Nektar Highlights Innovative New Product Development in the Areas of
Oncology, Anti-Infectives, CNS and Pain Therapies
NEW YORK, Nov. 14 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) showcased its two industry-leading Pulmonary and PEGylation technology platforms and the company's innovative proprietary product pipeline at its R&D Day held today at The Palace Hotel in New York.
"Nektar's R&D Day presentation emphasizes our world-class talent and innovative work in the development of breakthrough biopharmaceuticals that leverage our two technology platforms," said Howard W. Robin, President and Chief Executive Officer of Nektar. "Our ground-breaking work in small molecule PEGylation represent significant value for Nektar and promises to result in great improvements to many drugs."
During the event, Nektar scientists and drug development experts highlighted Nektar's pioneering research in the area of small molecule PEGylation and the company's initial market applications of this innovative technology platform in oncology and central nervous system (CNS) therapeutics.
Company Previews NKTR-102 and NKTR-118 Phase 2 Trial Designs
Nektar also previewed its proprietary product clinical development programs, including the Phase 2 clinical trial designs for NKTR-102 (PEG- irinotecan), the company's lead oncolytic candidate under development for the treatment of solid tumors, and NKTR-118 (oral PEG naloxol) for opioid bowel dysfunction.
Nektar Chief Operating Officer and Head of the PEGylation Business Unit, Hoyoung Huh, M.D., Ph.D. said, "Based on positive Phase 1 results with our two lead PEG products that leverage our important research in small molecule PEGylation technology, we plan to advance NKTR-102 and NKTR-118 into Phase 2 development by year-end."
The Phase 2 program for NKTR-102 is designed to evaluate the safety and efficacy of NKTR-102 in combination with standard cetuximab as a second-line colorectal cancer treatment in irinotecan-naive patients as compared to treatment with cetuximab and irinotecan alone. The open label, randomized, double-arm study is planned to be conducted at over 40 centers in the U.S. and the European Union. NKTR-102 is currently in an ongoing Phase 1 trial evaluating this potentially powerful cancer treatment in multiple solid tumor settings.
In the central nervous system (CNS) area, NKTR-118 is being evaluated as an oral therapy to treat opioid-bowel dysfunction (OBD), including opioid- induced constipation, in patients using opioids for management of pain. NKTR- 118 is a peripherally acting opiod receptor antagonist. PEGylation of naloxol was designed to alleviate constipation while reducing it's entrance into the CNS and preserving the central analgesic effect of opioid therapy.
The Phase 2 clinical trial for NKTR-118 will be a double-blind, randomized, dose escalation trial designed to evaluate the safety and efficacy of the product in patients on opioid therapy exhibiting symptoms of OBD, including constipation. The trial will be conducted at approximately 55 centers in North America and the European Union.
New Preclinical Programs Unveiled in Oncology, CNS and Inhaled Antibiotics
Nektar scientists introduced additional small molecule preclinical programs underway at Nektar, including a new PEGylated oncolytic candidate, NKTR-105 (PEG-docetaxel), which was developed using Nektar's innovative small molecule PEGylation technology platform.
Positive early preclinical studies were highlighted for NKTR-105 (PEG- docetaxel). NKTR-105 exhibited significant tumor growth inhibition in mouse xenograft models of human lung, prostate and breast cancer cell lines. In addition, treatment with NKTR-105 in a preclinical model resulted in lower neutropenia as compared to standard docetaxel. NKTR-105 is currently undergoing additional preclinical trials, and if successful, the company plans to advance this product candidate into Phase 1 clinical development in 2008.
NKTR-125 (oral PEG-diphenhydramine) was also unveiled today, a new small molecule PEGylation preclinical development program in the CNS area exploring improved treatment options for allergic rhinitis. NKTR-125 utilizes Nektar's small molecule PEGylation technology and is designed to treat allergy symptoms while preventing unwanted CNS side effects, such as drowsiness.
Nektar's Liquid Pulmonary Technology Platform Showcased
One of the company's most important product candidates, NKTR-061 (inhaled amikacin), which utilizes Nektar's leading liquid pulmonary delivery technology, was reviewed. The development of NKTR-061 for the treatment of Gram-negative pneumonia is taking place in partnership with Bayer Schering Pharma under the agreement announced in August of 2007. NKTR-061 is in Phase 2 clinical trials and is expected to advance into Phase 3 trials in 2008.
Nektar also introduced NKTR-063 (inhaled vancomycin) today, a new inhaled antibiotic product candidate under development that utilizes Nektar's liquid pulmonary delivery platform used in NKTR-061. NKTR-063 (inhaled vancomycin) is in preclinical development for evaluation of the treatment potential for Gram-positive pneumonias.
To Access the Event and Webcast Replay with Slideshow
The event began at 12:00 PM Eastern time and will conclude at approximately 5:00 PM. The presentations and Q&A sessions from today's event will be accessible via a live audio and slideshow Webcast through a link on the Nektar website: http://www.nektar.com/wt/page/rd This Webcast will be available for replay until November 21, 2007.
Nektar Therapeutics is a biopharmaceutical company that develops and enables differentiated therapeutics with its industry-leading PEGylation and pulmonary drug development platforms. Nektar PEGylation and pulmonary technology, expertise, manufacturing capabilities have enabled nine approved products for partners, which include the world's leading pharmaceutical and biotechnology companies. Nektar also develops its own products by applying its PEGylation and pulmonary technology platforms to existing medicines with the objective to enhance performance, such as improving efficacy, safety and compliance.
This press release contains forward-looking statements that reflect the company's current views as to the value, relative competitive position, and application of the company's technology platforms, and statements regarding the progress, potential, and future clinical plans for the company's proprietary product candidates in clinical and preclinical development. These forward-looking statements involve risks and uncertainties, including but not limited to: (i) the company's proprietary product candidates and those of certain of its partners are in the early phases of clinical development and pre-clinical development and the risk of failure is high and can unexpectedly occur at any stage, (ii) the timing or success of the commencement or conclusion of planned clinical trials is subject to a number of uncertainties including but not limited to clinical design, patient enrollment, regulatory requirements and clinical outcomes, (iii) the company's or its partner's success in meeting minimum clinical end points and obtaining regulatory approvals for product candidates, (iv) the company may not successfully complete new collaborative partnerships with respect to its product candidates, or if any partnerships the company does negotiate do not include sufficiently favorable commercial terms, the company may not receive an adequate return on these investments and our results of operations and financial condition would suffer, (v) the company's patent applications for its proprietary or partner product candidates may not issue, patents that have issued may not be enforceable or sufficient to protect against competitive products, or intellectual property licenses from third parties may be required in the future, (vi) the outcome of any existing or future intellectual property or other litigation related to the company's proprietary product candidates, and (vii) potential competition from existing approved products (branded or generic) or product candidates under development by other companies could negatively impact the commercial potential of the company's product candidates due to such competitive factors as efficacy and safety profiles, pricing, and reimbursement by third party payers. Other important risks and uncertainties are detailed in the company's reports and other filings with the Securities and Exchange Commission (SEC), including its most recent Quarterly Report on Form 10-Q filed with the SEC on November 9, 2007. Actual results could differ materially from the forward-looking statements contained in this press release. The company undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise. No information regarding or presented at the company's R&D day either posted on the company's website or presented orally or visually through the Webcast is intended to be incorporated by reference in this press release.
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|SOURCE Nektar Therapeutics|
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