- CellTherapy 2010. Save the date. Submit your session ideas. www.celltherapy2010.com
- While you're planning your calendar, plan on the 2009 World Stem Cell Summit September 21-23, 2009. Baltimore Convention Center Baltiomore, Maryland. (the 2008 World Stem Cell Summit webcast and downloadable World Stem Cell Report are at www.worldstemcellsummit.com).
- Curiously, the Regenerative Medicine Foundation (I know. I hadn't heard of it either until now.) has announced that its "Translational Issues in Regenerative Medicine" conference is the "premiere event for leaders in regenerative medicine translation, representing academic research, clinical, healthcare policy, regulatory, reimbursement, investment and biotechnology industry interests." Curious because it has yet to ever occur. That being said, if they do what they promise, it may just well be. I'm trying to learn more and when I do I'll let you know. Meantime, this is about all I know:
Twin City Quarter
Winston-Salem, NC
"...to facilitate business development opportunities, the conference will feature a venture forum including 15 regenerative medicine companies, as well as partnering sessions."
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Do yourself a favor. Stop monkeying around with home-made cryopreservation brew or, for than matter, any media not built to minimize cellular damage from freezing and thawing.
Do your cells a favor. Try CryoStore and HypoThermosol.www.biolifesolutions.com
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I'm dedicating this issue of Cell Therapy Industry HiLites to TiGenix NV (NYSE EURONEXT: TIG). TiGenix wins the Cell Therapy Group "kick-ass cell therapy company of the week" award which is, of course, something I just made up but they had have a great week raising several million dollars, announcing plans for a new European facility, and receiving a positive opinion from the EMEA CHMP which all but assures them of an MAA within 90 days applicable in 30 European countries. See details below.
FINANCE
TiGenix (NYSE EURONEXT: TIG) has secured the necessary financing to fund the set-up of a GMP manufacturing facility in Europe through a private placement for a total amount of EUR 5,4 million. The investment agreement was subscribed by NV Industriebank LIOF, Particon BV, Limburg Ventures BV and LRM NV. The funds will be used to set up a new cell expansion facility in Europe for the commercial production of its cell based products in the Netherlands. The financing for the facility has been secured through a private placement. After carefully evaluating a number of options throughout Europe, taking into consideration technical, logistical, regulatory and financial criteria, TiGenix has selected a building on the Chemelot Campus, near to Maastricht, the Netherlands, to locate its new cell expansion facility. The site is centrally located in TiGenix’ key European markets, in a region that is strong in distribution and (bio)logistics and that is highly committed to develop as a transnational knowledge centre in life sciences and regenerative medicine.
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After raising $40+ million last year and over $14 million so far this year, Cytori Therapeutics Inc (NASDAQ: CYTX) has announced it has entered into an agreement to raise up to another $20 million over the next year. The company announced recently that it had raised $850,000 in what is described as an agreement by Orlando, FL-based fund, Seaside 88, to buy 7.15 million shares over the next year by buying a specified allotment every two weeks at an agreed discount of the then current stock price. The agreement could being in roughly $20 million for the company depending on share price. Cytori intends to use the proceeds to "accelerate marketing efforts and continue our investment in clinical trials to broaden the number of potential applications for which the Celution® System may be applied".**
A bankruptcy court hearing is scheduled for July 6 in which Isolagen Inc. (AMEX:ILE) will request final approval of its debtor-in-possession financing plan under Chapter 11 bankruptcy reorganization protection.**
Always a master at the art of spinning good profile, NeoStem, Inc. (NYSE: NBS) (AMEX: NBS), in the business of collection, processing and long-term storage of adult stem cells for future medical need, garnered a feature in Gene Marcial's prominent Business Week column, "Inside Wall Street," on June 18, 2009. The same week saw the company profiled in a piece on the investment potential for adult stem cell businesses in a Fortune Magazine article distributed by CNNMoney.com. The company has been on a deal-making, press release and publications tear the past few months. "Big plans by tiny NeoStem (NBS)," Mr. Marcial observed, "have helped catapult its stock to $2.27 a share from 50 cents on March 9." It must be the plans because the company which has been doing what it does since 2006, generated a mere $45,100 in total revenuefor the three months ended March 31, 2009. The good news is that is up from the $700 generated in the three months ended March 31, 2008.The company also announced another deal saying it has signed an exclusive 10-year agreement with Enhance BioMedical Holdings Limited, a
CLINICAL
Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced six-month interim data from a Phase II clinical trial evaluating Prochymal, the Company's formulation of adult mesenchymal stem cells, for the treatment of chronic obstructive pulmonary disease (COPD). The trial failed to demonstrate an improvement in pulmonary function in COPD patients. The company, quickly becoming practised at spinning what might be considered bad news, said they were pleased the data did provide additional evidence of safety for the product in addition to demonstrating significantly decreased inflammation in the COPD patients. Sixty-two patients were enrolled and are being followed for two years in the placebo-controlled study.
