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Trading Review for Cardium Therapeutics Inc. Issued by Beacon Equity
* Press Release
* Source: Beacon Equity
* On 6:50 am EDT, Tuesday October 20, 2009
http://finance.yahoo.com/news/Trading-Review-for-Cardium-pz-2536838746.html?x=0&.v=1
ProLogis Leases 227,000 Square Feet at ProLogis Park Neuenstadt in Germany
Date : 10/20/2009 @ 7:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1256044480&article=39967694&symbol=NY^PLD
- Two Customers Will Occupy Space in ProLogis' Development Portfolio At a Newly Developed Distribution Park -
DUSSELDORF, Germany, Oct. 20 /PRNewswire-FirstCall/ -- ProLogis (NYSE: PLD), a leading global provider of distribution facilities, announced today it has leased a total of 227,000 square feet (21,100 square meters) to two customers in southwestern Germany at ProLogis Park Neuenstadt.
"In a challenging market environment, we are very pleased to have signed two new leases - both of significant size - in our German development portfolio," said Christian Bischoff, ProLogis managing director of northern Europe. "This distribution park has received significant interest from both new and existing ProLogis customers for its prime location, modern amenities and sustainable features."
The third-quarter transactions included leases with:
-- Panalpina, one of the world's leading providers of forwarding and logistics services, which signed an agreement for 114,000 square feet (10,600 square meters) in Building One at ProLogis Park Neuenstadt.
Panalpina will use the space to serve its customers' regional and national distribution needs. This is the fourth lease agreement between ProLogis and the customer; Panalpina now occupies ProLogis distribution space in France, Germany and the United States.
-- A leading retail company based in Germany, which signed an agreement for 113,000 square feet (10,500 square meters) in Building Two at the park. The logistics provider will use the space to support the distribution needs of its customers in southwestern Germany.
ProLogis Park Neuenstadt is located in the trade and industrial park of Unteres Kochertal (GIK), in the city of Neuenstadt. The site is near major transportation infrastructure and a large population center, and easily doubles as a business complex for companies with distribution and office operations. With three buildings and more than 773,000 square feet (71,800 square meters) at the park, ProLogis maintains the largest market share of available, modern industrial distribution space in the Heilbronn-Neuenstadt region of Germany.
ProLogis is the largest provider of industrial space in Germany with approximately 15 million square feet (1.4 million square meters) owned, managed or under development. Other ProLogis customers in the country include BLG, Dachser, DSV, Jack Wolfskin, LGI and Rewe.
About ProLogis
ProLogis is a leading global provider of distribution facilities, with more than 475 million square feet of industrial space (44 million square meters) in markets across North America, Europe and Asia. The company leases its industrial facilities to more than 4,500 customers, including manufacturers, retailers, transportation companies, third-party logistics providers and other enterprises with large-scale distribution needs. For additional information about the company, go to http://www.prologis.com/.
DATASOURCE: ProLogis
CONTACT: Media, Mo Sheahan of ProLogis, +1-303-567-5434,
, or Suzanne Dawson of Linden Alschuler & Kaplan, Inc.,
+1-212-329-1420, , for ProLogis; or Investors, Melissa
Marsden of ProLogis, +1-303-567-5622,
Web Site: http://www.prologis.com/
Crosstex Energy Acquires Eunice Natural Gas Liquids Processing Plant, Fractionation Facility for $42 Million
Date : 10/20/2009 @ 7:00AM
Source : Business Wire
Stock : (XTXI)
http://ih.advfn.com/p.php?pid=nmona&cb=1256044480&article=39967563&symbol=N^XTXI
NexMed Confirms Nasdaq Hearing Date
Date : 10/20/2009 @ 9:00AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1256044356&article=39971243&symbol=N^NEXM
Novavax Launches Pivotal Clinical Study of Novel 2009 H1N1 VLP Flu Vaccine in Mexico
Date : 10/20/2009 @ 4:30AM
Source : PR Newswire
Stock : (NVAX)
http://ih.advfn.com/p.php?pid=nmona&cb=1256044356&article=39964297&symbol=N^NVAX
Developer says Cel-Sci's L.E.A.P.S. technology has extensive applications
Written by M.E.Garza
Monday, 19 October 2009 00:00
http://biomedreports.com/articles/most-popular/13801-developer-says-cel-scis-leaps-technology-has-extensive-applications.html
DOW JONES - 101xx
ProLogis Leases 188,000 Square Feet of its Development Portfolio to Two Customers Near Tokyo
Date : 10/19/2009 @ 7:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1255967244&article=39949190&symbol=NY^PLD
- Two Global Customers, Including Cat Logistics, Expand Presence With ProLogis -
TOKYO, Oct. 19 /PRNewswire-FirstCall/ -- ProLogis (NYSE:PLD), a leading global provider of distribution facilities, announced today it has leased 188,000 square feet (17,500 square meters) during the third quarter to two customers in Japan.
Caterpillar Logistics Services, Inc. (Cat Logistics), the logistics arm of Caterpillar, the world's largest maker of construction and mining equipment, diesel and natural gas engines and industrial gas turbines, will occupy 95,000 square feet (8,800 square meters) at ProLogis Parc Narita III, near Tokyo. This is Caterpillar's first lease with ProLogis in Japan; the customer now leases with ProLogis in multiple locations across the United States, Europe and Asia.
In addition, a global supplier of office products and services has leased 93,000 square feet (8,600 square meters) of distribution space at ProLogis Parc Ichikawa I, a distribution facility in Ichikawa City, near Tokyo. This is the sixth lease agreement between ProLogis and the customer, which now occupies approximately 1.2 million square feet (107,000 square meters) of ProLogis distribution space in the United States, Mexico and Japan.
"ProLogis continues to demonstrate the ability to serve its customers on multiple continents because of its geographically diverse portfolio," said Mike Yamada, ProLogis president of Japan. "We are very pleased to welcome both companies to our portfolio in Japan."
ProLogis Parc Narita III is located in the town of Shibayama, Chiba Prefecture. Comprising 570,000 square feet (53,000 square meters), the newly developed distribution facility is approximately 40 miles (64 kilometers) northeast of Tokyo and is adjacent to the Narita International Airport. Sustainable features at the facility include a solar-powered outdoor lighting system and a state-of-the-art, pre-cast concrete seismic isolation system.
Completed in November 2008, ProLogis Parc Ichikawa I is a five-story, 1.3-million-square-foot (125,200-square-meter) distribution facility. Strategically located along Wangan expressway and Route 357, a highway connection to major roadways throughout the region, ProLogis Parc Ichikawa I supports distribution to the greater Tokyo and Chiba regions. Sustainable features include a pre-cast concrete seismic isolation system, a rainwater recycling system and solar-powered outdoor lighting.
Yamada added, "Distribution locations in and around Tokyo have continued to attract steady interest from our customers. While the challenging economic environment still plays a large role in business decisions, many companies continue to look for ways to consolidate distribution networks from inefficient, older facilities into newer, state-of-the-art distribution centers to increase efficiencies. Locating near Tokyo enables customers to easily reach a population of more than 12 million people and provides convenient highway access to all areas of the country."
ProLogis is one of the largest providers of distribution space in Japan with approximately 8.5 million square feet (794,000 square meters) completed and under development, as well as 98 acres (39.7 hectares) of land available for future development. Major ProLogis customers in Japan include Kirin Logistics, Yamato Logistics, Konoike Transport, Costco, Daikin Industries, Sanyo Electric Logistics and Kintetsu World Express.
About ProLogis
ProLogis is a leading global provider of distribution facilities, with more than 475 million square feet of industrial space (44 million square meters) in markets across North America, Europe and Asia. The company leases its industrial facilities to more than 4,500 customers, including manufacturers, retailers, transportation companies, third-party logistics providers and other enterprises with large-scale distribution needs. For additional information about the company, go to http://www.prologis.com/.
DATASOURCE: ProLogis
CONTACT: media, Mo Sheahan of ProLogis, +1-303-567-5434,
; or Suzanne Dawson of Linden Alschuler & Kaplan, Inc.,
+1-212-329-1420, , for ProLogis; or investors, Melissa
Marsden of ProLogis, +1-303-567-5622,
Web Site: http://www.prologis.com/
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS TO BE HELD ON NOVEMBER 18, 2009
http://ih.advfn.com/p.php?pid=nmona&cb=1255965349&article=39954605&symbol=NY^SRZ
Encorium Group, Inc. Completes $1.6 Million Private Placement of Common Stock and Executes Warrant Exchange Agreement
Date : 10/19/2009 @ 8:30AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1255962611&article=39951827&symbol=N^ENCO
Encorium to Report Third Quarter 2009 Financial Results on November 16 and Hold Conference Call on November 17, 2009
BERWYN, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Encorium Group, Inc. (NASDAQ:ENCO), a full-service multinational contract research organization (CRO) that provides design, development, and management capabilities for clinical trials and patient registries to many of the world's leading pharmaceutical companies, today announced that it has completed a private placement of 3,937,500 shares of its common stock with a private investor for an aggregate purchase price of $1,575,000, or $.40 per share.
Prior to the transaction, the Company has entered into Warrant Exchange Agreements with two investors (the "Investors") pursuant to which the Company issued to the Investors an aggregate of 1,864,000 shares of Common Stock (collectively, the "Exchange Shares") and warrants to purchase an aggregate of 874,126 shares of Common Stock, exercisable for a period of five years, at an exercise price of $.40 per share (collectively, the "Exchange Warrants"). The Exchange Shares and Exchange Warrants were issued in exchange for warrants dated as of May 9, 2007 held by the Investors to purchase an aggregate of 874,126 shares of Common Stock of the Company (collectively, the "Original Warrants").
