BioTime submits protocol for initiation of human clinical trials of Renevia in Europe

BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced it has submitted a Clinical Investigation Protocol (CIP) to European regulatory authorities for approval to initiate studies for its Renevia™stem cell delivery platform. The Principal Investigator for the studies will be Ramon Llull, MD, and the planned trials will be conducted at the Stem Center, Palma de Mallorca, Spain (www.stem-center.com). The Stem Center is operated by the GID Group, Inc., of Louisville, Colorado. BioTime is currently completing the production of clinical materials according to current Good Manufacturing Practice regulations. The initiation of human clinical studies is expected in Q2 of this year upon approval of the CIP. Renevia™, a member of the Company’s HyStem® family of hydrogels, is a proprietary formulation that mimics the human extracellular matrix, a web of molecules surrounding cells that is essential to cellular function. Renevia™ is designed to be a liquid injectable matrix capable of safely polymerizing in the body into a three-dimensional tissue-like scaffold in combination with transplanted cells. Anchoring the transplanted cells in such a biocompatible matrix generally increases the percentage of viable cell engraftment. HyStem® hydrogels are currently being used by researchers at a number of leading medical schools in laboratory studies to investigate a broad array of stem cell therapies, including wound healing, treatment of ischemic stroke, brain cancer, vocal fold scarring, and cardiac infarct. Videos describing the technology by the inventor Glenn Prestwich, PhD, are available for viewing online at www.biotimeinc.com/corporate-videos/. “This is an important step forward in our commercialization efforts and brings us closer to delivering this much-needed matrix technology for the emerging field of regenerative medicine,” stated William P. Tew, PhD, Chief Commercialization Officer of BioTime, Inc. “The technology forms a foundation for the delivery of cell-based therapeutic products in both the adult and embryonic stem cell marketplace. Current preclinical studies at leading medical institutions have shown that HyStem®hydrogels are compatible with a wide variety of tissue types including brain, bone, skin, nerve, cartilage, and heart.” In the clinical application described in this CIP, Renevia™ will be used as a delivery matrix for autologous adipose cells in order to restore subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects. Restoration of the normal skin contour is an important quality-of-life issue, not only in elective cosmetic procedures, but also in reconstructive surgeries needed to repair deformities and traumatic injuries to the face and upper extremities. BioTime’s plan is to bring Renevia™ to the medical market first in the European Union, where the regulatory pathway will allow for faster approval. Once the use of Renevia™ is established in Europe, BioTime plans to address an even larger potential market in the United States. Evaluation of Renevia™ in ISO 10993 biocompatibility studies has been successfully completed as prescribed by the International Organization for Standardization for permanent implantable medical devices. This testing is required by the United States Food and Drug Administration and European Union regulatory authorities prior to the initiation of clinical studies in humans. The results of these preclinical studies successfully demonstrated the safety and biocompatibility of Renevia™. ....... ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, BTX is up again to $4.43 on 3xs the normal volume. I have only 100 share, wish I'd bought more. BTX may soon be the future in bio-tech. I will slowly buy more shares, when it drops and it will drop. Most like after I buy. ............................... Good luck in this rigged casino,

BTX up again

BioTime up again, 30 cents to close at $4.18 on huge volume of 985,959 shares. The three month avg. volume is 118,479 shares. ............................Geron up one cent to close at $1.64 on 788,531 shares. The three month avg. volume is 1.1 million shares............ACTC down a liitle at 0.08 cents on 18.4 million shares. the three month volume is 8.3 million shares.........................Amazing that BioTime is still going up and ACTC still going down.....................Good luck in this rigged casino.

BioTime up big

I do not understand why BioTime is up again today and ACTC is down. BioTime needs 50 million dollars just to finish Phase 1 trials on Geron's [now BioTime's] acute spiral cord injuries. ACTC had great results at the half way mark, of there Phase 1/2 trials and they closed down.......BTX closed up 43 cents at $3.88 on outstanding volume of 581,946 shares, the three month avg. volume is 104,146 shares. .....ACTC was down under 9 cents at 0.082 on 46,081,681 shares wow! The three month avg is 8.3 million shares.....Geron was up 3 cents to close at $1.63 on only 470,695 shares. The three month avg. is 1.1 million shares. ....Good luck in this rigged casino,

