Archive: Company News

Company News: biocrea acquires CNS pipeline and PDE inhibitor platform from Biotie

In a management-buyout, biocrea GmbH is taking over  the CNS pipeline and phosphodiesterase enzyme (PDE) inhibitor platform from Finnish Biotie Therapies Corp.

The company currently has a pipeline of three PDE inhibitors at research and preclinical stages, which will be advanced into clinical development by 2012. The compounds have already demonstrated efficacy in preclinical animal models for schizophrenia, memory impairment, depression and anxiety.

biocrea is based in Radebeul near Dresden, Germany, and will be led by Dr. Tom Kronbach, former CSO of Biotie.

More details can be found soon at biocrea’s website.

Company News: Micromet Announces IND for MT111 Trial Obtained by Partner MedImmune

Micromet, Inc. (NASDAQ: MITI) today announced that MedImmune, licensee for Micromet’s MT111, plans to initiate a Phase 1 trial in patients with advanced gastrointestinal cancers based on an investigational new drug (IND) application recently accepted by the U.S. Food and Drug Administration (FDA).

MT111, also known as MEDI-565, is a BiTE® antibody designed to direct a patient’s T cells, the body’s most potent killer cells, against cancer cells that express carcinoembryonic antigen (CEA). CEA is a protein found on the surface of a number of gastrointestinal cancers, including colorectal, esophageal and gastric cancers.

MT111 will be Micromet’s third BiTE antibody to progress to clinical trials. Moreover, MedImmune’s decision demonstrates its ongoing confidence in the BiTE principle. Last year, MedImmune had decided to hand back to Micromet all rights to blinatumomab, a BiTE molecule in development for blood cancers.
Blinatumomab last months entered a pivotal trial in adult patients with MRD-positive acute lymphoblastic leukemia (ALL) and a Phase II trial in adult patients with relapsed/refractory ALL.

Company News: SoluBest – A Solution Solution

– Drug Delivery Partnership with Dr. Reddy´s Announced Today –

Investors and media alike use to think of drug delivery as a boring aspect of today’s biotech and pharma business. However, noting that 40% of marketed drugs have solubility issues that cannot be easily solved and about 70% of compounds in discovery are so insoluble that they do not have adequate and consistent gastrointestinal absorption to ensure efficacy, it is clear that the problem is not trivial.

One can look at the problem also from another angle: take, for example, diclofenac, a widely used drug for the treatment of pain and inflammation. In Germany alone, patients consume about 90 metric tons per year. As about 70% of the drug is excreted unchanged because of poor solubility, this means that each year 63 tons are released into sanitary wastewater and ultimately into the environment, as sewage plants cannot clear it from the water. It is long since known that Diclofenac causes damage to fish gills and kidneys.

Better solubility of drugs means improved bioavailability and less substance necessary for the desired therapeutic effect.

There are numerous physical and chemical approaches to improve solubility, including particle size reduction, drug dispersion, complexation and microemulsions as well as nanotechnology approaches – however most add considerable costs and complexity to manufacturing and do not create novel IP.

Enter SoluBest, a new client of akampion: the company is using self-assembling constructs in which active drug molecules are uniquely interwoven with FDA-approved polymers. Once in the body, these oral, solid-dosage formulations disintegrate into colloidal dispersions, increasing drug solubility and absorption, thus improving the bio-performance of insoluble drugs and nutritional actives. Today, the company disclosed the signing of a drug delivery collaboration with Dr. Reddy’s to develop new, proprietary formulations for the Indian drug giant (see press release).

The main advantages of SoluBest’s technology are two-fold. For one, thanks to the self-assembling property of the polymers, the procedure involves just 2 steps: the preparation of a liquid feed, followed by its spray drying to obtain a solid, oral formulation. As a result, the procedure does not add extra complexity to the manufacturing process. Moreover, each formulation can be protected by composition of matter patents and therefore is ideally suited for life-cycle management.
Once in the body, formulation disintegrates into colloidal dispersions, increasing drug solubility and absorption, thus improving the bio-performance of insoluble drugs and nutritional actives.

Company News: Micromet Initiates Pivotal Study of Lead Compound Blinatumomab

Micromet Inc (NASDAQ:MITI), a biotech company located in the US and in Germany, today announced the start of two Phase II trials of Blinatumomab, a so-called BiTE antibody which is designed to recruit T killer cells of the patient’s body to the cancer cells.

The so-called BLAST study (Blinatumomab Adult ALL MRD Study of T cell engagement) is designed to evaluate the efficacy, safety and tolerability of blinatumomab in up to 130 adult patients suffering from B-precursor acute lymphoblastic leukemia (ALL) who received chemotherapy but still have leukemia cells in the bone marrow (so-called minimal residual disease – MRD). About 70 centers in Europe and the US will take part in the study which will take about 2 years to complete. Primary endpoint is MRD response, i.e. disappearance of leukemia cells in the bone marrow.

If successful, the study could  serve as the basis for filing for approval.

A further Phase II study initiated today is designed to evaluate the efficacy, safety and tolerability of blinatumomab in 20 adult patients suffering from B-precursor acute lymphoblastic leukemia (ALL) who are resistant or intolerant to standard chemotherapy.

Details can be found in the press releases describing the BLAST trial and the refractory ALL trial.

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