THE WOODLANDS, TX, USA I May 13, 2014 I Opexa Therapeutics, Inc. (OPXA), a biotechnology company developing Tcelna® (imilecleucel-T), a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today reported it has reached the targeted enrollment in its Phase IIb clinical trial in Secondary Progressive Multiple Sclerosis. As of today, 180 patients with Secondary Progressive MS have been randomized in the Phase IIb “Abili-T” clinical study of Tcelna. The Company will also allow patients who are currently in the screening process at the time of full enrollment and who meet the trial’s entry criteria to also be enrolled in the trial.
“Interest from physicians and patients to participate in the study was high, underscoring the need for innovative treatments for Secondary Progressive MS, an area of high unmet medical need,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “This is an important milestone for Opexa as we continue to work towards developing patient-specific immunotherapies for the treatment of Multiple Sclerosis.”
Mr. Warma credited the outstanding support of the clinical trial sites across the United States and Canada for helping the Company achieve its targeted enrollment. Even though the Company has reached the full 180-patient enrollment it sought for the Abili-T trial, the Company will continue to support those patients currently in the screening process. This likely means that the Abili-T trial will complete enrollment with a modest number of patients in excess of the 180 targeted as the Company believes it is important to support patients that had already started the enrollment process.
Edward Fox, M.D., Ph.D., one of the enrolling neurologists in the Abili-T trial, noted that there are few treatment options for patients with Secondary Progressive MS. “Achieving this significant milestone provides hope for this group and all individuals with MS.”
The Abili-T trial is a Phase IIb study of Tcelna in patients with Secondary Progressive MS in 35 leading clinical sites in the U.S. and Canada. Each patient is receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Top line data is expected in mid-2016. Opexa has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Tcelna in Secondary Progressive Multiple Sclerosis. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, as well as fill an unmet medical need and get important new drugs to patients earlier.
In February 2013, Opexa entered into an option and license agreement for Tcelna with Merck Serono, one of the leading multinational companies focused on the treatment of MS. Merck Serono’s option is exercisable prior to or upon completion of the Abili-T trial. Under the agreement, Opexa could be eligible to receive up to $220 million in milestone payments, as well as 8 to 15 percent in royalties.
Mr. Warma will discuss the Abili-T trial progress during Opexa’s Q1 earnings call on Wednesday, May 14th at 5:00 P.M. EDT. To listen to the conference call, dial in approximately ten minutes before the scheduled 5:00 P.M. time to (253) 237-1170 or toll free at (877) 372-0867. Please reference conference ID 44945084 or the Opexa Therapeutics Earnings Call.
A live webcast of the call can also be accessed here or via the webcast link on the Investor Relations page of Opexa’s website (www.opexatherapeutics.com).
About Opexa
Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning the interests of patients, employees and shareholders. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive MS. Tcelna is derived from T-cells isolated from a patient’s peripheral blood, expanded ex vivo, and reintroduced into the patient via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin.
About Multiple Sclerosis (MS)
MS is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide.
While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. The Secondary Progressive form of MS represents about a third of the MS patient population.
About Tcelna
Tcelna® is a potential personalized therapy that is under development to be specifically tailored to each patient’s disease profile. Tcelna is manufactured using ImmPath®, Opexa’s proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.
Opexa is currently conducting a Phase IIb study of Tcelna. Named “Abili-T,” the trial is a randomized, double-blind, placebo-controlled clinical study in patients who demonstrate evidence of disease progression with or without associated relapses. The trial is being conducted at approximately 35 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS, including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate and changes in disability as measured by EDSS and the MS Functional Composite.
SOURCE: Opexa
Post Views: 222
THE WOODLANDS, TX, USA I May 13, 2014 I Opexa Therapeutics, Inc. (OPXA), a biotechnology company developing Tcelna® (imilecleucel-T), a novel T-cell immunotherapy for the treatment of multiple sclerosis (MS), today reported it has reached the targeted enrollment in its Phase IIb clinical trial in Secondary Progressive Multiple Sclerosis. As of today, 180 patients with Secondary Progressive MS have been randomized in the Phase IIb “Abili-T” clinical study of Tcelna. The Company will also allow patients who are currently in the screening process at the time of full enrollment and who meet the trial’s entry criteria to also be enrolled in the trial.
“Interest from physicians and patients to participate in the study was high, underscoring the need for innovative treatments for Secondary Progressive MS, an area of high unmet medical need,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “This is an important milestone for Opexa as we continue to work towards developing patient-specific immunotherapies for the treatment of Multiple Sclerosis.”
Mr. Warma credited the outstanding support of the clinical trial sites across the United States and Canada for helping the Company achieve its targeted enrollment. Even though the Company has reached the full 180-patient enrollment it sought for the Abili-T trial, the Company will continue to support those patients currently in the screening process. This likely means that the Abili-T trial will complete enrollment with a modest number of patients in excess of the 180 targeted as the Company believes it is important to support patients that had already started the enrollment process.
Edward Fox, M.D., Ph.D., one of the enrolling neurologists in the Abili-T trial, noted that there are few treatment options for patients with Secondary Progressive MS. “Achieving this significant milestone provides hope for this group and all individuals with MS.”
The Abili-T trial is a Phase IIb study of Tcelna in patients with Secondary Progressive MS in 35 leading clinical sites in the U.S. and Canada. Each patient is receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Top line data is expected in mid-2016. Opexa has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Tcelna in Secondary Progressive Multiple Sclerosis. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, as well as fill an unmet medical need and get important new drugs to patients earlier.
In February 2013, Opexa entered into an option and license agreement for Tcelna with Merck Serono, one of the leading multinational companies focused on the treatment of MS. Merck Serono’s option is exercisable prior to or upon completion of the Abili-T trial. Under the agreement, Opexa could be eligible to receive up to $220 million in milestone payments, as well as 8 to 15 percent in royalties.
Mr. Warma will discuss the Abili-T trial progress during Opexa’s Q1 earnings call on Wednesday, May 14th at 5:00 P.M. EDT. To listen to the conference call, dial in approximately ten minutes before the scheduled 5:00 P.M. time to (253) 237-1170 or toll free at (877) 372-0867. Please reference conference ID 44945084 or the Opexa Therapeutics Earnings Call.
A live webcast of the call can also be accessed here or via the webcast link on the Investor Relations page of Opexa’s website (www.opexatherapeutics.com).
About Opexa
Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning the interests of patients, employees and shareholders. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive MS. Tcelna is derived from T-cells isolated from a patient’s peripheral blood, expanded ex vivo, and reintroduced into the patient via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin.
About Multiple Sclerosis (MS)
MS is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide.
While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. The Secondary Progressive form of MS represents about a third of the MS patient population.
About Tcelna
Tcelna® is a potential personalized therapy that is under development to be specifically tailored to each patient’s disease profile. Tcelna is manufactured using ImmPath®, Opexa’s proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.
Opexa is currently conducting a Phase IIb study of Tcelna. Named “Abili-T,” the trial is a randomized, double-blind, placebo-controlled clinical study in patients who demonstrate evidence of disease progression with or without associated relapses. The trial is being conducted at approximately 35 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS, including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate and changes in disability as measured by EDSS and the MS Functional Composite.
SOURCE: Opexa
Post Views: 222
