Company* (Country; Symbol)




Status (Date)


Abbott Laboratories (NYSE:ABT)

Humira (FDA-approved)

Adalimumab; a tumor necrosis factor antagonist

Rheumatoid arthritis

Data from three studies demonstrated that Humira improved work productivity (6/15)

Advanced Viral Research Corp. (OTC BB:ADVR)


Topically applied spray formulation

To reduce inflammation and redness associated with surgical incisions or dermatologic dermabrasion

Phase II data showed clinical activity (6/18)

Anacor Pharmaceuticals Inc.*


A topical therapy that suppresses the phospho-diesterase 4 enzyme


Phase I data demonstrated tolerability, as well as activity, comparable to existing treatments (6/6)

Array BioPharma Inc. (ARRY)

ARRY-162 and ARRY-797

MEK inhibitor and p38 inhibitor

Rheumatoid arthritis

Phase I data showed ARRY-162 inhibited the production of IL-1beta, TNF-alpha, IL-6 and phosphoERK and oral ARRY-797 inhibited the production of IL-1beta, TNF-alpha and PGE2 (6/20)

Aspreva Pharmaceuticals Corp. (ASPV)


Oral mycophenolate mofetil

Lupus nephritis

The induction portion of a Phase III trial missed its primary endpoint (6/27)

Centocor Inc. (unit of Johnson & Johnson)

Remicade (FDA-approved)


Ankylosing spondylitis

Two-year data showed patients experienced significant improvement in spinal mobility, and showed sustained reductions in spinal inflammation as detected by MRI (6/15)

Chelsea Therapeutics International Ltd. (CHTP)


A metabolically inert antifolate

Rheumatoid arthritis

Started a bioequivalence study to determine a comparable dose range for its new disodium composition (6/27)

CombinatoRx Inc. (CRXX)


A cytokine modulator

Rheumatoid arthritis

CRx-150 did not achieve reduced C-reactive protein levels, the primary endpoint; the company discontinued development (6/28)

Genmab A/S (Denmark; CSE:GEN) and GlaxoSmithKline plc (UK)



Rheumatoid arthritis

Phase II data showed that 46% of patients achieved ACR20, 24% achieved ACR50 and 6% achieved ACR70, compared to 15%, 5% and zero in the placebo group (6/15)

Human Genome Sciences Inc. (HGSI)



Systemic lupus erythematosus

Phase II data demonstrated that LymphoStat-B significantly reduced disease activity across multiple clinical measures, was well tolerated and improved quality of life in patients (6/14)

NicOx SA (France; Eurolist:NICOX)

HCT 3012

Naproxcinod; nitric oxidedonating derivative of naproxen


Started a third pivotal Phase III trial (6/29)

Protalex Inc. (OTC BB:PRTX)


A purified form of the Staphylococcal bacterial program known as Protein A

Rheumatoid arthritis

Began a Phase Ib study (6/28)

Targeted Genetics Corp. (TGEN)


Anti-TNF-alpha gene therapy

Inflammatory arthritis

Phase I/II data showed 13% (low dose) 14% (medium) and 33% (high) of patients achieved a two-point reduction in swelling 12 weeks after treatment, compared to none in the placebo group (6/4)


Algeta ASA (Norway; OSLO:ALGETA)


A radium-223-based targeted therapeutic

Prostate cancer and skeletal metastases

Started an open-label study of Alpharadin with 10 patients (6/29)

Allos Therapeutics Inc. (ALTH)


Pralatrexate; a small molecule chemotherapeutic agent designed to inhibit dihydrofolate reductase

Non-Hodgkin's lymphoma or Hodgkin's disease

Started patient enrollment in a Phase I/IIa trial of PDX and gemcitabine with vitamin B12 and folic acid supplementation (6/1)

Allos Therapeutics Inc. (ALTH)


Efaproxiral; small molecule designed to sensitize hypoxic areas of tumors during radiation therapy

Brain cancer metastasized from the breast

Phase III data of Efaproxyn in combination with whole-brain radiation therapy showed it missed the primary endpoint of improvement in overall survival; Allos is dropping the program (6/19)

Antisense Pharma GmbH* (Germany)

AP 12009

TGF-beta 2 inhibitor

Anaplastic astrocytoma

Phase IIb data showed it was superior to temozolomide (6/21)

Avalon Pharmaceuticals Inc. (AVRX)


An oral small molecule that inhibits inosine monosphosphate deydrogenase

Hematologic malignancies

Phase I data showed the drug induced stable disease in almost half of the 39 evaluable patients (6/20)

Biovest International Inc. (OTC BB:BVTI)


Cancer vaccine

Non-Hodgkin's lymphoma

Independent data monitoring committee had no safety concerns after reviewing blinded Phase III data (6/13); data showed that 40% of patients remained disease-free from 40 months to almost 70 months (6/27)

