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Amarillo Biosciences, Inc. Announces a Clinical Trial in Patients With Bone Marrow Disorders
AMARILLO, TX -- (MARKET WIRE) -- 03/10/2005 -- Amarillo Biosciences, Inc. (ABI) (OTC BB: AMAR) today announced that a study will commence to test low dose oral interferon alpha in forty patients with rare bone marrow proliferative disorders. The study will be conducted at a major cancer center in Texas with a leading medical authority who specializes in the treatment of these myeloproliferative disorders. Twenty patients, each with either polycythemia vera (PV) or primary thrombocythemia (ET), will be given low dose oral interferon alpha daily as a treatment to relieve the signs and symptoms associated with these disorders.
In 1997-1998, Amarillo Biosciences, in conjunction with a leading Midwestern medical center, conducted a 48-week pilot study in the treatment of PV and ET. Human interferon alpha lozenges were administered once daily to 7 PV and 6 ET patients. Because of the benefits noted in the pilot study, and because so few good treatment alternatives exist, this follow-up study is planned to commence in the second quarter of this year. The principal investigator, after conducting a review of previous studies, has determined that administering the interferon lozenges three times daily should maximize the potential efficacy of the therapy.
PV and ET are stem cell disorders considered to be incurable. Treatment is directed at reducing morbidity and preventing life-threatening complications. The clinical course of both ET and PV are characterized by vasomotor disturbances (headaches, dizziness), acral dysesthesia (impaired sensations in limbs, fingers, ears), erythromelalgia (diffused redness and atrophy of skin on legs), visual symptoms, thrombohemorrahagic (inappropriate clotting) events, and the risk of transformation into acute myeloid leukemia (AML) or fibrosis of the bone marrow (myelofibrosis).
Treatment efforts in ET strive to reduce clotting events in patients at high-risk for thrombosis without increasing the intrinsically low risk of developing leukemia. All patients with PV require phlebotomy (drawing blood), with the goal of reducing hematocrit levels (the concentration of red blood cells). This maneuver prolongs survival by decreasing the risk of thrombosis. The goal of therapy in PV is not only to prevent thrombosis, but also to reduce the risk of transformation into AML or myelofibrosis.
In the previous 1997-1998 study, treatment response in PV patients was based on changes in hematocrit levels and phlebotomy requirement. Four of 7 subjects had a greater than or equal to 50% reduction in phlebotomy requirement, compared to the 6 months prior to the study, and consequently were considered partial responders. Response in the ET subjects was based on changes in platelet count. One of 6 subjects experienced normalization of platelet count (complete response), 3 were unchanged and 2 experienced a progression of disease during interferon alpha lozenge therapy. No deaths or serious adverse events occurred in this study.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc., is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 20.6% of Amarillo Biosciences shares and has provided over $16.5 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including Sjogren's syndrome, Behçet's disease, and opportunistic infections in patients who are HIV positive. In its 20-year history, ABI has invested nearly $37 million to establish oral interferon as a therapeutic agent. The overwhelming majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the ABI web site at http://www.amarbio.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" of the Company's Form 10-KSB for the year ended December 31, 2003.
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Investor Relations:
Philippe Niemetz
WPH Consultants, Ltd.
Tel: 800-477-7570
Tel: 212-344-6464
Fax: 212-618-1276
e-mail: [email protected]
Joseph M. Cummins, DVM, PhD
Amarillo Biosciences, Inc.
Tel: 806-376-1741 x 13
Fax: 806-376-9301
e-mail: [email protected]
SOURCE: Amarillo Biosciences, Inc.
Cephalon, Inc. Announces Acquisition of TRISENOX(R) from Cell Therapeutics, Inc.
Frazer, Pennsylvania (ots/PRNewswire) -
- Transaction Accelerates Cephalon's Entry into Oncology Market
and Builds Platform for its Growing Oncology Franchise
Cephalon, Inc. (Nasdaq: CEPH) announced today that it has signed
an agreement with Cell Therapeutics, Inc. (Nasdaq and Nuovo Mercato: CTIC) and CTI Technologies, Inc., a wholly owned subsidiary of Cell Therapeutics, under which it will acquire all assets related to TRISENOX(R) (arsenic trioxide) injection for approximately US$70 million cash. The agreement provides for future cash payments to CTI, totaling up to US$100 million, upon the achievement of certain label expansions and sales milestones.
