Intratumoral delivery of plasmid DNA encoding interleukin-2

Melanoma tumors

Phase I showed the delivery followed by electroporation, was administered safely following sedative premedication (6/4)

Vion Pharmaceuticals Inc.(VION)

Cloretazine

VNP40101M; single agent

Refractory small-cell lung cancer

Phase II led to partial responses in six of 20 evaluable patients in the sensitive relapse arm (6/4)

Xanthus Pharmaceuticals Inc.*

Xanafide

A topoisomerase II inhibitor

Acute myeloid leukemia

Phase II indicated that 44% of patients achieved complete remission with or without complete hematopoietic recovery (6/4)

Ziopharm Oncology Inc. (ZIOP)

ZIO-101

Darinaparsin

Advanced multiple myeloma

Phase I/II showed four of 10 evaluable patients achieved stable disease of more than four months; treatment was well tolerated (6/4)

ZymoGenetics Inc. (ZGEN)

Atacicept

Formerly TACI-Ig

B-cell chronic lymphocytic leukemia

Interim Phase Ib data showed it was well tolerated and biologically active at all dose levels (6/4)


Notes:

* Privately held.

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