As Late, Late Show host, Craig Ferguson, says..."It's a great day for America. 'Why is it a great day for America,' you ask? Well, let me tell you".
The US House of Representatives has passed what promises to be (if approved by the Senate) the largest single budget increase for the FDA in the agency's history. Now many an economist or financial wizard may argue why this is fiscally irresponsible given America's economic woes but it certainly is promising for the biotech industry which has suffered due to a lack of resources in the Agency overseeing the sector. This lack of resources permeates into almost every interaction with the agency whether it be awaiting new Guidance, submission reviews, staff attrition, etc.
As it happens it is also a great day for the mother country from which America declared its independence because of their dastardly tea-taxing ways. "Oh, why ever it that so?", you might ask with a fake English accent. Well I'lltell you. It's because the UK Office for Life Sciences (OLS) has announced a "Life Sciences Blueprint" that will attempt to capitalise (well, that's how the English spell it) fully on its "leading global position in regenerative medicine". The OLS has announced £18 million funding from the Technology Strategy Board for a Regenerative Medicine programme (again with the English spelling) of investment to support key areas of commercial R&D and the development of R&D partnerships, supported by additional funding of £3.5 million from the Medical Research Council, the Engineering and Physical Sciences Research Council and the Biotechnology and Biological Sciences Research Council.
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I fell in love with this conference, the venue, and the charming city of Leipzig when it was held in 2007. For a unique and international take on the multi-disciplinary world of regenerative medicine, you should consider meeting at the WCRM 29-31 October 2009.
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Well I seem to be on a roll with anything related to Wake Forest recently so 'why stop now' I ask myself, without any compelling reply to the negative. This is just a little FYI. The Babcock Demon Incubator (BDI), a new venture incubator at WFU, promises to be a unique new venture incubator opportunity for regenerative medicine startups. The BDI has has fully equipped wet lab space with available equipment including chemical and tissue culture hoods, PCR, Gel systems, HPLC, microscopes, centrifuges, etc. In addition, BDI clients have access to collaborative opportunities at the Wake Forest Institute of Regenerative Medicine and to a wide range of services and specialized equipment. The incubator provides both residential and non-residential client models depending on client needs. All clients have access to office or lab space, can take advantage of business consulting, and access to an extensive services network designed to provide difficult-to-obtain resources to help young companies succeed. For more information, visit the BDI web site.
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As regular readers of my Industry HiLites will know, from time-to-time I occasionally profile a company here in the front-end of the post providing some background, analysis, and recent developments. I'll formalize this a little by calling it a COMPANY PROFILE but won't promise to include one every time.On another house-keeping matter you will note that I've changed the section title "FINANCIAL" to "FINANCIAL and DEALS".
COMPANY PROFILE
Bioheart, Inc., (OTC Bulletin Board: BHRT) has announced that they will proceed to the final phase of their clinical trial with muscle stem cells for treatment of cardiovascular disease.
The company convened a panel of experts to review pre-clinical data dating back to 1988 and clinical data from controlled studies which began in early 2000 (involving nearly 400 patients). Bioheart’s latest Phase II/III MARVEL study has undergone interim analysis. While the data has not been disclosed pending publication confidentiality, this panel of experts was reportedly asked to also review this data.
The panel is reported to have "unanimously and enthusiastically endorsed moving forward" to complete the final phase of clinical trials (MARVEL) to advance muscle stem cell (myoblast) therapy for treating heart failure with the goal of bringing the product to market with FDA approval and CMS reimbursement.
It's not entirely clear to me how or why this panel of experts was called together but a listen of the audio of the panel discussion frankly makes it sound a little bit like a love-in for Bioheart. In the accompanying slide deck, you will find an overview by Chairman and CEO, Howard J. Leonhardt listing an extremely aggressive list of deliverables for 2009 for a dizzying array of clinical products & programs.
On the financial front, Leonhardt states the company has to-date invested $125 million to support heart failure-related research - $85 million of which was in paid capital.
From its May 20, 2009 Form 10-Q Quarterly Report filed with the SEC, "The Company has incurred significant operating losses over the past several years and has a deficit accumulated during the development stage of $98.6 million as of March 31, 2009. In addition, as of March 31, 2009, the Company’s current liabilities exceed current assets by $12.7 million. Current liabilities include notes payable of $5.4 million. ...the Company also has an obligation of $3 million to the Company’s Chairman and spouse [they repaid the principal on a company loan and a pro rata portion of accrued interest ]. The Company does not have sufficient cash to support its operations through December 2009. The Company will need to secure significant additional sources of capital in June 2009 to develop its business and product candidates as planned."
