NeoPharm's Cintredekin Besudotox Continues to Show Evidence of Prolonged Overall Survival in Patients with Recurrent Glioblastoma Multiforme

-- Median Survival Of More Than One Year Observed

-- Catheter Placement Key Predictor of Prolonged Survival

NeoPharm, Inc. (Nasdaq:NEOL) today announced that cintredekinbesudotox (IL13-PE38QQR) continues to show evidence of prolongedoverall survival in patients with recurrent glioblastoma multiforme(GBM). Updated data for GBM patients treated in Phase I/II studies andresults from a Phase I/II subset analysis is being presented at the74th Annual Meeting of the American Association of NeurologicalSurgeons (AANS) held in San Francisco on Monday, April 24, 2006.

Sandeep Kunwar, MD, Associate Professor of Neurological Surgery,University of California at San Francisco (UCSF) and lead investigatorof the pivotal Phase III PRECISE trial of cintredekin besudotox, willpresent updated data for the 45 GBM patients treated in the Phase I/IIintraparenchymal setting. Overall median survival for these patientswas 44.0 weeks, with survival increasing to 53.6 weeks for the 26patients with two or more optimally placed catheters.

Additionally, Dr. Kunwar reported the UCSF experience in along-term follow-up Phase I study (IL13PEI-002) and highlighted that22 GBM patients treated with cintredekin besudotox via convectionenhanced delivery (CED) at his center had a median survival of morethan one year (57.4 weeks). Sixteen of these patients with two or moreoptimally placed catheters had a median survival of 69.9 weeks. Inaddition, four patients at UCSF remain alive with a median follow-upof more than three and half years (188 weeks) including one patientwith a follow-up of almost five years (244 weeks) who is stillprogression free.

Dr. Kunwar also indicated that an independent statistical analysisof the Phase I/II data confirmed that catheter placement was a keyprognostic factor related to prolonged survival. The catheterplacement guidelines developed during the cintredekin besudotox PhaseI/II clinical trial experience were incorporated by NeoPharm into thedesign of the pivotal Phase III PRECISE trial of cintredekin besudotoxin first recurrent GBM.
GBM Patients from Phase I/II Intraparenchymal Setting
(IL13PEI-002, 105 and 103R02)

Median Lower CI(a) Upper CI(a)
Overall (n=45) 44.0 36.1 55.6
(1)Optimal Catheter Placement (n=26) 53.6 36.1 70.3
(1)Sub-Optimal Catheter Placement (n=19) 39.3 29.0 51.9

Subset of Phase I (IL13PEI-002) Patients Treated at UCSF

Median Lower CI(a) Upper CI(a)
Overall (n=22) 57.4 37.4 78.0
(1)Optimal Catheter Placement (n=16) 69.9 37.6 98.6
(1)Sub-Optimal Catheter Placement (n=6) 41.6 32.0 51.9

(1) = Catheter placement is an objective score system based on
catheter depth from brain surfaces including any intervening brain
structures along the catheter trajectory as well as proximity to the
tumor resection cavity.

(a) = 95% Confidence Interval

"These data are encouraging when you consider that median patientsurvival is approximately 28 weeks with currently available treatmentoptions for recurrent GBM," said Dr. Kunwar. "The data furthersuggests that with improved drug delivery, via optimally placedcatheters, we can further improve survival benefit. With its highselectivity and potency, cintredekin besudotox has the potential to bean important, clinically meaningful treatment for GBM patients."

A copy of Dr. Kunwar's presentation is available on NeoPharm's"Company Information\Abstracts" page of its corporate website atwww.neopharm.com.

Study Background

In the Phase I/II cintredekin besudotox program, a subset ofpatients (part of the Phase I study IL13PEI-002) was treated at theUCSF from June 2001 to June 2004. All patients underwent tumorresection followed by intraparenchymal infusion (within the brainsurrounding the resection cavity) of cintredekin besudotox. Patientswere followed with serial MRI scans, with no additional treatmentunless there was evidence of tumor recurrence. Postoperative andfollow-up MRI scans, performance status and survival were evaluated. Atotal of 22 patients with histologically confirmed GBM were treated ata dose level of 0.25 - 0.50 ug/mL. Intraparenchymal cintredekinbesudotox was administered via 1-3 catheters over 4 to 6 days.

