- In Patients With BPH, Clinical Benefit After Ozarelix Was Maintained For
Up To Six Months - Pivotal Trials Expected To Commence Before Year End Or Soon Thereafter
IRVINE, Calif., Sept. 5 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI) today presented updated Phase 2 safety and efficacy data for ozarelix, the Company's drug candidate for the treatment of benign prostatic hypertrophy (BPH), at the 29th Congress of the Societe Internationale d'Urologie in Paris, France.
"The results of this Phase 2 study demonstrate that the effects of a single dosing regimen consisting of two injections on day one and fifteen are maintained for up to six months, which is superior to what is usually seen with currently approved drugs for BPH," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "A second 78-patient U.S. Phase 2b study, in which duration of follow-up is 9 months, completed enrollment in May. We look to the Phase 2b data to verify and expand on the experience from the Phase 2 study presented today. We continue to believe that ozarelix could help serve the large unmet medical need for more effective BPH treatments."
The efficacy and safety of ozarelix, a GnRH antagonist, given intramuscularly (IM) was assessed in men with moderate to severe Lower Urinary Tract Symptoms (LUTS) due to BPH in a randomized, double-blind, placebo- controlled, multi-center, Phase 2 dose-ranging study.
Eligible patients entered a 4-week, single blind, placebo run-in to establish baseline IPSS and urine-flow values. Patients (N=144) meeting the inclusion criteria were randomly allocated and received an IM injection on Day1 and Day 15 in one of five dose groups:
Group 1: placebo, + placebo
Group 2: 5mg ozarelix + 5mg ozarelix;
Group 3: 10mg ozarelix +10mg ozarelix;
Group 4: 15mg ozarelix + 15mg ozarelix; and,
Group 5: 20mg ozarelix + placebo.
Study participants were followed for six months. The primary efficacy endpoint was a change in the International Prostate Symposium Score (IPSS) at 12 weeks compared to baseline. Secondary efficacy endpoints included changes in IPSS Quality of Life (QoL), IPSS improvement by > 30% and > 40%, uroflow values (Qmax), PVR and prostate volume at time points up to 28 weeks. Safety analysis included changes in erectile function (IIEF-5), treatment emergent AEs, lab values (including testosterone, PSA) and vital signs. Mean age was 69.1 (range 52 - 85), IPSS 19.8, Qmax 9.7 mL/sec and prostate size (cm cubed) 41.6 at baseline.
Compared to baseline, ozarelix significantly improved scores for IPSS, IPSS > 30% change and Qmax, at 12 and 28 weeks versus placebo. Testosterone levels declined transiently, but returned to baseline in all groups by 6 weeks. No impact on erectile function was observed; IIEF-5 scores remained unchanged from baseline for all treatment groups at all timepoints.
Ozarelix was well tolerated and maintained statistically significant and clinically meaningful efficacy in the treatment of LUTS secondary to BPH for six months following dosing. Serious Adverse Events were reported in 4 patients but were not considered treatment related. No systemic allergic reactions were seen, and the injections were well tolerated.
About Ozarelix and Development Alliance with AEterna Zentaris
Ozarelix is a fourth generation Luteinizing Hormone Releasing Hormone (LHRH) antagonist administered as an intramuscular injection. In August 2004, Spectrum received an exclusive license from AEterna Zentaris to develop and market ozarelix for all potential indications in North America (including Canada and Mexico) and India.
In addition, Spectrum will receive 50 percent of any upfront and milestone payments, royalties and/or profits from sales of the product in Japan. Japanese rights for all potential oncology indications have recently been licensed to Nippon Kayaku, a key player in the Japanese oncology market.
Spectrum is developing ozarelix for benign prostatic hypertrophy (BPH), hormone-dependent prostate cancer and other indications.
About Benign Prostatic Hypertrophy
Benign prostatic hypertrophy is a non-cancerous enlargement of the prostate frequently occurring in men over the age of 50. According to the National Institutes of Health, BPH affects more than 50% of men over the age of 60 and as many as 90% of men over the age of 70 and it is estimated that there are currently more than 28 million men suffering from BPH in the United States.
The IPSS (also known as AUA symptom index) is a standardized scoring system that evaluates the seven principal symptoms of BPH. The enlargement can result in the gradual squeezing of the urethra, resulting in increased frequency or difficulty in urinating. Treatment options for BPH include surgery and medications to reduce the amount of tissue and increase the flow of urine. Current treatment options have limited efficacy, leading to inadequate compliance. Medications currently available belong to two classes: alpha blockers (such as FLOMAX(R), CARDURA(R) and HYTRIN(R)) which relax the muscles in the neck of the bladder and in the prostate, but have no direct effect on the prostate growth itself, and alpha reductase inhibitors (such as PROSCAR(R) and AVODART(R)), which can result in some reduction of the prostate size but have a very slow onset of action, and may be associated with impotence and decreased libido.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. 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 http://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, that pivotal trials are expected to commence before year end or soon thereafter, the safety and efficacy of ozarelix, that we continue to believe that ozarelix could help serve the large unmet medical need for more effective BPH treatments 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.
 FLOMAX is a registered trademark of Boehringer Ingelheim
 CARDURA is a registered trademark of Pfizer, Inc.
 HYTRIN is a registered trademark of Abbott Laboratories
 PROSCAR is a registered trademark of MERCK & CO., Inc.
 AVODART is a registered trademark of GlaxoSmithKline
COMPANY CONTACTS MEDIA CONTACT
Russell Skibsted Susan Neath
SVP & Chief Business Officer Porter Novelli Life Sciences
Manager, Investor Relations
|SOURCE Spectrum Pharmaceuticals, Inc.|
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