Bioaccelerate Holdings Inc. and Symbollon Pharmaceuticals, Inc. Announce the Start of the IoGen-TM- Phase III Clinical Trial.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of & FRAMINGHAM, Mass. -- Bioaccelerate Holdings Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BACLE) and Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) today announced the initiation of patient enrollment in the first multi-center Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA pivotal clinical trial of IoGen(TM), an oral dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. of Symbollon's proprietary iodine technology, in patients with moderate to severe periodic breast pain associated with symptomatic fibrocystic breast disease Noun 1. fibrocystic breast disease - the presence of one or more cysts in a breast cystic breast disease, cystic mastitis, fibrocystic disease of the breast disease - an impairment of health or a condition of abnormal functioning (FBD FBD Fluid(ized) Bed Dryer FBD Fully Buffered DIMM (memory) FBD Free Body Diagram FBD Far Beyond Driven (album) FBD Functional Block Diagram(s) ). The randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled, single-dose study will evaluate the clinical effects of IoGen in about 175 women. Patients will receive one 6.0 mg tablet of IoGen or placebo daily for six months. The primary objective of the study is the evaluation of efficacy of IoGen by comparing the proportion of patients in the treatment and placebo groups that experience a clinically meaningful reduction in breast pain and tenderness. Nodularity (lumpiness caused by excess breast tissue) will be evaluated by physicians and used as a secondary efficacy endpoint. Dr. Jack Kessler, the Chief Scientific Officer of Symbollon, said that "The purpose of this pivotal trial is to establish the effectiveness of IoGen utilizing a protocol agreed to under the special protocol assessment procedures with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . We are encouraged by the broad support of the medical community for this trial and look forward to the successful completion of the study." "This is an important step in the IoGen program," stated Christopher O'Toole, Head of Specialty Pharmaceuticals for Bioaccelerate. "We are excited about the commercial potential for IoGen to treat cyclic breast pain. Establishing the efficacy of the drug in this pivotal trial is one of the last significant steps in the clinical development program." For more information about the study, including a list of the sites participating in the study, visit Symbollon's website at http://www.symbollon.com. About IoGen IoGen is an oral dosage form of Symbollon's technology, which generates molecular iodine in situ In place. When something is "in situ," it is in its original location. in the stomach of the patient. IoGen is entering Phase III clinical trials for the treatment of moderate to severe cylic breast pain and tenderness (mastalgia) associated with fibrocystic breast disease (FBD). FBD is a benign breast condition characterized by lumpiness, breast pain and tenderness. FBD affects approximately 30 to 50% of the women of childbearing age, which represents about 20 to 33 million women in the United States. It has been estimated that moderate to severe mastalgia occurs in approximately 11 to 20% of the women of childbearing age, or about 7 to 13 million women in the United States. Besides causing pain and discomfort, this condition can mimic the appearance of breast cancer on mammograms, leading to false positives. In addition, fibrocystic fibrocystic /fi·bro·cys·tic/ (-sis´tik) characterized by an overgrowth of fibrous tissue and development of cystic spaces, especially in a gland. fi·bro·cys·tic adj. changes can also hide true cancers, and women with fibrocystic breast disease may also have a greater tendency toward breast cancer. The cause of cyclic breast pain is unclear, though higher than normal levels of the hormone levels may be involved. Conventional treatment for cyclic mastalgia involves anti-inflammatory medications and, sometimes, hormonal treatments. About Bioaccelerate Bioaccelerate Holdings Inc. (BACLE.OB) is a pharmaceutical development organization ("PDO PDO Php Data Objects (PHP extension) PDO Protected Designation of Origin (EC) PDO Pacific Decadal Oscillation (weather) PDO Property Damage Only ") that seeks to acquire, develop and commercialize novel pharmaceutical compounds in an efficient, cost-effective way. Bioaccelerate uses its broad network of academic, industry and capital market relationships to expedite drug development and raise capital to create and fund its subsidiary companies, which are organized by vertical portfolios in five therapeutic areas: oncology, specialty pharmaceuticals, central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ), cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and anti-infectives. Bioaccelerate conducts its business directly and through its subsidiaries. The company holds majority equity interests in 10 biopharmaceutical companies, three of which are public, and holds minority interests in four biopharmaceutical companies, two of which are public. The company also holds a minority equity interest in a public nanotechnology company. Bioaccelerate's strategy relies on its development network for research, clinical development and project management to guide early-stage compounds from the discovery process through to Phase II/III development where incremental value can be created. Bioaccelerate Holdings is listed on the Over-The-Counter Bulletin Board under the symbol "BACLE.OB." For more information on Bioaccelerate, visit the company's website at http://www.bioaccelerate.com. Bioaccelerate Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Certain statements contained herein are "forward-looking" statements (as such term is defined in 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). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with pre-clinical and clinical developments in the biopharmaceutical industry in general and in Amilar Pharmaceuticals or Bioaccelerate's compounds under development in particular; the potential failure of Amilar Pharmaceuticals or Bioaccelerate's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Amilar Pharmaceuticals or Bioaccelerate's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Amilar Pharmaceuticals or Bioaccelerate's business, structure or projections; the development of competing products; uncertainties related to Amilar Pharmaceuticals or Bioaccelerate's dependence on third parties and partners; and those risks described in the filings with the SEC, all of which are under Bioaccelerate's prior name Mobile Design Concepts, Inc. Amilar Pharmaceuticals and Bioaccelerate disclaim any obligation to update these forward-looking statements. About Symbollon Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) is a specialty pharmaceutical company focused on the development and commercialization of proprietary drugs based on its molecular iodine technology. Symbollon already has completed Phase I and II clinical trials evaluating IoGen as a potential treatment for moderate to severe cyclic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD). FBD is a condition that affects approximately 20 to 33 million women in the U.S., and there are approximately 7 to 13 million women suffering from clinical cyclic mastalgia. The Company believes IoGen also may be useful in treating and/or preventing endometriosis endometriosis (ĕn'dəmē'trē-ō`sĭs), a condition in which small pieces of the endometrium (the lining of the uterus) migrate to other places in the pelvic area. , ovarian cysts Ovarian Cysts Definition Ovarian cysts are sacs containing fluid or semisolid material that develop in or on the surface of an ovary. Description Ovarian cysts are common and the vast majority are harmless. , and premenopausal pre·me·no·paus·al adj. Of or relating to the years or the stage of life immediately before the onset of menopause. premenopausal adjective breast cancer. For more information about Symbollon, visit the company's website at http://www.symbollon.com. Symbollon Safe Harbor Statement This news release contains statements by the Company that involve risks and uncertainties and may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including, but not limited to, the risks and uncertainties associated with whether (i) future clinical trial results will support the use of IoGen for the treatment of fibrocystic breast disease, (ii) the clinical data acquired from Mimetix Inc. will be acceptable exposure data for IoGen, (iii) Symbollon will be able to obtain the resources necessary to continue as a going concern, (iv) IoGen will successfully complete the regulatory approval process, (v) competitive products will receive regulatory approval, (vi) the Company's ability to enter into new arrangements with corporate partners and (vii) such other factors as may be disclosed from time-to-time in the Company's reports as filed with the Securities and Exchange Commission. |
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