Spectrum Pharmaceuticals Announces Data From Three Oncology Programs Presented at the American Association of Cancer Research Annual Meeting1 EOquin Instillation Immediately Following Transurethral Resection is Well Tolerated in Phase 2b Bladder Cancer Study
IRVINE, Calif., April 19, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today announced results of a Phase 2b study of EOquin, in non-invasive bladder cancer and the presentation of preclinical data of SPI (IRL)-1620 and satraplatin at the annual meeting of the American Association of Cancer Research, held at the Los Angeles Convention Center in Los Angeles, California April 14-18, 2007.
Abstract #LB-359 -- Effect on Wound Healing and Pharmacokinetics of Single Intravesical Administration of Apaziquone (EOquin(R)) Immediately Following Transurethral Resection of Superficial Bladder Cancer -- Initial Results of a Phase 2b Study
The Phase 2b study was a multicenter, single-arm, open-label safety study with the objective of assessing the effect on surgical wound healing and systemic absorption of EOquin when given intravesically as a single dose immediately after transurethral resection of bladder tumor (TUR-BT). EOquin in 40mL of instillate was instilled into the bladder within 6 hours of TUR-BT. After an hour, the bladder was drained and patients were assessed for adverse events during the one-hour retention. Wound healing was assessed by cystoscopy performed at postoperative day 85.
A total of 23 patients were enrolled and 20 patients received EOquin immediately following TUR-BT. EOquin instillation and retention were well tolerated by all patients, and no deaths or dropouts were reported. Four Serious Adverse Events were reported in three patients: two hematuria, one bacterial cystitis, and one urinary retention. Ten patients were examined by cystoscopy at day 85 and all showed complete reepithelialization without evidence of impaired wound healing. Neither the parent drug (EO9) nor its metabolite (EO54a) was detected in plasma samples utilizing an extremely sensitive assay method.
It was concluded that a single, intravesical dose of EOquin was well tolerated, and was not systemically absorbed when administered to patients immediately following TUR-BT for noninvasive bladder cancer. Based on the results of this Phase 2b study as well as a previously conducted Phase 1 study, a larger, Phase 3 trial of EOquin in non-invasive bladder cancer is being initiated.
Abstract #5434 -- Synergistic Interaction between the Oral Platinum Analog Satraplatin and Erlotinib
In preclinical studies, satraplatin was active in a number of various tumor models and in cells resistant to cisplatin, carboplatin and oxaliplatin. Erlotinib (Tarceva(R)) is a potent inhibitor of the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Since upregulation of the Erk and p38 pathways, which are downstream of EGFR, may play a role in the resistance to platinum analogs, the evaluation of whether inhibition of this pathway by erlotinib would enhance the sensitivity of non-small cell lung (A549, SW1573), colon (Lovo, WiDr) and ovarian (A2780, 2008) cancer cell lines to satraplatin was examined.
Satraplatin is synergistic with erlotinib, which may be related to changes in signaling, especially the p-Erk pathway. A randomized Phase 2 trial is currently investigating the clinical benefit of satraplatin and erlotinib, administered in a sequential schedule, for elderly patients with advanced non- small cell lung cancer (NSCLC).
Abstract #3118 -- SPI (IRL) -1620 Increases the Efficacy of Radiation Treatment in Mice Bearing Lymphoma Cell Induced Tumors
SPI (IRL)-1620 is a selective ETB receptor agonist that has been demonstrated in preclinical studies to selectively enhance tumor blood flow and potentiate the efficacy of chemotherapeutics in various tumor models. Improved transient blood flow to the tumor is associated with a net increase in tumor oxygenation, which may be exploited to increase the effectiveness of radiotherapy. The study was conducted to determine whether administration of SPI (IRL)-1620 prior to radiation enhances the efficacy of radiotherapy.
SPI (IRL)-1620 was administered in doses ranging from 1 to 9 nmol/kg via tail vein 15 minutes prior to radiation administration. Tumor diameter was measured twice a week for a total of 70 days.
Control animals showed a progressive increase in tumor volume and all animals died by 53 days after tumor induction. As expected, no significant response to SPI (IRL)-1620 or to radiation therapy alone was seen. Animals treated with SPI-1620 followed by radiation experienced significantly reduced tumor volume and there was a significant increase in life span. This effect was dose proportional, with best effect seen at the higher dose.
Researchers concluded that SPI (IRL)-1620 significantly enhanced the efficacy of radiation treatment in mice.