Following the acquisition, Cephalon will assume the worldwide
marketing, sales and development of TRISENOX. In 2004, worldwide
sales of TRISENOX were US$26.6 million. Cephalon will offer
employment to CTI sales and commercial personnel now supporting the TRISENOX brand. The acquisition is subject to the approval of
regulatory agencies, and is expected to close in the third quarter of
2005. Cephalon anticipates the transaction will be neutral to its
2005 earnings.
TRISENOX was approved for marketing in the United States and
Europe in 2000 and 2002, respectively, for the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APL), a life-threatening hematologic cancer. In clinical trials, TRISENOX has been shown to provide high complete response rates (70-75 percent) and a high molecular remission rate (82 percent) in patients with relapsed disease. Numerous studies of TRISENOX are being conducted by independent investigators in a variety of hematologic cancers.
"With TRISENOX for APL and its associated commercial
infrastructure, TREANDA(TM) for non-Hodgkin's lymphoma from the
pending acquisition of Salmedix, and the promise of CEP-701 for acute myeloid leukemia, we are building a fully integrated oncology
business," said Frank Baldino, Jr., Ph.D., Chairman and CEO of
Cephalon.
"This acquisition allows us to enter the oncology market with a
foundation of experienced sales and scientific personnel in
oncology," added Robert Roche, Executive Vice President, Worldwide Pharmaceutical Operations. "Cephalon has demonstrated success in focusing commercial and scientific resources to maximize the value of early stage commercial products. We believe we have a similar opportunity to make TRISENOX a mainstay in our growing oncology portfolio."
In connection with the transaction, Cephalon also will re-acquire
rights to its proteasome inhibitors, which are currently in
pre-clinical development under a co-development agreement with CTI. Proteasomes are enzymes that play a role in regulating cell function and growth. The goal of this proteasome inhibitors program is to develop a new and improved therapy for multiple myeloma.
About Acute Promyelocytic leukemia (APL)
APL is one of eight subtypes of acute myeloid or myelogenous
leukemia (AML). According to the American Cancer Society,
approximately 12,000 patients are diagnosed with AML in the United
States every year, 10 to 15 percent of whom will have the APL
subtype. Research indicates that approximately 10 to 30 percent of
patients with APL will not respond to, or will relapse from
first-line therapy.
About TRISENOX
TRISENOX is believed to have multiple mechanisms of action
including, induction of programmed cell death (apoptosis) and damage and degradation of the fusion protein PML/RAR. TRISENOX is indicated for the induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. For details on adverse events associated with TRISENOX, including boxed warning, full prescribing information is available at http://www.trisenox.com.
Cephalon, Inc.
Cephalon currently employs more than 2,200 people in the United
States and Europe. U.S. sites include corporate headquarters in
Frazer, Pennsylvania, and offices, laboratories or manufacturing
facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and
suburban Minneapolis, Minnesota. Cephalon's major European offices
are located in Guildford, England, Martinsried, Germany, and
Maisons-Alfort, France.
The company currently markets three proprietary products in the
United States: PROVIGIL(R) (modafinil) Tablets [C-IV], GABITRIL(R)
(tiagabine hydrochloride), and ACTIQ(R) (oral transmucosal fentanyl
citrate) [C-II], and more than 20 products internationally. Further
information about Cephalon and full prescribing information on its
U.S. products is available at http://www.cephalon.com or by calling
1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements.
Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding the TRISENOX acquisition including the benefits of the acquisition and the Company's ability to build a fully integrated oncology business or to maximize the value of TRISENOX and the timing of the closing of the transaction, anticipated scientific progress on its research programs, development of potential pharmaceutical products, including TREANDA and CEP-701, interpretation of clinical results of TRISENOX, manufacturing development and capabilities, market prospects for its products, yearly and quarterly sales and earnings guidance for 2005, including the impact of the TRISENOX transaction on 2005 guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Web site: http://www.cephalon.com
http://www.trisenox.com
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