Lundbeck and Ovid Therapeutics Announce Exclusive Worldwide Licensing Agreement for Gaboxadol Ovid plans to commence Phase 2 trials in two orphan neurological indications, Angelman Syndrome and Fragile X Syndrome, in 2016 NEW YORK & VALBY, Denmark--(BUSINESS WIRE)--H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY), A global pharmaceutical company specialized in brain diseases
A global pharmaceutical company specialized in brain diseases, and privately-held Ovid Therapeutics Inc. (Ovid), a biopharmaceutical company focused on developing therapies for rare and orphan diseases of the brain, today announced that on March 25, 2015 they entered into an exclusive worldwide license agreement for gaboxadol, the first oral medicine which holds the potential to treat patients with Angelman Syndrome and Fragile X Syndrome. Gaboxadol (OV101) is the only small molecule, highly selective extrasynaptic GABA(A) receptor agonist (SEGA) that has been tested in clinical trials.
Under the terms of the agreement, Ovid obtained exclusive worldwide development and commercialization rights for OV101. In connection with the license, Lundbeck became a minority shareholder in Ovid, and will receive certain milestone payments and royalties on sales. Ovid is responsible for all future development and commercialization for OV101. Additional financial terms were not disclosed.
Ovid plans to pursue the development of OV101 in Angelman Syndrome and Fragile X Syndrome, two orphan neurological disease indications with no available treatment options, and expects to commence a Phase 2 trial for Angelman Syndrome in 2016, followed by a Phase 2 trial in Fragile X Syndrome.
"We are delighted to secure OV101, and are proud to have Lundbeck as a stakeholder in Ovid,” stated Dr. Jeremy Levin, Chairman and Chief Executive Officer of Ovid. “This agreement comes at a time as we simultaneously experience a revolution in the understanding of the genetics and molecular basis of neurological diseases, coupled with a similar advance in understanding the molecular pharmacology of existing drugs. This nexus of new knowledge creates an important opportunity for us to match the right molecule to the right indication. OV101 is the first such molecule for Ovid. We are actively taking advantage of this approach to identify and add products to our growing pipeline."
“We are happy with this agreement allowing development of gaboxadol as a potential treatment for patients who have no medical options available today. If successful, these development programs can change the lives of these patients, and we look forward to following Ovid in their pursuit of realizing gaboxadol’s potential in these indications,” said Anders Gersel Pedersen, Executive Vice President and Head of R&D at Lundbeck.
“OV101 is the only SEGA that has been tested in clinical trials to date. By restoring tonic inhibition at low doses, it has shown promising functional improvement in models of Angelman Syndrome, Fragile X Syndrome, as well as genetic epilepsy models. It is fitting that on the 50-year anniversary of Dr. Harry Angelman’s first description of the syndrome, the development of a potential new therapeutic option is underway,” stated Dr. Matthew During, President and Chief Scientific Officer of Ovid. “There is a critical need for therapies that address rare and orphan neurological diseases such as Angelman Syndrome and Fragile X Syndrome. We look forward to working with the Food and Drug Administration, key thought leaders as well as patients, families and disease foundations, including Foundation for Angelman Syndrome Therapeutics, the Angelman Syndrome Foundation and Fragile X Foundation, to advance gaboxadol through the clinic.”
The selection of Angelman Syndrome and Fragile X Syndrome as initial indications is based upon Ovid’s expectation of a highly favorable benefit-to-risk profile for OV101. The company believes that clinical and preclinical evidence to date strongly support OV101’s anti-epileptic, motor improvement and cognitive enhancement effects. OV101 is the only drug that has been shown to correct the motor deficit, a cause of major morbidity in patients, in a mouse genetic model for Angelman Syndrome. OV101 has been shown to be well tolerated in clinical trials involving approximately 3,000 patients.
About Angelman Syndrome and Fragile X Syndrome
Angelman Syndrome is a rare genetic neurological disorder characterized by global severe developmental delay, movement and balance disorder, seizures, sleep disturbances, severe speech impairment and a happy, excitable demeanor. Approximately 1 in 15,000 live births have Angelman Syndrome, with an estimated 4,000 patients in the United States. There are no therapeutic agents approved to treat Angelman Syndrome. Fragile X syndrome is a genetic neurological disorder that causes intellectual disability, behavioral and learning challenges and various physical characteristics. There are approximately 100,000 patients with Fragile X Syndrome in the United States. No therapeutic agents have been approved to date to treat this disease.
About Ovid Therapeutics Inc.
