***FOR IMMEDIATE RELEASE***
Paul Arndt, NEOPHARM
Geoff Curtis, WeissComm Partners
NEOPHARM AnNOUNCES Presentation of FINAL SAFETY DATA FROM PHASE 1 TRIAL OF CINTREDEKIN BESUDOTOX for Newly Diagnosed
Ø Phase 2 Trial Expected To Begin In The First Half Of 2007
WAUKEGAN, Illinois ? November 20, 2006 - NEOPHARM, Inc. (Nasdaq: NEOL) today announced the presentation of final Phase 1 safety results at the Society for Neuro-Oncology (SNO) 11th Annual Meeting in Orlando, FL. Data from this 22 patient trial showed that 0.5 µg/mL of CINTREDEKIN BESUDOTOX delivered via Convection-Enhanced Delivery (CED) followed by external beam radiation therapy (EBRT) with or without concurrent temozolomide following tumor resection appears to be safe and well-tolerated in patients with newly diagnosed malignant glioma.
“This safety data is very encouraging and supports the potential for CINTREDEKIN BESUDOTOX delivered via Convection-Enhanced Delivery as a safe treatment option for patients with malignant glioma at initial diagnosis,” said Michael Vogelbaum, M.D., Ph.D., Vice-Chairman and Associate Director of Neurosurgical Oncology, Brain Tumor Institute, Cleveland Clinic Foundation.
The Phase 1 trial evaluated the safety and tolerability of CINTREDEKIN BESUDOTOX delivered via convection enhanced delivery followed by treatment with EBRT alone or EBRT plus temozolomide in patients with newly diagnosed malignant glioma following tumor resection. CED of CINTREDEKIN BESUDOTOX at the highest dose, 0.5 µg/mL, followed by EBRT with or without concurrent temozolomide was shown to be well-tolerated in patients with newly-diagnosed malignant glioma. Interim progression-free survival and overall survival were also assessed.
“Along with the growing body of clinical evidence from our earlier Phase 1/2 studies in the recurrent patient population, this study allows for the potential expansion of CINTREDEKIN BESUDOTOX to newly-diagnosed patients,” said Guillermo Herrera, President and Chief Executive Officer of NEOPHARM. “We are expecting that the Phase 2 trial in newly diagnosed patients will begin in the first half of next year.”
The Phase 1 trial, which was conducted in six U.S. cancer centers, enrolled patients into four cohorts receiving either 0.25 μg/mL or 0.50 μg/mL CINTREDEKIN BESUDOTOX, with either EBRT alone or EBRT plus temozolomide. The last patient was enrolled in the study approximately 20 weeks ago with patients surviving as long as 113 weeks to date. Patients will continue to be monitored for long-term survival.
Adverse events related to CINTREDEKIN BESUDOTOX or catheter placement were consistent with adverse events observed in Phase 1 studies of CINTREDEKIN BESUDOTOX administered as monotherapy in patients with recurrent malignant glioma and, regardless of causality, included asthenia, headache, alopecia, and nausea.
About Malignant Glioma
Gliomas are the most common malignant brain tumor in adults, and include glioblastoma multiforme (GBM), anaplastic astrocytoma and malignant mixed oligoastrocytoma tumors. According to the Central Brain Tumor Registry of the United States (www.cbtrus.org), approximately 10,000 people are diagnosed annually with malignant glioma. Although primary treatment is sometimes successful in temporarily stopping the progression of the tumor, the disease is eventually fatal for most patients. Survival time for GBM patients ranges from six months for recurrent disease to 12 months with newly diagnosed disease despite aggressive treatments including surgery, radiation therapy and chemotherapy.
About CINTREDEKIN BESUDOTOX
CINTREDEKIN BESUDOTOX is a recombinant protein consisting of a single molecule composed of two parts: a tumor-targeting molecule (Interleukin-13 or IL13) and a cytotoxic agent (Pseudomonas Exotoxin, or PE38). IL13 receptors are present in appreciable numbers on malignant glioma cells, but only to a minimal amount if at all on healthy brain cells. The IL13 portion is designed to bind to receptors on tumor cells like a key fits into a lock. The cancer cell appears to latch onto and absorb the IL13 and the attached PE38, causing destruction of the cancer cell. Healthy brain cells appear to be unharmed because they do not internalize the PE.
CINTREDEKIN BESUDOTOX is also being evaluated in the Phase 3 PRECISE (Phase 3 Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint) trial, a randomized, controlled clinical trial that enrolled 294 patients (276 intent-to-treat) with confirmed GBM at first recurrence at study entry surgical resection for the intent-to-treat patient population. Patients were randomized in a ratio of 2:1 to receive either CINTREDEKIN BESUDOTOX via CED, or Gliadel Wafers. The trial compares overall survival, drug safety and quality of life of patients receiving CINTREDEKIN BESUDOTOX with patients receiving Gliadel Wafer in the treatment of first recurrent GBM following surgical tumor resection. The PRECISE trial enrolled patients at more than 50 participating sites in North America, Europe and Israel.
CINTREDEKIN BESUDOTOX has received Orphan Drug designation and Fast Track designation from the U.S. Food and Drug Administration (FDA) and was accepted into FDA's continuous marketing application (CMA) Pilot 2 Program. CINTREDEKIN BESUDOTOX also has received Orphan Drug designation in Europe.
About Convection Enhanced Delivery
Convection enhanced delivery (CED) involves the placement of one or more catheters into a brain tumor or nearby brain tissue used to infuse slowly and continuously an anti-tumor drug or other substance over several days. This technique allows relatively large volumes of brain tissue to be treated. CED is used to infuse cintredekin besudotox directly to brain tissue at risk for residual infiltrating tumor in order to prevent or delay tumor recurrence (tumor cell growth).
According to a recent report from the Cleveland Clinic, CED is one of the top ten potential medical breakthroughs that are expected to help shape the future of healthcare.
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. The Company's oncology portfolio is built on two novel, proprietary platforms: a tumor-targeting platform (CINTREDEKIN BESUDOTOX ), and the NeoLipid® 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 cintredekin besudotox, future patient survival in the Company’s ongoing Phase 1/2 studies and the PRECISE trial for Cintredekin besudotox, the use of the CED procedure 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 for production and potential marketing of cintredekin besudotox, unexpected side effects or inadequate therapeutic efficacy of Cintredekin besudotox that could slow or prevent Cintredekin besudotox from coming to market, uncertainty regarding the Company's ability to market its drug and non-drug products including, but not limited to, cintredekin besudotox, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including its most recent quarterly report 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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