Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

(Los Angeles, CA) -- The HIV gene medicines company Calimmune announced today that the first patient has begun treatment in a Phase I/II clinical trial designed to determine whether a pioneering genetic medicine approach can help to protect individuals infected with HIV from the effects of the virus. The study, “Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection,” utilizes a gene medicine called Cal-1, developed in the lab of Nobel Laureate Dr. David Baltimore and by Calimmune.

In the study, 12 HIV-positive participants will be infused with their own T cells and stem cells (hematopoietic stem cells, HSC), which have been modified to block the HIV receptor CCR5, and to prevent HIV fusion. The procedure is designed to prevent the virus from entering and damaging protected cells. The dual approach used in the study is designed to reduce the possibility that HIV can develop resistance to the procedure.

The goal of the study is to assess the safety, feasibility, and tolerability of Cal-1 in HIV- infected individuals who have previously been on highly active antiretroviral therapy (HAART) but are not currently taking any antiretroviral agent.  In addition to routine clinical and laboratory assessments to monitor general health and HIV infection, the study will monitor the presence of Cal-1 protected cells in various cell types in the blood and lymphoid tissue. Other analyses will monitor the safety of Cal-1. The first patient was treated in the study in late June. Data from this study are expected in 2015.

All participants in the study’s three arms will receive the Cal-1 gene transfer. Participants in two of the three study arms will also receive different doses of a preconditioning drug known as busulfan, which may make the therapy more effective.

“This study is an early but important step in an emerging area of scientific exploration, representing the culmination of more than a decade of research and development,” said Calimmune Chief Executive Officer Louis Breton.  “We are optimistic that what we learn from this study may bring us closer to the day when a one-time treatment could provide an alternative to a lifetime of antiretroviral therapy.”

The study has been partially funded by the California Institute for Regenerative Medicine (CIRM).  The study will take place at clinical trial sites in Los Angeles and San Francisco, Calif., under the direction of Principal Investigators Ron Mitsayasu, M.D., of UCLA and Jacob P. Lalezari, M.D., of Quest Clinical Research. For more information, visit www.clinicaltrials.gov.

ResearchMatch Connects HIV Study Volunteers with Researchers

I highly encourage everyone to join our important attempt to accelerate the cure of HIV.  Research Match also helps connect patients with other diseases with private investigators. Please forward to your friends and families.  Anyone can participate.

Thank you in advance for supporting this platform!

Contact: Kathy Edson

(615) 343-2571/ kathleen.edson@vanderbilt.edu

ResearchMatch Connects HIV Study Volunteers with Researchers

Nashville, TN – June 1, 2013 -- ResearchMatch (RM), the country’s first nationwide, non-profit research volunteer recruitment platform for all health conditions is launching an HIV sub-registry in collaboration with Program for Wellness Restoration (PoWeR), a national grassroots HIV advocacy andeducation organization.

RM has a simple goal – to bring together two groups of people who are searching for each other: people who are trying to find research studies, and researchers who are looking for people to participate in their studies. It is a free, secure online registry that has been developed by major academicinstitutions across the country that want to engage others in the mission of today’s ethical, expedited research that will hopefully make a real difference for people with HIV/AIDS in the future.

The Centers for Disease Control (CDC) estimates that 1,148,200 persons are living with HIV infection in the United States, including 207,600 (18.1%) who are unaware of their HIV status. Although great strides have been made in developing medications that treat HIV, research volunteers are needed foremerging HIV cure research studies that may lead to a functional HIV cure in the future. Presently, Researchmatch.org is the only non-profit clinical trials registry that proactively connects potential volunteers and researchers.

“ResearchMatch.org will make a dramatic difference in accelerating HIV cure research by connecting researchers with volunteers who want to help but don’t know how to get involved or where to turn. The hope is that many people will register to volunteer and that academic and research institutions will takeadvantage of this free service that promotes faster study enrollment,” said Nelson Vergel, HIV activist/educator and director of PoWeR.

All volunteers who register with RM indicating HIV as one of their conditions will be informed of enrolling studies in their area and also be connected with investigators who register studies at sites in their area. New RM registered members will also be prompted to consider answering optional questionsabout their condition to enhance the precision and prescreening process for matching volunteers and research teams.

To register as a volunteer or a researcher, please visit researchmatch.org.

About ResearchMatch

ResearchMatch is a national partnership created as a centralized, web-based recruitment registry, connecting individuals who are interested in participating in research with researchers nationwide. The site is a funded in part by the National Institutes of Health (NIH) and Clinical and Translational ScienceAward (CTSA) program grants. The CTSA program is led by the NIH’s National Center for Advancing Translational Science (NCATS). The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH.

About Program for Wellness Restoration

Program for Wellness Restoration (PoWeR) is a national non-profit all-volunteer organization that provides patient-friendly educational information to HIV-positive people and their healthcare providers about ways to improve HIV treatment response, side effects and quality of life. More information can be found at www.powerusa.org.