Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Amgen Inc. (AMGN)

Enbrel (FDA-approved)

Etanercept; anti-tumor necrosis factor-alpha antibody

Rheumatoid arthritis

Partner Wyeth gained approval of Enbrel in Europe for use with methotrexate in adult RA patients whose response to other drugs has been inadequate (5/26)

Abbott Laboratories

Humira (FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Rheumatoid arthritis

European regulators issued a positive opinion for a label extension to reduce progression of joint damage, in combination with methotrexate (5/6)

Biogen Idec Inc. (BIIB)

Amevive (FDA-approved)

Alefacept; targets the CD45RO+ subset of T cells

Chronic plaque psoriasis

Israeli authorities approved the drug there for moderate to severe disease; Biogen also received a positive opinion letter from Swiss regulators (5/3)

CANCER

Ardana Bioscience* (UK)

Teverelix LA

Sustained-release gonadotrophin-releasing hormone antagonist

Prostate cancer

Began a Phase IIa trial testing two doses in 28 patients (5/17)

Attenuon LLC*

ATN-224

Second-generation version of tetrathiomolybdate, an angiogenesis inhibitor that binds to copper

Solid tumors

Began Phase I trial in the UK that will evaluate safety, tolerability and dosing in up to 16 refractory patients (5/24)

Genmab A/S (Denmark; CSE:GEN)

HuMax-CD4

Human antibody that targets the CD4 receptor on T lymphocytes

Cutaneous T-cell lymphoma

The product was granted orphan designation in Europe in that indication (5/25)

Oncolytics Biotech Inc. (Canada; ONCY)

Reolysin

Formulation of the human reovirus

Advanced solid tumors

Began Phase I trial in up to 40 refractory patients in the UK to test dosing and safety as well as immune responses and antitumor activity (5/26)

PharmaMar SA* (Spain)

Aplidin

Cyclodepsipeptide derived from the marine tunicate Aplidium albicans

Small-cell lung cancer

Began a Phase II trial in the U.S. and Europe to assess responses in patients who have relapsed or progressed; also expanded Phase II trial in melanoma after positive responses were seen (5/10)

Protherics plc (UK; LSE:PTI)

NQ02

Small-molecule prodrug combining CB1954 with an enzyme co-substrate

Solid tumors

Began a Phase I trial in 40 patients (5/20)

Responsif GmbH* (Germany)

--

Immunotherapy consisting of patient-derived tumor cells coated with Annexin

Renal-cell carcinoma

Began first trial of the product, a study in Germany to evalaute the tolerability of treatment (5/26)

CARDIOVASCULAR

Opperbas Holding BV* (the Netherlands)

--

Pegylated liposomes delivering Factor VIII

Hemophilia A

Began a Phase II trial; details were not disclosed (5/28)

United Therapeutics Corp. (UTHR)

Remodulin (FDA-approved)

Treprostinil sodium injection

Pulmonary arterial hypertension

Product gained approval in Australia for treating patients with NYHA Class III and IV to diminish symptoms associated with exercise (5/21)

INFECTION

Acambis plc (UK; ACAM)

ChimeriVax-West Nile

Vaccine

West Nile virus

The number of subjects in Phase I trial was increased to 110 from 60 and a placebo arm was added after two adverse events were reported (5/25)

Bavarian Nordic A/S* (Denmark)

Imvamune

Third-generation smallpox vaccine candidate

Smallpox infection

Phase ll dose-finding trial in 165 healthy volunteers confirmed favorable safety and immunogenicity profile seen earlier (5/11)

Bavarian Nordic A/S* (Denmark)

Imvamune

Third-generation smallpox vaccine candidate

Smallpox infection

Company began Phase I trial in 60 subjects in Europe, including people suffering from atopic dermatitis (5/5)

Biosyn Inc.*

C31G vaginal gel (1 percent)

Gel designed to prevent sexual transmission of HIV

HIV prevention

Began pivotal Phase III trial that will include 2,200 at-risk women in Ghana; parallel study in Nigeria is expected to follow (5/20)

Hemispherx Biopharma Inc. (AMEX:HEB)

Alferon LDO

Low-dose, oral alpha-interferon cocktail

HIV

World Foundation Aids Research began a trial to assess viral load and immune effect in 40 patients in Africa (5/10)

NexMed Inc. (NEXM)

NM100060

Marketed oral antifungal delivered with NexACT technology

Toenail fungal infections

Trial in 120 patients showed the product was well tolerated and produced encouraging efficacy results (5/5)

Peninsula Pharmaceuticals Inc.*

PPI-0903

Next-generation cephalosporin antibiotic

Infections and pneumonias

Began Phase I trial in the UK to assess safety and tolerability of intravenous PPI-0903 in healthy subjects (5/20)

Xcellentis (subsidiary of Innogentics NV; Belgium)

LymphoDerm

Human keratinocyte lysate in a topical formulation

Hard-to-treat venous leg ulcers

Final data from Phase II trial confirmed improved total wound closure for the drug group vs. control groups (5/13)

MISCELLANEOUS

Arakis Ltd.* (UK) and Vectura Ltd.* (UK)

AD 237

Bronchodilator treatment containing marketed anti-muscarinic drug

Chronic obstructive pulmonary disease

Phase IIa study showed an optimized inhaled formulation was suitable for once-daily use (5/14)

Enzo Biochem Inc. (NYSE:ENZ)

EGS21

Beta-D-glucosylceramide compound that acts on immune regulatory cells

Various diseases

Got approval to begin Phase I trial in Israel to test safety (5/20)

Pharmagene plc (UK; LSE:PGN)

PGN0052

Human secretin

Cystic fibrosis and asthma

Two Phase I trials in healthy volunteers and one in patients with asthma showed the product was well tolerated and showed effects on respiratory function; a Phase IIa trial in the UK in 18 CF patients is under way (5/24)

Vectura Ltd.* (UK)

VR004

Inhaled apomorphine

Erectile dysfunction

Early stage clinical trial showed product was tolerated and was rapidly and efficiently absorbed following inhalation (5/26)


Notes:

* Privately held.

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

AMEX = American Stock Exchange; CSE = Cophenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange.

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