Neratinib Graduates from I-SPY 2 TRIAL
LOS ANGELES, Calif., Dec. 4, 2013 – (CRWE Press Release) – Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, today announced top line results from the Phase II clinical trial of Puma’s investigational drug PB272 (neratinib) for the neoadjuvant treatment of breast cancer (I-SPY 2 TRIAL).
The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) is a randomized Phase II clinical trial for women with newly diagnosed Stage 2 or higher (tumor size at least 2.5 cm) breast cancer that addresses whether adding investigational drugs to standard chemotherapy in the neoadjuvant setting is better than standard chemotherapy. The primary endpoint is pathological complete response (pCR) in the breast and the lymph nodes at the time of surgery. The goal of the trial is to match investigational regimens with patient subsets on the basis of molecular characteristics (referred to as biomarker signatures) that benefit from the regimen.
The I-SPY 2 TRIAL involves an adaptive trial design based on Bayesian predictive probability that a regimen will be shown to be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial. Regimens that have a high Bayesian predictive probability of showing superiority in at least one of 10 predefined signatures graduate from the trial. Regimens are dropped for futility if they show a low predictive probability of showing superiority over standard therapy in all 10 signatures. A maximum total of 120 patients can be assigned to each experimental regimen. A regimen can graduate early and at any time after having 60 patients assigned to it.
The neratinib-containing regimen (neratinib plus paclitaxel followed by doxorubicin and cyclophosphamide) graduated from the I-SPY 2 TRIAL based on having a high probability of success in Phase III with a signature of HER2-positive/HR-negative. In this group, treatment with the neratinib-containing regimen resulted in a higher pCR rate compared to the control arm (standard neoadjuvant chemotherapy: paclitaxel in combination with Herceptin (trastuzumab) followed by doxorubicin and cyclophosphamide). The Bayesian probability of superiority for the neratinib-containing regimen (compared to standard therapy) is 94.7%, which is analogous to a p-value of 0.053. In addition, the Bayesian predictive probability of showing statistical superiority in a 300-patient Phase III randomized trial of paclitaxel plus neratinib versus paclitaxel plus trastuzumab, both followed by doxorubicin/cyclophosphamide, is 78.1%.
There were 115 patients assigned to neratinib in the trial, including 65 patients who were HER2-positive. For the patients in the trial who were HER2-positive (including those who were either hormone receptor-positive or negative), treatment with the neratinib-containing regimen also resulted in a higher pCR rate compared to the control arm. The Bayesian probability of superiority for the neratinib-containing regimen is 95.3%, which is analogous to a p-value of 0.047. In addition, the Bayesian predictive probability of showing statistical superiority in a 300-patient Phase III randomized trial of paclitaxel plus neratinib versus paclitaxel plus trastuzumab is 72.5%. Based on the results from the I-SPY 2 TRIAL, neratinib is now eligible for the upcoming I-SPY 3 Phase III trial.
Full results of the I-SPY 2 TRIAL for PB272 will be presented at a future scientific meeting.
The I-SPY 2 TRIAL is a collaborative effort among academic investigators from approximately 20 major cancer research centers across the country, the U.S. Food and Drug Administration, Quantum Leap Healthcare Collaborative, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. Major supporters include The Safeway Foundation and the Bill Bowes Foundation.
The trial enrolled patients who had a high risk of relapse using up-front tumor profiling (including tumor size, hormone receptor status (HR), HER2 status, and the MammaPrint 70-gene signature test).
“We are very pleased to have neratinib graduate from the I-SPY 2 trial and honored to have been involved with such an innovative trial,” said Alan H. Auerbach, Chief Executive Officer and President. “This represents the first clinical data on neratinib in the neoadjuvant treatment of HER2-positive breast cancer and suggests that the combination of paclitaxel plus neratinib has potent activity for the treatment of HER2-positive breast cancer. We look forward to advancing PB272 forward for the neoadjuvant treatment of HER2-positive breast cancer and look forward to potential future involvement with the I-SPY 3 trial.”
I-SPY 2 Principal Investigators Dr. Laura Esserman, Director of the Carol Franc Buck Breast Care Center and Co-Leader of the Breast Oncology Program at the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, and Dr. Donald Berry, Professor of the Department of Biostatistics at the University of Texas MD Anderson Cancer Center, stated, “We are excited for the opportunity to confirm these promising results in I-SPY 3 in our quest to get better treatments to those women who stand to benefit most.”
