Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

BioMS Medical Corp. (Canada; TSX:MS)

MBP8298

Synthetic peptide

Multiple sclerosis

Received FDA clearance for a pivotal Phase III trial (1/22)

CANCER

Alfacell Corp. (ACEL)

Onconase

Ranpirnase; cytotoxic ribonuclease

Malignant mesotheliioma

FDA granted orphan drug desination (1/30)

BN Immuno-Therapeutics Inc.*

MVA-BN-HER2

Vaccine

Breast cancer

FDA accepted the IND; company expects to begin clinical testing early this year (1/3)

Cell Therapeutics Inc. (CTIC)

Xyotax

Paclitaxel linked to a biodegradable polyglutamate polymer

Advanced lung cancer

Filed for an SPA with the FDA for guidance on a Phase III trial (1/10)

Cel-Sci Corp. (AMEX:CVM)

MultiKine

Mixture of human cytokines designed to stimulate an immune response

Head and neck cancer

FDA approved the start of a Phase III trial with endpoints of overall survival and control of the disease (1/16)

Dendreon Corp. (DNDN)

Provenge

Sipuleucel-T; active cellular immunotherapy

Asymptomatic metastatic androgen-independent prostate cancer

FDA accepted its BLA and designated it for priority review (1/16)

Enzon Pharmaceuticals Inc. (ENZN)

HIF-1alpha

A hypoxia-inducible factor 1 alpha antagonist

Cancer

FDA approved its IND to begin Phase I trials in the first half of 2007 (1/26)

GenVec Inc. (GNVC)

TNFerade

Endoscopic ultrasound administration of an adenovector containing the gene for tumor necrosis factor-alpha

Advanced pancreatic cancer

Company reached agreement with the FDA to proceed with endoscopic ultrasound administration as an additional option to percutaneous injection (1/12)

Gloucester Pharmaceuticals Inc.*

Romidepsin

Depsipeptide; histone deacetylase inhibitor

Peripheral T-cell lymphoma

Reached an agreement with the FDA under the SPA process for design of a pivotal trial (1/30)

Hana Biosciences Inc. (HNAB)

Marqibo

Vincristine sulfate liposomes injection

Acute lymphoblastic leukemia

FDA granted orphan drug designation (1/16)

Humanetics Corp.*

BIO 300

Non-synthetic oral drug

Acute radiation syndrome

FDA cleared the company's IND to start Phase I trials (1/12)

Innovive Pharmaceuticals Inc. (OTC BB:IVPH)

INNO-406

Oral dual Bcr-Abl and Lyn-kinase inhibitor

Gleevec-resistant or intolerant chronic myelogenous leukemia

FDA granted orphan drug designation to INNO-406 (1/3)

Light Sciences Oncology Inc.*

Litx

Light Infusion Therapy

Metastatic colorectal cancer

Reached agreement with the FDA on an SPA for a study with 450 patients (1/30)

Neoprobe Corp. (OTC BB:NEOP)

Lymphoseek

Lymphatic tissue targeting agent

Prostate and colon cancers

Received FDA authorization to begin enrolling patients in two Phase I trials (1/17)

Pharmion Corp. (PHRM)

Vidaza

Azacitidine for injection; DNA demethylating agent

Myelodysplastic syndromes

FDA approved the NDA supplement to add intravenous use as a new route of administration (1/29)

Poniard Pharmaceuticals Inc. (PARD)

Picoplatin

New-generation platinum therapy designed to prevent or overcome platinum resistance associated with chemotherapy

Small-cell lung cancer

Formed an SPA with the FDA to conduct a single Phase III trial, testing overall survival as the primary endpoint (1/3)

Protherics plc (UK; PTIL; LSE:PTI)

Voraxaze

Adjunctive therapy for patients at risk of toxicity from methotrexate

Cancer

FDA granted fast-track designation (1/12)

Provectus Pharmaceuticals Inc. (OTC BB:PVCT)

PV-10

Injectable formulation of Rose Bengal (Provecta)

Metastatic melanoma

Received orphan drug status (1/8)

Vicus Therapeutics LLC*

VT-122

Targets multiple inflammatory and other key pathways involved in the pathophysiology of cancer cachexia

Cachexia in non-small-cell lung cancer

FDA is allowing company to proceed with a Phase II trial (1/16)