Ovid Therapeutics Inc. is a privately-held, New York based, biopharmaceutical company committed to transforming the lives of patients with rare and orphan diseases of the brain and few, if any, treatment options - patients who currently have no hope of cure or improvement. Ovid focuses on patients and their needs. Using the significant operational, product development and business development experience of its management team, Ovid aims to become a leading neurology company, with multiple products and a rich pipeline coupled with compelling research and development.
Geller Biopharm Inc. and Hogan Lovell US LLP represented Ovid in its negotiations.
For more information on Ovid, please visit http://www.ovidrx.com.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are alcohol dependence, Alzheimer's disease, bipolar disorder, depression/anxiety, epilepsy, Huntington's disease, Parkinson's disease, schizophrenia and symptomatic neurogenic orthostatic hypotension (NOH).
In 2015, Lundbeck celebrates its 100th anniversary. During the past century, millions of people have been treated with our therapies. It is complex and challenging to develop improved treatments for brain disease, but we keep our focus: There is still so much we need to achieve in the next 100 years to ensure a better life for people living with brain disease.
Our approximately 6,000 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China, Denmark and the United States and production facilities in China, Denmark, France and Italy. Lundbeck generated core revenue of DKK 13.5 billion in 2014 (EUR 1.8 billion; USD 2.4 billion).
For additional information, we encourage you to visit our corporate www.lundbeck.com.
Ovid Therapeutics Inc.
Anna Kazanchyan, MD, +1 212-776-4381
SVP, Product Development
Burns McClellan, on behalf of Ovid Therapeutics
+1 212-213-0006, ext. 327
Cancer Prevention Pharmaceuticals, Inc. (CPP) and Tillotts Pharma AG (Tillotts), a wholly-owned subsidiary of Zeria Pharmaceutical Co., Ltd. (Zeria), are pleased to announce today that the companies have entered into an exclusive licensing agreement for European and Japanese rights to develop and commercialize the combination of CPP-1X/sulindac for the treatment of familial adenomatous polyposis (FAP), an orphan disease, and other gastrointestinal conditions.
Under the terms of the agreement, Tillotts will provide CPP with upfront and milestone payments for European and Japanese development programs under a co-development framework. CPP may also receive payments of over $100 million, including upfront and milestone payments for development and for reaching certain sales levels as well as royalties escalating to double digits on product sales. The agreement can potentially be expanded into additional indications for which CPP-1X/sulindac has shown promise. CPP will be responsible for product development and Tillotts for regulatory and marketing for the respective markets. In addition, Zeria will be responsible for development and marketing in Japan. CPP continues to retain all rights to CPP-1X/sulindac outside of Europe and Japan and outside the gastrointestinal field.
Thomas A. Tóth von Kiskér, CEO of Tillotts commented, “This deal is an important step in our forceful efforts to build an attractive and innovative product portfolio. It is a prime example of Tillotts’ commitment to develop products that improve the lives of patients with gastrointestinal diseases and we are delighted to join forces on this important project with an experienced company like CPP.”
“We are excited to add CPP-1X/sulindac to our product pipeline, as we believe it has the potential to be an important new therapy for gastrointestinal conditions with a high medical need. It matches our development and marketing capabilities and we look forward to developing CPP-1X/sulindac together with CPP,” said Dirk Reckert, Chief Business Development Officer of Tillotts.
Jeffrey Jacob, Chairman and CEO of CPP, said "We are very pleased to partner with Tillotts and Zeria, companies that have shown strength and focus in the GI therapeutic area in Europe and Japan. We are delighted to share the benefits of both their scientific and business expertise in the development and future commercialization of CPP-1X/sulindac. Tillotts and Zeria share our belief in the great potential of CPP-1X/sulindac in familial adenomatous polyposis, an orphan indication with limited treatment options."
Geller Biopharm, Inc. served as CPP’s exclusive agent for this license agreement. DLA Piper LLP and Rusing, Lopez & Lizardi, PLLC acted as CPP’s legal counsel on this transaction.
FAP is an inherited disorder characterized by cancer of the colon and rectum. Patients with the classic presentation of FAP begin to develop multiple benign polyps in the colon in their early teenage years. Eventually, the colon becomes carpeted with hundreds to thousands of polyps and there is a near 100% chance that the polyps will become cancerous if left untreated. Current medical practice dictates the removal of the colon and sometimes the rectum in the formative years for the typical FAP patient. CPP’s lead product CPP-1X/sulindac is being developed to minimize the occurrence and/or recurrence of polyps and tumors associated with FAP and offers the potential of non-surgical pharmacopreventive therapy across the spectrum of FAP patients.
