NEOPHARM focuses on developing innovative cancer drugs for cancer. The firm has built its drug pipeline based on two proprietary technology platforms: a tumor-targeting platform and the NeoLipid® drug delivery system.  

Neopharm uses a recombinant protein cintredekin besudotox (IL13-PE38QQR) consisting of a single molecule composed of two parts: a tumor-targeting molecule (IL13) and a cytotoxic agent (PE38). IL13 receptors are found on malignant glioma cells, but not to any measurable degree, if at all, on healthy brain cells. cintredekin besudotox is designed to bind to IL13 receptors on the tumor like a key fits in a lock. The cancer cell latches onto, and absorbs the IL13 and the attached PE38. As a result, the cancer cell dies. Healthy brain cells are expected to be unharmed because they do not have the IL13 receptors, and thus do not ingest the PE38.

NeoLipid® technology uses an innovative liposome-based drug delivery system to deliver anticancer drugs to tumors. Liposomes are microscopic membrane-like structures created from lipids (fats). Because tumor cells need to consume large amounts of fats to sustain their extremely rapid growth, they recognize the liposomal drug as a potential source of nutrition.

The firm believes NeoLipid® technology may have applications in a variety of other areas, in addition to the drug product candidates in clinical development. Furthermore, Neopharm is hoping to leverage NeoLipid® technology to develop therapeutic formulations of small molecules and is currently conducting and planning research to investigate potential drug candidates.

Glioblastoma Multiformes (GBMs)

These tumors are the most common type of primary brain cancers in adults. They are dreadfully aggressive. They have tentacles that spread and mix with normal functional brain tissue and damage adjacent tissue as they grow uncontrollably in the brain. Treatment success has not significantly changed over the last 20 years, with most patients living less than one year after diagnosis despite aggressive surgery, radiation and chemotherapy.

Radiation therapy has been the most effective adjuvant therapy for these tumors, but the risk is high, as inherent resistance to radiation therapy exists and damaging the adjacent normal brain tissue with radiation limits its overall efficacy. The tumors are resistant to most chemotherapy and very few drugs cross the natural barrier present in the blood vessels of the brain (blood-brain barrier) which means that even drugs that work in the laboratory and in animals cannot reach the tumor cells within the brain. The FDA approved only one chemotherapy for this type of tumor with two forms of delivery, by vein or by local biodegradable wafers. The impact of these approved therapies, although statistically significant, increases survival in patients with this deadly tumor by only a few weeks.

Cintredekin besudotox is delivered by convection-enhanced delivery (direct micro infusion into the brain), on the other hand, is designed to molecularly target the tumor cells while sparing the healthy brain tissue. This form of regional and molecular targeting may represent one of the first scientifically sound treatment regimens, providing hope for overcoming one of the greatest hurdles in brain tumor therapy. The very problem that prevented drugs from entering the brain may now be used to keep the drug in the brain.
Early preliminary data from the Phase 1 studies has shown evidence of long term, sustained results in several patients. Although the response to the treatment may be variable, a number of patients had responses that were sustained and clinically significant.   

NEWS

3/27/07 The FDA asked the firm for another Phase 3 clinical trial on cintredekin besudotox for glioblastoma multiformes. The firm knew since the trial data emerged that the results were not conclusive, yet, after a few months, precisely on March 13, 2007, the firm said that it intended to have a meeting with the FDA at the end of this month to find out if the product is still approvable. NeoPharm added that there was no assurance that the product could be approved or that the FDA would not require additional clinical work.

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