18.09.2006 12:00:00
|
NEOPHARM Presents Updated CINTREDEKIN BESUDOTOX Phase I/II Median Survival Data at European Association of Neuro-Oncology (EANO) Meeting
NEOPHARM, Inc. (Nasdaq:NEOL) today announced that, based onlong-term follow up data from its Phase I/II clinical studies,CINTREDEKIN BESUDOTOX (IL13-PE38QQR) continues to show evidence ofprolonged overall survival in patients with recurrent glioblastomamultiforme (GBM). Specifically, updated survival data for GBM patientstreated in the Company's Phase I/II studies and results from a subsetanalysis of these Phase I/II studies was presented in a scientificsymposium on brain tumor treatments at the annual meeting of theEuropean Association of Neuro Oncology (EANO) meeting in Vienna,Austria on Saturday, September 16, 2006.
Sandeep Kunwar, M.D., Associate Professor of Neurological Surgery,University of California, San Francisco (UCSF), and PrincipalInvestigator of the Company's on-going Phase III PRECISE trial forCINTREDEKIN BESUDOTOX, presented updated data for the 45 GBM patientstreated in the Phase I/II intraparenchymal setting in a scientificpresentation entitled Advances in the Treatment of GBM: CED ofCINTREDEKIN BESUDOTOX (IL13-PE38QQR). Overall median survival forthese patients continued to be 44.0 weeks; however, median survivalincreased to 55.6 weeks for the 27 patients with two or more optimallyplaced catheters.
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. Furthermore,post-operative stereotactic catheter placement, in which catheters areplaced 2-4 days post-tumor resection, provided a statisticallysignificant improvement (p=0.003) in achieving optimal catheterpositioning (79% of deferred catheter placement (n=51) vs. 49% ofintra-operative catheter placement (n=88)).
The catheter placement guidelines developed during the Phase I/IIclinical trial experience were incorporated by NEOPHARM into thedesign of the pivotal Phase III PRECISE trial of CINTREDEKIN BESUDOTOXin first recurrent GBM. Training physicians in the proper placement ofcatheters was an integral part of the PRECISE trial program.
Recurrent GBM Patients From Phase I/II Intraparenchymal Setting
(IL13PEI-002, 105 and 103R02)
Median Lower Upper One-Year Two-Year
Survival CI CI Survival Survival
(Weeks) (a) (a) (%) (%)
Overall (n=45) 44 36.1 55.6
(1) Optimal Catheter
Placement (n=27) 55.6 36.1 74.3 51.9 18.5
(1) Sub-Optimal Catheter
Placement (n=18) 38.4 29.0 45.9 22.2 5.6
Subset of Phase I/II (IL13PEI-002) Patients Treated at UCSF
Median Lower Upper
Survival CI CI
(Weeks) (a) (a)
Overall (n=22) 57.4 37.4 78.0
(1) Optimal Catheter
Placement (n=27) 69.9 37.6 98.6
(1) Sub-Optimal Catheter
Placement (n=19) 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) = Confidence Interval. Approaching significance by Log Rank Test
(p=0.081). Significant by Cox Proportional Hazards Model (p=0.004)
"These data are encouraging when you consider that median patientsurvival is approximately 28 weeks with currently available treatmentoptions for recurrent GBM," said Dr. Kunwar. "Convection EnhancedDelivery of CINTREDEKIN BESUDOTOX represents a promising potentialadvancement in the treatment of GBM where we can selectively targetthe infiltrative tumor cells without damaging functional tissue.Importantly, post-operative catheter placement provides a significantimprovement in optimizing catheter positioning, which appears to playan important role in drug distribution and patient outcomes."
A copy of Dr. Kunwar's presentation is available on NEOPHARM's"Company Information\Abstracts" page of its corporate website atwww.NEOPHARM.com.