The Company will host a conference call to discuss the I-SPY 2 trial results at 2:00 p.m. PST (5:00 p.m. EST) on December 4, 2013.
The conference call may be accessed by dialing 1-877-709-8150 for domestic callers and 1-201-689-8354 for international callers. Please specify to the operator that you would like to join the “Puma Biotechnology I-SPY 2 TRIAL Update Call.” The conference call will also be webcast live and accessible through the Investor Relations section of Puma’s website at http://www.pumabiotechnology.com/ir_events.html and will be archived there for 10 days following the call. Please visit Puma’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive metastatic breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements: This press release contains forward-looking statements, including statements regarding anticipated timing for the commencement and completion of various clinical trials and the announcement of data relative to these trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company’s dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company’s drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company’s products, the Company’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company’s dependence on licensed intellectual property, and the other risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.
Source: Puma Biotechnology, Inc
NEW YORK, Dec. 2, 2013 – (CRWE Press Release) – The Goldman Sachs Group, Inc. (NYSE: GS) today announced that the Federal Reserve did not object to Goldman Sachs’ re-submitted 2013 Capital Plan.
The Goldman Sachs Group, Inc. is a leading global investment banking, securities and investment management firm that provides a wide range of financial services to a substantial and diversified client base that includes corporations, financial institutions, governments and high-net-worth individuals. Founded in 1869, the firm is headquartered in New York and maintains offices in all major financial centers around the world.
The Goldman Sachs Group, Inc.
Source: The Goldman Sachs Group, Inc.
Chairman Howard Jonas Appointed CEO
Newark, NJ – Nov. 29, 2013 – (CRWE Press Release) – Genie Energy Ltd., (NYSE: GNE) a leading independent retail energy provider and a developer of unconventional energy projects, today said that its Board of Directors has appointed Chairman Howard Jonas to assume the additional role of Chief Executive Officer effective January 1, 2014.
Mr. Jonas has served as Genie’s Chairman since it was spun off from IDT Corporation in 2011. Claude Pupkin, Genie’s current CEO, will remain at Genie and continue to serve as President of Genie’s American Shale Oil subsidiary and Senior Vice President of Business Development. Geoff Rochwarger will remain as Genie’s Vice Chairman and CEO of its IDT Energy subsidiary.
“Claude Pupkin deserves tremendous credit for structuring and developing Genie Oil and Gas (GOGAS), preparing and managing Genie Energy through the spin-off from IDT, and for vigorously driving Genie’s overall strategic development,” Howard Jonas said. “He has done an outstanding job.”
“I am very pleased with the progress we have made since becoming a public company just over two years ago,” Mr. Pupkin said. “IDT Energy has become one of the largest independent retail suppliers to residential customers in the Northeast, and Genie Oil and Gas has identified and is pursuing oil and gas exploration and development projects on three continents which hold tremendous promise. I look forward to continuing to contribute to the growth of Genie under Howard’s active leadership.”
“Genie is poised for further growth and expansion, building on the existing strong base,” Mr. Jonas said. “I am tremendously excited by the growth prospects of our retail energy business, and by the technologies and resources that GOGAS is pursuing. The global economy continues to recover, and with it, the need for oil and gas, particularly for transportation fuels. We have within our grasp the potential to help meet this demand with abundant, affordable and secure supplies of fuel. I look forward to taking a more active role in Genie at this stage as we continue to drive these opportunities for the benefit of our stockholders and partners.”
About Genie Energy Ltd.:
Genie Energy Ltd (NYSE: GNE) is comprised of IDT Energy and Genie Oil and Gas (GOGAS). IDT Energy is a leading independent retail energy provider supplying electricity and natural gas to residential and small business customers in the Northeastern United States. GOGAS is a resource and technology development company focused on producing clean and affordable transportation fuels from the world’s abundant kerogen-based oil shales and other oil and gas resources. GOGAS is currently developing oil shale projects in Colorado, Israel and Mongolia, and an oil and gas exploration project in Israel. For more information, visit www.genie.com.
Genie Energy Investor Relations
Bill Ulrey, 973-438-3848
Source: Genie Energy Ltd.
