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Genta Incorporated
(OTCBB: GNTA - http://finance.aol.com/quotes/genta-incorporated/gnta/nab ) (Mon, Jan 5, 2009) Genta Incorporated announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that tesetaxel, the latest addition to Genta's oncology product portfolio, has been granted designation as an "Orphan Drug" for treatment of patients with advanced gastric cancer. Orphan drug status provides for a period of marketing exclusivity, certain tax benefits, and an exemption from certain fees upon submission of a New Drug Application. As a late Phase 2 agent, the Company believes tesetaxel is the leading oral taxane currently in clinical development.
In the completed Phase 2 study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m2 once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or Xeloda , and all but 2 patients had received a third chemotherapy drug with this regimen. Final intent-to-treat analysis, including all patients enrolled in the study, showed that 5 patients achieved a partial response, 2 patients achieved a partial response unconfirmed by CT scan, and 14 patients achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients. Six patients failed to complete the first course of treatment. Five patients died on study from differing causes that included intestinal perforation, pneumonia, hepatic failure, hemorrhagic shock, and rapid disease progression. One patient withdrew before receiving the first treatment dose.
"These response data for tesetaxel in a critically ill patient population show clinical activity at levels that are at least comparable to studies with other taxanes," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "Based on these data, we have consulted extensively with international experts and will be defining a global registration path for tesetaxel as a 2nd-line treatment for patients with advanced gastric cancer. FDA designation as an Orphan Drug provides important assistance in the clinical development process."
Advanced Cell Technology, Inc.
(Pink Sheets: ACTC - http://finance.aol.com/quotes/advanced-cell-technology-inc/actc/nao ) (Mon, Jan 5, 2009) Advanced Cell Technology, Inc. ("ACT") reported that it is feasible to differentiate human embryonic stem cells (hESCs) into functional human vasculature. The research, which appears in the January issue of the journal Regenerative Medicine, shows for the first time that human progenitor cells -known as hemangioblasts- have the potential for both endothelial cell (EC) and vascular smooth muscle cell (SMC) lineage differentiation. This dual potentiality is critical for the effective treatment of human vascular disease, especially the repair and formation of mature and larger-size (non-capillary) vessels.
"The cells participated in the formation of new blood vessels -both capillaries and larger vessels-and were capable of repairing damaged vessels in multiple vasculatures," said Robert Lanza, M.D., Chief Scientific Officer at ACT, and senior author of the study. "The cells restored blood flow in ischemic limbs to near normal levels. They also showed a similar regenerative capacity after myocardial infarction and participated in the repair of vascular injury in diabetic animals. The formation of mature and functional vasculature, except for capillary vessels, requires the interaction of endothelial and smooth muscle cells, the later playing a critical role in the structural and functional support of the vascular network. Thus, the ability to generate large numbers of these progenitor cells makes them an ideal source of cells for the treatment of human diseases caused by deficient vessel growth."
Although endothelial cells play an essential role in vasculogenesis and angiogenesis and form capillary vasculatures, they alone cannot complete the process of vessel growth and development. Vascular smooth muscle cells play a critical role in the support of the vascular network by stabilizing nascent endothelial vessels during vascular development and blood vessel growth. This outer layer of cells also protects the fragile channels from rupture and helps control blood flow.
Until now there was no evidence that blast cells (hemangioblasts) or their equivalents generated from hESCs possessed the ability to differentiate into smooth muscle cells. "The hESC-derived smooth muscle expressed SMC-specific markers (Ai-SM actin and calponin) and contracted upon stimulation with carbachol," stated Shi-Jiang Lu, first author of the paper. "When implanted in nude mice, the cells formed microvasculature with endothelial cells in Matrigel. The cells differentiated into both ECs and SMCs, and incorporated into blood vessels after injection into ischemic tissues, indicating that these cells are functional both in vitro and in vivo."
"We believe these cells could play an important future therapeutic role for patients with vascular disease," stated William M. Caldwell, CEO and Chairman of ACTC. "We are pleased to continue this work through our new joint venture with CHA Biotech Co, Ltd. (CHA). ACT scientists will work with the new company "Stem Cell & Regenerative Medicine International" to help translate this research into clinical therapies."
The paper's other researchers are Yordanka Ivanova, Qiang Feng, and Chenmei Luo.
Veridigm, Inc.
