Winston-Salem, NC -- (SBWIRE) -- 12/16/2013 -- Coronado Biosciences (NASDAQ: CNDO) $1.78. Announced Thursday after market close that Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine of Yeshiva University and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and Einstein, presented interim data from his pilot study of oral TSO (Trichuris suis ova or CNDO-201) to treat autism at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.
The study is a double-blind, randomized, placebo-controlled, cross-over study and enrolled 10 high-functioning adult autism spectrum disorder patients who were able to give informed consent to participate in the study and who had a history of allergies and/or a family history of immune-inflammatory illness. They were treated for 12 weeks with either TSO or placebo, followed by a 4-week washout phase and then 12 weeks of placebo or TSO. The TSO dosage used in the study was 2,500 ova once every two weeks.
In the first 5 patients that completed the study, there was a statistically significant separation from placebo in favor of TSO on three measures of disease: the Montefiore-Einstein Rigidity Scale (MERS), the Repetitive Behavior Scale-Revised (RBS-R) Sameness Scale, and the Social Responsiveness Scale (SRS)-Repetitive Behaviors Scale. The treatment was well tolerated.
The study is still ongoing and final results are expected in the middle of 2014.
What They Do: Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The company's two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of immune-mediated diseases such as psoriasis, ulcerative colitis and multiple sclerosis, and other diseases such as autism; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML), multiple myeloma and solid tumors.
Merrimack Pharmaceuticals (NASDAQ: MACK) $4.54. Today announced Phase 1 clinical trial results for MM-302, a novel HER2-targeted liposomal doxorubicin for the treatment of advanced HER2-positive breast cancer. Primary objectives for the trial are to assess the safety of MM-302 as a monotherapy and in combination with trastuzumab, as well as to determine the Phase 2 dose for MM-302. Data were presented at the 2013 San Antonio Breast Cancer Symposium, Dec. 10-14, 2013 in San Antonio, Texas.
In this ongoing Phase 1 study, patients treated with MM-302 showed no signs of clinical decline in cardiac function. The most common adverse events were fatigue, nausea and decreased appetite; the rates of these events were consistent across MM-302 as a monotherapy and in combination with trastuzumab. Results from the trial also showed that patients treated with MM-302 as a monotherapy at doses of 30, 40 and 50 mg/m2 had an estimated progression free survival (PFS) of 5.6 months (95% CI: 2.8-10.9 months) and a clinical benefit response rate of 37%. Of note, 5 of 9 patients who had not been previously treated with anthracyclines had a PFS of greater than 9 months.
A Phase 2 study for MM-302 is being planned in patients with HER2-positive breast cancer.
What They Do: Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer.
AcelRx Pharmaceuticals (NASDAQ: ACRX) $7.88. Today announced additional detail from the Phase 2 dose-finding study of ARX-04, an investigational single-dose sublingual sufentanil NanoTab for moderate-to-severe acute pain, for which topline results were reported in April 2013. Patients treated with the 30 mcg dose of sufentanil showed a rapid onset of action with a statistically significant beneficial difference in pain relief (pth Annual PostGraduate Assembly in Anesthesia being held in New York City.
"These additional analyses of data from our Phase 2 study demonstrate a rapid onset of action and a sustained strong analgesic effect for ARX-04 (30 mcg), a non-invasive, healthcare provider-administered analgesic product candidate for the short-term treatment of moderate-to-severe acute pain where intravenous access may not be desirable or readily available," stated Dr. Pamela Palmer, Chief Medical Officer, AcelRx Pharmaceuticals. "These data will be reviewed in our End-of-Phase 2 meeting with the FDA later this month in order to define the Phase 3 development program for ARX-04, which we hope to initiate in the second half of 2014."
What They Do: AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain.
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