Celgene Corp. (CELG)

Revlimid (FDA-approved)


Multiple myeloma

Phase I/II data of Revlimid plus melphalan and prednisone showed an overall survival rate after two years of 91% (6/11)

ChemGenex Pharmaceuticals Ltd. (Australia; CXSP)



Chronic myeloid leukemia

Data demonstrated a patient treated with Ceflatonin experienced a 50% reduction of T3151 Bcr-Abl levels within 2.5 months (6/12)

Coley Pharmaceutical Group Inc. (COLY)


Toll-like receptor 9 agonist drug candidate

Non-small-cell lung cancer

Phase III data produced no evidence of an additional clinical efficacy over that achieved with the standard cytotoxic chemotherapy

CuraGen Corp. (CRGN)


Histone deacetylase inhibitor

Lymphoma, ovarian cancer and solid tumors

Interim Phase II data showed it generated complete and partial responses; a Phase I/II solid tumor trial achieved stable disease (6/12)

Cyclacel Pharmaceuticals Inc. (CYCC)


An orally-available inhibitor of Aurora kinases A and B, and VEGFR2

Advanced solid tumors

Began a Phase I trial (6/30)

Cylene Pharmaceuticals Inc.*


RNA biogenesis inhibitor, quarfloxin; small molecule

Chronic lymphocytic leukemia

Started a single-agent Phase II trial (6/28)

Cytogen Corp. (CYTO)

Quadramet (FDA-approved)

Samarium Sm-153 lexidronam injection

Relapsed multiple myeloma

Phase I data of Quadramet in combination with bortezomib showed it was tolerated and 15 of 32 patients had a response or stabilization (6/28)

Cytokinetics Inc. (CYTK)


Kinesin spindle protein inhibitor

Metastatic breast cancer

The best overall responses observed with ispinesib were partial responses in 4 of 45 evaluable patients in Phase II (6/28)

EntreMed Inc. (ENMD)

Panzem NCD


Metastatic breast cancer

Phase Ib data demonstrated that the combination of Panzem NCD and Taxol caused one complete response, one partial response and one case of a 30% reduction in tumor volume out of 10 patients (6/6)

Epeius Biotechnologies Corp.*


A tumor-targeted nanomedicine delivered by intravenous infusion

Breast cancer and all types of sarcomas

Expanded ongoing clinical trials to include patients with breast cancer and all types of sarcomas who have failed standard chemotherapy (6/4)

Erimos Pharmaceuticals Inc.*


Terameprocol; a synthetic tetra-methylated derivative of nordihydrogualaretic acid

Solid tumors

Began patient dosing in a Phase I study (6/11)

Gentium SpA (Italy; GENT)


Single-stranded DNA designed to protect vascular endothelial cells

Multiple myeloma

Phase I/II trial of Defibrotide in combination with melphalan, prednisone and thalidomide showed a major response rate of 53% (6/27)

Geron Corp. (GERN)


Telomerase inhibitor

Chronic lympho-cytic leukemia

Phase I/II data showed good pharmacokinetics and tolerability (6/12)

Immunomedics Inc. (IMMU)


Humanized anti-MUC1 monoclonal antibody, labeled with yttrium-90

Unresectable and metastatic pancreatic cancer

Phase I data showed two of 11 patients had tumor shrinkage, but all had disease progression at or after eight weeks (6/5)

Immunomedics Inc. (IMMU)


Anticarcinoembryonic antigen antibody labeled with the radioisotope iodine-131

Colorectal cancer

Phase II showed it was safe and active when given in two doses to patients with colorectal cancer that has metastasized to the liver (6/4)

Immunomedics Inc. (IMMU)


New radioimmunotherapy using epratuzumab to deliver toxic radiation directly to lymphoma cells

Non-Hodgkin's lymphoma

54 patients had an overall objective response rate of 59% and a complete response rate of 43% (6/11)

Inovio Biomedical Corp. (AMEX:INO)


Selective Electrochemical Tumor Ablation

Squamous cell head and neck cancer

Company halted two Phase III trials after a data monitoring committee had concerns of efficacy and higher mortality rates (6/5)

Inovio Biomedical Corp. (AMEX:INO)


Selective Electrochemical Tumor Ablation therapy

Breast cancer

Phase I/II resulted in complete responses in six of eight evaluable patients and caused no serious adverse events (6/19)

Insert Therapeutics Inc. (subsidiary of Arrowhead Research Corp.; ARWR)


The cancer drug camptothecin combined with Cyclosert polymer technology

Inoperable or metastatic tumors

Interim Phase I data show it is well tolerated with a dose-limiting toxicity of pancytopenia (6/1)

Introgen Therapeutics Inc. (INGN)