Cancer Prevention Pharmaceuticals, Inc. (CPP) is developing prevention therapies for people with an elevated risk of cancer. CPP's approach has been used with great success in other disease categories such as cardiovascular, neurovascular and infectious disease. Agents that target pre-disease states have helped reduce death rates from these conditions by 50%-70% over the past 30 years (source: Jemal, A. et al. CA Cancer J Clin 2008; 58:71-96). Just as these other prevention therapies represent the largest-selling drug classes on the market today, CPP believes there is even more potential for therapies that reduce the risk of cancer if we are able to move upstream to identify and treat the risk factors associated with cancer. In addition to this Phase III trial, CPP, in collaboration with the National Cancer Institute (NCI) and the SWOG cancer research cooperative group, is sponsoring a large 1,340 patient Phase III trial in colon cancer survivors. CPP is also working collaboratively with non-profit groups to support trials in neuroblastoma—treating and preventing—with three active clinical trials. Additional information is available at www.canprevent.com.
Tillotts Pharma AG is a fast-growing specialty pharma company with 200 employees in Switzerland and abroad. Tillotts is dedicated to the development, in/out-licensing and commercialization of innovative pharmaceutical products, medical devices and diagnostics, all in the field of gastroenterology. Please visit our website www.tillotts.com. Tillotts successfully market its own products Asacol® and Colpermin® as well as in-licensed products, such as Simtomax® in over 55 countries through its own affiliates within Europe and a carefully chosen network of gastroenterology-focused marketing partners throughout the world.
Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, focusing on R&D, manufacturing and sales of prescription drugs as well as OTC products. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559). Zeria holds a leading position within the gastroenterology field in Japan and operates internationally through a number of subsidiaries. For more information about Zeria please visit www.zeria.co.jp. All trademarks used or mentioned in this release are protected by law. Tillotts' trademarks Asacol®, Octasa®, Asacolon®, Colpermin®, are either registered or applied for in up to 70 countries. The trademark Asacol® is a registered trademark by Actavis in the United States of America, Canada and the United Kingdom. Asacol® is a registered trademark in Italy by Giuliani. Colpermin® is a registered trademark by Johnson & Johnson for the United Kingdom and Ireland.
Geller Biopharm is a healthcare investment banking division of Financial West Group, member FINRA/SIPC. Geller Biopharm, Inc. and Financial West Group are unaffiliated entities.
Cancer Prevention Pharmaceuticals, Inc.
Tillotts Pharma AG
Geller Biopharm Inc. announced today that they have successfully acted as an exclusive advisor to IGAN Biosciences of Boston, Massachusetts in its transaction with Shire with respect to IGAN’s preclinical product candidate, IgA protease for the treatment of IgA nephropathy, a rare renal disorder. The economic terms of the transaction are undisclosed.
"We are pleased to have advised IGAN Biosciences in successfully finding an organization to develop their IgA protease for the treatment of IgA nephropathy. It has been an excellent experience, working closely with the outstanding management team of IGAN," said Matthew Geller, PhD, of Geller Biopharm Inc. "Shire is the ideal company to take the development forward. The transaction provides validation of this promising preclinical product candidate, while at the same time potentially providing a meaningful path forward for patients suffering from this orphan renal disorder."
Dr Andrew Plaut, scientific co-founder and Chief Medical Officer of IGAN Biosciences, stated, "We are very pleased that Shire will commit scientific and drug development resources to treat IgA nephropathy. This illness has worldwide impact and often begins in children and young adults in whom kidney failure is a common and serious outcome. Many patients and their families have been following our work at IGAN with great interest, and will rightly be encouraged that a company with the expertise of Shire will take the next steps to seek to address this unmet medical need. We are grateful to Geller Biopharm Inc. for having introduced us to Shire. Geller Biopharm Inc.’s expertise and counsel has certainly been very useful in successfully closing this transaction," he concluded.
About IGAN Biosciences
IGAN Biosciences is a private biotechnology company focused on the research and development of products to provide innovative health solutions to address critical unmet medical needs. For further information, please visit www.iganbio.com.
About Geller Biopharm Inc.
Geller Biopharm Inc. is a healthcare advisory firm based in NYC that has extensive experience and is actively engaged in licensing and consulting assignments for biotech, pharmaceutical and medical device companies. All securities and investment advisory services, including mergers, acquisitions and financial raises provided by Geller Biopharm Inc.’s members are offered through Financial West Group (FWG), member FINRA/SIPC. Geller Biopharm and FWG are not affiliated.
Geller Biopharm Inc.
