Phase II Clinical Trial of NeoPharm's LE-SN38 Initiated by NCI CALGB in Patients with Metastatic Colorectal Cancer; First Patients Treated.WAUKEGAN, Ill. -- NeoPharm, Inc. (Nasdaq:NEOL) today announced that patient enrollment has commenced in a multi-center Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of LE-SN38 in the treatment of patients with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. . The trial is being conducted by Cancer and Leukemia Group B Cancer and Leukemia Group B (CALGB) is a cancer research cooperative group in the United States. CALGB research is focused on seven major disease areas: leukemia, lymphoma, breast cancer, lung cancer, gastrointestinal malignancies, genito-urinary malignancies, and melanoma. (CALGB CALGB Cancer and Leukemia Group B ), an oncology clinical research group sponsored by the National Cancer Institute (NCI See Liberate. ). LE-SN38 is NeoPharm's NeoLipid(R) liposomal formulation of SN-38, the active metabolite active metabolite Therapeutics A drug metabolite with therapeutic activity similar to the parent compound, which must be considered in therapeutic pharmacokinetics of irinotecan (Camptosar(R)), a chemotherapeutic pro-drug approved for the treatment of advanced colorectal cancer. "The CALGB is pleased to be collaborating with NeoPharm on the clinical development of LE-SN38," said Richard L. Schilsky, MD, Professor of Medicine and Associate Dean for Clinical Research, Biological Sciences Division of the University of Chicago, and Chairman of the Cancer and Leukemia Group B. "We welcome the opportunity to provide colorectal cancer patients with an additional clinical trial treatment option." "Our LE-SN38 drug candidate, as well as the underlying NeoLipid(R) drug delivery platform are an important part of our oncology portfolio," said Guillermo Herrera, NeoPharm's President and Chief Executive Officer. "We are pleased to be moving LE-SN38 into Phase II testing with CALGB, one of the premiere oncology clinical research groups, in the hope of eventually providing colorectal cancer patients with a new and potentially less toxic treatment option." The Phase II trial will seek to enroll up to 54 patients. The primary endpoint of the trial is overall tumor response rate (ORR) following treatment with LE-SN38 as a second-line treatment in patients with metastatic colorectal cancer. Other endpoints include determining the safety profile of LE-SN38 in this patient population, as well as the progression-free survival (PFS PFS, n post facilitation stretch; therapeutic approach utilized during proprioceptive neuromuscular facilitation in which the patient begins the stretch midway between the fully relaxed and fully stretched position and uses maximum level of effort to ) and overall survival (OS) for the patients treated. Patients will receive LE-SN38 by intravenous infusion over 90 minutes every 21 days as long as the tumor does not grow or patients are unable to tolerate the treatment. It is currently expected to take up to 1 year to fully enroll the trial. An initial assessment of tumor response will be made after the first 21 patients are treated. Enrollment will continue while tumor response is being evaluated in the initial group of patients. If results from the CALGB study appear promising, future LE-SN38 development could include possible development and initiation of a Phase III trial. There are multiple study sites across the U.S. currently recruiting patients into the CALGB study. For specific study information, please visit www.clinicaltrials.gov, keyword "LE-SN38." About Colorectal Cancer Colorectal cancer develops in the colon (large intestine large intestine End section of the intestine. It is about 5 ft (1.5 m) long, is wider than the small intestine, and has a smooth inner wall. In the first half, enzymes from the small intestine complete digestion, and bacteria produce many B vitamins and vitamin K. ) and/or the rectum, and affects more than 150,000 patients annually. According to the National Cancer Institute (www.cancer.gov), colorectal cancer is the third most common cancer and the third leading cause of cancer-related mortality in the United States. Colorectal cancer is associated with severe morbidities, including bowel obstruction Bowel obstruction A blockage in the intestine which prevents the normal flow of waste down the length of the intestine. Mentioned in: Anal Atresia, Diverticulosis and Diverticulitis bowel obstruction , liver failure liver failure Clinical medicine Liver insufficiency that results in death, requires a liver transplant, or is characterized by recovery after encephalopathy, or while awaiting a transplant; also defined as a condition with ≥ 3 of following: albumin < 3. , pain, weakness, and wasting. Until age 50, men and women have similar incidence and mortality rates; after age 50, men are more vulnerable. The NCI estimates that approximately $8.4 billion (in 2004 dollars) is spent annually in the United States on treatment of colorectal cancer. About LE-SN38 LE-SN38 is the Company's NeoLipid(R) Liposomal formulation of SN-38, the active, but poorly soluble, metabolite metabolite, organic compound that is a starting material in, an intermediate in, or an end product of metabolism. Starting materials are substances, usually small and of simple structure, absorbed by the organism as food. of Camptosar(R), a chemotherapeutic pro-drug, which is used as a first-line and second-line treatment for advanced colorectal cancer. A pro-drug is a compound that is converted into the active drug in the body. However, Camptosar(R) is converted into SN-38 in colorectal cancer cells at different rates in different patients, and this variability in conversion rates may result in suboptimal Suboptimal A solution is called suboptimal if a part of the solution has been optimized without regards to the overall objective. treatment. By employing the Company's proprietary NeoLipid(R) technology to directly deliver SN-38, the Company hopes to minimize treatment variability. A Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I was completed in 2005 and showed the potential for decreased side effects Side effects Effects of a proposed project on other parts of the firm. , particularly diarrhea, compared to published results of Camptosar(R). The results of that trial were presented at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) meeting in June 2005, and were used to determine the Phase II study dose. About the Cancer and Leukemia Group B - CALGB The CALGB is a national clinical research group sponsored by the National Cancer Institute, with its central office headquartered at the University of Chicago and its statistical center located at Duke University. The CALGB was founded in 1956 with a goal of bringing together clinical oncologists and laboratory investigators to develop better treatments for cancer. Since 1956, CALGB has grown into a national network of 29 university medical centers, more than 225 community hospitals and more than 3000 oncology specialists who collaborate in clinical research studies aimed at reducing the morbidity and mortality Morbidity and Mortality can refer to:
CALGB research is focused on seven major disease areas: leukemia, lymphoma, breast cancer, lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. , gastrointestinal malignancies, genito-urinary malignancies, and melanoma. In each of these areas, multi-modality treatment programs are designed by national experts in an attempt to cure more patients with cancer. Treatment protocols are carefully developed and monitored and are often coupled with studies of cancer biology, quality of life, pharmacology and cost-effectiveness measures so that improvements in therapy can be placed in the proper clinical perspective in today's health care marketplace. NeoPharm's Commitment to Oncology NeoPharm employees share a common goal: bringing hope to cancer patients and their families through the research and development of new cancer drugs and therapies. NeoPharm's oncology portfolio is built on two novel, proprietary platforms: a tumor-targeting platform, and the NeoLipid(R) Liposomal Drug Delivery platform. Through its research and clinical studies, as well as its work with physicians, scientists, and advocacy groups, NeoPharm is helping to enhance the lives of cancer patients. 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. Forward Looking Statements - This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's drug development program, including, but not limited to clinical trials involving LE-SN38, future patient recruitment for or patient survival in the Company's ongoing Phase II studies, for LE-SN38, the possible initiation of a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for LE-SN38, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in financing, development, testing, obtaining regulatory approval, production and marketing of the Company's drug and non-drug compounds, including, but not limited to, LE-SN38, uncertainty regarding the availability of third party production capacity, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug and non-drug compounds, including, but not limited to, LE-SN38, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to market its drug and non-drug products, including, but not limited to, LE-SN38, directly or through independent distributors, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, LE-SN38, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including its annual reports on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and quarterly reports on Forms 10-Q. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on these forward-looking statements as a prediction of actual future results. |
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