The Company also announced that it has terminated previously announced negotiations for the sale of the Company's wholly-owned subsidiary Encorium OY to a clinical research organization based in the United States and will not pursue a sale of the Company or Encorium OY at this time. Given the Company's recent successes with respect to its strategy to grow into the world's leading vaccine franchise, including the recently announced $8.7 million of new business contract wins and the selection by a major pharmaceutical company for participation in a swine flu vaccine program, together with the investment announced today, the Company believes it is well positioned to win future contracts in the vaccine and oncology fields. As a result, the Company believes stockholder value will be maximized by moving ahead independently, while continuing to focus on clinical vaccine development.
Dr. Kai Lindevall, executive chairman stated, "We are very pleased that we were able to close this financing to shore up our balance sheet and provide the Company with additional working capital. Our experience and capabilities in the vaccine field coupled with the recent new awards in this area demonstrate the long term potential we have to grow into a leading vaccine franchise with expertise in pre-clinical support, regulatory consultancy and strategic trial planning. We believe these developments will position us to move ahead independently and are in the best interest of all stockholders."
Of the 35,000,000 authorized capital stock of the Company, 26,325,383 shares of common stock will be issued and outstanding immediately following the closing.
The shares of common stock issued in connection with the above transactions have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration under the Securities Act and applicable state securities laws or an applicable exemption from those registration requirements. The Exchange Shares will be immediately freely transferable pursuant to Rule 144 of the Act since the Investors are not affiliates of the Company and since the Investors will be deemed to have held the Exchange Shares for greater than 6 months pursuant to (d)(3)(ii) of Rule 144. For additional information on the transactions described below, please see our Current Report on Form 8-K filed with the SEC on October 19, 2009, which is available on the SEC website at http://www.sec.gov/
Quarterly Results and Conference Call
Financial results for the third quarter ended September 30, 2009 are scheduled for Monday, November 16, 2009, after the market closes. Encorium will hold a conference call at 11:00 a.m. EST Tuesday, November 17, 2009, to discuss its financial results and corporate developments. Additional details will be forthcoming.
This press release does not constitute an offer to sell or the solicitation of an offer to buy nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.
About Encorium Group, Inc.
Encorium Group, Inc. is a global clinical research organization specializing in the design and management of complex clinical trials and Patient Registries for the pharmaceutical, biotechnology and medical device industries. The Company's mission is to provide its clients with high quality, full-service support for their biopharmaceutical and medical device development programs. Encorium offers therapeutic expertise, experienced team management and advanced technologies. The Company has drug and biologics development as well as clinical trial experience across a wide variety of therapeutic areas such as infectious diseases, cardiovascular, vaccines, oncology, diabetes endocrinology/metabolism, gene therapy, immunology, neurology, gastroenterology, dermatology, hepatology, women's health and respiratory medicine. Encorium believes that its expertise in the design of complex clinical trials, its therapeutic experience and commitment to excellence, and its application of innovative technologies, offer its clients a means to more quickly and cost effectively move products through the clinical development process.
This press release contains forward-looking statements identified by words such as "estimate," "project," "expect," "intend," "believe," "anticipate" and similar expressions. Those statements involve risks and uncertainties, and actual results could differ materially from those discussed. Factors that could cause or contribute to such differences include, but are not limited to: (i) the risk that we may not have sufficient funds to operate our business; (ii) our success in attracting new business and retaining existing clients and projects; (iii) the size, duration and timing of clinical trials we are currently managing may change unexpectedly; (iv) the termination, delay or cancellation of clinical trials we are currently managing could cause revenues and cash-on-hand to decline unexpectedly; (v) the timing difference between our receipt of contract milestone or scheduled payments and our incurring costs to manage these trials; (vi) outsourcing trends in the pharmaceutical, biotechnology and medical device industries; (vii) the ability to maintain profit margins in a competitive marketplace; (viii) our ability to attract and retain qualified personnel; (ix) the sensitivity of our business to general economic conditions; (x) other economic, competitive, governmental and technological factors affecting our operations, markets, products, services and prices; (xi) announced awards received from existing and potential customers are not definitive until fully negotiated contracts are executed by the parties; (xii) our backlog may not be indicative of future results and may not generate the revenues expected; and (xiii) uncertainties regarding the availability of additional capital and continued listing of our common stock on Nasdaq. You should not place undue reliance on any forward-looking statement. We undertake no obligation to publicly release the result of any revision of these forward-looking statements to reflect events or circumstances after the date they are made or to reflect the occurrence of unanticipated events. Please refer to the section entitled "Risk Factors" in the Company Annual Report on Form 10-K for the year ended December 31, 2008 and the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2009 for a more complete discussion of factors which could cause our actual results and financial position to change.
http://www.encorium.com/
DATASOURCE: Encorium Group, Inc.
CONTACT: Philip L. Calamia, Chief Financial Officer, Encorium Group,
Inc., +1-610-989-4208
Web Site: http://www.encorium.com/
! already days ago here adjusted in the board !
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42193042
2009 H1N1 Flu U.S. Situation Update
October 16, 2009, 11:00 AM ET
http://www.cdc.gov/h1n1flu/updates/us/
... -
Mailbag: Feuerstein Digs My Reporting?
Written by M.E.Garza
Thursday, 15 October 2009 20:35
http://biomedreports.com/articles/most-popular/13519-mailbag-adam-feuerstein-contacts-biomedreports.html
_bbb_: you are wrong!
Partnership Discussions for H1N1?
Written by Staff and Wire Reports
Thursday, 15 October 2009 06:15
http://biomedreports.com/articles/subscriber-only-content/13413-partnership-discussions-for-h1n1.html
...Oppenheimer says Novavax, Inc. (PNASDAQ:NVAX) is likely in partnership discussions for their H1N1 vaccines based on the company's virus-like particle (VLP) platform technology...
Cel-Sci Corporation
- Presentation Oct. 2009
http://www.cel-sci.com/CVM_Presentation_web_Oct09%282%29.pdf
- Presentation Sept. 2009
http://www.cel-sci.com/CVM_Fin_Presentation_Sept_2009.pdf
Cel-Sci Corporation - Presentation Oct. 2009
http://www.cel-sci.com/CVM_Presentation_web_Oct09%282%29.pdf
Presentation May Shed More Light on CEL-SCI's New Technology
Written by M.E.Garza
Thursday, 15 October 2009 00:00
http://biomedreports.com/articles/most-popular/13357-presentation-may-shed-more-light-on-leaps-technologys-potential.html
yup!
- for now - IMO fuxx timing and not in "small cap investors" interest!
...going LONGer
Cardium Announces $6.0 Million Registered Direct Offering
Date : 10/15/2009 @ 9:15AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1255612718&article=39910497&symbol=A^CXM
SAN DIEGO, Oct. 15 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced a registered direct offering of common stock to selected investors for aggregate gross proceeds of $6.0 million. The offering is made pursuant to a registration statement that was filed by Cardium Therapeutics with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 15, 2007. Details concerning the terms of the financing and the warrants can be found in the Company's Current Report on Form 8-K to be filed with the SEC at http://www.sec.gov/.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
The securities in the offering include an estimated 4,615,385 shares of Cardium common stock at a price of $1.30 and warrants to purchase up to 3,000,000 shares of Cardium common stock at an exercise price of $1.40. The warrants are exercisable six months after the date of issuance, and will expire six years from the date they are first exercisable. Dawson James Securities acted as exclusive placement agent for the offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offer will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for tissue repair and cardiovascular indications. In October 2009, Cardium announced results for the Matrix Phase 2b clinical study of the Excellarate product candidate as a treatment for patients with non-healing diabetic ulcers. News from Cardium is located at http://www.cardiumthx.com/.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that the MATRIX study or other human clinical trials can be conducted and completed in an efficient and successful manner, that product formulation enhancements will be successful or will effectively simplify or expand the use of product candidates or technologies, that the GAM technology can be successfully broadened or applied to additional wound healing or tissue repair opportunities, that Excellarate or our other candidates will prove to be sufficiently safe and effective, that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, that clinical studies even if successful will lead to product advancement or partnering, that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive, that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value, that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population, or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) and Generx® are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellarate(TM) and Osteorate(TM)
are trademarks of Tissue Repair Company.
Other trademarks are the property of their respective owners.
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
http://photoarchive.ap.org/
DATASOURCE: Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations, Cardium
Therapeutics, Inc., +1-858-436-1018,
Web Site: http://www.cardiumthx.com/
Positive Findings from Excellarate(TM) Phase 1/2 Clinical Study Published in Journal of Wound Repair and Regeneration
Date : 10/15/2009 @ 9:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1255612718&article=39910247&symbol=A^CXM
SAN DIEGO, Oct. 15 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced the publication of positive findings from the open label multi-center Phase 1/2 clinical study of Excellarate(TM) (GAM501, Ad5PDGF-B / 2.6% collagen), its product candidate for the potential treatment of non-healing diabetic foot ulcers. The clinical findings, entitled Treatment of Nonhealing Diabetic Foot Ulcers with a Platelet-Derived Growth Factor Gene-Activated Matrix (GAM501): Results of a Phase 1/2 trial (Mulder, et al), are to be published in the October 2009 issue of Wound Repair and Regeneration, a peer-reviewed medical journal of the Wound Healing Society. The publication is now available online at the following website: http://www3.interscience.wiley.com/journal/122648469/abstract.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
As reported in the article, the primary objectives of the Phase 1/2 clinical study were to evaluate the safety, maximum-tolerated dose, and preliminary biological activity of the Excellarate product candidate. The open label study evaluated fifteen patients with chronic, non-healing ulcers who were treated with local application at the wound site of either a single administration of the Excellarate product candidate at one of three dose levels, or up to four administrations of Excellarate at one-week intervals.