(Pink Sheets: VRGD - http://finance.aol.com/quotes/veridigm-inc/vrgd/nao ) (Mon, Jan 5, 2009) Veridigm, Inc. announced the Board has initiated final preparations for Mobile Media Unlimited, Inc. to be traded as a public company. Veridigm, Inc. (DE) will be name changed to Mobile Media Unlimited Holdings, Inc. (DE) in due course.
The Veridigm Board of Directors and MMU Advisors welcomes incoming Chairman, Chief Executive Officer Anthony Sasso effective Jan 01 2009.
Veridigm President Gary Freeman stated: "We have gone to extraordinary lengths to ensure that the Veridigm entity is up to date in all areas of previously unpaid taxation and that Veridigm is in good standing. This arduous task was necessary for the caliber of MMU clients who require qualifying 'means tests,' as well as long overdue Veridigm housekeeping in preparation for Y/E 2008 consolidated auditing and re filing for OTC BB listing status. Simultaneously, MMU's investors garnered control of a 'to be named' secondary US public company which will be utilized for alternative MMU financed projects, proprietary database research and analysis tools, licensing & branding of applications to 3rd parties, joint ventures & other miscellaneous investments that do not immediately qualify as MMU/Veridigm core competencies."
Manny J. Shulman, managing partner of Shulman and Associates LLC who advises Mr. Sasso, MMU & Veridigm, commented: "We are now satisfied that the criteria and qualifications of Veridigm are habitable for the MMU deal. Veridigm has just effected common stock cancellations to its treasury of 40,111,000 or 14.6% shares of common stock. We have formally closed Veridigm's Regulation D 504 offering as of 12/31/08 and irrevocably cancelled all outstanding Reg D 504 exemption legal opinions, Blue Sky exemptions and previously issued 504 shares are no longer exempt from registration. The Company is reporting a not inconsequential & wholly unexplainable differential between its free trading common share count issued and outstanding as reported by CEDE & Co/DTCC and its common share NOBO/OBO count as reported by S&P as compared to its recent Transfer Agent ledger. We do not foresee an immediate resolution of this suspicious differential and we believe this differential may be responsible for VRGD's recent and extended price and volume volatility."
Mr. Shulman continued: "The Company's equity capital remains 510,000,000 shares authorized. 72% of 100% of the controlling VRGD super voting preferred shares are owned by MMU entities & Mr. Sasso. These preferred shares have no conversion ability to common under present restrictions. The remaining 8% of VRGD preferred shares are now owned by two institutional clients who have no ability to convert to common under present restrictions. For more information about MMU's unique business platform please visit www.mmusms.com."
Solar Power, Inc.
(OTCBB: SOPW - http://finance.aol.com/quotes/solar-power-inc/sopw/nab ) (Mon, Jan 5, 2009) Solar Power, Inc. ("SPI") has entered into a one-year supply agreement with JA Solar Holding Co., Ltd. ("JA Solar") (NASDAQ: JASO). JA Solar has committed to supply up to 60 megawatts of its 6" polycrystalline photovoltaic ("PV") cells based on monthly requirements from SPI. Based in Hebei, China, JA Solar is one of the world's top producers of high-performance solar cells. The cells will be used for the ongoing production of SPI's solar modules and to meet growing demand for the company's products in Europe, Asia, and for turnkey systems in the United States. Supply to SPI begins immediately.
"We are excited about our agreement with JA Solar. Their products are known for quality and performance and we are very fortunate to be able to integrate them into our own," said Steve Kircher, CEO Solar Power, Inc. "This is a true strategic relationship with strong mutual benefit. It will allow us to leverage our vertical integration business model through a significant amount of supply and we will be able to offer competitive pricing that we believe is unprecedented," Mr. Kircher added. "It also provides our SPI commercial operations and our growing Yes! Solar SolutionsTM franchise network with strong advantages in cost of installation and will have a significant positive effect on our competitive position relative to international sales," Mr. Kircher concluded.
The agreement provides SPI with immediate supply of high-quality cells to meet anticipated production requirements of the company's family of solar modules during 2009. "We are happy to be providing Solar Power, Inc. with cells for their high-quality PV modules," said Mr. Samuel Yang, CEO of JA Solar Holding Co., Ltd. "This agreement represents a strategic alliance between our company and one of the leading solar solution providers in the world today. Through SPI we will be able to expand sales of our cells and gain deeper penetration into the U.S. market."
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