Abstract #4058 -- ETB Receptor Agonist, SPI (IRL)-1620, Enhances the Efficacy of Cyclophosphamide and Cisplatin in Ovarian Tumor Bearing Mice
Ovarian cancer represents the most malignant carcinoma of the female genital tract and is often diagnosed only after the disease has reached the advanced stage. Currently, primary therapy includes surgery followed by chemotherapy. In preclinical studies, SPI (IRL)-1620 has demonstrated an enhanced efficacy of anti-neoplastic agents in breast and prostate tumor bearing rats. The present study was conducted to evaluate the effect of SPI (IRL)-1620 on the efficacy of cyclophosphamide and cisplatin in ovarian tumor bearing athymic (nu+/nu+) mice.
Tumor volume of saline or SPI (IRL)-1620 alone treated mice increased at a similar rate, while cyclophosphamide and cisplatin produced reduction in tumor volume. However, SPI (IRL)-1620 administration prior to cyclophosphamide and cisplatin significantly enhanced the reduction in tumor volume produced by cyclophosphamide and cisplatin. There was a 130 percent, 65 percent and 70 percent decrease in the tumor volume of animals administered with SPI (IRL)-1620 plus cyclophosphamide as compared to cyclophosphamide alone on day 10, 16 and 22, respectively. Similarly, the reduction in tumor volume in SPI (IRL)-1620 plus cisplatin treated animals was 31 percent, 68 percent and 80 percent greater on day 10, 16 and 22, respectively compared to cisplatin alone treated animals.
In conclusion, SPI (IRL)-1620 significantly enhanced the efficacy of cyclophosphamide and cisplatin in a preclinical model of ovarian tumor in mice.
EOquin (apaziquone for intravesical instillation) is a drug currently being developed for the treatment of non-invasive bladder cancer, which is a cancer that has invaded the inner most lining of the bladder. EOquin, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. In a Phase 2 pilot study for which patient accrual was completed this year, EOquin instilled into the bladder following TUR-BT was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, would carry a low risk of harming the rest of the body.
Spectrum Pharmaceuticals completed a multi-center, Phase 2 clinical trial in Europe. The results of the trial showed that EOquin was well-tolerated and produced 67% CRs (complete responses) in patients, many of whom had been treated multiple times. EOquin received a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) for non-invasive bladder cancer and the Company expects to begin enrollment of the first patients in the Phase 3 trial this quarter.
Satraplatin, a fourth-generation, oral investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum- based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an oral compound and is given as capsules that patients can take at home.
In addition to HRPC, satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.
In 2002, Spectrum licensed the global rights to GPC Biotech . GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin. GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories. Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC.
Satraplatin is a novel platinum analog with good oral bioavailability. A New Drug Application (NDA) for its initial indication, advanced hormone refractory prostate cancer, has recently been accepted by the FDA and given priority review status, with a date of August 15, 2007 for a decision regarding the approval of the NDA.
SPI-1620 is an endothelin B agonist that stimulates receptors on endothelial cells, the innermost layer of cells lining the blood vessels, to selectively dilate blood vessels in the tumor, resulting in a transient increase in blood flow and a consequent increase in the delivery of anti- cancer drugs to the tumor, as shown in animal studies to date. Tumors get their blood supply from blood vessels that are different from normal blood vessels and lack the surrounding smooth muscle cells -and associated innervations - found in the blood vessels of healthy tissues. Thus, this technology could increase blood flow in tumors, allowing the delivery of cytotoxic agents more selectively to those tumors. Spectrum has proprietary worldwide rights to SPI-1620. SPI-1620 is expected to enter clinical trials later this year.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is opportunistically acquiring and advancing a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum's expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit our website at www.spectrumpharm.com.
Forward-looking statement -- This press release may contain forward- looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, our team's ability to identify promising drugs and move these drugs through development and toward commercialization, the safety and efficacy of EOquin, satraplatin, and SPI- 1620, the initiation of and enrollment of patients in a Phase 3 trial of EOquin in non-invasive bladder cancer, that trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned, that SPI-1620 is expected to enter clinical trials later this year and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
COMPANY CONTACTS MEDIA CONTACT Russell Skibsted Susan Neath SVP & Chief Business Officer Porter Novelli Life Sciences 619-849-6007 Paul Arndt Manager, Investor Relations 949-788-6700
CONTACT: Russell Skibsted, SVP & Chief Business Officer, or Paul ArndtManager, Investor Relations, both of Spectrum Pharmaceuticals, Inc.,+1-949-788-6700; or Media Contact, Susan Neath of Porter Novelli LifeSciences, +1-619-849-6007, for Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
Ticker Symbol: (NASDAQ-NMS:SPPI),(NASDAQ-NMS:GPCB)
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Posted: April 2007