The principal findings of the Phase 1/2 clinical study as reported in the article include the following:
-- Excellarate appeared to be both safe and well tolerated following administration in patients with non-healing diabetic ulcers, with no evidence of systemic or local toxicity at any dose level (therefore no maximum-tolerated dose was reached); -- Ad5PDGF-B and the collagen matrix of Excellarate, as well as the encoded PDGF-B protein, appeared to remain localized within the wound site (as evidenced by an absence of circulating adenoviral DNA, and the absence of any detectable antibodies to either the encoded PDGF-B protein or the collagen in the blood of patients); -- Complete wound closure was observed by 14 weeks in ten of the fifteen patients (67%), seven of whom had received only a single application of the Excellarate product candidate; and
-- Excellarate appeared to be associated with early rapid healing responses (around half of the patients achieved a 50-99% reduction in wound size by week 2).
The Excellarate product candidate (referred to as GAM501 in the article) is initially being developed to facilitate wound closure in non-healing diabetic foot ulcers. Excellarate is a collagen-based topical gel employing Cardium's Gene Activated Matrix(TM) technology to locally stimulate the release of platelet-derived growth factor-B protein (PDGF-B) and provide a matrix for cell migration, which are believed to be important keys in the human body's wound healing process. The sustained localized production of PDGF-B by a patient's own cells directly in the wound site is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of cells such as monocytes, fibroblasts and endothelial cells. Cardium's customized collagen matrix (Excellagen(TM)), which forms an integral part of the Excellarate product, is believed to support the process of wound healing by promoting retention of Ad5PDGF-B and the encoded PDGF-B protein within the wound site, and also serves as a scaffold to support the infiltration and proliferation of wound repair cells. These activities are considered to be important for the effective stimulation of a variety of wound healing processes.
While other advanced care products for treating diabetic wounds are available, the article also observed that several aspects of those approaches can limit their use and additional new therapies are needed. As noted, "Living skin equivalents (e.g., Apligraf® and Dermagraft®) are effective in accelerating ulcer repair; however, multiple weekly applications are typically required. The usage of these products is limited due to short shelf life (5-10 days) and expense. Becaplermin (Regranex®, platelet-derived growth factor-B homodimer [PDGF-BB], Systagenix Wound Management, Gargrave, UK) is the only growth factor protein approved for use in diabetic ulcers. However, the healing incidence is only 15% greater than placebo-treated ulcers. Problems with maintenance of the protein at the ulcer site (daily application required), and for a sufficient period of time (weeks to months), have been identified as factors contributing to this low rate of efficacy [citations omitted]."
"The publication of the positive safety and open label efficacy findings of our Matrix Phase 1/2 clinical study in the peer-reviewed Wound Repair and Regeneration journal provides an opportunity for the medical community to review the significant advancements that we are making in the fields of DNA-based gene therapy and wound healing. The findings from this Phase 1/2 clinical study are consistent with and further supported by results from our much larger blinded Phase 2b clinical study as reported yesterday, which suggest that both Excellarate and its component collagen matrix known as Excellagen appear to promote wound healing at rates substantially higher than with standard of care and may have important roles as new therapeutic tools for the potential treatment of soft tissue wounds such as diabetic ulcers," reported Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.
"Based on collective data obtained in the Phase 1/2 and Phase 2b clinical studies, and approvals related to the use of collagen in a number of clinical settings, the Company plans to advance Excellagen along an abbreviated FDA 510(k) pathway as a medical device - and to advance Excellarate to a Phase 3 clinical development program for the potential treatment of diabetic lower extremity ulcers, which are the leading cause of amputations and associated morbidity and mortality in the U.S. and other industrialized countries," Mr. Reinhard added.
Findings of the Phase 1/2 Excellarate Clinical Study
The Phase 1/2 study was a multi-center, open label, dose-escalation study. Fifteen patients with previously non-healing foot ulcers were enrolled and received either a single dose of Excellarate or up to four administrations of Excellarate at one-week intervals and were then evaluated for up to seven months. In addition to the application of Excellarate, patients also followed a standard of care treatment regimen for the entire treatment and evaluation period. Standard of care consisted of surgical debridement, dressing changes and use of an off-loading device. The mean size of ulcers at treatment was 3.0 +/-1.8 cm2 (range 1.17 - 7.2 cm2), and these ulcers were considered chronic, having remained unhealed prior to treatment for a mean of 76 weeks (range 8 - 284 weeks).
In this study, 10 of the 15 patients (67%) achieved ulcer closure during the study period with two additional patients achieving at least a 50-99% decrease in ulcer area. The onset of response was rapid with 7 of 15 (47%) patients achieving a 50-99% decrease in ulcer area by week 2, and 9 of 15 (60%) patients achieving a 50-99% decrease in ulcer area by week 6. Overall, most of the patients (93%) had a positive response, as assessed by decreases in ulcer size.
The chronic non-healing nature of these diabetic ulcers prior to treatment and comparison of the healing response for Excellarate-treated ulcers with the previously published healing incidence in standard of care trials of 24% at 12 weeks, support a potential biological effect of Excellarate in promoting wound healing.
The researchers concluded that "the potential benefits from a single (or double) administration of GAM501 [Excellarate] could one day offer medical practitioners and their diabetic patients an important new treatment option having a higher degree of therapeutic efficacy than SOC (standard of care), and a simplified treatment regimen compared with other advanced therapies that require strict patient compliance for prolonged periods of time. Such a new treatment option could thereby provide a better daily quality of life and perhaps reduce amputations for patients suffering from chronic diabetic foot ulcers."
The Excellarate clinical development program is focused on developing new and innovative ways to enhance the treatment of diabetic foot ulcers, which affect about 15% of the almost 24 million diabetic patients in the United States, or 3.6 million people. Each year, over 800,000 patients in the U.S. develop diabetic foot ulcers. Of these patients, 6 percent will be hospitalized due to infection or other ulcer-related complications. The cost of diabetic ulcers to the U.S. healthcare system is approximately $5 billion per year with treatment and subsequent lower limb amputations adding an additional $1 billion per year. Diabetes is the leading cause of non-traumatic lower extremity amputations and approximately 14 to 24 percent of patients with diabetes who develop foot ulcers eventually have an amputation. The three year survival rate after amputation is only 50 percent.
Gene Activated Matrix Technology Platform
Cardium's proprietary Gene Activated Matrix(TM) technology platform is designed to provide a therapeutic level of protein synthesis at a specific site in the body and can be used in soft tissue such as skin, ligament, tendons and cartilage, as well as in hard tissue such as bone. The technology is distinctive in that it is immobilized gene delivery that allows for gene uptake restricted to the application site. The Gene Activated Matrix comprises any biocompatible matrix containing a gene or DNA vector encoding for a growth factor or any therapeutic protein. The technology allows for a broad spectrum of formulations and the use of any biocompatible matrix, natural or synthetic, which would include, but not be limited to, collagen, de-mineralized bone, allograft and other synthetic graft materials.
The Company's studies have shown that proliferative cells migrate into the Gene Activated Matrix and then take up the immobilized gene resulting in localized and sustained production of small but physiologically active quantities of growth factor proteins or other therapeutic proteins based on the protein-producing DNA of choice. Compared with current protein therapy, which may be limited due to the inherently short half-life of proteins, the Company believes that the localized and sustained production of therapeutically significant concentrations of DNA-driven proteins at the delivery site can significantly enhance the stimulation of localized therapeutic processes such as tissue repair.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that Excellarate or our other candidates will prove to be sufficiently safe and effective, or that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the Excellarate product candidate offers the potential for simpler or more cost-effective treatment for physicians and patients than other FDA-approved products that currently are or will be on the market; that the Matrix clinical study program or other human clinical trials can be conducted and completed in an efficient and successful manner; that we can develop a DNA-based orthobiologics product portfolio; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) and Generx® are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM) and Osteorate(TM)
are trademarks of Tissue Repair Company.
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
http://photoarchive.ap.org/
DATASOURCE: Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations, Cardium
Therapeutics, Inc., +1-858-436-1018,
Web Site: http://www.cardiumthx.com/
DOW JONES - 10000
Candidate, where we thought that they fulfill the requirements
GERS
be careful, its still a Cornell Stock !!! ( PUMP & DUMP )
...to all PLI-newbies ==> IBOX
...look at this Q-play!
Weekly Digest's Investor Essentials Special Report Identifies Unique Investing Opportunities in the H1N1 'Swine Flu' Outbreak
Date : 10/14/2009 @ 11:06AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1255533849&article=39892864&symbol=A^HEB
...IMO - manipulation as its best!
...IMO - manipulation as its best!
IBOX updated!