+1 (212) 315-0600
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Galaxy Biotech, LLC (“Galaxy”) announced that Roche has licensed exclusive worldwide development and commercialization rights to Galaxy’s antibodies targeting fibroblast growth factor 2 (FGF2) for the treatment of cancer.
FGF2 is overexpressed in many types of cancer, and for some tumor types a high level of FGF2 expression correlates with poor clinical outcome. FGF2 has been shown to stimulate not only angiogenesis but also lymphangiogenesis, which may be important in cancer metastasis. Galaxy has developed a novel antibody that neutralizes the biological activity of FGF2, and in published scientific work has shown that the antibody effectively inhibits the growth of certain tumors in animal models.
Under the terms of the agreement, Galaxy will receive an $8 million license fee, and milestone payments contingent on various preclinical, clinical, and regulatory development events, as well as royalties on product sales.
Mike Burgess, acting Head of Roche Pharma Research and Early Development, commented “Galaxy’s humanized monoclonal antibody to FGF2 has demonstrated considerable promise in preclinical studies, and we look forward to developing this and possibly other derivative compounds to complement Roche’s already strong portfolio of antibody products in the oncology field.”
Dr. Cary Queen, President of Galaxy Biotech, said “Roche is one of the world’s leading healthcare companies, with a broad portfolio of innovative products. We are very gratified by their interest in our anti-FGF2 antibodies, and extremely pleased that they will take responsibility for clinical development and commercialization of the program. We could not have hoped for a better partner.”
Geller Biopharm Inc served as Galaxy’s exclusive agent for this license agreement. DLA Piper LLP acted as Galaxy’s legal counsel on this transaction. Partial funding for Galaxy’s FGF2 antibody program has been provided by Small Business Innovation Research (SBIR) grants from the National Institutes of Health.
About Galaxy Biotech
Galaxy Biotech, LLC, is a closely held 10-year old company with laboratories in Sunnyvale, CA, which is developing humanized antibodies against growth factors and their receptors for the treatment of cancer. Including the current agreement, Galaxy has licensed three of its antibody programs to biopharmaceutical companies, although the rights to antibodies targeting hepatocyte growth factor (HGF) were recently returned to the company, and the company is currently seeking a new partner for clinical development and commercialization. Galaxy was founded by Cary Queen, Ph.D., a senior biotechnology executive who previously co-founded Protein Design Labs, Inc. and developed fundamental technology for the humanization of antibodies that has been widely used and licensed in the pharmaceutical industry; K. Jin Kim, Ph.D., a leading scientist in the field of monoclonal antibodies and their application to cancer, who led the development of the mouse precursor antibody of Avastin® while a Senior Scientist at Genentech, Inc.; and James Larrick, M.D., Ph.D., who has founded numerous biotechnology companies. For more information: www.galaxybiotech.com
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com
All trademarks used or mentioned in this release are protected by law.
Geller Biopharm is a healthcare investment banking division of Financial West Group, member FINRA/SIPC. Geller Biopharm, Inc. and Financial West Group are unaffiliated entities.
Galaxy Biotech, LLC
Cary Queen, President
Data has demonstrated platform’s capability to create large collections of novel monoclonal antibodies against difficult transmembrane protein targets. SDIX (Nasdaq: SDIX) today announced that it will be showcasing progress with its advanced Genomic Antibody Technology™ (GAT™) data package this week’s BIO International Convention, one of the largest global partnering events for the biotechnology industry. Advanced GAT is the next generation of the Company’s well-established and successfully marketed proprietary DNA-immunization-based technology. The 2012 event is taking place at the Boston Convention & Exhibition Center in Boston, MA, on June 18-21.
SDIX will be participating in the BIO Partnering sessions on June 18-20. Fran DiNuzzo, CEO, and Klaus Lindpaintner, CSO and VP of R&D of SDIX plan to engage in discussions with Biotechnology and Pharmaceutical companies to share new data documenting the capabilities of the advanced GAT platform.
Management plans to share recent developments demonstrating the platform’s capabilities to create large collections of novel monoclonal antibodies against transmembrane protein targets, including GPCRs. The company believes that these transmembrane protein targets represent a large potential market opportunity - approximately one third of all currently pursued drug targets. The data will include results from initial targets that include CXCR4 and CD-20. These data show that the company’s proprietary technology created large collections of highly diverse monoclonal antibodies, as indicated by both sequence diversity and epitope mapping data, that are functionally active.
