• Aastrom Biosciences Inc., of Ann Arbor, Mich., disclosed results from two studies involving ixmyelocel-t, the company’s lead product candidate, published in Stem Cell Research & Therapy. Results from the first showed that ixmyelocel-t contains M2-like macrophages characterized by expression of multiple, well-known M2 macrophage markers, decreased secretion of pro-inflammatory cytokines after inflammatory stimuli, and efficient removal of apoptotic cells. The population of macrophages generated in ixmyelocel-t is believed to play a role in tissue repair and regeneration. In the second study, ixmyelocel-t was treated with modified low-density lipoprotein (LDL) similar to that found in atherosclerotic plaques. The amounts of LDL uptake and expression of cytokines and key cholesterol transport genes were then measured in an attempt to mimic the pro-inflammatory environment in atherosclerotic lesions. The results of the analyses showed that ixmyelocel-t macrophages are able to influx modified cholesterol, remain anti-inflammatory in the face of lipid loading and inflammatory challenge, and display enhanced cholesterol efflux capabilities.

• Acadia Pharmaceuticals Inc., of San Diego, published data from a pivotal Phase III study of pimavanserin in Parkinson’s disease psychosis showing significant and clinically meaningful benefits in The Lancet. The drug significantly reduced psychosis and maintained motor control in patients with Parkinson’s disease. Benefits were also seen in nighttime sleep, daytime wakefulness and caregiver burden. Pimavanserin was also well tolerated with no significant safety concerns or impairment in motor function.

• Cevec Pharmaceuticals GmbH, of Cologne, Germany, said a Dutch consortium led by TNO and including biopharma firm Alloksys Life Sciences BV, of Utrecht, the Netherlands, reported the safe completion of a Phase I study of recombinant human alkaline phosphatase (hRESCAP) derived from Cevec’s CAP cells, immortalized suspension cells for stable protein production. The dose-escalating study tested the safety and pharmacokinetics of parenterally delivered hRESCAP in healthy volunteers.

• Five Prime Therapeutics Inc., of South San Francisco, said it completed dosing of the first cohort of healthy volunteers in its Phase I study of FPA008, a monoclonal antibody designed to inhibit colony-stimulating factor-1 receptor aimed at treating inflammatory diseases such as rheumatoid arthritis (RA). The three-part study will enroll both healthy subjects and patients with active RA, with the primary endpoint measuring safety and secondary endpoints evaluating pharmacokinetics and pharmacodynamics. Preliminary healthy volunteer data from the first two parts of the three-part study are expected by the end of 2014.

• Prima Biomed Ltd., of Sydney, Australia, provided an update on the Can-003 Phase II study evaluating the effects of Cvac cancer vaccine, as compared to an observation-only control arm, in epithelial ovarian cancer patients in complete remission after first or second line treatment. The company will continue monitoring patients from the trial for overall survival data. It is expected that the data will be mature enough for evaluation by approximately the end of calendar year 2014. Further detailed analysis of immune monitoring is ongoing. To date, the intracellular cytokine staining data indicate that Cvac increases T-cell activity directed at mucin 1.

Zalicus Inc., of Cambridge, Mass., said that in a Phase Ib study of pain candidate Z944, the drug showed statistically significant and meaningful reductions at each of three doses compared to placebo in inflammatory and neuropathic pain. In the double-blind, placebo-controlled, randomized crossover study, 16 healthy volunteers were exposed to UV light to induce hypersensitivity to laser thermal stimulation to simulate inflammatory pain, and topical capsaicin as a model of neuropathic pain. Electroencephalography was used to quantify electrical voltage fluctuations evoked by laser thermal stimulation.