Cardium Announces Commercial Development of Excellagen(TM) a Customized Collagen-Based Topical Gel for Initial Use as an Adjunct to Surgical Debridement in Patients With Diabetic Foot Ulcers
Important Clinical Findings Provide New Therapeutic Insights into Healing Potential of Cardium's Matrix Technology Platform
* Press Release
* Source: Cardium Therapeutics
* On 9:04 am EDT, Wednesday October 14, 2009
http://finance.yahoo.com/news/Cardium-Announces-Commercial-prnews-2777496271.html?x=0&.v=1
SAN DIEGO, Oct. 14 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced plans for the commercial development of a new product candidate Excellagen(TM), a collagen-based topical gel for use by physicians in conjunction with surgical debridement of wounds in patients with chronic or non-chronic diabetic foot ulcers. This new product opportunity is based on clinical study findings reported today from the Excellarate(TM) Phase 2b clinical study. As reported, Cardium's customized collagen formulation (Excellagen, the matrix component of Excellarate), which has been modified to include structural stabilizers and hydrolytic enzyme inhibitors, appears to substantially promote the healing process of neuropathic diabetic foot ulcers when used as an adjunct to standard of care (including surgical debridement).
Both Excellagen and Excellarate appear to be safe and well tolerated in human patients. As reported in connection with the Phase 2b clinical study, there were no substantial differences observed with respect to adverse events, clinical laboratory results, physical exam findings or immunological antibody responses to either collagen or to the adenovector in patients receiving either one or two doses of product, as compared to each other or to standard of care.
Collagen formulations have been registered as medical devices with FDA 510(k) clearances in the U.S. and with analogous clearances in many other countries. Collagen is broadly used as a dermal filler and in certain reconstructive surgery applications. Cardium's Excellagen formulation has also been used in two human clinical studies for wound repair (as the collagen matrix component of Excellarate). Excellagen is believed to provide a physical and biological substrate conducive to cell migration and proliferation at the wound site, which are believed to be important for promoting robust wound repair responses. In the context of wound healing, the Company believes that its Excellagen formulation has certain advantages over other forms of collagen and may provide an important adjunct to surgical debridement, which is an essential component of standard care for all diabetic foot ulcers. Debridement removes dead or damaged tissue in and around the wound site and is known to promote wound healing. Cardium believes that Excellagen applied to a debrided wound provides a scaffold that can then promote and support the influx of repair cells in the wound bed.
Cardium's Excellarate product candidate comprises not only the collagen matrix but an adenovector encoding PDGF-B protein. PDGF-B is believed to promote wound healing by directly stimulating cells involved in wound repair and also by eliciting the production of other growth factors. Excellarate is being developed to provide advanced wound care for chronic non-healing diabetic foot ulcers, which are difficult to heal with standard of care and are associated with substantial risks of infection or amputation.
The Phase 2b Matrix clinical study was not powered to nor did it differentiate between the relative contributions of the individual Ad5PDGF-B and collagen components that make up Excellarate - but both the Excellarate and the collagen matrix study arms showed substantial improvements in achieving wound closure as compared to standard of care, which is the FDA-accepted control considered appropriate for product registration studies. Approximately 45% of patients receiving the collagen matrix in the Phase 2b study had complete wound closure by 12 weeks, compared to a 31% wound closure rate for the standard of care group. Based on the Company's clinical studies to date, Cardium will consider submitting an application for FDA 510(k) clearance of Excellagen for use in wound healing applications.
In addition to Excellagen (which would be advanced using a 510(k) registration pathway) and Excellarate (which is expected to proceed to a Phase 3 clinical study for non-healing diabetic foot ulcers), Cardium's formulation know-how and the unique properties of Excellagen are expected to enable additional new product opportunities by incorporating other agents including peptides, DNA or other biologics designed to address particular wound healing and other tissue repair applications.
Webcast and Conference Call
The Company will hold a webcast and conference call to discuss the clinical results of the Excellarate Matrix Phase 2b clinical study today, October 14, 2009, at 5:00 p.m. ET. Participants can access the live conference call by dialing 800-259-0251 (U.S.) or 617-614-3671 (International) using the conference passcode 98344451. The call and accompanying slides can also be accessed via the webcast through the Company's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-calendar. If you are unable to attend the webcast, a replay of the conference call will be available approximately two hours after the conclusion of the call by dialing 888-286-8010 (U.S.) or 617-801-6888 (International) using passcode 68300091. The webcast will be archived for 90 days.
Gene Activated Matrix Technology Platform
Cardium's proprietary Gene Activated Matrix(TM) technology platform is designed to provide a therapeutic level of protein synthesis at a specific site in the body and can be used in soft tissue such as skin, ligament, tendons and cartilage, as well as in hard tissue such as bone. The technology is distinctive in that it is immobilized gene delivery that allows for gene uptake restricted to the application site. The Gene Activated Matrix comprises any biocompatible matrix containing a gene or DNA vector encoding for a growth factor or any therapeutic protein. The technology allows for a broad spectrum of formulations and the use of any biocompatible matrix, natural or synthetic, which would include, but not be limited to, collagen, de-mineralized bone, allograft and other synthetic graft materials.
The Company's studies have shown that proliferative cells migrate into the Gene Activated Matrix and then take up the immobilized gene resulting in localized and sustained production of small but physiologically active quantities of growth factor proteins or other therapeutic proteins based on the protein-producing DNA of choice. Compared with current protein therapy, which may be limited due to the inherently short half-life of proteins, the Company believes that the localized and sustained production of therapeutically significant concentrations of DNA-driven proteins at the delivery site can significantly enhance the stimulation of localized therapeutic processes such as tissue repair.
Wound Care Applications and Pharmacoeconomics
The Matrix clinical development program is focused on developing new and innovative ways to enhance the treatment of diabetic foot ulcers, which affect about 15% of the almost 24 million diabetic patients in the United States, or 3.6 million people. Each year, over 800,000 patients in the U.S. develop diabetic foot ulcers. Of these patients, 6 percent will be hospitalized due to infection or other ulcer-related complications. The cost of diabetic ulcers to the U.S. healthcare system is approximately $5 billion per year with treatment and subsequent lower limb amputations adding an additional $1 billion per year. Diabetes is the leading cause of non-traumatic lower extremity amputations and approximately 14 to 24 percent of patients with diabetes who develop foot ulcers eventually have an amputation. The three year survival rate after amputation is only 50 percent.
As reported in the Journal of the American Academy of Physician Assistants (JAAPA, August 2009), chronic wounds affect an estimated 5.7 million patients in the U.S. and cost the healthcare system approximately $20 billion annually. The article's author further notes that optimal wound care requires a portfolio of treatments including the only FDA-approved protein-based topical gel becaplermin (PDGF-B protein), bioengineered skin substitutes, hyperbaric oxygen therapy, and subatmospheric wound therapy (also known as negative-pressure wound therapy), as well as institutional support from the growing number of nationwide wound-care centers that offer specialized, multidisciplinary approaches to the treatment of chronic wounds. The author also reports that the cost of treating non-healing ulcers of longer than one year's duration is estimated to range from approximately $20,000 to $27,000, based on the level of advanced care.
As reported in the International Wound Journal (December, 2007), "one of the most feared complications of diabetes is the lower extremity amputation." Other studies report that diabetes is the leading cause of nontraumatic lower extremity amputations in the U.S., amounting to greater than 75,000 per year or over 200 per day. Limb amputation occurs 10 to 30 times more often in a diabetic person than in the general population. Among patients with lower extremity amputation procedures, 5-17% will die during the operation and 2-30% will die within 30 days of surgery. Longer term survival is even worse. Mortality following amputation ranges from 13-40% at one year, 35-65% at 3 years and 39-80% at 5 years. These mortality rates are worse than many common types of cancer. Despite these grim statistics, many remain unaware of the very serious nature of non-healing diabetic ulcers.
Cardium Orthobiologics Initiative
Cardium recently announced its plans to develop a DNA-based orthobiologics product portfolio based on research and development that will initially focus on non-union bone fractures for medically-compromised patients, and spinal fusions for patients with degenerative disc disease. Orthobiologics is a rapidly growing segment of the orthopedics market and represents biologically-active products designed to enhance musculo-skeletal repair and regeneration. The initial orthobiologics focus will be on the development of Osteorate(TM), a DNA-based non-surgical injectable bone graft gel to repair bone fractures and regenerate tissue in certain medically-compromised patient populations. Osteorate will be based on a reformulation of the Excellarate wound healing product candidate. The Gene Activated Matrix technology allows for a broad spectrum of formulations which would include, but not be limited to, collagen, demineralized bone matrices, allograft and synthetic graft materials.
In addition, Cardium recently announced the results of preclinical research published in the scientific journal, Gene Therapy, demonstrating the potential benefits of its Gene Activated Matrix technology for accelerating and enhancing periodontal tissue repair and oral implant osseointegration. This research further supports Cardium's decision to expand the Company's focus of its regenerative medicine technologies to include the emerging new high growth market segment of orthobiologics.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that Excellagen, Excellarate or our other candidates will prove to be sufficiently safe and effective, or that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the Excellagen or Excellarate product candidate offers the potential for simpler or more cost-effective treatment for physicians and patients than other FDA-approved products that currently are or will be on the market; that the Matrix clinical study program or other human clinical trials can be conducted and completed in an efficient and successful manner; that we can develop a DNA-based orthobiologics product portfolio; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
Cardium Therapeutics(TM) and Generx® are trademarks of Cardium
Therapeutics, Inc. Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM) and Osteorate(TM) are trademarks of Tissue Repair Company.
Regranex® and other trademarks are the property of their respective owners.