INGN 241

An mda-7/IL-24 tumor suppressor agent

Advanced solid tumors

Phase I/II data showed the product induced killing in all treated tumors (6/1)

Keryx Biopharmaceuticals Inc. (KERX)


Perifosine; oral agent that modulates AKT and other signal transduction pathways

Advanced multiple myeloma and Waldenstrom's macro-globulinemia

Clinical data demonstrated an overall response rate of 31% when used with Velcade; when used with dexamethasone, 78% had at least stable disease; and when used with lenalidomide and dexamethasone, 50% achieved a partial response or better (6/29)

Marshall Edwards Inc. (MSHL)


Agent designed to induce apoptosis by removing intracellular proteins XIAP and c-FLIP

Recurring ovarian cancer

First patient was enrolled in a worldwide Phase III trial of phenoxodiol with carboplatin (6/1)

Neoprobe Corp. (OTC BB:NEOP)


Technetium Tc99m DTPA-mannosyl-dextran; radioactive targeting agent

For use in biopsy procedures

Phase II data showed that the primary endpoint was 90% Lymphoseek localization to lymphoid tissue (6/20)

NicOx SA (France; FSE:NXO)

NCX 4016

Insulin-sensitizing agent

Colon cancer

Ended a Phase I trial following preclinical results of the genotoxicity of NCX 415, a potential specific metabolite of NCX 4016 (6/18)

Novelos Therapeutics Inc. (OTC BB:NVLT)


Neoadjuvant treatment

Early stage breast cancer; ovarian cancer

Medical University of South Carolina Hollings Cancer Center has enrolled the first patient in a Phase II trial of NOV-002 in combination with chemotherapy (6/5); Phase II data showed one of 10 women with ovarian cancer had a partial response and five had stable disease (6/18)

Oncolytics Biotech Inc. (Canada; ONCY)


A formulation of the human reovirus

Advanced cancers

Phase I data showed the drug can be delivered systemically to patients with advanced and metastatic cancers and causes anti-tumor activity (6/5); began enrollment in a Phase II (6/27)

OSI Pharmaceuticals Inc. (OSIP)


An oral insulin-like growth factor-1 receptor inhibitor

Solid tumor

Started two Phase I trials (6/19)

Peregrine Pharmaceuticals Inc. (PPHM)


Tumor necrosis therapy agent

Glioblastoma multiforme

Began a Phase II study (6/25)

Pfizer Inc.

Sutent (FDA-approved)

Sunitinib malate

Metastatic colorectal cancer

Started a Phase III trial (6/28)

Pharmacyclics Inc. (PCYC)


Motexafin gadolinium injection

Non-small-cell lung cancer

Phase II data showed it appeared to be well tolerated and had a confirmed response rate of 5.2% (6/1); 85% of those receiving Xcytrin and Alimta achieved stabilization of their tumors, and 13 of 14 of those receiving Xcytrin and Taxotere achieved stabilization (6/27)

Poniard Pharmaceuticals Inc. (PARD)


A next-generation platinum

Metastatic colorectal cancer and hormone-refractory prostate cancer

Two Phase I trials showed the drug can be safely administered with fluorouracil and leucovorin in colorectal cancer and with docetaxel in prostate cancer (6/1)

Protox Therapeutics Inc. (Canada; CDNX:PRX)


Prodrug designed to kill cancer cells upon activation by prostate specific antigen

Prostate cancer

Completed enrollment in a Phase I trial (6/6)

S*BIO Pte. Ltd.* (Singapore)


A histone deacetylase inhibitor


Started a Phase I trial (6/21)

Sunesis Pharmaceuticals Inc. (SNSS)


Cell-cycle inhibitor

Acute leukemias

Phase I data showed five of 10 patients experienced bone marrow blast reductions of more than 95% (6/11)

Thallion Pharmaceuticals Inc. (Canada; TSX:TLN)


Small molecule derived from a nonpathogenic micro-organism

Advanced cancer

Phase I/II data showed the product was well tolerated in 14 patients during the Phase I portion, with no maximum tolerated dose reached (6/1)

Vion Pharmaceuticals Inc. (VION)


Single agent; VNP40101M

Acute myelogenous leukemia or high-risk myelodysplastic syndrome

Phase II data showed an overall response rate of 25% (6/11)

Viventia Biotech Inc.* (Canada)


A humanized antibody fragment targeting EpCAM fused with the company's de-immunized form of cytotoxic protein Bouganin


Started patient dosing for the Phase I trial (6/11)

Ziopharm Oncology Inc. (ZIOP)


Small-molecule organic arsenic compound

Advanced solid tumors

Received clearance to start a Phase I trial of an oral capsule form (6/1)


Archemix Corp.*


Designed to selectively block the activation, adhesion and aggregation of platelets by inhibiting von Willebrand factor to the GPIb receptor on platelets