HONOLULU – November 26, 2013 – (CRWE Press Release) – Tickets are now on sale for Hawaiian Airlines` new non-stop service between Honolulu and Beijing, its first Mainland China gateway destination, which launches April 16, 2014, subject to government approval. The new service will offer flights three days weekly.
Travelers in Beijing can book tickets through their favorite travel agent or by calling Hawaiian Airlines` sales office in Beijing at +86-10-8522-7835. For English-speaking travelers, tickets can be purchased through any travel agent or by calling Hawaiian`s Reservations Department toll-free at (800) 367-5320. Tickets can be purchased online at www.HawaiianAirlines.com in the U.S. beginning December 13, 2013 and www.HawaiianAirlines.com.cn in China on December 14, 2013.
“We look forward to offering travelers from Beijing our industry-leading on-board hospitality, which makes the travel experience to the Hawaiian Islands so much more enjoyable,” said Peter Ingram, Hawaiian`s executive vice president and chief commercial officer. “Our customers in Hawai`i and North America will get to enjoy our first Mainland China destination, which is one of the most populous and exciting cities in the world.”
Along with being a vibrant center of politics, culture and arts and education, Beijing is the capital of the People`s Republic of China and home to world-renowned, historical sites including the Forbidden City, the Temple of Heaven and the Great Wall.
Beginning April 16, 2014, subject to government approval, Hawaiian Airlines Flight HA 897 will depart Honolulu International Airport at 12:01 a.m. every Monday, Wednesday, and Friday, cross the international dateline, and land at Beijing Capital International Airport at 5:55 a.m. the following day.
Beginning April 18, 2014, Flight HA 898 will depart Beijing at 1:05 a.m. every Wednesday, Friday and Sunday, cross the international dateline, and arrive in Honolulu at 4:40 p.m. the previous day (Tuesday, Thursday and Saturday).
Hawaiian Airlines customers flying to Beijing from any of its 11 gateway cities in North America can also take advantage of free stopovers in Hawai`i, giving them added flexibility in planning trips.
The new Beijing-Honolulu service will be operated by Hawaiian Airlines` wide-body Airbus A330-200 aircraft, seating 294 passengers. Travelers will enjoy an inflight experience not offered by any other airline. From the moment they board, Hawaiian Airlines` signature Mea Ho`okipa (translation:I am host) onboard service will engage them throughout the flight with its warm and friendly celebration of the culture, people, and Aloha Spirit of the Hawaiian Islands.
The comfort, roominess and amenities of Hawaiian Airlines` A330 aircraft will add to the enjoyment of customers` travel experience on the new route. With high-resolution LCD touch-screen monitors in each seatback, the A330`s state-of-the-art entertainment system lets customers choose from a wide-range of movies, TV programs, music, and video games, while also offering a USB port for the use of their own personal media players. Customers sitting in Business Class will also enjoy iPod compatibility.
Members of HawaiianMiles, Hawaiian Airlines` frequent flyer program, can immediately start earning and redeeming mileage for travel on the new route. New members can enroll for free online at www.HawaiianAirlines.com and take advantage of membership benefits right away.
About Hawaiian Airlines
Hawaiian Airlines has led all U.S. carriers in on-time performance for each of the past nine years (2004-2012) as reported by the U.S. Department of Transportation. Consumer surveys by Condé Nast Traveler, Travel + Leisure and Zagat have all ranked Hawaiian the highest of all domestic airlines serving Hawai`i.
Now in its 84th year of continuous service, Hawaiian is Hawai`i`s biggest and longest-serving airline, as well as the largest provider of passenger air service from its primary visitor markets on the U.S. mainland. Hawaiian offers non-stop service to Hawai`i from more U.S. gateway cities (11) than any other airline, along with service from Japan, South Korea, Taiwan, Australia, Ne w Zealand, American Samoa, and Tahiti. New non-stop service will begin between Honolulu and Beijing, China in April 2014, subject to government approval. Hawaiian also provides approximately 160 jet flights daily between the Hawaiian Islands.
Hawaiian Airlines, Inc. is a subsidiary of Hawaiian Holdings, Inc. (NASDAQ: HA). Additional information is available at HawaiianAirlines.com. Follow updates on Twitter about Hawaiian (@HawaiianAir) and its special fare offers (@HawaiianFares), and become a fan on its Facebook page (Hawaiian Airlines).
Source: Hawaiian Holdings, Inc