Cardium Announces Commercial Development of Excellagen(TM) a Customized Collagen-Based Topical Gel for Initial Use as an Adjunct to Surgical Debridement in Patients With Diabetic Foot Ulcers
Important Clinical Findings Provide New Therapeutic Insights into Healing Potential of Cardium's Matrix Technology Platform
* Press Release
* Source: Cardium Therapeutics
* On 9:04 am EDT, Wednesday October 14, 2009
http://finance.yahoo.com/news/Cardium-Announces-Commercial-prnews-2777496271.html?x=0&.v=1
Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase 3 Program
Excellarate Offers Potential for Simpler and Enhanced Treatment Opportunities within the Spectrum of Advanced Wound Care Biologics, Bio-Engineered Dermal Substitutes and Medical Devices
* Press Release
* Source: Cardium Therapeutics
* On 9:00 am EDT, Wednesday October 14, 2009
http://finance.yahoo.com/news/Cardium-Reports-Positive-Data-prnews-3741923328.html?x=0&.v=1
Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase 3 Program
Excellarate Offers Potential for Simpler and Enhanced Treatment Opportunities within the Spectrum of Advanced Wound Care Biologics, Bio-Engineered Dermal Substitutes and Medical Devices
* Press Release
* Source: Cardium Therapeutics
* On 9:00 am EDT, Wednesday October 14, 2009
http://finance.yahoo.com/news/Cardium-Reports-Positive-Data-prnews-3741923328.html?x=0&.v=1
SAN DIEGO, Oct. 14 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported positive data from its Matrix Phase 2b clinical trial of Excellarate(TM) for the potential treatment of patients with chronic non-healing diabetic foot ulcers based on the Company's Gene Activated Matrix (GAM) technology platform. The study evaluated patients treated with the Excellarate product candidate (GAM501, which is a combination of Ad5PDGF-B and 2.6% collagen) or 2.6% collagen alone (matrix), compared to patients who received only the protocol-specified standard of care without any applied Ad5PDGF-B or collagen matrix. The Company will hold a webcast and conference call to discuss the clinical results of the Excellarate Matrix Phase 2b clinical study today, October 14, 2009, at 5:00 p.m. ET (access information is provided below).
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
The Excellarate product candidate and its components Ad5PDGF-B and collagen matrix appear to be both safe and well tolerated by patients. The Phase 2b study was abbreviated and enrollment ended early after key efficacy measures among blinded groups were observed at rates substantially higher than those expected for patients receiving only standard of care. Consistent with those observations, the unblinded data set showed a substantial (55%) relative improvement in achieving complete wound closure by 12 weeks (the key efficacy measure for a Phase 3 product registration program) among patients treated with a single dose of Excellarate as compared to patients receiving standard of care. Nearly half of patients (48%) receiving a one-time Excellarate treatment had complete wound closure by 12 weeks, compared to a 31% wound closure rate for standard of care. Among combined one and two dose groups of Excellarate approximately 41% of patients achieved complete closure by 12 weeks. However, since re-dosing was based on group randomization rather than apparent need, a majority of patients randomized to receive a second dose of Excellarate at 4 weeks following initial product administration either did not receive one because their wounds were closed by that point, or they received only a very small second dose (less than 100 microliters) because their wounds were extremely small.
In addition to overall wound closures by 12 weeks, the Phase 2b study also evaluated wound closure rates and trajectories following product administration in order to assess the timing and extent of bioactivity. The unblinded data revealed that patients receiving Excellarate exhibited early and rapid wound healing responses as evidenced by very substantial reductions in wound radius over the first several weeks following product administration, which responses were both greater and faster than those observed among patients that had received standard of care. For example, a 108% relative improvement (decrease in ulcer radius) compared to standard of care was observed over the first week following administration of Excellarate, and a 50% relative improvement was observed as an average over the first four weeks.
The collagen matrix, which forms an integral component of Excellarate (by promoting Ad5PDGF-B binding and PDGF-B protein retention within the wound site), had not been associated with substantial wound healing responses in preclinical animal models used for design of the clinical studies. In human diabetic patients, however, the collagen matrix appeared to contribute substantially to wound healing responses. As a result, the collagen arm was not a negative control as expected based on preclinical studies. While the clinical study was not powered to nor did it differentiate between the relative contributions of the individual Ad5PDGF-B and collagen components that make up Excellarate -- both the Excellarate and the collagen matrix study arms showed substantial improvements in achieving wound closure as compared to standard of care. The standard of care (SOC) arm is the accepted control based on FDA guidance for wound healing products, and is expected to be used as the control arm in a planned Phase 3 program for product registration.
The Company's customized collagen matrix is a modified form of collagen that includes certain structural stabilizers and hydrolytic enzyme inhibitors. Based on observations from the Phase 2b clinical study, it appears that this collagen formulation which is referred to as Excellagen(TM), may play an active role in promoting wound healing, particularly when used in combination with standard of care (including surgical debridement).
It is believed that the collagen matrix supports the body's inherent processes of wound repair by providing a molecular scaffolding within the wound bed to promote the infiltration and proliferation of cells associated with tissue repair such as monocytes, fibroblasts and endothelial cells. Surgical debridement, a process of removing dead or damaged tissue in and around the wound site, forms a key part of standard of care and is known to promote wound healing. Regular debridement was practiced in all patients in the Phase 2b clinical study and is believed to account for a substantial portion of the wound healing response observed in the SOC group. The data from this Phase 2b and prior studies suggest that collagen may further support the wound healing process in humans and that PDGF-B, which is a growth factor known to stimulate a variety of wound repair cells, may provide an additional biologic stimulus.
Based on these data, the Company believes that its collagen matrix may prove to be very beneficial as an adjunct to existing wound care therapies, such as debridement. Since collagen has been approved by the FDA as a medical device, Cardium intends to a develop a registration pathway for its collagen to be used in conjunction with debridement, which is typically applied as standard of care for all diabetic foot ulcers and many other types of soft tissue wounds. As announced today, the Company plans to advance this collagen-based product termed Excellagen(TM) along an abbreviated 510(k) registration process in consultation with the FDA.
Following completion of safety and preliminary efficacy data, the Company also plans to schedule a meeting with the FDA to review the complete integrated data set and outline plans for a Phase 3 clinical study program designed to confirm the safety and effectiveness of Excellarate as compared to standard of care, since PDGF-B is known to contribute to the biologic process of wound healing and is itself an approved protein product for use in advanced wound care. The Company believes that the combination of collagen and PDGF-B as provided by the Excellarate product candidate holds the potential to further promote wound healing in non-healing diabetic foot ulcers and other difficult-to-treat wounds. Based on feedback from study investigators, and with the additional positive safety data from the Phase 2b study, the Phase 3 program is also expected to allow for one or two follow-up doses in patients that exhibit a slower healing rate or who have not yet achieved substantial closure following the initial administration of product.
Regranex® (becaplermin, 0.01%) is a PDGF-B protein therapy that is currently the only FDA-approved advanced care biologic for the treatment of patients with lower extremity neuropathic diabetic foot ulcers. PDGF-B protein-based therapy is a daily use prescription medication for treatment for up to 20 weeks, which would require up to 140 daily administrations of product and an additional 140 daily wound cleansings by patients. Based on published studies reflected in the prescribing information sheet for becaplermin, daily application of product combined with daily wound cleansings resulted in a 35% relative improvement in wound closures at 20 weeks (i.e. a 50% wound closure rate for becaplermin-treated patients compared to a 37% wound closure rate for control patients). Based on additional published data from these studies, by 12 weeks (as in the shorter Excellarate study period), the wound closure rate was about 34% for becaplermin-treated patients as compared to a 25% complete closure rate for control patients, representing a 36% relative improvement in wound closure.
In contrast to becaplermin, the Excellarate product candidate is designed to stimulate a physiologic level of sustained and locally-confined PDGF-B protein by cells at the wound site. It is estimated from preclinical analyses that following a single Excellarate administration the localized cellular expression of PDGF-B would be about 55 nanograms, which is on the order of 60,000-fold lower than the approximately 3.0 million nanograms of PDGF-B protein that would be topically applied by patients over a 20-week treatment course with becaplermin. Also, unlike becaplermin, the PDGF-B protein encoded by Excellarate is a naturally-occurring version of the protein that retains its native extracellular matrix-binding domain, which further promotes retention of the growth factor within the wound site.
"The completion of the Matrix Phase 2b clinical study represents a major advance in our plans to establish an important new therapeutic class of biologics for the potential treatment of diabetic foot ulcers and other wounds. Despite years of research and effort, diabetic wounds remain a serious unmet clinical need. Lower limb amputations occur up to 30 times more often in diabetic patients, and the resulting mortality rates for these patients can be similar to or worse than many forms of cancer. We believe that, because of the complex nature of lower extremity diabetic ulcers, patients will benefit from the availability of multiple wound healing agents and therapies that can be tailored to appropriately address their specific medical conditions, and our Excellarate and Excellagen development efforts seek to expand treatment options for patients requiring advanced wound care therapy," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
Webcast and Conference Call
The Company will hold a webcast and conference call to discuss the clinical results of the Excellarate Matrix Phase 2b clinical study today, October 14, 2009, at 5:00 p.m. ET. Participants can access the live conference call by dialing 800-259-0251 (U.S.) or 617-614-3671 (International) using the conference passcode 98344451. The call and accompanying slides can also be accessed via the webcast through the Company's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-calendar. If you are unable to attend the webcast, a replay of the conference call will be available approximately two hours after the conclusion of the call by dialing 888-286-8010 (U.S.) or 617-801-6888 (International) using passcode 68300091. The webcast will be archived for 90 days.