For use in angioplasty and thrombotic thrombocytopenic purpura

Completed a Phase I trial (6/8)

Cardiome Pharma Corp. (Canada; CRME; TSX:COM)


Intravenous form; selective ion channel blocker

Atrial fibrillation after coronary artery bypass graft surgery

Phase III data showed that 47% of dosed patients got conversion to normal heart rhythm within 90 minutes, compared to 14% of placebo patients (6/4)

DeCode Genetics Inc. (Iceland; DCGN)


Next-generation oral anti-platelet therapy; antagonist of the EP3 receptor for prostaglandins E2

Peripheral arterial disease

Phase IIa study demonstrated reductions in several markers of inflammation in a dose-dependent manner (6/25)

Discovery Laboratories Inc. (DSCO)


Lucinactant; a peptide-containing synthetic surfactant

Acute respiratory failure

Started a Phase II trial (6/7)

EPIX Pharmaceuticals Inc. (EPIX)


Gadofosveset trisodium injection

For use as a blood-pool imaging agent

FDA has determined that additional trials may not be needed for approval (6/19)

Gentium SpA (Italy; GENT)


Single-stranded DNA designed to protect vascular endothelial cells

To prevent veno-occlusive disease

Trial showed 58 patients receiving it twice daily for 28 days demonstrated efficacy by reducing the incidence of VOD and severe hemorrhagic complications (6/1)

MediQuest Therapeutics Inc.*


A topical formulation

Raynaud's disease

Phase III met its primary endpoint and demonstrated statistical significance for the intent-to-treat population (6/25)

Metabasis Therapeutics Inc. (MBRX)


An oral, thyroid hormone receptor-beta agonist targeted to the liver


Started a Phase Ib trial (6/20)

Molecular Insight Pharmaceuticals Inc. (MIPI)


Iodofiltic acid 1123

To diagnose cardiac ischemia

Started a pivotal Phase II trial (6/25)

Neose Technologies Inc. (NTEC) and Novo Nordisk A/S (Denmark)

GlycoPEG-ylated Factor VIIa

A long-acting version of NovoSeven Coagulation Factor VIIa(recombinant)


Novo started a Phase I trial in healthy volunteers (6/15)

NovaCardia Inc.*


An adenosine A1 receptor antagonist

Acute congestive heart failure

Phase III data indicate a strong trend toward efficacy for the 30-mg dose (6/11)

Nuvelo Inc. (NUVO)


Recombinant nematode anticoagulant protein C2

Non-ST-elevation acute coronary syndromes

Phase II demonstrated that 7.5 mcg/kg and 10 mcg/kg doses reduced the incidence and duration of ischemia by more than 50% and did not significantly increase bleeding (6/19)

Paion AG* (Germany) and Forest Laboratories Inc.


Genetically engineered version of a clot dissolving protein found in the saliva of the vampire bat

Acute ischemic stroke

Phase III data showed it failed to hit the primary endpoint, and 14 of those on the higher of two doses died, although 10 of the deaths are attributed to something other than the drug (6/1)

Scios Inc.*

Natrecor (FDA-approved)


Acutely decompensated heart failure

Began enrollment of the first patients in the ASCEND-HF study (6/8)

Speedel Holding AG (Switzerland; SWX:SPPN)


Next-generation renin inhibitor


Completed a Phase IIa trial showing it was safe and well tolerated (6/28)

Surface Logix Inc.*


An enterocyte-specific microsomal triglyceride transfer protein inhibitor


Started a Phase IIa trial (6/6)

Surface Logix Inc.*


A long-acting PDE-5 inhibitor

Hypertension; Raynaud's disease

Started Phase IIa trials (6/21 and 6/28)

Vical Inc. (VICL) and AnGes MG Inc. (Japan)

AMG 0001

Uses Vical DNA delivery technology to deliver a gene encoding Hepatocyte Growth Factor

Critical limb ischemia

Stopped a Phase III trial because it had already met the primary endpoint (6/18)


Acadia Pharmaceuticals Inc. (ACAD)


Selective for the 5-HT2A and dopamine D2 receptors

Parkinson's disease psychosis

Acadia started the first of two pivotal Phase III trials (6/11)

Acadia Pharmaceuticals Inc. (ACAD)


N-desmethylclozapine; a major metabolite of clozapine


Started a Phase IIb trial (6/26)

Accera Inc.*


Ketasyn; neuronal cell-targeting agent

Alzheimer's disease

Open-label Phase IIb trial confirmed earlier studies (6/12)

Acorda Therapeutics Inc. (ACOR)


Sustained release 4-aminopyridine

Multiple sclerosis

Clinical data showed it significantly increased the probability of patients increasing their walking speed (6/4); began a second Phase III study (6/6)