On July 9, the company issued a press release saying that between October 1, 2008, and July 7, 2009, Bioheart received proceeds in the amount of $2,855,830 from the placement of restricted common stock and warrants under its current offering which it has now extended through October 2009. There's a little positive spinning here because this would appear to include the approximately $1.8 million raised in the sale of stocks and warrants which it announced back in October 2008. The new ~$1M appears to be coming in dribs and drabs from the sale of small chunks of stock or warrants including, if I'm reading it right, the granting of stock in repayment of an outstanding loan (see the May 2009 Quarterly Report for clarification and details).
FINANCIAL and DEALS
Bioheart, Inc., (OTCBB: BHRT) has raised approximately $1 million over the past few month in an ongoing offering (see details above).
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Aastrom Biosciences, Inc. (Nasdaq:ASTM) has gained a modest extension from NASDAQ to comply with the $1.00 minimum closing bid price rule in order to remain listed on the Nasdaq Capital Market. This means they now have until October 1, 2009 to regain compliance by achieving a $1.00 closing bid price for a minimum of 10 consecutive trading days anytime before that date. If not, they get kicked off the NASDAQ and forced to find another market for their listing. Absent a stock split it seems an unlikely goal give that the stock is currently trading in the region of .35 cents and the 52 range for the stock is 0.15 - 0.78. Continuing on its very active deal-making course to becoming one of the premier sources of stem cell lines, media, antibodies, cultureware, and characterization kits in the pre-clinical end of the cell therapy sector, Millipore Corporation has signed a co-marketing deal with BioTime, Inc. (OTCBB:BTIM) subsidiary Embryome Sciences, Inc whereby Millipore will become a worldwide distributor of the ACTCellerate™ human progenitor cell lines derived from human embryonic stem cells but not fully differentiated into specific cell types
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Not to be outdone by its sub, BioTime, Inc. (OTCBB:BTIM) announced that two of its shareholders have completed the funding of the second tranche of their equity investments in BioTime following the exercise of their rights to purchase additional shares and warrants under the terms of their May 2009 stock and warrant purchase agreements. Broadwood Partners, L.P. and George Karfunkel have each purchased an additional 1,100,000 BioTime common shares and 1,100,000 stock purchase warrants. BioTime received $4,000,000 from the sale of the additional shares and warrants. The warrants, which are substantially the same as BioTime’s publicly traded stock purchase warrants, entitle the investors to purchase additional common shares at an exercise price of $2.00 per share. The warrants will expire on October 31, 2010 and may not be exercised after that date. “The $8,000,000 of new equity capital we have raised since May from these investors, plus our $4,700,000 research grant from the California Institute for Regenerative Medicine, will be available to finance our strategic programs to build our product and technology portfolios in the emerging fields of stem cell research and regenerative medicine,” said Michael West, Ph.D., BioTime’s CEO.
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America Stem Cell, Inc. has been awarded $2.5 million from the Texas Emerging Technology Fund to use in developing its enzyme technology platforms (ASC-101 and ASC-201) designed to improve the homing and engraftment of stem cells to target organs and increase their therapeutic potential for cancer patients. Additionally, these platforms have the potential to enhance stem cell treatment of inflammation from chemotherapy/radiation, solid tumors, autoimmune diseases, and ischemic diseases including myocardial infarction and stroke.
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Quantum Immunologics, Inc, a Tampa, Florida company focusing on the research and development of cancer immunotherapies, announced that the first patient in its breast cancer trial has begun to receive its dendritic cell therapy. QI is currently sponsoring and conducting an FDA-authorized Phase I/II clinical trial testing the safety and efficacy of its immunotherapy on 27 Stage IV breast cancer patients who have failed conventional therapy. Each patient will receive three monthly injections of the patient's own dendritic cells that have been sensitized to OFA (oncofetal antigen) - a cancer antigen (a protein found on cancer cells that can be targeted by the body's own immune system) found in many tumor cell lines or fetal tissue, but absent on normal, healthy tissue. When the sensitized cells are injected back into the patient, QI expects the patient's T-cells will locate the OFA found on the patient's cancer cells, thereby generating an immune response with the goal of killing the cancer cells and preventing further spread of the disease.Quantum Immunologics Inc., a Tampa, Fla.-based developer of cancer immunotherpeutics, has raised $2.2 million in VC funding from Mentor Capital, Inc. (Pink Sheets:MNTR). In addition to providing $2.2 Million in funding to help support the FDA trials through approximately February 2010, Mentor Capital has agreed to assist QI in funding future strategic stock or cash acquisitions. Mentor will also stand by as a preferred funding source for QI during later stage or additional trials. This commitment, of course, stands to reason given that QI represents the majority of Mentor Capital’s portfolio assets.
