NEOPHARM, Inc. presented its updated development projections for its drug candidates pipeline at its Annual Shareholder Meeting
WAUKEGAN, IL, USA | August 16, 2007 | NEOPHARM, Inc. (NASDAQ:NEOL) presented its updated development projections for its drug candidates pipeline at its Annual Shareholder Meeting. A copy of the Company's presentation can be found in its most recent 8-K filing.
"After a comprehensive review of the Company's pipeline, we have identified several opportunities in which we will be able to capitalize on the intellectual property NEOPHARM has created to date. As such, we have made initial projections regarding the clinical development cycle of many of our drug candidates," commented Laurence Birch, President and Chief Executive Officer of NEOPHARM. "Additionally, we have successfully completed the restructuring initiative we announced in April 2007. Based on our efforts, we were able to significantly reduce NEOPHARM's cash consumption rate to approximately $5 million, before external clinical costs and certain legacy costs, and retain key technical positions that will support development activities in order to achieve the Company's next meaningful inflection point."
Mr. Birch continued, "Based on our review of the pipeline, coupled with the progress we have made in reducing our cash consumption rate, we believe that the current available cash balance of $25 million, as of June 30, 2007, is sufficient to fund several of our drug candidates through Phase I and Phase II completion. Going forward, we will continue to identify new out-license and partnership opportunities, as well as drive R&D activities to bring the current pipeline to fruition."
NeoLipid(R) Platform
NEOPHARM currently plans to initiate a Phase II trial for its LEP-ETU drug candidate in early 2008. This drug candidate is being tested for the treatment of breast cancer.
The Company also plans to explore initiating patient enrollment for a new Phase II clinical trial of LE-SN38 in mid-to-late 2008, for the treatment of triple negative breast cancer.
Preclinical work continues on NEOPHARM's LE-DT formulation. Following the completion of this work in late 2007, the Company expects to thereafter be able to promptly file an IND. Assuming all regulatory requirements are met, NEOPHARM hopes to initiate a Phase I trial for this drug candidate in early 2008.
The Company plans to complete reformulation of LE-rafAON, a compound being tested for its effectiveness in treating pancreatic cancer, in late 2007. Additionally, NEOPHARM plans to amend its IND by the end of this year, followed closely by the patient enrollment for its Phase I trial.
Cintredekin Besudotox (IL13-PE38QQR)
NEOPHARM announced in June 2007, the exclusive licensing agreement with the National Institutes of Health (NIH) for the use of Cintredekin Besudotox for the treatment of Pulmonary Fibrosis and Asthma.
According to the estimates of the National Foundation of Pulmonary Fibrosis, approximately 40,000 Americans die each year of this deadly disease. Pre-clinical studies performed at the NIH, FDA and University of Michigan, appear to be promising, as they provided preliminary evidence of the reversal of the disease and its scarring in the animal models of IPF when Cintredekin Besudotox is administered as a nebulized product.
Based on this initial research, the Company believes that an important opportunity may exist for IL-13 for the treatment of Pulmonary Fibrosis and Asthma. As such, NEOPHARM expects to initiate a Phase I clinical trail in mid-2008.
The Company continues to explore partnership opportunities and new drug delivery technologies for IL-13 for indication of recurrent GBM.
Currently Projected Trial Completion Dates
2007 2008 2009
---------------- ---------------- ----------------
Phase II
LEP-ETU Completion -
mid-2008
Phase II
LE-SN38 Completion -
mid-to-late 2008
Phase I Phase II
LE-DT IND submission - Completion - Completion -
late 2007 late 2008 mid-to-late 2009
Phase I Phase II
LE-rafAON IND submission - Completion - Completion -
late 2007 mid-to-late 2008 mid-2009
----------------------------------------------------------------------
IL-13 Phase I
(Pulmonary Fibrosis) Completion -
early 2009
IL-13 Active review of
(Recurrent GBM) program -
ongoing
About NEOPHARM, Inc.
NEOPHARM, Inc., based in Waukegan, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. Additional information, including ongoing clinical trials, can be obtained by visiting NEOPHARM's Web site at www.neopharm.com.
SOURCE: NEOPHARM INC. |