Excellarate Product Candidate Observations
Two patients in the Matrix clinical trial were featured in local television news programs because of the rapid healing of previously non-healing wounds observed by their physicians. Data unblinding revealed that both patients had received the Excellarate product candidate. To learn more about the clinical experiences of these patients, click here to view a television segment featuring an investigator in the study, Dr. Peter A. Blume of the Yale University School of Medicine, and click here to view a segment featuring Dr. Barbara Aung of the Aung Foothealth Clinics, and their patients enrolled in the Matrix clinical study. The Matrix study media segments can also be accessed at www.cardiumthx.com.
Matrix Phase 2b Clinical Study
The Matrix Phase 2b clinical study was a multi-center U.S.-based study designed to evaluate Excellarate for the potential treatment of non-healing diabetic foot ulcers. Enrollment in the study was ended early after key efficacy measures among blinded groups were observed at rates substantially higher than those expected for patients receiving only standard of care. The study, which was conducted at 20 medical centers, evaluated patients that were treated with the gene-activated Excellarate product candidate (Ad5PDGF-B / 2.6% collagen) or the collagen matrix component of Excellarate, compared to patients who received only standard of care treatment without any applied Ad5PDGF-B or collagen. A per protocol data analysis included 113 patients with lower extremity neuropathic ulcers that were chronically non-healing despite receiving standard of care. Eleven additional patients who were initially recruited into the trial were excluded (7 patients were lost to evaluation or had a disqualifying surgical procedure and 4 were determined to have been mis-enrolled based on prespecified enrollment criteria, which led to exclusions before study completion and unblinding). The Matrix study evaluated safety as assessed by adverse events, clinical laboratory measurements, vital signs, concomitant medications, physical exam findings and serum antibody concentrations to collagen and adenovector. Preliminary measures of efficacy included the incidence of complete wound closure by 12 weeks and the effect of Excellarate on healing rates as measured by the change of the ulcer radius during the 4-week period following Excellarate treatment. In addition, patients whose wounds were successfully closed are being followed for up to three additional months to further evaluate wound healing durability. Durability results will be reported at a later date.
Excellarate appeared to be both safe and well tolerated in human patients with diabetic neuropathy. There were no substantial differences observed with respect to adverse events, clinical laboratory results, physical exam findings or immunological antibody responses to collagen or the adenovector in patients receiving either one or two doses of Excellarate or collagen matrix, as compared to each other or to standard of care.
Collagen, an FDA approved medical device, is an important and required element of the Company's Gene Activated Matrix technology and was also included as a key comparator group in the Phase 2b study, as an independent collagen-only treatment arm. Based on preclinical animal data suggesting that collagen would not contribute substantially to wound healing, the study was expected to demonstrate that collagen administration would be equivalent to standard of care, and that these groups would collectively form a control group. However, based on a preliminary review of the top line data, collagen appears to contribute to the healing response in human diabetic patients. While the standard of care (SOC) control group in the Phase 2b study was too small to support statistical differentiation of the groups, the 31% wound closure rate observed in the SOC group was similar to that observed in prior published studies and substantially lower than that observed for patients receiving Excellarate or collagen alone. Among patients receiving a single dose of Excellarate, there was a 55% relative improvement in complete wound closure by 12 weeks as compared to the SOC group, which is considered to be a key efficacy criterion for a Phase 3 product registration program.
During the course of the Phase 2b Matrix study, some investigators expressed an interest in having the flexibility to re-dose patients (to allow for a second or third treatment during the 12-week study period) in response to observed healing slowdowns or plateaus following an initially rapid healing response among some patients. In addition, while early rapid healing following product administration was not a prespecified efficacy measure, the unblinded Phase 2b data revealed that patients receiving Excellarate exhibited a 108% relative improvement (decrease in ulcer radius) as compared to SOC over the first week following a one-time administration of product, and a 50% relative improvement was observed as an average over the first four weeks. The Phase 2b clinical study included a second dose treatment cohort, but the observed healing slowdowns or plateaus did not necessarily coincide with the protocol's established second dosing at week 4 following initial dosing, and a number of patients prespecified by randomization to receive a second dose either did not require it (because their wounds had already closed) or received only an extremely small second dose (because their wounds were almost closed). Based on continuing safety data from the Matrix Phase 2b study, as well as the open label Phase 1/2 clinical study and preclinical research, all of which included some re-dosing, the Excellarate product candidate appears to be both safe and well tolerated, with no significant differences observed in immunological antibody responses to either collagen or to the adenovector in patients receiving Excellarate as compared to those receiving only standard of care. These findings together with the initial healing rate change over time observed in the Phase 2b study support allowing investigators in future studies to re-dose a subset of patients who have not yet achieved a prespecified rate or extent of wound closure. As a result, subject to review with the FDA, we would consider the inclusion of a re-dosing protocol into the planned Phase 3 clinical study program. Cardium believes that this added feature may offer the potential to further enhance efficacy in practical real world clinical settings by optimizing the interaction between Ad5PDGF-B production, which is believed to occur predominantly over the first few weeks following administration, with the individual patient's underlying physiology within the wound site.
Planned Phase 3 Clinical Program
Following completion of the Phase 2b study's durability phase and a complete statistical data analysis, Cardium plans to meet with the FDA to review the complete clinical trial results and to review the Company's proposed Phase 3 clinical study program. The Company will seek to establish a clinical development plan, which could include a special protocol agreement, to define the size and scope of the proposed program which will be based on the important information acquired from the Phase 1/2 and Phase 2b clinical studies. Based on FDA guidance documents and other clinical studies that have supported other product registrations, the Phase 3 program will include a prospective, randomized, double-blind, controlled multi-center study that will evaluate continued safety and definitive efficacy. Cardium is also planning that this study program will utilize a single primary efficacy endpoint, percent of complete wound closure at 12 weeks or earlier, as compared to standard of care.
Excellarate Product Candidate
The Excellarate product candidate is initially being developed to facilitate wound closure in non-healing diabetic foot ulcers. Excellarate is a collagen-based topical gel employing Cardium's Gene Activated Matrix(TM) technology to locally stimulate the release of platelet-derived growth factor-B protein (PDGF-B) and provide a matrix for cell migration, which are believed to be important keys in the human body's wound healing process. The sustained localized release and retention of PDGF-B by a patient's own cells directly at the wound site is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of cells such as monocytes, fibroblasts and endothelial cells. These cell types are considered critical for the effective stimulation of a variety of wound healing processes.
The Excellarate product candidate is being designed to provide physicians and patients with a potentially simpler, easy-to-use treatment regimen compared to most diabetic wound healing agents or devices in use that require repeated administrations over a long term (weeks to months). Based on recently announced advancements, Excellarate is also expected be re-formulated as an easy-to-use single syringe that would be pre-mixed and ready to be applied to patients' wounds. The reformulation will allow Excellarate to be maintained in a physician's office using a standard refrigerator (at a temperature of about 4 degrees C) and is expected to have a shelf life of at least 15-18 months.
Gene Activated Matrix Technology Platform
Cardium's proprietary Gene Activated Matrix(TM) technology platform is designed to provide a therapeutic level of protein synthesis at a specific site in the body and can be used in soft tissue such as skin, ligament, tendons and cartilage, as well as in hard tissue such as bone. The technology is distinctive in that it is immobilized gene delivery that allows for gene uptake restricted to the application site. The Gene Activated Matrix comprises any biocompatible matrix containing a gene or DNA vector encoding for a growth factor or any therapeutic protein. The technology allows for a broad spectrum of formulations and the use of any biocompatible matrix, natural or synthetic, which would include, but not be limited to, collagen, de-mineralized bone, allograft and other synthetic graft materials.
The Company's studies have shown that proliferative cells migrate into the Gene Activated Matrix and then take up the immobilized gene resulting in localized and sustained production of small but physiologically active quantities of growth factor proteins or other therapeutic proteins based on the protein-producing DNA of choice. Compared with current protein therapy, which may be limited due to the inherently short half-life of proteins, the Company believes that the localized and sustained production of therapeutically significant concentrations of DNA-driven proteins at the delivery site can significantly enhance the stimulation of localized therapeutic processes such as tissue repair.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that Excellarate or our other candidates will prove to be sufficiently safe and effective, or that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that the Excellarate product candidate offers the potential for simpler or more cost-effective treatment for physicians and patients than other FDA-approved products that currently are or will be on the market; that the Matrix clinical study program or other human clinical trials can be conducted and completed in an efficient and successful manner; that we can develop a DNA-based orthobiologics product portfolio; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
Cardium Therapeutics(TM) and Generx® are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM) and Osteorate(TM)
are trademarks of Tissue Repair Company.
Regranex® and other trademarks are the property of their respective owners.
ProLogis Closes on $123 Million of Portfolio Refinancings for Two ProLogis Property Funds
Date : 10/13/2009 @ 5:00PM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1255524692&article=39877862&symbol=NY^PLD
DENVER, Oct. 13 /PRNewswire-FirstCall/ -- ProLogis (NYSE:PLD), a leading global provider of distribution facilities, announced today that it has closed on $123 million of secured financings for two of its property funds.
The first is a seven-year, $52.5 million secured financing with a major life insurance company on behalf of ProLogis California Fund. The financing has a 6.60 percent interest rate, a loan-to-value of approximately 50 percent and is secured by 11 industrial properties located in the LA Basin. The proceeds were used to refinance outstanding debt, and with this refinancing, the fund has addressed debt maturities into 2014.
