Updated Clinical Studies Continue to Show Promise of OXiGENE's Drug Candidate, CA4P, for the Treatment of Advanced Ovarian Cancer.WALTHAM, Mass. -- OXiGENE, Inc. -- Principal Investigator Provides Interim Update to Clinical Trial; Data Shows Additional Responders in Patients with Advanced Ovarian Cancer-- -- CA4P in Combination with Chemotherapy is Well Tolerated; No Drug-Related Serious Adverse Events or Cardiac Toxicities Observed-- -- Dosing Regimen Established for Phase II Clinical Trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II in Platinum-Resistant Ovarian Cancer-- At the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics--OXiGENE, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : OXGN, XSSE: OXGN), a leading developer of biopharmaceutical compounds to treat cancer and certain ophthalmologic diseases, today announced the presentation of new and positive patient response data from an ongoing Phase Ib clinical trial evaluating OXiGENE's Combretastatin A4P (CA4P) in combination therapy with either carboplatin, paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); or both treatments combined. The data indicate a 67 per cent response rate among a sub-population of evaluable patients with advanced, inoperable inoperable /in·op·er·a·ble/ (in-op´er-ah-b'l) not susceptible to treatment by surgery. in·op·er·a·ble adj. Unsuitable for a surgical procedure. ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast who were treated with a combination of CA4P and chemotherapy, all of whom had failed previous, alternate cancer treatments. OXiGENE believes that the patient response rate observed to date provides an early indication of the potential success of this therapeutic combination as it enters a multi-center, international, Phase II clinical trial. Gordon Rustin, M.D., Director of Medical Oncology at Mount Vernon Cancer Centre in the United Kingdom, presented a paper entitled, A Dose Escalating Study Combining Combretastatin A-4 Phosphate (CA4P) in Combination with Carboplatin or Paclitaxel in Patients with Advanced Cancer, at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics being held in Philadelphia, PA. Dr. Rustin noted in his presentation today that a total of 43 patients have now been enrolled in the trial, and that the trial has entered the final stage in which the triple combination of CA4P/Carboplatin/Taxol is being administered consecutively. Tumor response, as defined according to RECIST RECIST Response Evaluation Criteria in Solid Tumors (oncology review criteria) or CA125, was observed in ten out of 15 evaluable patients with ovarian cancer. Four additional ovarian cancer patients had disease stabilization during treatment, and partial responses were seen in patients with esophageal cancer and small cell lung cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. . "This combination of CA4P with either carboplatin or paclitaxel, or both together, is well tolerated and has shown signs of anti-tumor activity in heavily pre-treated patients," commented Dr. Rustin. "It is important to note that these patients have failed previous rounds of alternate therapies but have now responded to this combination therapy of CA4P and chemotherapy. We are eager to move forward into the next level of clinical development in the recently initiated Phase II trial in platinum resistant ovarian cancer." Dr. Rustin offered an update in his presentation today to the dose and associated side effect profile of CA4P in double and triple combination therapy triple combination therapy AIDS See HAART. , and discussed the recommended dosing level for the previously announced Phase II clinical trial evaluating the effectiveness of CA4P in combination with carboplatin/taxol for the treatment of patients with advanced, platinum-resistant ovarian cancer. Dr. Rustin noted that minimal myelosuppression has been seen at a dose of CA4P at 54 mg/m2 or CA4P at 63 mg/m2 administered 18 - 22 hours prior to carboplatin, paclitaxel or both drugs combined. Significant myelosuppression is a classic side effect of carboplatin/taxol treatment. The double and triple combination therapies have been well tolerated to date, with no drug-related, serious adverse events. The most common side effects observed were headache, fatigue and transient hypertension. No cardiac toxicities were observed. Dr. Rustin continued by reporting that in this dose-escalating study--in which the goal of the study is to determine the maximum tolerable drug dosage (MTD MTD Mounted MTD Maximum Tolerated Dose MTD Memory Technology Device MTD Month To-Date MTD Methadone (drug screening) MTD motion to dismiss (legal) MtD Mountain Dew MTD Memory Technology Driver ) level--dosing levels of CA4P were raised to 72mg/m2. "Dose limiting toxicities (DLT (Digital Linear Tape) A magnetic tape technology originally developed by