Opexa Therapeutics reported (3/5/10) a net loss of $1.43 M or $0.11 per diluted share for FY09 compared to $11.85 M or $1.12 per diluted share in FY08. FY09 highlights:
- The pivotal point in the year was the completion of the stem cell transaction with Novartis (NVS) Pharmaceuticals for an upfront payment of $3 M and potential technology transfer milestone payments totaling another $1 M (with total potential payments from the deal that could exceed $50 M),
- Securing the 1st milestone payment from NVS related to the stem cell transaction of $0.5 M,
- Completing the TERMS Phase IIb clinical study analysis, which demonstrated that Tovaxin is safe and well tolerated with promising efficacy across key clinical endpoints including Annualized Relapse Rate and disability (EDSS),
- Closing 2 financings: $5.1 M in gross proceeds from a registered direct offering and $1.3 M in gross proceeds from a private placement of secured notes.
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ASTMD reported the final patient treatment in the ongoing cardiac regeneration US P 2 surgical clinical trial designated IMPACT-DCM. Treated at Emory University Hospital Midtown in Atlanta, GA, this patient received direct injections of ASTMD’s tissue repair cells for the treatment of dilated cardiomyopathy (DCM), a severe form of congestive heart failure in which the heart becomes weakened and enlarged and cannot pump blood efficiently.
- With the treatment of the final patient in this trial, Aastrom is positioned to report 6 month interim data on all enrolled patients in late 2010.
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ASTMD has regained compliance with the $1.00 minimum bid price requirement under the NASDAQ Listing Rule.
- On 2/18/10, ASTMD affected a reverse stock split to increase the per-share trading price of its common stock to meet the NASDAQ requirement,
- The ticker symbol for Aastrom Biosciences will revert from ASTMD to ASTM on 3/18/10.
ASTMD reported results (2/24/10) from interim analysis of the multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI.
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Geron’s (GERN) collaboration with Corning launches Synthemax™ surface, a novel synthetic surface supporting the growth and differentiation of stem cells and growing hESCs.
- Industrial production of human embryonic stem cells (hESCs) can be problematic because the surface coating on which they are usually grown are expensive; subject to variability thus needing to be tested to ensure they are pathogen-free,
- Synthemax is designed to provide a synthetic contaminant growth matrix that supports the stable proliferation of undifferentiated hESCs in quantities suitable for cell therapy production,
- The advantage of this technology is that it can support cell differentiation after multiple passages.
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PSTI (3/2/10) received approval from an independent Data Safety Monitoring Board (DSMB) to advance its placenta-derived cell therapy product, PLX-PAD.
- This Phase I study in the EU is to evaluate the safety of PLX-PAD for 3 dosing levels in 15 patients for the treatment of Critical Limb Ischemia (CLI), the end-stage of peripheral artery disease (PAD).
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The FDA has granted Orphan Drug designation for Advanced Cell Technology‘s (ACTC.OB) MA09-hRPE cells for use in the treatment of Stargardt’s Macular Dystrophy (SMD).
- As a result, ACTC.OB is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of as long as 7 years.
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Merck KGaA agreed to buy Millipore (MIL), a supplier of drug-development equipment for biotechnology companies for about $6 B in cash, beating a rival offer from Thermo Fisher Scientific. BTIM’s ACTCellerate™ progenitor cell lines and ESpan™ cell growth media sell through MIL. Merck KGaA will pay $107 a share and is a Germany based company. The offer is 13 % more than Millipore’s closing price on 2/26/10 and 50 % higher. Millipore, based in Billerica, Massachusetts, put itself up for sale after getting an unsolicited takeover bid worth less than $95 a share from Thermo Fisher (Bloomberg).
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GERN reported a Q4/09 net loss of $18.4 M, or $0.20 a share based on higher operating expenses. FY09’s loss was $70.4 M, or $0.80 a share. Q4/09 revenue was $605 K, with $1.7 M in revenue for FY09. Revenues in 2009 reflected royalty and license fee revenue and collaboration funding from various agreements. GERN in Q4 had operating expenses of $19 M, with R&D expenses of $15.3 M which increased primarily due to higher non-cash compensation expense for equity-based awards. Q4 G&A expenses were $3.6 M with FY09 operating expenses finishing at $72 M. Shares of Geron fell $0.25, or 4.3 % to $5.55 in Friday’s trading. Shares have traded between $3.67 and $9.24 over the last 52 weeks. Don’t count GERN down and out with $178.62 M in cash!
The biggest issue in Q4/09 … was the FDA placing Geron’s IND for GRNOPC1 (a cell therapy for neurologically complete, sub-acute spinal cord injury) on clinical hold after GERN notified the agency of additional preclinical animal study data.
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Programs to create a new center for the study of stem cells and to increase capacity to deal with global health issues were among 7 scientific initiatives announced 2/25/10 by NIH Director Francis S. Collins, MD, PhD.
The 7 research programs are supported through the NIH Common Fund, which encourages collaborative research programs across the NIH institutes and centers (IC) to accomplish work that no single IC could do alone. These programs are all scheduled to begin during FY10. The research programs will distribute $17.8 M in NIH Common Fund support in FY10 and additional funds in future years. These projects capitalize on emerging scientific opportunities and technology advances to fuel biomedical discovery, strengthen the biomedical community nationally and globally and hasten the translation of science discoveries into new and better treatments.
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The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), 2/24/10 unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.
The initiative involves 2 interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.
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