Alexza Pharmaceuticals Inc. (ALXA)


Staccato loxapine

Migraine headache

Started a Phase IIa proof-of-concept trial (6/20)

Biogen Idec Inc. (BIIB) and UCB SA (Belgium; BR:UCB)


An oral VLA-4 antagonist; small-molecule compound

Relapsing-remitting multiple slcerosis

Started a Phase II study (6/26)

BioMS Medical Corp. (Canada; TSX:MS)


A synthetic peptide

Multiple sclerosis

First patients have been enrolled in MAESTRO-03, a U.S. pivotal Phase III trial (6/5)

Corcept Therapeutics Inc. (CORT)


Mifepristone; oral GR II antagonist with potential mitigating effects on cortisol


Top-line results from a proof-of-concept study indicate a statistically significant reduction in weight gain in those who took olanzapine plus Corlux compared to those who took olanzapine alone (6/21)

CytRx Corp. (CYTR)


Small molecule designed to protect cells by activating molecular chaperone proteins

Amyotrophic lateral sclerosis

Dosed at 100 mg three times daily for six months was well tolerated (4/27)

Debiopharm Group* (Switzerland)

Debio 9902 SR implants

Monthly sustained-release acetylcholinesterase inhibitor

Alzheimer's disease

Phase I data showed it was well tolerated; Phase IIa data showed an oral formulation resulted in improvements on three efficacy scales (6/11)

Endo Pharmaceuticals Inc. (ENDP)


Frovatriptan succinate 2.5 mg tablets

Menstrual migraine

Phase III data demonstrated that FROVA significantly reduced the frequency and severity of MM as well as the disabilities related to them (6/11)

EPIX Pharmaceuticals Inc. (EPIX)


A long-acting 5-HT1A agonist

Generalized anxiety disorder

Drug demonstrated a trend in reducing the level of anxiety vs. placebo in Phase III (6/13)

Evotec AG (Germany; FSE:EVT)

EVT 201

A partial positive allosteric modulator of the GABAA receptor complex

Primary chronic insomnia

Phase II data showed statistically significant improvements between both doses of EVT 201 and placebo (6/4)

Faust Pharmaceuticals SA* (France)


Small-molecule glutamate release inhibitor

Parkinson's disease

Phase IIa data demonstrated tolerability and improved Parkinsonian symptoms and motor fluctuations (6/6)

Intra-Cellular Therapeutics Inc.*

ITI-007; ITI-722

First-in-class dual 5HT2A receptor antagonist/dopamine receptor phosphoprotein modulator; low-dose formulation of ITI-007 with selective 5HT2A receptor antagonist properties

Schizophrenia; sleep maintenance insomnia

Began Phase I trial (6/21)

Javelin Pharmaceuticals Inc. (AMEX:JAV)


Intranasal morphine

Pain after elective orthopedic surgery

Two Phase III studies showed it met its primary endpoint (6/19)

Labopharm Inc. (Canada; DDSS)


A Contramid-based once-daily formulation of the antidepressant trazodone

Major unipolar depressive disorder

Started a Phase III trial (6/7)

Medivation Inc. (AMEX:MDX)


Neuroprotectant agent that's been on the market in Russia since 1983

Alzheimer's disease

12-month Phase II data showed Dimebon preserved function and prevented progressive deterioration in Alzheimer's disease patients (6/11)

Neurogen Corp. (NRGN)


Selective modulator of gamma aminobutyric (GABA) receptors


Phase I data showed that 60 mg was the maximum tolerated dose (6/12); Phase IIb trials showed it achieved primary endpoints in sleep maintenance and sleep onset (6/25)

NeurogesX Inc. (NGSX)


An agonist of transient receptor potential vanilloid 1, or TRPV1

Postherpetic neuralgia

Phase III data showed statistically significant pain relief vs. control over eight and 12-week periods (6/7); completed enrollment in a second Phase III trial (6/11)

Neuro-Hitech Inc. (OTC BB:NHPI)

Huperzine A

A second-generation acetylcholinesterase inhibitor

Alzheimer's disease

The Phase II trial is fully enrolled with 210 subjects (6/11)

Newron Pharmaceuticals SpA (Italy; SWX:NWRN) and Merck Serono SA (Switzerland)


An oral alpha-aminoamide derivative

Parkinson's disease

Phase III data showed safinamide resulted in an improvement in cognitive domains (6/8)

NuPathe Inc.*

NP101 SmartRelief

Combines NuPathe's ion-tophoretic transdermal technology with sumatriptan

Acute migraine

Phase I data showed the product maintained continual therapeutic dosing levels of sumatriptan an average of four times longer than treatment with a 6 mg injection of Imitrex; it also was well tolerated (6/8)

Opexa Therapeutics Inc. (OPXA)


