Clinical Research

In 2014, there will be an estimated 22,240 new cases of ovarian cancer in the United States and over 40,000 new cases in the European Union. Ovarian cancer is one of the most lethal gynecologic cancers. Women with recurrent or persistent ovarian cancer recur within 6-12 months of completion with a platinum-containing regimen and there remains a high unmet need for improved treatment options.
Enrollment in a randomized Phase II clinical trial of Pracinostat in combination with azacitidine in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome (MDS) has been completed. The multi-center, placebo-controlled, double-blind study enrolled a total of 108 patients with a one-to-one randomization.

The Company plans to unblind the study approximately six months after the last patient was enrolled and report topline data in Q1 2015.

A newly developed antifungal named isavuconazole is as effective as voriconazole against invasive mold disease in cancer patients with less adverse effects, according to phase 3 clinical data.

A simple solution to a persistent problem. Credit: Ashok A. Kumar

By Ashok A. Kumar, Harvard University

Every year, 300,000 children are born with sickle-cell disease, primarily in Africa and India.

It is a genetic disorder that causes some blood cells to become abnormally shaped. The result is that those who suffer from it have a shorter lifespan.

 Reperfusion injury prevention isn't possible just yet. The administration of an experimental agent known as TRO40303 to patients who have had a heart attack, with the hope of preventing tissue damage when impaired blood flow is corrected (reperfusion), was disappointingly ineffective, according to results of a European study of patients with acute ST-elevation myocardial infarction (STEMI) presented today at ESC Congress 2014 and published in the European Heart Journal.

Oxidized lipids are known to play a key role in inflaming blood vessels and hardening arteries, which causes diseases like atherosclerosis. A new study at UCLA demonstrates that they may also contribute to pulmonary hypertension, a serious lung disease that narrows the small blood vessels in the lungs.

Using a rodent model, the researchers showed that a peptide mimicking part of the main protein in high-density lipoprotein (HDL), the so-called "good" cholesterol, may help reduce the production of oxidized lipids in pulmonary hypertension. They also found that reducing the amount of oxidized lipids improved the rodents' heart and lung function.

An investigational drug known as APT102 significantly reduced damage to heart muscle from a heart attack and minimized the risk of bleeding during follow-up treatments, according to an animal study based on a decade of work by APT Therapeutics, scientists at Washington University School of Medicine in St. Louis and colleagues at Cornell and Harvard.

Standard heart attack treatment often causes heart tissue damage. Once the blood clot that causes a heart attack is removed from an artery, molecules from dead and dying cells mix with blood rushing back through the artery. One of these molecules, adenosine triphosphate (ATP), is inflammatory; another, adenosine diphosphate (ADP), causes more clotting.

Amyotrophic lateral sclerosis (Lou Gehrig's disease) is in the popular media because celebrities are dumping buckets of ice on their heads to raise awareness. Researchers probably wish they would donate money to research rather than raising awareness and hoping someone else donates money rather than dumping water on their heads too, but all medical outreach is good medical outreach.

Researchers at Mayo Clinic and The Scripps Research Institute in Florida have done something a little more practical; they developed a new therapeutic strategy to combat the most common genetic risk factor for ALS and frontotemporal dementia

Generex Biotechnology Corporation has announced publication of a follow-up study from a Phase I clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer. The study demonstrates an association between a specific immune response generated by AE37 and improved overall survival.  

A prior study showed that AE37-immunized patients had better overall and disease-free survival as a group than would be expected from their disease status and the current study shows that patients with the strongest immunological response did the best. In particular, both the presence of AE37-induced T cells in peripheral blood as well as a robust delayed type hypersensitivity (DTH) response elicited by AE37 correlated significantly with overall survival.