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Biotech / Medical : Biotech & Pharma.T.A, -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (2450)	12/1/2008 10:13:31 AM
From: Jibacoa	Respond to of 3722

NEOL is up 15.31% on low volume of only 7,325 bigcharts.marketwatch.com It recently announced a Cintredekin Besudotox (CB)-related CRADA with the NINDS, a part of the NIH for clinical research on CB for untreatable brain diseases in humans. Commenting on their pipeline, they stated that "while it is still too early to discuss preliminary results, we anticipate the release of meaningful data points on our PII LEP in recurrent breast cancer and PI of LE-DT, a liposomal modality of treatment with docetaxel, the active ingredient of Taxotere®, in solid tumors. We are encouraged with the clinical data so far and we project completion of these trials by the end of 2008 or early 2009” The Drug Candidate Pipeline Update: Cintredekin Besudotox, IL13-PE38QQR, for Glioblastoma Multiforme NeoPharm signed a contract with SIRO ClinPharm during the third quarter of 2008 to oversee a planned initial confirmatory PIII for its drug product candidate Cintredekin Besudotox (IL13-PE38QQR) (“IL-13”), for the treatment of patients suffering from Recurrent Glioblastoma Multiforme (GBM). This PIII is projected to begin enrolling the first of an expected 45 patients by the end of calendar 2008 and anticipates that this PIII will generate substantial data by the end of calendar year 2009. LEP-ETU, Liposomal Encapsulated Paclitaxel In March 2008, the Company initiated a PII open-label, multicenter outpatient study for LEP-ETU, Liposomal Paclitaxel, designed to evaluate the anti-tumor effect and safety/tolerability of LEP-ETU in metastatic breast cancer. Targeted enrollment for the trial is scheduled to be completed by the end of 2008 or early 2009. LE-DT, Liposomal Encapsulated Taxotere® Has begun enrolling patients at TGen Clinical Research Services at Scottsdale Healthcare and at The Lombardi Comprehensive Cancer Center at Georgetown University in a multi-center PI for LE-DT, a proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere®, for the treatment of patients with metastatic solid cancer. We are currently targeting the fourth quarter of 2008 for completion of the LE-DT PI trial. Cintredekin Besudotox, IL13-PE38QQR, for Idiopathic Pulmonary Fibrosis Licensed IL13-PE38 from NIH, FDA, and University of Michigan as a potential therapeutic agent for the treatment of pulmonary fibrosis and asthma.Collaborators have completed extensive preclinical studies in animal models for the control and reversal of pulmonary fibrosis with this agent. Preclinical studies relating to asthma have also been performed. In the 3rdQ, the NEOL entered into an agreement with Lovelace Respiratory Research Institute for the completion of a two week inhalation toxicology study designed to provide a detailed preclinical evaluation of this product through nebulization to fully characterize the physio-chemical behavior of the nebulized product. Assuming favorable results from this study,it anticipates filing an IND related to IL13-PE38 IPF during the 1stQ of 2009. LE-rafAON, for Pancreatic Cancer with Gemcitabine Is currently on target to complete IND submission for LE-rafAON by the end of the 4thQ of 2008. All preclinical studies related to the IND submission are completed, and preclinical data is positive. NEOL is in the process of developing clinical protocol of PI and II for pancreatic cancer with Gemcitabine Not that bad for a company trading around 0.2xBV :>) Bernard