T-cell vaccine

Multiple sclerosis

Top-line Phase I/II data showed Tovaxin was safe and effective (6/21)

Orchestra Therapeutics Inc. (OTC BB:OCHT)

Neurovax sclerosis

T-Cell receptor peptide vaccine

Relapsin-remitting multiple

Phase II data showed NeuroVax increased levels of TCR-specific T cells (6/11)

Orexigen Therapeutics Inc. (OREX)


Sustained-release formulation; a key component in Empatic


Phase I data showed it achieved a significant reduction in the incidence of spontaneous adverse events (6/7)

Orexigen Therapeutics Inc. (OREX)


A fixed-dose combination of sustained-release bupropion and Orexigen's sustained-release naltrexone


Phase IIb data showed Contrave reduced visceral fat by more than 13% compared to a 4.6% reduction in the placebo group (6/25)

Penwest Pharmaceuticals Co. (PPCO)

Nalbuphine ER

A nalbuphine hydrochloride extended-release tablet


Began a Phase IIa study (6/12)

Pipex Pharmaceuticals Inc. (OTC BB:PPEX)


Oral estriol

Multiple sclerosis

Started a Phase II/III trial (6/11)

Pozen Inc. (POZN) and GlaxoSmithKline plc (UK)


A tablet containint sumatriptan 85 mg formulated with RT technology and naproxen sodium 500 mg


New data from two large trials show that Trexima, when taken early, was nearly twice as effective as placebo in eliminating all traditional migraine symptoms at two and four hours (6/8)

PrimeCell Therapeutics LLC* (Australia)

Autologous bone marrow stem cells

Spinal cord injury

Preliminary results of a 25-patient trial showed that 60% and 40% could walk; no adverse events were observed (6/27)

ProEthic Pharmaceuticals Inc.*


Uses ProEthic's Dynamic Buffering Technology


Phase III data showed the drug relieved migraine pain within 30 minutes (6/8)

TransOral Pharmaceuticals Inc.*


Low-dose, sublingual formulation of zolpidem


Phase III data showed that both the 3.5-mg and 1.75-mg doses demonstrated highly statistically significant results in nonelderly adult patients (6/15)

Valeant Pharmaceuticals International (NYSE:VRX)


First-in-class neuronal potassium channel opener

Pain associated with postherpetic neuralgia

Will start a Phase IIa proof-of-concept study (6/1)


Alteon Inc. (AMEX:ALT)


Glutathione peroxidase mimetic


Started a Phase II trial (6/28)

Avanir Pharmaceuticals Inc. (AVNR)


Dextromethorphan/quinidine; an NMDA receptor antagonist and sigma-1 agonist

Diabetic peripheral neuropathic pain

Phase III data showed a 45-mg dose achieved 53%, 59% and 59% improvements on a pain scale vs. baseline at days 30, 60 and 90 (6/8)

Biodel Inc. (BIOD)


A rapid-acting form of injectable human insulin

Type I and Type II diabetes

Phase III data demonstrated statistically significant daily mealtime dose reductions (6/25)

ConjuChem Biotechnologies Inc. (Canada; TSX:CJB)

PC-DAC: Exendin-4

Albumin conjugate

Type II diabetes

Phase I/II data showed reductions in fasting plasma glucose that were statistically significant vs.baseline over the five-week treatment period (6/19)

Diamyd Medical AB (Sweden; SSE:DIAMB)


Therapeutic vaccine

Autoimmune diabetes

Company had invalidated a Phase II/III study due to poor clinical design and poor execution (6/19)

DIObex Inc.*


A cortisol synthesis inhibitor

Type II diabetes

Phase IIa demonstrated a trend toward improved glycemic control as measured by HbA1c, fructosamine and fasting blood glucose, as well as significant dose-dependent reductions in total and LDL cholesterol (6/25)

Elixir Pharmaceuticals Inc.*


Mitiglinide calcium hydrate


Phase II data demonstrated that Glufast managed HbA1c better than acarbose, and that the combination of Glufast and metformin was more effective than metformin alone (6/25)

Sangamo BioSciences Inc. (SGMO)


A formulation of a zinc finger DNA-binding protein transcription factor

Diabetic neuropathy

Phase Ib data demonstrated statistically significant improvements in subjects with diabetic neuropathy (6/25)

Transition Therapeutics Inc. (Canada; TSX:TTH)


Combination of epidermal growth factor analogue and gastrin analogue

Type II diabetes

Phase IIa data indicated treatment showed sustained reductions in blood glucose control parameters for six months (6/28)

Tranzyme Pharma*


An intravenous ghrelin agonist

Gastroparesis in diabetic patients

Phase IIa data showed all three dose levels significantly accelerated gastric emptying, while placebo had no effect (6/26)

VeroScience LLC* and S2 Therapeutics Inc.*


A quick-release formulation of bromocriptine mesylate


Phase IIIb data showed a serious adverse event rate similar to placebo (6/25)


Accentia Bio-pharmaceuticals Inc. (ABPI)


Intranasal lavage of 0.01% amphotericin B

Chronic sinusitis

Phase III trial showed that 42% of patients reported resolution of one or both cardinal symptoms of chronic sinusitis (6/27)

Advanced Life Sciences Holdings Inc.