Xanthus Pharmaceuticals Inc.*

Xanafide

Amonafide malate; an ATP-independent tropois-omerase 2 inhibitor

Acute myeloid leukemia

FDA granted orphan drug designation (1/8)

CARDIOVASCULAR

Chelsea Therapeutics International Ltd. (CHTP)

Droxidopa

Orally active synthetic precursor of norepinephrine

Symptomatic neurogenic orthostatic hypotension

FDA granted orphan drug designation in patients with primary autonomic failure (1/22)

Discovery Laboratories Inc. (DSCO)

Surfaxin

Engineered version of natural human lung surfactant

To prevent respiratory distress syndrome

Received guidance from the FDA regarding potential approval, and no new trials are required (1/22)

Gentium SpA (Italy; AMEX:GNT)

Defibrotide

Single-stranded DNA designed to protect vascular endothelial cells

To prevent hepatic veno-occlusive

Received FDA orphan drug designation (1/17)

CENTRAL NERVOUS SYSTEM

Avanir Pharmaceuticals (AVNR)

FazaClo (FDA-approved)

Orally disintegrating form of clozapine

Schizophrenia

Received an approvable letter and acceptable labeling from the FDA for a new formulation with a 12.5 mg dosing strength (1/31)

Horizon Therapeutics Inc.*

HZT-501

Formulation of the non-steroidal anti-inflammatory drug ibuprofen, combined with the H2 receptor antagonist famotidine

Pain

Reached agreement with the FDA on an SPA for a Phase III program (1/8)

Neurocrine Biosciences Inc. (NBIX)

Indiplon

A non-benzodiazepine agent that acts on a specific site of the GABA-A receptor

Insomnia

Company plans to resubmit the NDA for the immediate-release drug during the second quarter (1/23)

ProEthic Pharmaceuticals Inc.*

PRO-513

Uses ProEthic's Dynamic Buffering Technology

Migraine headaches

Plans to file an NDA based on positive Phase III data showing it reached all of its primary end-points (1/8)

DIABETES

ICo Therapeutics Inc.* (Canada)

iCo-007

A second-generation antisense drug that targets c-Raf kinase messenger RNA

Diabetic macular edema

FDA accepted the IND for a Phase I trial (1/22)

Innocoll Inc.*

CollaRx Gentamicin

Topical antibiotic; biodegradable and fully resorbable gentamicin-collagen sponge formulated with CollaRx technology

Mildly infected diabetic foot ulcers

FDA approved its IND for a Phase II study (1/22)

INFECTION

AlphaVax Inc.*

Vaccine developed using the company's alphavaccine technology; contains the hemagglutinin gene from a single flu strain

Influenza and cytomegalovirus

FDA gave the go-ahead to begin clinical testing (1/29)

Lux Biosciences Inc.*

LX211

A next-generation calcineurin inhibitor

Uveitis

FDA granted orphan drug designation (1/16)

Sequella Inc.*

SQ109

Orally active diamine antibiotic

Pulmonary tuberculosis

Received fast-track status (1/22)

VioQuest Pharmaceuticals Inc. (OTC BB:VQPH)

VQD-001

Sodium stibogluconate

Cutaneous form of leishmaniasis

Granted orphan drug designation for the active moiety of VQD-001 (1/17)

MISCELLANEOUS

Adeza Biomedical Corp. (ADZA)

Gestiva

Long-acting form of a naturally occurring progesterone

To prevent preterm birth

FDA granted orphan drug designation (1/31)

Ark Therapeutics Group plc (UK; LSE:AKT)

Trinam

VEGF gene in an adenoviral vector delivered with Ark's biodegradable collagen collar device

To prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery

FDA gave approval for the company to start a Phase III trial (1/17)**

Lux Biosciences Inc.*

LX201

A cyclosporine A-eluting silicone matrix ocular implant

To prevent rejection in corneal transplantation

FDA granted orphan drug designation (1/16)

Tercica Inc. (TRCA) and Ipsen SA (France)

Somatuline Autogel

A 28-day sustained-release formulation

Acromegaly

FDA accepted the filing of the NDA (1/16)


Notes:

* Privately held; ** Denotes the date the item ran in BioWorld International.

BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment.

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSX = Toronto Stock Exchange