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RegMed Daily Dialogue, 7/25/11, markets are holding their breathe

The 6 W’s: Who, what, where, when, why and what of it…


Stocks tumbled on Monday as political brinkmanship in Washington over the debt ceiling sparked fears of a rating downgrade, sending world equities lower. A divided Congress pursued rival budget plans that appear … unlikely to win broad support.  Something could happen later in the week or weekend but … until then, the macro outweighs … any … good micro stories

 

Regenerative medicine/stem cell universe is needing visibility as no one wants to be … too … long or short but, bottoms … speak to me” on 7/25/11 … The NASDAQ is DOWN -2.55 (-0.09%) to 2,851.55. The Dow is DOWN -38.83 (-0.31%) to 12,642.33.

 

Who is UP … Aastrom (ASTM), Athersys (NASDAQ:ATHX), Opexa (OPXA), ReNeuron (LSE.RENE.L) …

 
What’s driving the regenerative medicine/stem cell market …

FDA allows study of gene therapy for immunodeficiency disease: Children’s Hospital Boston and France’s Genethon received FDA approval to conduct a clinical trial of a gene therapy in patients with Wiskott-Aldrich syndrome, a rare immunodeficiency disease. The National Heart, Lung and Blood Institute is financing the study through its Gene Therapy Resource Program.

British researchers call for tighter rules on animal-human testing:  Research projects that involve injecting human genes or cells into lab animals have yielded valuable findings in the several areas including research on cancer, stroke and Down syndrome. Stricter rules and special oversight should ensure that scientists don’t go too far … 

Experts decipher DNA modification in embryonic stem cells: Scientists at the University of California, Los Angeles, have finished sequencing in human embryonic stem cells a DNA alteration called 5-hydroxymethylcytosine that is commonly found in active genes. The study, published in Genome Biology, might lead to new approaches to control cancer and other diseases in which genes are known to affect development.

Mosaic Biosciences venture funding: Mosaic Biosciences secured $1M in a round of venture financing. The Colorado-based firm will use the money to support research into biochemical processes that can help regenerate muscles, bone and other body tissues. Any monies in speaks ..

Genesis Biopharma is tapping into Lonza’s manufacturing expertise for Contego, an autologous cell therapy for stage IV metastatic melanoma: Lonza will conduct process development and scale-up activities. Genesis announced that it would expand beyond antibody-based cancer therapeutics into cell therapy. Contego contains tumor-infiltrating lymphocytes (TILs) obtained from a patient’s metastatic melanoma tumors. TILs are isolated from the resected tumor and expanded in vitro to several hundred million cells. The expanded TILs are then infused into the patient, where they subsequently attack melanoma tumors throughout the body. Contego is based on a TIL adoptive cell therapy being used at the NCI, MD Anderson Cancer Center, and the H. Lee Moffitt Cancer & Research Institute.  TIL adoptive cell therapy has reportedly been shown to be safe and highly-selective in identifying various tumors, with little or no detection of normal or benign tissues. The parent antibody also recognized metastases indicating potential for use in late-stage disease. VG102 is being developed as a monotherapy for colorectal cancer and as a combination therapy with rituximab for lymphoma.

Brainstorm Cell Therapeutics has picked PharmaNet: OTC: BCLI signed an agreement with PharmaNet to assist in the development of the protocol and IND filing for submission to the FDA for approval of its ALS human clinical trials in the US. Still very early … but, Joyce Frey-Vasconcells, PhD, will be leading the efforts on behalf of PharmaNet. She has more than 12 years experience working at the FDA where she served as the deputy director, offi ce of cellular, tissue and gene therapies with the Center of Biologics Evaluation and Research. Knows her … “stuff” …