ACTC Achieves Clinical Milestone: Up again

Advanced Cell Technology Achieves Clinical Milestone Font size: A | A | A 8:30 AM ET 1/8/13 | BusinessWire Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC or the "Company"), a leader in the field of regenerative medicine, announced today that investigators for the Company's Phase I/II clinical trials for Stargardt's macular dystrophy (SMD) and dry age-related macular degeneration (dry AMD) have observed evidence of engraftment of the transplanted human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells and visual acuity gain in patients treated over the 18 months since the trials were first initiated. The Company believes this observation of engraftment and persistence is clinically important because engraftment of cells in the proper area, and recapitulation of normal RPE cell layer structure is important to the ultimate efficacy of the RPE cells in the treatments. Additionally, investigators have not observed any issues of safety relating to the transplanted human embryonic stem cell (hESC)-derived RPE cells in any of the 18 patients treated. The company believes this warrants early (though cautious) optimism as the company looks forward to initiating the second half of the three trials. "Now that we are at the halfway point in all three of our ongoing trials, we have had the opportunity to stop and assess not only the data relating to safety, but also to the activity of the transplanted RPE cells," said Gary Rabin, chairman and CEO. "In our first report of hESC-derived cells transplanted into patients, published in the Lancet, we reported no adverse safety signals and that both patients that had been treated by that point showed some signs of visual improvements. For both of those patients, those gains in visual acuity have persisted for nearly 18 months now. In addition, we have observed persisting engraftment of the transplanted RPE cells in our more recent SMD and dry AMD patients. This is the first time we have shown this in dry AMD patients, which we find particularly encouraging, given that dry AMD represents one of the largest unmet medical needs in the world." "We are optimistic about the prospects of our RPE cells ultimately impacting positively on various forms of macular degeneration," said Robert Lanza, M.D., ACT's chief scientific officer. "As we have added additional clinical trial sites, the pace of patient treatments has picked up. At the same time, we are extending our observations to a greater number of patients, as well as collecting data over extended periods of time after the surgery." Mr. Rabin will be providing an overview of the company's progress, including providing some representative examples of anatomical data of RPE engraftment in the trials, in his presentation on Tuesday, Jan. 8 at Biotech Showcase 2013 in San Francisco. Pictures of the engraftment will be included in Mr. Rabin's presentation, which will be posted to the Presentations section of the ACT site, and a link to a webcast of the presentation will be available on the Events section. Great news, should move up to 10 cents................................................ ......................................................................................................................................................................................................................................................................Good luck in this rigged casino,

Great day for BTX and ACTC

BTX picked up 400 patents dealing with human embryonic stem cells from Geron. BTX was up 25 cents to close at $3.45. The volume was 268,062 shares. The three month avg. volume is 95,221 shares. BTX needs $500,000,000 [just a guess] to finish the trials on the acute spiral cord injuries. They have around $20 million. I think they will be taking donations....................................................................... ACTC up big to close at 0.0899 an huge volume of 73,331,184 shares. The three month avg. is 6.6 million shares. CEO Gary Rabin will present at Biotech Showcase, Jan. 8 in San Francisco.......................................................................... Geron was up 2 cents to close at $1.60 on only 877,078 shares. ........................ Good luck in this rigged casino,

BioTime done deal with Geron. ACTC up big again

What a great day! BioTime signs definitive agreement with Geron regarding stem cell assets. BTX up 10% and Geron up 2 cents. This is great news, the Phase 1 trial should start again. That's the one trying to repair acute spiral cord injuries, yea baby. So BioTime is now the future in bio-tech, you heard it here first...................... ............................................................................................................................................................................................................................................................................................................................................................ACTC up big again over 9 cents. No news, thinking it's coming very soon, maybe Tuesday Jan. 8th the CEO is speaking.,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,Good luck in this rigged casino,

ACTC up 31% YEA BABY

ACTC up 31% on heavy volume to close at 0.0799. Looked for news, nothing great. Thinking maybe more good results on Phase 1/2 trials, are coming out soon. ACTC volume was 25.5 million shares, the three month avg. 6.4 million shares.........Geron was up 5 cents to close at $1.58 on only 756,396 shares. No news, only have a few shares like, so with my luck Geron should hit $5 this year..... Good luck in this rigged casino,