jeudi 22 mars 2007

Micromet/TRACON/D93, Arielle Immuno/RTL1000, Arxxant

Micromet and TRACON Pharmaceuticals Sign Exclusive Worldwide License Agreement to Develop and Commercialize D93, a Humanized Antibody for Cancer Treatment

CARLSBAD, Calif., and SAN DIEGO, March 16 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development of novel and proprietary antibody-based products for cancer, inflammatory and autoimmune diseases, and TRACON Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of products for cancer treatment, including agents that inhibit angiogenesis, today announced an agreement granting TRACON exclusive worldwide rights to develop and commercialize Micromet's D93 antibody with a novel mode of action for the treatment of cancer. TRACON Pharmaceuticals was founded in 2005 by Paramount BioSciences, LLC.

D93 is a recombinant humanized IgG1 monoclonal antibody that inhibits angiogenesis, tumor cell growth and metastasis by targeting cleaved collagen, which is predominantly produced in the extracellular matrix of tumors. Preclinical studies indicate that D93 has the potential to treat different types of cancer as a single agent and in combination with chemotherapeutics. Because of its anti-angiogenic activity, D93 may also provide a new therapeutic approach for other diseases involving
neo-vascularization such as wet age-related macular degeneration or proliferative diabetic retinopathy. In 2006, Micromet filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for clinical testing of D93 in patients with cancer.

TRACON Pharmaceuticals (http://www.traconpharma.com)
Paramount BioSciences, LLC (http://www.paramountbio.com)
Micromet, Inc. (http://www.micromet-inc.com)


Artielle ImmunoTherapeutics Initiates Clinical Trials For Multiple Sclerosis

PORTLAND, Ore./EWORLDWIRE/March 15, 2007 --- Artielle ImmunoTherapeutics, Inc. today announced that the company has initiated a Phase I clinical trial to evaluate its novel drug candidate, RTL1000, for the treatment of multiple sclerosis (MS). RTL1000 is a novel protein drug with a highly-selective mechanism of action that targets pathogenic T-cells responsible for triggering and sustaining MS.

The trial is currently open for enrollment and is a multi-center, double-blind, placebo controlled, single dose Phase I study to be conducted with 30 MS patients in the United States. The clinical trial is designed to assess the safety and pharmacokinetic properties of RTL1000. The study will be conducted at research centers located in New Haven, Connecticut; Indianapolis, Indiana; Kansas City, Kansas; Baltimore, Maryland; Portland, Oregon and Seattle, Washington. Clinical trial information can be obtained at

http://www.clinicaltrials.gov/ct/show/NCT00411723
http://www.nationalmssociety.org/Research-trialsrecruiting.asp

About RTL1000

MS is caused when T cells, part of the body's immune system, target nerves in the spinal cord and brain creating lesions in the myelin sheath. In MS, activation of these T cells triggers the release of inflammatory cytokines that lead to the destruction of the myelin. RTL1000 disrupts the activation of the T cells, preventing the release of the inflammatory cytokines and causing the release of anti-inflammatory cytokines. RTL1000 has been found to be both safe and efficacious in animal models of MS.

http://www.artielle.com


Eli Lilly Withdraws Its Marketing Authorization Application for Arxxant

The European Medicines Agency (EMEA) has been formally notified by Eli Lilly Nederland B.V. of its decision to withdraw the application for a centralised marketing authorisation for the medicinal product ARXXANT (ruboxistaurin). The application for marketing authorisation for ARXXANT was submitted to the EMEA on 30 May 2006. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).


Isotechnika Receives USAN Approval for Generic Name for Lead Immunosuppressive Drug

Isotechnika Inc. announcedtoday that the Company has received approval from United StatesAdopted Name (USAN) for naming of its lead immunosuppressive drug,ISA247. The name, voclosporin, is now being reviewed by the InternationalNonproprietary Name (INN) expert committee. The INN is scheduled topublish the proposed list of approved names sometime in mid 2007.Official notification from the INN would allow Isotechnika to use thename voclosporin in labelling, publications, and on drug information.The name will serve to identify the active pharmaceutical substanceduring the drugs' life-time worldwide.

ISA247 (voclosporin) is a calcineurin inhibitor, currently beinginvestigated in a Phase 3 European/Canadian trial for the treatmentof moderate to severe psoriasis and a Phase 2b North American trialfor the prevention of organ rejection in kidney transplant patientsand as a treatment for uveitis in three separate pivotal Phase2/Phase 3 trials. The latter trial is being coordinated by ourpartner, Lux Biosciences.

"Moving toward the name of voclosporin from the previousnomenclature of ISA247 should assist us in initiating our commercialbranding process. The next step in the naming process is to requestthat the USAN approved name, voclosporin, be approved by theInternational Nonproprietary Name (INN) Programme of the World HealthOrganization (WHO). Pending receipt of this INN approval, ISA247will, in all future materials, be referred to by its new genericname, voclosporin," commented Dr. Randall Yatscoff, Isotechnika'sPresident & CEO.

Aucun commentaire: