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Biotech / Medical : BJCT-BIOJECT-needle less injection product -- Ignore unavailable to you. Want to Upgrade?

To: Marc Kahn who wrote (420)	1/5/2000 5:39:00 PM
From: geewiz	Respond to of 534

Hello Marc, and best for you in the new year too; and I am always hopefully for our company! Thanks for your insights to the different Vical trials; I am lucky to remember the partner companies, forget the drugs! So the internal biojector is in development - that's really going to give us a less invasive market potential. It will also catapult us into the two highest revenue sectors of health care, cardiovascular and oncology. Imagine if we can experience assimilation to cardiology similar to what the stent makers did!! On another topic, have you been following the NIH investigation into the death of Jesse Gelsinger? From a November 26th 1999 Wall St: The December meeting of the NIH Recombinant DNA Advisory Committee is sure to be among the most significant ever. The committee will grapple with why Mr. Gelsinger died from the treatment when others didn't and whether he should have been part of the experiment at all. They will also explore whether numerous other human trials involving similar gene-delivery methods are safe. At issue is a particular type of virus, adenovirus, which is often used as a vehicle to insert new genes into the body in an attempt to repair a genetic defect or to treat diseases such as cancer. In Mr. Gelsinger's case, a high dose of adenovirus conveying new genes was delivered directly into a main blood vessel in his liver; four days later he died. James Wilson, research scientist who heads the U of Penn's Institute for Human Gene Therapy says "we should be extremely cautious about conducting any gene-therapy trial in which adenovirus is injected into the bloodstream". Copywrite WSJ 11/26/99 This sounds positive for use of our platform, not just for naked DNA vaccines. Any thoughts? later art

To: Marc Kahn who wrote (420)	1/5/2000 9:59:00 PM
From: geewiz	Respond to of 534

Hi Marc, an addendum to my prior post; biospace.com Some details about Gelsinger's death revealed at the meeting were surprising, disturbing, and unexpected, and they raise many more questions than have been answered so far. First, the vector was found throughout his body, in especially high concentrations in the spleen, bone marrow,lymphatic tissue and gonads. Second, his bone marrow was completely depleted of precursor cells, which some believe could not have occurred in the few days following vector infusion. There was evidence of parvovirus, of unknown origin, which French Anderson believes could have caused the bone marrow to become depleted and possibly to have pushed Gelsinger's immune system into overdrive. In addition, unlike other patients given the vector, Gelsinger's IL-6 levels rose but never declined, and his IL-10 levels never rose sufficiently. This might have been a result of his fever, parvo infection, or both--the cause remains unclear. Despite the "unusually narrow window of toxicity" Gelsinger experienced,Wilson maintains that he was "comfortable" with the dose he gave Gelsinger. Since the death, the FDA has suspended Schering-Plough's liver cancer trials at the same high dose, using the same route of administration. ............. In general, Verma believes that gene therapy vectors need to be better matched to the tissues they are to treat. He has also calls vectors gene therapy's "Achilles heel," and has said that adenovirus vectors like the one used in the OTC trial may well soon be abandoned in favor of improved ones like Merck's "gutless" versions--except perhaps in cancer, where the damage caused by current vectors may actually benefit treatment. Onyx' results with its adenoviral vector in head and neck cancer were the only clearly efficacious results discussed at the meeting. These and other data concerning the use of adenoviral vectors to deliver chemotherapeutics directly into tumors by local injection "were very encouraging," says GenVec's Fischer. Trials by Onyx, Schering-Plough and RPR Gencell/Introgen "showed lower toxicity compared to most drugs, including Schering-Plough's high dose trial," he states. "Other than fever and chills, cancer patients showed no great toxicity." Antibodies are generally not an issue for intratumoral injections. But, "it's a different story to give the vector intravascularly," he acknowledges. The researchers and FDA queried whether the vector should have been given directly into the liver--an issue that had been discussed at length at the original RAC meeting in 1995. Ultimately it was decided that administering it via the hepatic artery would be the most direct and possibly least toxic route, and that it would only be given to one lobe of the liver, leaving the other free in case of irreversible liver damage. Copywrite Biospace later, art