A ketolide antibiotic

Community-acquired pneumonia proved antibiotic (6/21)

First of two Phase III trials met its primary endpoint of non-inferior cure rates compared to an ap-(ADLS)

Alnylam Pharmaceuticals Inc. (ALNY)


RNAi therapeutic

Respiratory syncytial virus infection

Started a Phase II trial (6/26)

GenVec Inc. (GNVC)


Adeno-based vaccine

HIV-1 infection

Began a Phase I trial (6/21)

Gilead Sciences Inc. (GILD)

Viread (FDA-approved)

Tenofovir disoproxil fumarate

Chronic hepatitis B virus

Phase III data showed it met the primary endpoint of non-inferiority to once-daily Hepsera (6/7); a second Phase III also met the primary endpoint (6/25)

Human Genome Sciences Inc. (HGSI)


Albinterferon alfa-2b

Chronic hepatitis C virus

Phase IIb data showed 900 mcg and 1200 mcg dosed every two weeks provided a sustained virologic response in 58.5% and 55.5% of patients, respectively, compared to 57.9% on Pegasys (6/7)

Idenix Pharmaceuticals Inc. (IDIX)


First-in-class nucleoside polymerase inhibitor

Hepatitis C virus

Phase II data showed consistently higher rates of HCV PCR-negativity, compared to the standard of care alone (6/12)

KaloBios Pharmaceuticals Inc.*


Targets and neutralizes the PcrV protein of the Type III secretion system of the Pseudomonas bacterium

Pseudomonas aeruginosa infections

Began dosing subjects in a U.S. Phase I study (6/11)

Koronis Pharmaceuticals Inc.*


An oral small-molecule therapeutic designed to work through Viral Decay Acceleration


Started enrolling patients in a Phase IIa study (6/26)

Novagali Pharma SA* (France)


A cyclosporine A drug

Vernal kerato-conjunctivitis

Phase III showed the drug improved both symptoms and signs of disease (6/25)

Panacos Pharmaceuticals Inc. (PANC)


Bevirimat; HIV maturation inhibitor


Bevirimat plasma concentrations and antiviral effect were approximately double those seen in the first Phase IIb cohort that had used a suboptimal tablet formulation (6/21)

Replidyne Inc. (RDYN)


A topical antibiotic


Three Phase I trials showed the product was safe, well tolerated and is associated with low systemic exposure (6/26)

SciClone Pharmaceuticals Inc. (SCLN)


Oral form of synthetic dipeptide; immunomodulatory agent

Hepatitis C virus

Started a Phase II trial (6/27)

Vertex Pharmaceuticals Inc. (VRTX)


Protease inhibitor

Hepatitis C virus

Phase IIb data confirmed efficacy and safety (6/12)

XTL Biopharmaceuticals Ltd. (XTLB)


An oral non-nucleoside hepatitis C virus polymerase inhibitor

Chronic hepatitis C

A 56-patient Phase I trial showed that HCV-RNA viral load reductions were not significantly different from those seen in the placebo group; the company has suspended further development (6/6)


Alkermes Inc. (ALKS)

AIR parathyroid hormone

An inhaled version of Eli Lilly and Co.'s recombinant, injected parathyroid hormone, Forteo (teriparatide)


Started a Phase I trial in post-menopausal women (6/7)

Barrier Therapeutics Inc. (BTRX)


Agent designed to block retinoic acid metabolism

Lamellar ichthyosis

Phase II/III trial showed it effectively treated the disorder in 41% and 50% of patients taking one of two doses (6/14)

BioMimetic Therapeutics Inc. (BMTI)

GEM OS1 Bone Graft

Combines recombinant platelet-derived growth factor with a synthetic bone matrix, beta tricalcium phosphate

For use in foot and ankle fusion procedures

Initiated enrollment on 125 patients in a new study (6/7)

Bionovo Inc. (BNVI)


Estrogen receptor beta selective modulator

Hot flashes

Phase II data showed the 10-g/day dose was statistically superior to placebo in reducing the number of hot flashes; the 5-g/day dose showed a positive trend (6/4)

Clinuvel Pharmaceuticals Ltd. (Australia; ASX:CUV)


Agent designed to stimulate production of eumelanin

Erythropoietic protoporphyria

Dosed the first patients in a Phase III trial (6/5)