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Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX: PJT) received approval from the Paul Ehrlich Institute to begin clinical trials evaluating the company’s placental-derived adherent stromal cell product, PLX-PAD, for the treatment of critical limb ischemia.**
Aastrom Biosciences’ (NASDAQ:ASTM) trial of its cell therapy for severe chronic heart failure was released from a clinical hold by the FDA. The the agency determined the therapy did not cause the death of a participant which resulted in the hold in May.**
The University of Pittsburgh Cancer Institute began enrolling patients in a Phase III study evaluating the safety and efficacy of Gamida Cell Ltd's StemEx cord blood stem cell therapy for the treatment of blood cancers.**
Having received regulatory approval late last year to proceed with its clinical trial in New Zealand, Living Cell Technologies Limited (ASX:LCT; OTCQX:LVCLY) CEO Paul Tan said enrolment of patients should be complete in about two months to begin testing their pig islet cells implanted in humans to treat diabetes.**
Neuralstem, Inc. (NYSE Amex: CUR) has entered into a sponsored research agreement with the China Medical University & Hospital of Taiwan, in Taichung, Taiwan, to prepare for a human clinical trial using Neuralstem’s human spinal cord neural stem cells to treat stroke patients. The therapy will focus on patients whose post-stroke symptoms, including complete or partial paralysis, have stopped improving more than six months after an ischemic stroke.COMMERCIAL
Not to be outdone by finance and operational teams, the regulatory team at TiGenix also announced reason to celebrate this week. TiGenix (NYSE EURONEXT: TIG) announced that the company received a positive opinion from the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on the European Marketing Authorisation application (MAA) for
its lead product ChondroCelect.
CHMP opinions are forwarded to the European Commission for adoption of the final community Marketing Authorisation, which is typically issued between 60 and 90 days from adoption of the CHMP opinion. I'm told that European Commission generally follows the advice of the CHMP but, as Dendreon, there's little reason to celebrate until the formal approval is formalized. For the EMEA take and related info on the decision, click here.
Upon approval, ChondroCelect will be, I believe, the first product approved under the new ATMP regulatory framework. It will certainly be the first cell based product to be centrally approved in the 27 member states of the European Union as well as in Iceland, Lichtenstein and Norway under the new Advanced-Therapy Medicinal Products (ATMP) legislation.
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Meanwhile, rumor has it the company is already in talks with another potential suitor.
Here are a couple hints for your next press release. It's rarely newsworthy to have as the primary point of your release an announcement about what you are going to do, rather than what you've done; secondly, don't announce seemingly contradictory information. I'm just saying....Further to my March 31 speculation about who might be the buyer of York Pharma plc (and its two cell therapy products on the market) and my April 13 post that ULURU Inc. (NYSE Amex: ULU) had signed a non-binding offer letter to acquire the company, ULURU Inc. (NYSE Amex: ULU) has announced that at this time discussions to acquire York Pharma, plc have been terminated. ULURU has notified York that the $1 million USD line of credit it had extended York are due plus accrud interest. The revolving credit facility is secured by substantially all of the assets of York and its subsidiaries. York is now actively pursuing alternative funding facilities in order to repay the line of credit within 30 days and to meet its ongoing working capital requirements.
Meanwhile, rumor has it the company is already in talks with another potential suitor.
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Stem Cell Therapy International, Inc. (OTCBB: SCII), through its wholly owned subsidiary AmStem International, Inc., announced that it has "started the process" to enable it distribute Histostem's products in anticipation of the finalization of the merger between Stem Cell Therapy International, Inc. and Histostem. This is intented, according to the SCTI President and CEO, to "enable AmStem International, Inc. to begin US distribution and immediately bolster the company's cash flow". However, the product has yet to be the subject of a clinical study in the U.S. for which they are seeking "investigators...of the highest caliber, to compare its Stem Cell Facial Cream with others on the market."
The companies reportedly continue "to work on the necessary steps to finalize the merger, and both sides are working diligently to manage its many details."
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Community Blood Services has entered into a licensing agreement with AuxoCell Laboratories, Inc. to use AuxoCell’s exclusive patent rights and propriety process to extract fetal mesenchymal stem cells from the Wharton’s Jelly of donated umbilical cords, allowing Community Blood Services to operate the first Wharton’s Jelly derived stem cell bank in the United States.**
After netting $221 million last month by nearly 12 million shares at $19.20 apiece, Dendreon Therapeutics Inc (NASDAQ:DNDN) expects to spend up to $50 million in a two-phase expansion of its manufacturing facility in Morris Plains, New Jersey. Monday in a regulatory filing. Additional quality control laboratories, data center, training areas, infrastructure and offices are scheduled to by done by mid-December. The final phase, with additional manufacturing clean-room work stations, production support areas, warehouse, infrastructure and offices, is to be substantially complete by April 23 of next year. Dendreon finished the initial build-out of its 158,000-square-foot facility in July 2006, before its FDA application was tabled to await additional clinical results.**
Apparently yet another way has been invented to derive stem cells from placenta - reportedly a source much richer in stem cells than umbilical cord blood. The inventors are looking for commercial partners.
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Cell Genesys, Inc. (NASDAQ:CEGE) - the company that just won't go away - is still pursuing "strategic alternatives". Meanwhile, it expects its cash balance will be approximately $36 million upon imminent completetion of its stock exchange offer.MISCELLANIA
This week's issue of Science has a special focus on stem cells including a piece on "" by Donald W. Fink, Jr. of FDA, CBER, an article on stem cell tourism and 3 reviews. 26 June 2009. Vol 324, Issue 5935, Pages 1603-1754
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The Production Assistance for Cellular Therapies Group (PACT) Educational Web Seminar: Topic: "Deviation Management of Type 351 & 361 Cell Products" Date: Thursday, July 16, 2009 Time: 12:00pm-1:00pm (Eastern US Time) Register is now open for this Web Seminar at www.pactgroup.net. Sign-off
Thanks again to BioLife Solutons. Congratulations to Tigenix. May the force be with all of you and for those going to ISSCR later this week....safe travels and please try not to enjoy Barcelona too much without me!
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