The second, as announced earlier by ProLogis European Properties Fund (Euronext: PEPR), is a euro 48 million ($70.5 million), five-year, secured financing with a German Landesbank that is secured by four properties in Sweden. The proceeds from this financing were used to refinance outstanding debt.
"We continue to aggressively address fund debt maturities. So far this year, we have successfully addressed, refinanced or paid off $2.2 billion of 2009 and 2010 fund debt maturities, including virtually one hundred percent of $1.4 billion of 2009 maturities," said William E. Sullivan, chief financial officer.
About ProLogis
ProLogis is a leading global provider of distribution facilities, with more than 475 million square feet of industrial space (44 million square meters) in markets across North America, Europe and Asia. The company leases its industrial facilities to more than 4,500 customers, including manufacturers, retailers, transportation companies, third-party logistics providers and other enterprises with large-scale distribution needs. For additional information about the company, go to http://www.prologis.com/.
DATASOURCE: ProLogis
CONTACT: investor relations, Melissa Marsden, +1-303-567-5622,
; or media, Krista Shepard, +1-303-567-5907,
, both of ProLogis; or financial media, Suzanne Dawson of
Linden Alschuler & Kaplan, Inc, +1-212-329-1420, , for
ProLogis
Web Site: http://www.prologis.com/
NexMed Provides Update on Anti-Fungal Product
Date : 10/14/2009 @ 8:45AM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1255524478&article=39889357&symbol=N^NEXM
ProLogis Research Group Releases New Report on Industrial Property Markets in Europe
Date : 10/13/2009 @ 3:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1255456115&article=39861382&symbol=NY^PLD
AMSTERDAM, Oct. 13 /PRNewswire-FirstCall/ -- ProLogis (NYSE:PLD), a leading global provider of distribution facilities, announced today the release of a new research report on the state of the industrial property markets in Europe, entitled "Looking for the Rainbow."
The report is based on market statistics and data compiled from a variety of sources, including ProLogis market officers, brokerage companies and market research groups. The information covers distribution property markets in the United Kingdom as well as northern, southern and central Europe up to and including the first half of 2009.
"Europe's logistics property markets are feeling the weight of both a severe economic downturn and a lingering credit crunch," commented Len Sahling, first vice president of the ProLogis Research Group. "The European economies are starting to emerge from several quarters of negative GDP growth, and the logistics property leasing markets will follow suit, albeit with a lag. Meaningful GDP growth combined with obsolescence and no new supply will eventually pull Europe's logistics property leasing markets out of their slump."
Detailed findings in the report include the following:
-- During the first half of 2009, leasing market fundamentals continued to weaken throughout Europe, with the pan-European market occupancy rate slipping to 86 percent in the second quarter of 2009 from 87 percent in the previous quarter and 89 percent a year ago.
-- New deliveries to the Continental European markets have remained relatively stable throughout the current steep recession, largely because of the sizable overhang of construction projects begun last year before the credit crisis erupted.
-- All across Europe, new starts have tapered off in recent months and are now limited almost exclusively to build-to-suit projects. As a result, the construction pipelines have begun to shrink, suggesting that deliveries will soon begin to taper off.
-- Investors have developed a renewed appreciation for market risk and are now making sharper distinctions between countries in Europe regarding economic, currency and property market risks. There is a renewed market focus on prime properties in Europe, where the leases have strong covenants and lease terms of five years.
For a copy of the report on the property markets in Europe, please visit: http://www.prologisresearch.com/supplychain/default.asp?reid=A3U21446887DE.
The ProLogis Research Group monitors, analyzes and reports on key trends and dynamics in both real estate and supply-chain management, drawing from industry data and primary research conducted by company analysts and a network of affiliated academics and other professionals. Past reports have focused on global supply chain dynamics, internet retailing, RFID technology, offshore outsourcing and other related topics. For more, please visit http://www.prologisresearch.com/.
About ProLogis
ProLogis is a leading global provider of distribution facilities, with more than 475 million square feet of industrial space (44 million square meters) in markets across North America, Europe and Asia. The company leases its industrial facilities to more than 4,500 customers, including manufacturers, retailers, transportation companies, third-party logistics providers and other enterprises with large-scale distribution needs. For additional information about the company, go to http://www.prologis.com/.
DATASOURCE: ProLogis
CONTACT: Media, Mo Sheahan of ProLogis, +1-303-567-5434,
; or Suzanne Dawson of Linden Alschuler & Kaplan, Inc.,
+1-212-329-1420, , for ProLogis; or Investors, Melissa
Marsden of ProLogis, +1-303-567-5622,
Web Site: http://www.prologis.com/
http://www.prologisresearch.com/
ProLogis Announces Third-Quarter Leasing Activity in Mexico
Date : 10/12/2009 @ 7:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&cb=1255352193&article=39850294&symbol=NY^PLD
Company Signs Four Lease Agreements Totaling 860,000 Square Feet, Including 660,000 Square Feet of Development Portfolio Space -
MEXICO CITY, Oct. 12 /PRNewswire-FirstCall/ -- ProLogis (NYSE:PLD), a leading global provider of distribution facilities, announced today it signed third-quarter lease agreements in Mexico totaling approximately 860,000 square feet (79,900 square meters), including 660,000 square feet (61,300 square meters) in its development portfolio.
"We are very pleased to have leased a significant amount of distribution space during the third quarter in Mexico," said Silvano Solis, ProLogis managing director and head of Mexico operations. "ProLogis continues to demonstrate our unique ability to serve both local and global customers in the country, and even throughout challenging market conditions we have consistently met our customers' needs for modern, efficient and well-located facilities."
Recent activity within ProLogis' development portfolio included:
-- 450,000 square feet (41,800 square meters) leased to a global technology leader in consumer electronics, home appliances and mobile communications. The customer will occupy the space at ProLogis Park Cedros-Tepotzotlan Building 10. This is the ninth lease agreement between ProLogis and the company, which now occupies more than 2.8 million square feet (260,100 square meters) of ProLogis distribution space in the United States, The Netherlands, Poland and Mexico.
-- 148,000 square feet (13,700 square meters) leased to a leading business in the automotive industry. The existing ProLogis customer will occupy the space at ProLogis Park Toluca, located approximately 50 miles (80 kilometers) southwest of Mexico City along Interstate 15.
Currently comprising one, 448,000-square-foot (41,600-square-meter) facility, the 50-acre (20-hectare) site has the capacity to support an additional three buildings and 628,000 square feet (58,000 square meters) of industrial space.
-- 62,000 square feet (5,800 square meters) of additional space leased to Evenflo Mexico with a lease expansion. Currently occupying 73,000 square feet (6,800 square meters) at another ProLogis distribution center, the company is relocating and expanding to 135,000 square feet (12,500 square meters) of distribution space at ProLogis Park Izcalli Building One, located in Cuautitlan Izcalli, Mexico, approximately 20 miles north of Mexico City. Evenflo is a leading manufacturer of infant equipment, baby care and juvenile products.
Additional lease activity included:
-- 200,000 square feet (18,600 square meters) leased to Fisher and Paykel Healthcare, a world leader in the design and manufacture of respiratory care devices. The customer will take the space at Pacifico Industrial Center Building 13, located in Tijuana. ProLogis acquired this facility mid-2008.
ProLogis is one of Mexico's largest providers of industrial and distribution space with a 19-million-square-foot portfolio in 11 markets throughout the country. Additional ProLogis customers in Mexico include Bose Corporation, Black & Decker and Whirlpool.
About ProLogis
ProLogis is a leading global provider of distribution facilities, with more than 475 million square feet of industrial space (44 million square meters) in markets across North America, Europe and Asia. The company leases its industrial facilities to more than 4,500 customers, including manufacturers, retailers, transportation companies, third-party logistics providers and other enterprises with large-scale distribution needs. For additional information about the company, go to http://www.prologis.com/.
DATASOURCE: ProLogis
CONTACT: Media, Mo Sheahan of ProLogis, +1-303-567-5434,
; or Suzanne Dawson of Linden Alschuler & Kaplan, Inc.,
+1-212-329-1420, , for ProLogis; or Investors, Melissa
Marsden of ProLogis, +1-303-567-5622,
Web Site: http://www.prologis.com/
Cel-Sci Corporation - Presentation Sept 2009
Posted by: BlackThought Date: Sunday, October 11, 2009 3:28:41 PM
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42401326
==> http://www.cel-sci.com/CVM_Fin_Presentation_Sept_2009.pdf
Unilife Announces A$42.1 Million Capital Raising to Strengthen and Accelerate Global Business Expansion Strategy
Placement of A$32.1 Million to Accredited Investors in the US and Sophisticated and Professional Investors in Australia; Further Offer to Existing Shareholders of A$10 Million Under a Share Purchase Plan
* Press Release
* Source: Unilife Medical Solutions
* On 9:00 am EDT, Wednesday October 7, 2009
http://finance.yahoo.com/news/Unilife-Announces-A421-iw-405227164.html?x=0&.v=1
LEWISBERRY, PA--(Marketwire - 10/07/09) - Unilife Medical Solutions Limited (Unilife or the Company) (ASX:UNI - News) (Pinksheets:UNIFF - News) today announced that it has been successful in obtaining commitments for a capital raising of A$32.1 million (the Placement).
Unilife intends to use the proceeds raised from this Placement and a Share Purchase Plan (SPP) to accelerate the expansion of its operational capabilities, production facilities and equipment requirements in the United States, and complete the industrialisation of the Unilife Ready-to-Fill Syringe which is currently running 12 months ahead of its original schedule.