Digital for its VAX line. The technology was later sold to Quantum, which makes it available to other manufacturers. DLT uses half-inch, single-hub cartridges similar to IBM's 3480/3490/3590 line. ) were achieved at a dose of CA4P at 72mg/m2. These DLTs consisted of one patient who experienced hypertension that was rapidly reversed by sublingual sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue. sub·lin·gual adj. Abbr. SL Below or beneath the tongue; hypoglossal. nitroglycerin nitroglycerin (nī'trōglĭs`ərĭn), C3H5N3O9, colorless, oily, highly explosive liquid. It is the nitric acid triester of glycerol and is more correctly called glycerol trinitrate. , as well as one patient with reversible ataxia ataxia (ətăk`sēə), lack of coordination of the voluntary muscles resulting in irregular movements of the body. Ataxia can be brought on by an injury, infection, or degenerative disease of the central nervous system, e.g. . Therefore, we recommend a Phase II clinical trial dose in platinum resistant ovarian cancer of CA4P at 63mg/m2, combined with 175mg/m2 of paclitaxel and carboplatin at AUC AUC area under curve 5. We believe this dosing protocol minimizes myelosuppression, and we are confident we have optimized the dose for the next phase of this important clinical trial." "The data reported by Dr. Rustin and his team continue to be extremely encouraging," stated Frederick Driscoll, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of OXiGENE. "This patient response data, combined with a positive safety profile observed to date, reinforce the Company's decision to choose platinum-resistant ovarian cancer as a potential registrational pathway. We look forward to an update on that trial in 2006." About Combretastatin A4P (CA4P) CA4P leads a novel class of small molecule drug candidates called vascular disrupting agents (VDAs). CA4P works via two potentially synergistic processes that selectively target pericyte-depleted neovessels, which lack ensheathment from smooth muscle support cells. CA4P is a potent and reversible tubulin tubulin /tu·bu·lin/ (too´bu-lin) the constituent protein of microtubules. tu·bu·lin n. A globular protein that is the structural constituent of microtubules. depolymerizing agent that causes newly formed endothelial cells that line blood vessels to change shape, round up and detach from the vessel wall. Recent preclinical research has also shown that CA4P disrupts the molecular engagement of VE-cadherin, a junction protein important for endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium. Endothelial A layer of cells that lines the inside of certain body cavities, for example, blood vessels. cell survival and function, and inhibits the associated beta-catenin/AKT signaling pathway, leading to rapid vascular collapse and necrosis. These complementary mechanisms block the flow of blood to a tumor and deprive it of oxygen and nutrients essential to its survival. Similarly, in eye diseases that are characterized by abnormal blood vessel growth, CA4P has been shown in preclinical studies to suppress development and induce regression of these unnecessary blood vessels. CA4P is currently being studied in eight clinical trials in oncology, including anaplastic an·a·plas·tic adj. 1. Relating to the surgical restoration of a lost or absent part. 2. Of, relating to, or characterized by cells that have become less differentiated. anaplastic 1. thyroid, lung, head and neck, prostate, colorectal, ovarian, cervical cancers and other imageable tumor types. These clinical trials involve the use of CA4P in both single-agent and combination therapies. It is also currently being studied in a Phase II clinical trial in myopic macular degeneration. About OXiGENE, Inc. OXiGENE is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company's major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving and enhancing medicines to patients. Safe Harbor Statement Certain statements in this news release concerning clinical trials being conducted on OXiGENE's lead VTA VTA Valley Transportation Authority (San Jose, California) VTA Ventral Tegmental Area VTA Vacuum Triode Amplifier VTA VFR Terminal Area VTA Martha's Vineyard Transit Authority (Massachusetts) , CA4P, are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements include, but are not limited to: the timing and results of clinical development of CA4P and positive anti-tumor effects using CA4P in double or triple combination therapy, as well as any statements regarding timing of data or results from Phase II clinical trials. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; the ability to secure necessary patents; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's Form 10-Q, 8-K and 10-K reports. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. |
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