Cobalis Corp. (OTC BB:CLSC)


Agent designed to modulate levels of IgE, reducing the over-production of histamines

Ragweed allergy

Company is delaying release of Phase III data due to concerns of inconsistencies in the database for the Phase III trials (6/1)

Columbia Laboratories Inc. (CBRX)




It was well tolerated in a 42-patient, multidose pharmacokinetic study (6/27)

Critical Therapeutics Inc.(CRTX)

Zyflo (FDA-approved)

Zileuton; a leukotriene synthesis inhibitor


Data from a 12-week, 320-patient study suggested that combining zileuton with a low-dose inhaled corticosteroid improves pulmonary lung function (6/26)

Dynogen Pharmaceuticals Inc.*


An oral partial agonist of the serotonin Type 3 receptor

Gastroesophageal reflux disease

Phase Ib trial showed the 0.5-mg dose achieved statistical significance over placebo on the primary endpoint of reduction in the number of reflux events (6/7)

Indevus Pharmaceuticals Inc. (IDEV)


Testosterone undecanoate

Male hypogonadism

Phase III data showed that 94% of patients receiving 1,000 mg of Nebido and 86% of those receiving 750 mg achieved a normal testosterone level (6/7)

Indevus Pharmaceuticals Inc. (IDEV)


Non-benzodiazepine, selective GABA-A receptor agonist

Persistent developmental stuttering

Phase II data showed a mean reduction of 18% in the syllables stuttered, compared to 5% for placebo (6/12)

Isotechnika Inc. (Canada; TSX:ISA)


A next-generation calcineurin inhibitor

Kidney transplant

Company got a "no objection" letter from Health Canada for the long-term use of ISA247 in patients in the Canadian arm of the Phase IIb trial (6/7)

ISTA Pharmaceuticals Inc. (ISTA)

Ecabet sodium

Eye drop formulation designed to increase production of mucin

Dry eye syndrome

Phase IIb data showed treated patients achieved a strong trend in the objective sign of blink rate and had other positive findings (6/1)

Kythera Bio-pharmaceuticals Inc.*


Inhibits microtubule polymerization

Actinic keratosis

Completed enrollment of its Phase II study (6/26)

LifeCycle Pharma (Denmark; CSE:LCP)


A once-daily tacrolimus tablet

To prevent organ rejection

Started a Phase II trial (6/21)

Movetis NV* (Belgium)


Orally active, selective vasopressin antagonist that inhibits water reabsorption from the kidneys


Started a Phase IIa trial (6/6)

Neurochem Inc. (NRMX)



AA amyloidosis-associated renal disease

Phase II/III data showed Kiacta decreased the risk of the primary endpoint, a composite of worsening of renal function or death, by 42% (6/7)

NPS Pharmaceuticals Inc. (NPSP) and GlaxoSmithKline plc (UK)


Small-molecule calcilytic

Post-menopausal osteoporosis

Started a Phase II trial (6/5)

Othera Pharmaceuticals Inc.*


Eye drops; small molecule designed to act through multiple pathways to down-regulate the disease-induced overexpression of nuclear factor kappa B

Age-related macular degeneration

First patient was dosed in a Phase II trial (6/11)

Pharmos Corp. (PARS)


An enantiomer of racemictofisopam

Irritable bowel syndrome

Started a Phase IIb trial (6/20)

Progenics Pharmaceuticals Inc. (PGNX) and Wyeth Pharmaceuticals


Subcutaneous methylnaltrexone

Opioid-induced constipation

Mean laxation response rates of 42 patients in an open-label extension study were 45.5% in the first month, 57.7% in the second and 57.3% in the third (6/28)

Repros Therapeutics Inc. (RPRX)


Oral therapy


Top-line Phase III data indicated that Androxal is not inferior to Androgel (6/5)

Repros Therapeutics Inc. (RPRX)


Progesterone receptor modulator


Top-line data of the six-month study demonstrated that 50 mg reduces duration and intensity of pain more effectively than lower doses (6/12)

Salix Pharmaceuticals Ltd. (SLXP)

Balsalazide disodium

Active ingredient in Colazal capsules 750 mg

Ulcerative colitis

Phase III data showed a statistically significant greater proportion of subjects achieved clinical improvement compared to placebo (6/18)

Tercica Inc. (TRCA)

Increlex (FDA-approved)

Recombinant human insulin-like growth factor-1; a once-daily injection

Primary IGF-1 deficiency

Completed enrollment of a Phase IIIb trial with 45 patients (6/1)

Theravance Inc. (THRX)


Selective 5-HT4 agonist

Chronic constipation

Phase II showed all three doses achieved statistical significance in the primary endpoint of an increased number of spontaneous bowel movements per week over baseline compared to placebo (6/26)


* Privately held.

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