These proceeds will also be used to fast-track the commercialisation of additional pipeline products which Unilife had been developing more slowly in order to focus its available financial and personnel resources on the development of its initial key products. Unilife will now work to rapidly complete development of these additional products with other interested major pharmaceutical companies with whom the Company is currently in discussions. Furthermore, these proceeds will help ensure the Company has adequate cash reserves leading up to, and following, its proposed redomiciliation in the United States and proposed listing on NASDAQ.
Unilife has received significant interest in recent months from US and Australian investors, as well as other industry stakeholders, regarding its intention to redomicile the Unilife Group in the United States, list on NASDAQ and complete the full commercialization of an expanding portfolio of proprietary safety syringe products targeted for use within pharmaceutical and healthcare markets. The Board of Directors of Unilife has determined it is in the best interests of shareholders to act upon this strong interest prior to its anticipated NASDAQ listing to ensure the Company has sufficient cash reserves to support and accelerate significant business expansion activities which it expects to undertake within the United States.
Existing eligible Unilife shareholders will have the right to purchase up to A$15,000 of fully paid ordinary shares under a SPP at the same price of A$0.85 at which accredited US investors and Australian sophisticated and professional investors have committed to the Company under the Placement. YBR Securities Pty Limited has been appointed to place any shortfall that may occur under the SPP up to A$10 million. This offered price of A$0.85 represents a 7.7% discount from the Volume Weighted Average Price (VWAP) of Unilife shares traded during the last 30 days.
Placement
Unilife has received commitments for a private placement of 37,749,209 ordinary shares (Placement Shares) at an issue price of A$0.85 per share and 18,874,604 free attaching options (Placement Options) to sophisticated and professional investors in Australia, and accredited investors in the United States of America to raise A$32.1 million.
The Placement Shares that have been subscribed for under the Placement comprise:
20,762,065 ordinary shares which are available to be issued under Unilife's 15% placement capacity under ASX Listing Rule 7.1 (Firm Shares) which will be issued on or around 8 October 2009;
and
an additional 16,987,144 ordinary shares which are in excess of Unilife's 15% placement capacity under ASX Listing Rule 7.1 and which will be issued subject to shareholder approval (Additional Shares).
Under the terms of the Placement, each investor will receive two unlisted Placement Options (a tranche 1 option and a tranche 2 option) for every four Placement Shares subscribed for under the Placement. Each Placement Option will entitle the holder to acquire one fully paid ordinary share in the Company and will be issued for nil consideration. All of the Placement Options will be exercisable from the date of grant until the third anniversary of the date of grant and will have an exercise price of A$1.25 for the tranche 1 options and A$2.00 for the tranche 2 options.
In conjunction with the Placement, Unilife has also agreed to issue up to 3 million unlisted options to certain advisers and brokers as part of their fee arrangements with respect to the Placement and Share Purchase Plan described below (Broker Options). The options will each entitle the holder to acquire one fully paid ordinary share in the Company, and will be exercisable from the date of grant until the third anniversary of the date of grant and will have an exercise price of A$0.85.
The issue of the Additional Shares, the Placement Options and the Broker Options will be subject to shareholder approval, which will be sought at an Extraordinary General Meeting (EGM) of Unilife that is presently scheduled to take place on 13 November 2009.
Share Purchase Plan
Unilife is also pleased to announce the terms of an offer to eligible shareholders of the Company under a Share Purchase Plan (SPP) to raise A$10 million (or such greater amount as the directors determine subject to the limits in the ASX Listing Rules).
The SPP will provide eligible shareholders of Unilife with an opportunity to purchase shares in the Company without incurring brokerage or other transaction costs and at the same issue price as the Placement.
Under the SPP, each Unilife shareholder with a registered address in Australia and New Zealand who holds shares at the record date of 9 October 2009 will be entitled to acquire up to A$15,000 worth of new fully paid ordinary shares in the Company (SPP Shares) which will rank equally in all respects with the existing fully paid ordinary shares. The SPP Shares will be offered at an issue price of A$0.85 per share. ASIC regulations do not permit the Company to issue unlisted options under a SPP.
If subscriptions under the SPP exceed A$10 million, the Company may scale back the number of SPP Shares issued to each applicant. If applications are scaled back, any excess application monies will be refunded without interest. However, the Board retains the discretion to issue additional SPP Shares to satisfy all or part of such applications in excess of A$10 million, subject to a maximum number of SPP Shares to be issued being equal to 30% of the issued share capital of the Company at the date of issue (which is the limit imposed by the ASX Listing Rules).
In the event that less than A$10 million is raised under the SPP, YBR Securities Pty Limited has been appointed as placement agent to place any shortfall in subscriptions from shareholders under the SPP. Based on the level of support received from professional and sophisticated investors for the offer to date, YBR Securities Pty Limited has indicated to Unilife that it is confident of being able to place the full amount of any shortfall that may arise under the SPP, at the offer price of A$0.85 per share.
Shareholder approval is not required for the issue of Shares to shareholders under the SPP. However, shareholder approval will be sought at the EGM, presently scheduled to take place on 13 November 2009, for the placement of any shortfall under the SPP as described above.
The SPP documentation will be posted to eligible shareholders on or around 14 October 2009 together with an Application Form. Shareholders will need to complete and return the Application Form by 30 October 2009 in order to take up shares under the SPP. Shareholders should consider all of the SPP documentation, including the SPP Terms and Conditions, before deciding whether to participate in the offer.
Important Dates
Record date for determining entitlements under SPP
5.00pm (Sydney time) on October 2009
SPP documents despatched to eligible Unilife shareholders
14 October 2009
SPP offer opens
14 October 2009
SPP offer closes
5.00pm (Sydney time) on 30 October 2009
SPP Shares allotted
12 November 2009
Despatch of holding statements to shareholders
16 November 2009
The dates in the table above are indicative only and Unilife may amend this timetable. Unilife may also withdraw the offer of new shares under the SPP at any time before the allotment date in its absolute discretion.
Comments from Unilife CEO Mr. Alan Shortall
"Recent Unilife announcements regarding the commercialisation of our proprietary safety syringe products for pharmaceutical customers and other healthcare industry leaders and our proposed redomiciliation of our Company to the US and listing on NASDAQ has generated significant levels of investor interest. The Board considers it beneficial to raise additional capital at this time to take advantage of the rising market and the strength of the Australian dollar so that we are in a strong financial position with adequate cash reserves to facilitate significant business expansion activities that will consolidate and enhance our status as a US-based industry leader of innovative safety medical devices.
"At the commercial level, the Board believes that the improvement of our capital position and available cash reserves should make us a stronger candidate to secure institutional support in the open market, particularly after the NASDAQ listing, and help us withstand any future potential downturn that may occur in the global economy. At the operational level, we intend to utilize our stronger cash position to help complete the industrialisation, production and supply of our Unilife Ready-to-Fill Syringe and Unitract 1mL Syringes to pharmaceutical customers and other healthcare industry leaders. Anticipated pharmaceutical demand for the Unilife Ready-to-Fill Syringe will, in particular, require us to finance a number of operational matters including the purchase of additional manufacturing equipment and the development of a new production facility within Pennsylvania.
"If we are to meet the accelerated target dates for delivery of these products, we must make financial commitments and expend the funds for the new equipment and plant facilities in the very near future and therefore the Board considered it prudent to move the capital raise forward to now, from the original concept of mid-2010 after the NASDAQ listing. In addition, we consider that having a strong Balance Sheet with solid cash reserves will help Unilife management negotiate new agreements with major pharmaceutical companies from a position of strength.
"The capital raising should also help to fast-track the commercialization of additional pipeline products that we are in the process of developing but which have moved more slowly while we focused our available financial and personnel resources on our primary products. A number of these new products may have significant commercial potential, and we will now be able to bring them to market at a faster pace. We believe this capital raise will be sufficient to finance our needs well into the foreseeable future. By completing a significant capital raising at this time, management will now be able to focus their efforts on building Unilife's business rather than in a time consuming search for capital.
"We are pleased with the strong level of interest that we have received in recent months from sophisticated and professional investors within the US and Australia. As such, we are in the enviable position where we have been able to select investors to participate in the private placement that we believe best share our long-term interests. We appreciate the participation of YBR Securities Pty Limited, Inteq Limited, CCZ Statton Equities Pty Limited and their clients who participated in the Placement, and YBR's willingness to place any shortfall under the SPP. We consider that this is a positive sign that our Company is gaining recognition for its success in growing our business, establishing strong relationships with pharmaceutical leaders, and delivering upon key business milestones.
"I am pleased to report that Unilife's Board Chairman, a number of other eligible Directors and senior management and I will be participating fully in the Shareholder Purchase Plan. I hope that our eligible shareholders will also choose to participate with us."
About the Unilife Group
Unilife Medical Solutions Ltd is an ISO 13485 certified company that designs, develops and supplies innovative safety medical devices. Listed on the Australian Securities Exchange (ASX:UNI - News) since 2002, Unilife has FDA-registered manufacturing facilities in the US State of Pennsylvania and a proprietary portfolio of clinical and prefilled safety syringes designed for use within healthcare and pharmaceutical markets.
Contact:
For further information please contact:
Australia
Jeff Carter
T +61 2 8346 6500
F + 61 2 8346 6511
United States
Stuart Fine
T +1 908 469 1788
WNR - Reuters Company Research (29 Sep 2009)
http://www.scribd.com/doc/20482268/WNR-9-29-09
>50% of float was traded last Friday!
Float: 45,116,306
10/09: 23,875,442