Clinical Research

The idea of using stem cells to treat Type I Diabetes is very promising and could have huge practical impact. Real progress has been achieved toward this goal over the last decade. In perhaps another decade there might be a validated treatment. 

Obesity is a significant risk factor for the development of a number of diseases, but the first that comes to mind is type 2 diabetes. 

Seven Swedish women have had embryos reintroduced after receiving wombs from living donors and now one has delivered a healthy and normally developed boy, reveals the case study in The Lancet.

The uterus transplantation research project at the University of Gothenburg started in 1999 and the goal has been to enable women who were born without a womb or who have lost their wombs in cancer surgery to give birth to their own children.

Nine women in the project have received a womb from live donors – in most cases the recipient's mother but also other family members and close friends. The transplanted uterus was removed in two cases, in one case due to a serious infection and in the other due to blood clots in the transplanted blood vessels.


Investigators have announced discovery of a new molecule, the first of its kind, which allows for the multiplication of stem cells in a unit of cord blood. Umbilical cord blood contains adult stem cells used for transplants aimed at curing a number of blood-related diseases, including leukemia, myeloma and lymphoma.

For many patients this therapy comprises a treatment of last resort. 

Merck is discontinuing the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC).

Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy that is designed to stimulate the body's immune system to identify and target cells expressing the cell-surface glycoprotein MUC1. MUC1 is expressed in many cancers, including NSCLC, and has multiple roles in tumor growth and survival. Tecemotide was being investigated in the Phase III START2, START and INSPIRE trials for the treatment of unresectable, locally advanced Stage III NSCLC.
The U.S. Food and Drug Administration has approved Keytruda (pembrolizumab), a new immunotherapy drug to treat advanced melanoma after it was tested on more than 600 patients who had melanoma that had spread throughout their bodies.

Because so many of the patients in the early testing showed significant long-lasting responses, the study was continued and the FDA granted the drug “breakthrough therapy” status, allowing it to be fast-tracked for approval. The largest Phase 1 study in the history of oncology, the research was conducted at UCLA and 11 other sites in the U.S., Europe and Australia.
In an oral presentation at the 2014 European Society of Cardiology (ESC) Congress in Barcelona, Dr. Jan Johansson, senior vice president of medical affairs at Resverlogix, disclosed that patients with cardiovascular disease (CVD) arising from atherosclerosis when given RVX-208 had a 55% (p=0.02) relative risk reduction (RRR) in Major Adverse Cardiovascular Events (MACE).
Positive results from its final preclinical toxicology study of SYN-004 have led Synthetic Biologics to get ready for clinical trials of the anti-infective, second-generation product candidate for Clostridium difficile (C. difficile).

Synthetic Biologics is in the final stages of preparing its SYN-004 IND application for submission to the FDA, with the expectation of initiating Phase Ia and Ib clinical trials in the fourth quarter of 2014, and a Phase II efficacy study in the first half of 2015.
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.