|NeoPharm (OTC: NEOL.PK): A Pipeline with Multiple Catalysts|
|Friday, 02 October 2009 17:41|
NeoPharm (OTC: NEOL.PK) is an emerging bio-pharmaceutical company focused on the development of anti-cancer agents based on two proprietary technology platforms that include tumor-targeting toxins and a NeoLipid drug delivery system, which encapsulates hard-to-deliver chemotherapy drugs in a fat (lipid) membrane for preferential uptake by tumors and a more stable product formulation.
NeoPharm has advanced five drug product candidates into various stages of clinical and pre-clinical development for the treatment of cancer in addition to one drug product candidate in pre-clinical development for lung conditions (pulmonary fibrosis and asthma).
During 1Q09, NeoPharm completed the targeted enrollment of 35 patients for the first part of its Phase 2 open-label, multicenter outpatient study in India for LEP-ETU (Liposomal Paclitaxel) (a novel delivery formulation of Taxol®) to evaluate the effectiveness and safety / tolerability of LEP-ETU in metastatic breast cancer patients. Based on the encouraging results of the preliminary data in terms of tumor response and protection from toxicities related to the standard formulation of Taxol®, the Company submitted a request to the Office of Drugs Controller General in India (DCGI) in February 2009 to expand / double the targeted enrollment to 70 patients with recurrent breast cancer.
The expanded Phase 2 study should enable the Company to get a better understanding of the potential clinical role of LEP-ETU and better evaluate the degree of protection from side effects of standard Taxol® such as neurotoxicities and bone marrow toxicities. In mid-July, NeoPharm received approval from the DCGI to expand this Phase 2 trial and has already seen promising preliminary data from the first part of the study with the 35 initial patients. The Company has engaged an independent clinical trial firm to audit the results from the first part of the study and expects the results of that audit to be announced during 2H09. All of the patients in the first part of the study have received a dose of 275 mg/m2 every three weeks without the detection of any significant infusion related problems or unexpected toxicities with significant response rate.
NeoPharm has completed enrollment in a multi-center Phase I clinical trial for LE-DT (Liposomal Docetaxel) (a novel delivery form of Taxotere®) for the treatment of patients with metastatic solid tumors. This Phase 1 study is designed to more accurately define the maximum tolerated dose (MTD) and is being conducted at The Lombardi Comprehensive Cancer Center at Georgetown University, Washington, DC and at Translational Genomic Research Institute (TGen) at Scottsdale Health Care System, Scottsdale, Arizona.
Based upon the preliminary results from this Phase 1 trial, the Company is planning two Phase 2 studies of LE-DT. The first study will be conducted in hormone refractory metastatic prostate cancer patients and the protocol for this study had been submitted to FDA for review. The Company expects to enroll 40 patients in this trial that will begin at three locations in the U.S. during 4Q09. The second study will be a multicenter, open-label trial for advanced pancreatic cancer patients to assess the antitumor effects of LE-DT. This trial is anticipated to enroll patients at multiple sites later this year.
During 4Q08, NeoPharm signed a Cooperative Research and Development Agreement (CRADA) with the National Institute of Neurological Diseases and Stroke ("NINDS"), a part of the NIH for research on a therapeutic agent for untreatable brain diseases in humans. Under the terms of the CRADA, NINDS will deliver IL-13, in conjunction with a surrogate marker via NINDS' patented methodology of Convection Enhanced Delivery, which was previously licensed to NeoPharm.
The Company will provide its proprietary drug and technical resources to study its effects in various brain cancers in humans. NINDS Institutional Review Board has approved the protocol and NeoPharm has granted NINDS authorization to cross-reference its prior IL-13-PE38 Investigational New Drug application (IND) for the treatment of glioblastoma multiforme (GBM). Recently, the FDA has also allowed the start of a Phase 1 clinical trial in pediatric patients with brainstem glioma under the NINDS IND.
NeoPharm has licensed IL-13 PE38 from NIH, FDA, and The University of Michigan as a potential therapeutic agent for the treatment of pulmonary fibrosis and asthma, and has completed extensive preclinical studies in animal models to evaluate the control and reversal of pulmonary fibrosis with this agent. Cells initiating the harmful immune response targeted at the lungs over-express the IL-13 receptor, so that the selective destruction of cells presenting IL-13 receptors may reduce further damage and improve lung function in this patient population.
The Company recently completed a two-week inhalation toxicology study in non-human primates performed by the Lovelace Respiratory Research Institute. This study was designed to provide a detailed safety evaluation of the product in non-human primates through nebulization, to characterize the distribution in the lungs and other tissues, and to identify any toxicity related to any organ with IL-13 PE38 inhalation. Based upon the initial results from this study, and other preclinical studies, the Company anticipates filing an IND for IL-13 PE38 for pulmonary fibrosis during 4Q09.
All preclinical studies related to the IND submission for LE-rafAON (a liposomal formulation of the antisense oligonucleotide agent known as c-rafin that sensitizes cancer cells to the effects of radiation therapy and chemo) in the treatment of pancreatic cancer in combination with gemcitabine have been completed, and the preclinical data generated is positive. NeoPharm is developing clinical protocols for Phase 1 and 2 studies of pancreatic cancer with LE-rafAON in combination with the drug gemcitabine. However, during my 9/24/09 phone interview with President / CEO / Acting CFO, Laurence P. Birch, it was noted that an IND filing for LE-rafAON is not a priority at this time as the Company must prioritize its development programs in order to conserve and best apply its resources.
Mr. Birch also stated during the call that he was brought in as CEO with a restructuring focus aimed at greatly decreasing the Company’s cash burn rate following a significant investment by the previous management for expected commercialization of IL-13 for brain cancer (GBM), which ultimately failed to achieve its Phase 3 endpoints. However, Mr. Birch noted that the Company’s Chief Scientific Advisor and one of its founders, Dr. Aquilur Rahman, plays a key role in analyzing the Company’s patent portfolio (over 100 patents) and clinical trial patient selection process in order to prioritize and increase the chances for success in the ongoing clinical / preclinical development programs.
The Company has sufficient cash / equivalents ($8.5 million) to fund operations into mid-2010 as of its most recent update for 2Q09 results in late July. NeoPharm accessed a $5 million credit line during the latest quarter and has $14.6 million in long-term debt outstanding with a cash burn rate of approximately $2 million per quarter. With a share price of $0.40 as of 2-October and a market cap of about $11 million, NeoPharm represents a model example of a FDA Calendar Extreme Trade similar to many I have highlighted in this article series previously with multiple shots on goal in terms of clinical development compounds and a multitude of upcoming catalysts and news flow to fuel potential stock price and trading volume increases while keeping in mind the extreme / risk part of the equation.
Click here to visit Neopharm’s corporate profile page at OneMedPlace and the Company is also a component in my Emerging Cancer Diagnostic / Therapeutic (Dx / Tx) stock index, which is the top performing index among the 11 Health Trend Stock Indexes that I have created, revised, and tracked over the past few years that are now being tracked at the Investars YOU website.
Disclosure: No positions.
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