The most common treatment related adverse event were headache,hemiparesis, sensory disturbance and aphasia/speech disorderconsistent with an expected safety profile in a similar patientpopulation undergoing neurosurgical procedures and receivingcorticosteroids.

"Glioblastoma multiforme is one of the most aggressive braintumors and one of the hardest cancers to treat," says Rob Tufel, MSW,MPH, executive director of the National Brain Tumor Foundation."Providing patients with effective treatment options gives us hopethat we are making real progress in research."

About Glioblastoma Multiforme

Glioblastoma multiforme (GBM) is the most common type of malignantprimary brain tumor in adults. According to the Central Brain TumorRegistry of the United States (www.cbtrus.org), GBM tumors account forapproximately 22 percent of all adult primary brain tumors and usuallyaffect men more commonly than women, particularly men between the agesof 60 and 85 years. GBM is rare in children, comprising approximatelythree percent of all childhood tumors. According to the CBTRUS,approximately 18,500 people are diagnosed annually with primarymalignant brain tumors and approximately 13,000 people die from thisdisease annually. Survival time for patients ranges from six monthsfor recurrent disease to 12 months with newly diagnosed diseasedespite aggressive treatments including surgery, radiation therapy andchemotherapy.

GBM tumors mainly arise in the cerebral hemispheres (the mainportions of the brain), but they can also occur in the brain stem,cerebellum, or spinal cord. Symptoms of a GBM can include headachesthat are caused by increased intracranial pressure, memory loss,seizures, personality changes, and coordination difficulties.

About Cintredekin Besudotox (IL13-PE38QQR)

Cintredekin besudotox is a recombinant protein consisting of asingle molecule composed of two parts: a tumor-targeting molecule(Interleukin-13, or IL13) and a cytotoxic agent (Pseudomonas Exotoxin,or PE). The drug is delivered via Convection Enhanced Delivery (CED),a novel drug delivery system using catheters placed following tumorresection (removal), in areas with microscopic tumor spread or at riskof tumor spread around the tumor resection cavity. IL13 receptors arepresent in appreciable numbers on malignant glioma cells, but only toa minimal amount if at all on healthy brain cells. The IL13 portion isdesigned to bind to receptors on tumor cells like a key fits into alock. The cancer cell appears to latch onto and absorb the IL13 andthe attached PE, causing destruction of the cancer cell. Healthy braincells appear to be unharmed because they do not internalize the PE.

Cintredekin besudotox has received Orphan Drug designation andFast Track designation from the U.S. Food and Drug Administration(FDA). Cintredekin besudotox was also accepted into FDA's Pilot 2Program for continuous marketing applications. Cintredekin besudotoxhas also received Orphan Drug designation in Europe.

Promising data for this potential therapeutic advance in thetreatment of GBM has been observed in Phase I/II trials. In addition,the importance of adequate catheter positioning in order to achieveoptimal distribution of cintredekin besudotox in brain tissue wasassessed, leading to the specific guidelines for catheter positioningand deferred catheter placement used in the Company's ongoing PhaseIII PRECISE Trial. Improved catheter placement translated into abetter patient outcome for the 45 (complete Phase I/II patient set)recurrent GBM patients treated post-tumor resection in the Phase I/IItrials, with an overall median survival of 44.0 weeks (95% ConfidenceInterval (CI): 36.1-55.6) including 42 percent of patients with lessthan 2 adequately positioned catheters, while patients with greaterthan or equal to 2 catheters adequately positioned surviving with amedian of 53.6 weeks (95% CI: 36.1-70.3). Separately, one-year andtwo-year survival rates for recurrent GBM patients were 40 percent and13 percent respectively.

