WALTHAM, Mass., April 29, 2016 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a biopharmaceutical company developing an investigational new drug, octreotide capsules, for the maintenance treatment of acromegaly, today announced that the company will take part in the Acromegaly Community Conference, which is being held from April 29-May 1, 2016 in Chicago.
Hosted by the Acromegaly Community, a non-profit patient advocacy organization with nearly 1,500 members worldwide, this biennial event is intended to empower those with acromegaly and their loved ones by providing information about how to treat and cope with this rare disease. Chiasma will have exhibits at the conference, which takes place at the Sheraton Chicago O’Hare Hotel.
“Chiasma is proud to support the Acromegaly Community and participate in this unique forum for patients and their families,” said Mark Leuchtenberger, president and chief executive officer of Chiasma, who will be in attendance at the event. “We continue to focus on developing an oral treatment option for those who are afflicted with this rare and chronic condition and who are dissatisfied with today’s standard of care.”
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone (GH), ultimately leading to significant health problems and early death if untreated. There are an estimated 69,000 individuals with acromegaly worldwide. In 13 studies of acromegaly prevalence since 1980, an average of approximately 75 cases per million was determined, suggesting roughly 24,000 individuals with acromegaly in the United States, of which an estimated 8,000 are treated chronically with somatostatin analog injections. Because symptoms often develop slowly, diagnosis may be delayed by years or decades, making it difficult to determine the total number of people with the disease.
Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease.
Current treatment options include surgery to remove the pituitary tumor, radiation therapy to destroy any lingering tumor cells, and/or medical treatment in cases where these approaches are not possible or fully effective. Today's medical treatments include dopamine agonists, GH antagonists, and injectable somatostatin analogs, which are the current standard of care.
Chiasma is dedicated to improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently only available as injections. The company is conducting a Phase 3 clinical trial of its initial product candidate, Mycapssa™ (octreotide) capsules for the maintenance treatment of adult acromegaly patients, to support a planned submission of a Marketing Authorization Application to the European Medicines Agency. Chiasma received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on April 15, 2016 regarding its New Drug Application (NDA) for Mycapssa in the U.S. and intends to seek a meeting with the FDA to discuss the path forward. Chiasma is headquartered in the United States with a wholly owned subsidiary in Israel. Mycapssa and TPE are trademarks of Chiasma.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s participation in the Acromegaly Community Conference and statements regarding the company’s plans to meet with the FDA to discuss the Mycapssa NDA CRL. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the regulatory review process generally; risks associated with Chiasma’s Phase 3 clinical trial to support regulatory approval of Mycapssa in the E.U.; risks associated with Chiasma potentially conducting an additional randomized, double-blind and controlled Phase 3 clinical trial of Mycapssa in accordance with the FDA’s recommendation in the CRL, including risks related to the timing and associated expenses of any potential trial, to support regulatory approval of Mycapssa in the United States; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Chiasma’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk that octreotide capsules, if approved, will not be successfully commercialized; the risk of competition from currently approved therapies and from other companies developing products for similar uses; risk associated with Chiasma’s ability to manage operating expenses and/or obtain additional funding to support its business activities; and risks associated with Chiasma’s dependence on third parties. For additional discussion of certain of these and other risks and uncertainties, and other important factors, any of which could cause Chiasma’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Chiasma’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission on March 17, 2016. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.