Company (Location)

Product

Description

Indication

Status

Date

AUTOIMMUNE

XenoPort Inc. (Santa Clara, Calif.)

XP23829

A fumarate analogue

Relapsing-remitting multiple sclerosis and psoriasis

First subjects were dosed in a Phase I comparison study

7/25/12

CANCER

Actinium Pharmaceuticals Inc. (Newark, N.J.)

Actimab-A

Consists of the isotope Actinium 225 attached to the anti-CD33 monoclonal antibody lintuzumab

Acute myeloid leukemia

Treated the first cohort of patients in a Phase I/II study

7/20/12

Berg Pharma LLC (Boston)

BPM 31543

Topical compound

Chemotherapy-induced alopecia

Began a Phase I trial

7/24/12

Bio-Path Holdings Inc. (Houston)

BP-100.1.01

Liposomal Grb-1

Blood cancers

Started enrolling patients in the fourth dosage cohort for its Phase I trial

7/26/12

CytRx Corp. (Los Angeles)

Aldoxo-rubicin

Formerly INNO-206; a tumor-targeting conjugate of doxorubicin

Advanced solid tumors

Started a Phase Ib trial

7/26/12

ImmunoGen Inc. (Waltham, Mass.)

IMGN853

A targeted antibody payload compound

Ovarian cancer or other solid tumors

Started a Phase I trial

7/12/12

Momenta Pharmaceuticals Inc. (Cambridge, Mass.)

M402

A heparin sulfate glycosaminoglycan mimetic engineered from low-molecular-weight heparin

Pancreatic cancer

Began dosing in a Phase I/II trial in combination with gemcitabine

7/3/12

OncoMed Pharmaceuticals Inc. (Redwood City, Calif.)

OMP-54F28

A fusion protein based on a truncated form of the Frizzled8 receptor

Advanced solid tumor cancers

Patient dosing has begun in a Phase I trial

7/13/12

Peregrine Pharmaceuticals Inc. (Tustin, Calif.)

Bavituximab

Monoclonal antibody

Rectal adenocarcinoma

The open-label Phase I trial began and will enroll up to 18 patients

7/17/12

Viral Genetics Inc. (San Marino, Calif.)

HCQ

Hydroxychlor-oquine

Drug-resistant ovarian cancer

First patient was enrolled in a Phase I trial

7/20/12

CENTRAL NERVOUS SYSTEM

Acadia Pharmaceuticals Inc. (San Diego)

AM-831

A small molecule that combines muscarinic m1 partial agonism with dopamine D2 and serotonin 5-HT2A antagonism

Schizophrenia

Discontinued development because it did not meet pre-determined criteria for further development in a Phase I trial

7/16/12

Eisai Europe Ltd. (Hatfield, UK)

E2609

A beta-site amyloid precursor protein-cleaving enzyme inhibitor

Alzheimer's disease

Phase I data showed a reduction in plasma amyloid beta levels, and a statistically significant reduction of cerebrospinal fluid amyloid beta levels

7/25/12

BrainStorm Cell Therapeutics Inc. (New York)

NurOwn

Bone marrow-derived, autologous, differentiated mesenchymal stromal cells

Amyotrophic lateral sclerosis

Completed a planned interim safety review of its Phase I/II trial

7/24/12

Convergence Pharmaceuticals Ltd. (Cambridge, Mass.)

CNV2197944

Orally administered selective Cav2.2 blocker

Neuropathic pain

Phase I showed it was well tolerated with few adverse events reported at doses expected to fall within the predicted therapeutic range

7/19/12

Orexo AB (Uppsala, Sweden)

OX219

A formulation of buprenorphine with naloxone

Drug abuse

A study demonstrated comparative bioavailability for OX219 and Suboxone, as well as positive results for other product attributes

7/3/12

Supernus Pharmaceuticals Inc. (Rockville, Md.)

Trokendi XR

A once-daily extended-release formulation of topiramate

Epilepsy

Received a tentative letter from the FDA, stating that the agency had completed its review and that no additional clinical trials are required; for final approval, it must wait until the period of exclusivity protection expires

7/16/12

Zogenix Inc. (San Diego)

Relday

A candidate based on a combination of DosePro needle-free subcutaneous drug delivery system with its once-monthly formulation of risperidone

Schizophrenia and schizoaffective disorder

Started a Phase I trial testing Relday

7/13/12

INFECTION

Gilead Sciences Inc. (Foster City, Calif.)

GS-5885

NS5A inhibitor, used in combination with GS-7977

Hepatitis C virus

Gilead started a Phase I bioavailability study of a single-pill fixed-dose combination of GS-7977 and GS-5885

7/30/12

Inovio Pharmaceuticals Inc. (Blue Bell, Pa.)

H1N1 SynCon

Universal influenza vaccine

Influenza

The first patients were treated in a Phase I trial

7/11/12

Novavax Inc. (Rockville, Md.)

Novavax Fusion

Protein nanoparticle respiratory syncytial virus vaccine

Respiratory syncytial virus

Phase I data showed it was generally well tolerated

7/6/12

MISCELLANEOUS

Advanced Cell Technology Inc. (Marlborough, Mass.)

hESC RPE cells

Human embryonic stem cell-derived retinal pigment epithelial cells

Stargardt's macular dystrophy

Treated the fourth patient in its Phase I/II trial; treated the final patient

7/13/12; 7/31/12

Alnylam Pharmaceuticals Inc. (Cambridge, Mass.)

ALN-TTR02

An RNAi therapeutic targeting transthyretin

TTR-mediated amyloidosis

Phase I data showed a 94% knockdown of serum TTR levels, which was highly statistically significant

7/17/12

Conatus Pharmaceuticals Inc. (San Diego)

IDN-6556

Emricasan; a pan-caspase inhibitor

For islet cell transplants

Treated the first patient in an islet cell transplant Phase I/II trial

7/20/12

Ocular Therapeutix Inc. (Bedford, Mass.)

OTX-TP1

Travoprost punctum plug

Open-angle glaucoma

Initial results found that intraocular pressure was reduced 23.5% from baseline over the 30-day study period

7/30/12

Zalicus Inc. (Cambridge, Mass.)

Z944

Oral T-type calcium channel blocker

Seizures

Started a Phase I multiple-ascending dose study

7/11/12


Notes:

Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.

The date indicated refers to the BioWorld Today issue in which the news item can be found.