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CLINICALThe good news for StemCyte, Inc recently bagged $1 million in funding; the not as good news for StemCyte, Inc. is that it is a debt funding round from debt financing firm Agility Capital. Agility said that the senior secured growth capital loan closed in June. The firm has previously received venture funding from Sycamore Venture Capital, Asia Star IT Fund and National Technology Enterprise Co. of Kuwait, and the W.I. Harper Group. Agility is a provider of venture debt to high technology and other companies. This blogger speculates the debt financing will be used to fund the company's commitments to a recently announced joint venture, StemCyte Therapeutics India Pvt. Ltd, which is expected to be revenue-generating in the near-term.
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Harvest Technologies Corp. announced that the company-sponsored 60-patient clinical trial conducted in Chennai, India using the company's BMAC point-of-care System to treat patients with non-reconstructable Critical Limb Ischemia (CLI) has completed enrollment. Over 300 CLI patients have been treated with the Harvest BMAC treatment protocol in an ongoing multi-center FDA study in the U.S. and other studies in India, COMMERCIAL
Dendreon Inc (NASDAQ:DNDN) is currently eying Atlanta, GA as the location for a new $80 million, 300-person manufacturing facility. "Why Atlanta", you ask? "Ah, good question", I say. It all comes down to transportation logistics. An autologous cell therapy like Provenge requires the acquisition of a biological sample from the patient which is then used to manufacture a unit of the therapeutic that is then shipped back to the patient's clinical stie for administration. This makes logistics a primary consideration for the business model. Atlanta, has one of the world's busiest and most connected airports.
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Cord Blood America, Inc. (OTCBB:CBAI) has signed a lease for a 17,000 square foot building in Las Vegas, Nevada, for a state-of-the-art laboratory for the storage of multiple stem cell products including umbilical cord blood stem cells. Aggressively the company intents to start processing and storing its customer's umbilical cord blood stem cells in the facility in the fourth quarter of 2009. According the the company CEO, in 2010, CBAI intends to expand its cryogenic storage services to other forms of stem cells, including peripheral blood stem cell and adipose tissues. Presumably this move to self-manufacture will mean that its Corcell banking brand will no longer be able to claim the advantage of cGMP-quality processing and storage which it has made a part of its pitch since contracting with Progenitor Cell Therapy in 2007.Meanwhile CBAI has picked the pockets of Bio-Matrix Scientific Group Inc (OTCBB:BMSN) by hiring its former Vice President and Chief Operating Officer Geoffrey John O’Neill as its new Laboratory Director and Brian Pockett as Vice President of Laboratory Operations.
In its May 2009 quarterly report, Bio-Matrix Scientific Group Inc (OTCBB:BMSN) reported they had all of $6,621 cash on hand with current liabilities of $1,371,834 such liabilities consisting of Accounts Payable, Notes Payable, Accrued Payroll Taxes, Amounts due to Shareholder, Accrued Expenses and Accrued Interest. Additional financing will be required to meet cash requirements over the next twelve months.
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Living Cell Technologies Limited (ASX:LCT; OTCQX:LVCLY) has announced the formation of a subsidiary, LCT Biomedical Limited in Russia, to facilitate the commercial development of DIABECELL®, its lead product for the treatment of type 1 diabetes. Reportedly the regulatory process has already been initiated and it is envisaged that the pivotal study and product would be registrable by late 2011. They recently implanted their 8th patients with DIABECELL, their porcine xenogeneic cell therapy product in clinical trial for type 1 diabetes. The plan is for the product to be manufactured and supplied from New Zealand, where the company is located, for the foreseeable future.**
Progenitor Cell Therapy, LLC has appointed a Vice President of Manufacturing Operations with extensive pharmaceutical production experience to head its two U.S. contract manufacturing facilities. PCT recent announced the recent appointment of Daryl LeSueur as Vice President of Manufacturing Operations. As head of Manufacturing Operations, Daryl is responsible for managing and supervising the day-to-day conduct of the manufacturing, packaging, and operational functions of PCT’s two North American contract manufacturing facilities.**
TheraCell, Inc. aims to develop a revolutionary point-of-care device for isolating and processing stem cells that will facilitate the broad use of autologous stem cells combined with an injectable, highly oxygenated scaffold gel for for advanced regenerative medicine procedures such as spinal fusion. The company recently licensed the underlying technology for the planned device from Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., the technology transfer arm of the University. The technology was invented by a team headed by Professor Dan Gazit from the Faculty of Dental Medicine at the Hebrew University of Jerusalem.