Pivotal Phase III Trial - PRECISE

PRECISE, an acronym for Phase III Randomized Evaluation ofConvection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint,www.precisetrial.com, is a randomized, controlled Phase III clinicaltrial. It was designed to enroll up to 300 patients in order to obtain270 patients with confirmed GBM at first recurrence at study entrysurgical resection for the intent-to-treat patient population, andcompare overall survival, drug safety and quality of life of patientsreceiving cintredekin besudotox with patients receiving Gliadel(R)Wafer in the treatment of first recurrent GBM following surgical tumorresection.

PRECISE achieved the 270 patient intent-to-treat milestone (276intent-to-treat) in early December after enrolling 294 patients.Patients were randomized so that 2 patients received cintredekinbesudotox via CED for every 1 patient that received Gliadel(R) Waferplaced in the resection cavity at the time of resection. The primaryefficacy analysis of the trial will be based on the comparison of theoverall patient survival curves of the two treatment groups.

In December 2005, an independent Data Monitoring Committee (DMC)recommended that the PRECISE Trial continue as planned under theapproved protocol. The DMC observed no treatment related adverse orserious adverse events that differed from those seen in the Phase I/IItrials, and observed that, at that time, optimal catheter placement(greater than or equal to 2 catheters adequately positioned) had beenachieved in more than 80% of patients. A planned interim efficacyanalysis (triggered at 160 deaths) is expected to occur in late-secondor early third quarter of 2006, and a final efficacy analysis(triggered at 215 deaths) is currently expected to occur late in thefourth quarter of 2006 or first quarter of 2007.

NeoPharm's Commitment to Oncology

NeoPharm employees share a common goal: bringing hope to cancerpatients and their families through the research and development ofnew cancer drugs and therapies. The Company's oncology portfolio isbuilt on two novel, proprietary platforms: a tumor-targeting platform,and the NeoLipid(R) Liposomal Drug Delivery platform. Through itsresearch and clinical studies, as well as its work with physicians,scientists, and advocacy groups, NeoPharm is helping to enhance thelives of cancer patients.

About NeoPharm, Inc.

NeoPharm, Inc., based in Waukegan, Illinois, is a publicly tradedbiopharmaceutical company dedicated to the research, development andcommercialization of new and innovative cancer drugs for therapeuticapplications. Additional information, including ongoing clinicaltrials, can be obtained by visiting NeoPharm's Web site atwww.neopharm.com.

Forward Looking Statements - This press release contains"forward-looking statements" within the meaning of Section 27A of theSecurities Act of 1933 and Section 21E of the Securities Exchange Actof 1934. The Company has tried to identify such forward-lookingstatements by use of such words as "expects," "intends," "hopes,""anticipates," "believes," "could," "may," "evidences" and"estimates," and other similar expressions, but these words are notthe exclusive means of identifying such statements. Such statementsinclude, but are not limited to, any statements relating to theCompany's drug development program, including, but not limited toclinical trials involving cintredekin besudotox, future patientsurvival in the Company's ongoing Phase I/II studies and PRECISE trialfor cintredekin besudotox, and any other statements that are nothistorical facts. Such statements involve risks and uncertainties,including, but not limited to, those risks and uncertainties relatingto difficulties or delays in financing, development, testing,obtaining regulatory approval, production and marketing of theCompany's drug and non-drug compounds, including, but not limited to,cintredekin besudotox, uncertainty regarding the availability of thirdparty production capacity, unexpected adverse side effects orinadequate therapeutic efficacy of the Company's drug and non-drugcompounds, including, but not limited to, cintredekin besudotox, thatcould slow or prevent products coming to market, uncertainty regardingthe Company's ability to market its drug and non-drug products,including, but not limited to, cintredekin besudotox, directly orthrough independent distributors, the uncertainty of patent protectionfor the Company's intellectual property or trade secrets, including,but not limited to, cintredekin besudotox, and other risks detailedfrom time to time in filings the Company makes with the Securities andExchange Commission including its annual reports on Form 10-K andquarterly reports on Forms 10-Q. Such statements are based onmanagement's current expectations, but actual results may differmaterially due to various factors, including those risks anduncertainties mentioned or referred to in this press release.Accordingly, you should not rely on these forward-looking statementsas a prediction of actual future results.