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 (CBTRUS, www.cbtrus.org), GBM tumorstypically affect men more commonly than women, particularly menbetween the ages of 60 and 85 years. According to the CBTRUS,approximately 10,000 people are diagnosed annually with malignantglioma (GBM and anaplastic astrocytoma) and this disease is eventuallyfatal for most patients. Survival time for GBM patients ranges fromsix months for recurrent disease to 12 months with newly diagnoseddisease despite aggressive treatments including surgery, radiationtherapy and chemotherapy.
GBM tumors mainly arise in the cerebral hemispheres (the mainportions of the brain), but they can also occur in the brainstem,cerebellum, or spinal cord. Symptoms of a GBM can include headachesthat are caused by increased intracranial pressure, neurologicaldeficits such as weakness, sensory loss, coordination difficulties,visual impairment, cognitive impairment affecting memory and language,seizures, and personality changes.
About CINTREDEKIN BESUDOTOX
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 PE38). IL13 receptors are present in appreciable numbers onmalignant glioma cells, but only minimally, if at all, on healthybrain cells. The IL13 portion is designed to bind to receptors ontumor cells like a key fits into a lock. The cancer cell appears tolatch onto and absorb the IL13 and the attached PE38, causingdestruction of the cancer cell. Healthy brain cells appear to beunharmed because they do not internalize the PE. The drug is deliveredvia Convection Enhanced Delivery (CED), a novel drug delivery systemusing catheters placed following tumor resection (removal), in areaswith microscopic tumor spread or at risk of tumor spread around thetumor resection cavity.
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, the resultsof which have been previously reported by the Company. In addition,the importance of adequate catheter positioning in order to achieveeffective distribution of CINTREDEKIN BESUDOTOX in brain tissue wasassessed in these Phase I/II trials, leading to specific guidelinesfor catheter positioning and deferred catheter placement used in theCompany's ongoing Phase III PRECISE Trial. Improved catheter placementtranslated into a better patient outcome for the 45 (complete PhaseI/II patient set) recurrent GBM patients treated post-tumor resectionin the Phase I/II trials, with an overall median survival of 44.0weeks (95% Confidence Interval (CI): 36.1-55.6) including 40 percentof patients with less than 2 optimally positioned catheters, whilepatients with greater than or equal to 2 catheters optimallypositioned surviving with a median of 55.6 weeks (95% CI: 36.1-74.3).Separately, one-year and two-year survival rates for recurrent GBMpatients were approximately 52 percent and 18.5 percent respectively,for patients with greater than or equal to 2 catheters optimallypositioned.
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 Waferin 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 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 June 2006, after conducing the trial's interim efficacyanalysis after 160 patient deaths, the Data Monitoring Committee (DMC)recommended that the PRECISE Trial continue as planned under theapproved protocol. The DMC reported no treatment related adverse orserious adverse events that differed from previous reports and thosenormally associated with GBM and reported that compliance in terms ofcatheter placement guidelines was over 80%. The final efficacyanalysis is currently expected to occur in the 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 to,clinical trials involving cintredekin besudotox, future patientsurvival in the Company's ongoing Phase I/II studies and the PRECISEtrial for Cintredekin besudotox, the use of the CED procedure and anyother statements that are not historical facts. Such statementsinvolve risks and uncertainties, including, but not limited to, thoserisks and uncertainties relating to difficulties or delays infinancing, development, testing, obtaining regulatory approval, thedate when the final efficacy analysis in the PRECISE trial will bereported, production and marketing of cintredekin besudotox,unexpected side effects or inadequate therapeutic efficacy ofCintredekin besudotox that could slow or prevent Cintredekin besudotoxfrom coming to market, uncertainty regarding the Company's ability tomarket its drug and non-drug products including, but not limited to,cintredekin besudotox, and other risks detailed from time to time infilings the Company makes with the Securities and Exchange Commissionincluding its annual reports on Form 10-K and quarterly reports onForms 10-Q. Such statements are based on management's currentexpectations, but actual results may differ materially due to variousfactors, including those risks and uncertainties mentioned or referredto in this press release. Accordingly, you should not rely on theseforward-looking statements as a prediction of actual future results.
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu Insys Therapeutics Incmehr Nachrichten
Keine Nachrichten verfügbar. |