Included in the license was a special scaffold with a particularly high oxygen-carrying capacity, which aims to increase fusion rates by increasing local oxygenation at the surgical site. Scaffolds derived from this technology will act to improve oxygenation and encourage the activity of stem cells and bone-forming cells, or osteoblasts. In preclinical experiments in rodents, accelerated spinal fusion and bone fracture healing were observed, as well as improved stem cell survival. The licensed technology also includes a novel and efficient methods for purifying and manipulating stem cells as well as an innovative, biologically compatible, oxygenated gel that improves bone regeneration and fusion of bone grafts
The company intends to pursue a medical devise status for the combined technologies which would be faster than if it were deems a biologic or combination product.
Included in the license was a special scaffold with a particularly high oxygen-carrying capacity, which aims to increase fusion rates by increasing local oxygenation at the surgical site. Scaffolds derived from this technology will act to improve oxygenation and encourage the activity of stem cells and bone-forming cells, or osteoblasts. In preclinical experiments in rodents, accelerated spinal fusion and bone fracture healing were observed, as well as improved stem cell survival. The licensed technology also includes a novel and efficient methods for purifying and manipulating stem cells as well as an innovative, biologically compatible, oxygenated gel that improves bone regeneration and fusion of bone grafts
The company intends to pursue a medical devise status for the combined technologies which would be faster than if it were deems a biologic or combination product.
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In response to Cytori's Request for Designation, Cytori Therapeutics, Inc. (NASDAQ:CYTX) has been informed by the U.S. Food and Drug Administration (FDA) that its Celution(R) 700 System will be regulated as a medical device and reviewed by the FDA's Center for Biologics Evaluation and Research under the law applicable to medical devices. Cytori can now begin to compile and submit a marketing application to the FDA for the Celution(R) 700 System for use as a medical device in "aesthetic body contouring and/or filling of soft tissue voids" - in other words, "breasts". Before they get that far, however, there is still the unresolved issue of whether they will require further clinical trials. Clinical investigations, if required, would be conducted in accordance with the Investigational Device Exemption (IDE) regulations, not the Investigational New Drug regulations applicable to drugs and biologics
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New England Cord Blood Bank, Inc. (NECBB) announced that in August it will begin processing cord blood units using the fully closed and sterile AutoXpress™ System (AXP), developed by ThermoGenesis Corp. and distributed by GE Healthcare. They will, however, continue to operate their manual system, which will allow for processing of samples too small for the automated system. The company hopes that implementation of the automated system will bring NECBB one step closer to accreditation as a public cord blood bank in addition to offering its existing private banking services.
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Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC) announced that it has filed its Form 10-K for the year-ended December 31, 2008. The Company anticipates filing its Form 10-Q for its first quarter ended March 30, 2009 prior to the end of July. Upon completing that filing, the Company intends to file for relisting on the Over-the-Counter Bulletin Board as its financial statements will be current.
MISCELLANIA
The ERA Consulting Group is proud to announce the next intERActions seminars entitled:
The Regulation of “Advanced Therapy Medicinal Products*” in Europe, from the Clinic to Approval (*Cell Therapy, Gene Therapy and Tissue Engineered Products)
Topics to be covered:
* The EU regulatory framework for Advanced Therapy Medicinal Products (gene, cell therapy and tissue engineered products)
* Opportunities in the EU regulatory landscape, especially for rare diseases: How can they benefit your company?
* Current and future regulatory guidelines: Latest developments and implications for your company and product portfolio
* What are the EU CMC/quality issues/requirements at various stages of development?
* Preclinical development program: EU regulatory expectations - rational approach
* Clinical trials with Advanced Therapy Medicinal Products in the EU
Including Europe in your Strategy to Add Value to Early-Stage Biotech Product Development
Topics to be covered:
* The value of including an EU component into your overall regulatory strategy
* Optimizing interactions with European regulators and how this can aid development and add value
* The benefits of orphan medical product designation in the EU and an explanation of the procedure
* Clinical Development in the EU: The European Clinical Trials Directive
* Opportunities in the EU regulatory framework to add value and reduce time to approval, such as accelerated review, conditional approval or exceptional circumstances
* Compassionate use programs
The seminars will be held at The GreenV Sustainable Center of South San Francisco on 14th – 15th September 2009. For a complete program and registration information, please visit their website at: www.eraconsulting.com.
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Check out Daniel Kraft's TED talk on his MarrowMiner technology being developed by StemCor Systems, Inc.
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After 15 years in the biotech conference industry, the Williamsburg BioProcessing Foundation has shuttered its operation in financial distress. Hasta la vista, Wilbio.Sign-off
Ok, this is a stretch for inclusion in this blog which is why I leave it to this humble location in the post but two fellow Canadians have been named among the six researchers to receive prestigious awards from the American Society of Hematology later this year. Congratulations to stem cell researchers Connie Eaves and John Dick.
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