“We have recently made substantial progress in creating datasets on large numbers of monoclonal antibodies that demonstrate the strengths of our advanced GAT platform,” commented Dr. Lindpaintner. “Given that creating monoclonal antibodies against GPCRs and other membrane receptors has long been an area of unmet need in the pharma-biotech industry, we believe that these antibody capabilities may offer a large market opportunity for SDIX. Moreover, our platform’s ability to target a broader spectrum of a protein’s epitopes, not just the immunodominant ones, gives us added confidence in advanced GAT’s value proposition.”
Fran DiNuzzo, CEO, added, “We are excited to share our data with potential partners and to discuss the progress in our advanced GAT platform. In addition, we will be showcasing some of our currently available monoclonal antibody collections, such as those around CXCR4 and CD-20 targets, which are currently available for licensing to interested parties. For both targets, we have lead collections of 75 or more molecules. We believe these monoclonal antibody collections may represent differentiated biotherapeutic candidates for biopharma companies.”
SDIX is a biotechnology company with a core expertise in creating better antigens, better antibodies and better assays for the pharmaceutical, biotechnology and food safety markets. For over 20 years, SDIX has been a leading immuno-solutions company, developing results-oriented and innovative antibody-based solutions that enable customers to meet high performance research, diagnostic and commercialization objectives.
In the life science market, SDIX’s technology and capabilities are being used to help discover disease mechanisms, facilitate development of new drugs and provide antibodies and assays for the diagnosis of disease. In the food safety market, SDIX continues to expand its footprint as an international supplier of rapid pathogen test technologies that enable more accurate and cost-effective results.
Forward Looking Statements
This news release may contain forward-looking statements reflecting SDIX's current expectations. When used in this press release, words like “anticipate”, “could”, “enable”, “estimate”, “intend”, “expect”, “believe”, “can”, “potential”, “will”, “should”, “project”, “plan” and similar expressions as they relate to SDIX are intended to identify said forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, which may cause actual results to differ from those anticipated by SDIX at this time. Such risks and uncertainties include, without limitation, changes in demand for products, the application of our technologies to various uses, delays in product development, delays in market acceptance of new products, retention of customers and employees, adequate supply of raw materials, inability to obtain or delays in obtaining fourth party, or required government approvals, the ability to meet increased market demand, competition, protection of intellectual property, non-infringement of intellectual property, seasonality, and other factors more fully described in SDIX's public filings with the U.S. Securities and Exchange Commission.
CONTACT: Media Relations
111 Pencader Drive
Newark, DE 19702
Phase 1 Data Show Clinical Activity of Combining Two Anti-Vascular Approaches: Vascular Disrupting Agent (VDA) and Anti-angiogenic Antibody. OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced the publication of key clinical data from a Phase 1 trial combining fosbretabulin (ZYBRESTAT®, combretastatin A4 phosphate, or CA4P), its lead vascular disrupting agent (VDA), with the anti-VEGF antibody bevacizumab (Avastin ®) to treat patients with advanced solid tumors, without the use of any cytotoxic chemotherapy, and receiving only the combined two anti-vascular drugs.
A total of 15 patients with a median age of 51 years were enrolled in this Phase 1 trial. Nine of 14 patients (60%) treated experienced disease stabilization, and one patient with ovarian cancer had a CA125 response that lasted for more than one year. The combination of CA4P and bevacizumab appeared to be well tolerated. This trial was the first to combine a vascular disrupting agent with an anti-angiogenic monoclonal antibody. Results indicated that CA4P induced profound tumor vascular changes alone which were maintained by the addition of bevacizumab, thus demonstrating the complementary therapeutic effect of combination vascular disrupting and anti-angiogenic agents.
The data from the Phase 1 trial were published in the current issue of Clinical Cancer Research in an article titled, “Phase I Trial of Combretastatin A4 Phosphate (CA4P) in Combination with Bevacizumab in Patients with Advanced Cancer,” by Paul Nathan, MBBS, PhD, FRCP, Consultant Medical Oncologist and Director of R&D Mount Vernon Cancer Centre, Northwood, United Kingdom, and principal investigator for the trial.
Commented Dr. Nathan: “The combination of vascular targeting and anti-angiogenic agents has shown promise in pre-clinical cancer models. This important study is the first time that these two classes of agents have been combined in humans, and suggests that CA4P and bevacizumab could be combined safely in humans. Moreover, we demonstrated that the presence of bevacizumab prolonged the vascular shutdown induced by CA4P. We also showed the enhanced antitumor activity and potential clinical benefit that can be achieved by combining two anti-vascular agents that work through complementary mechanisms of action: a VDA that induces tumor necrosis by destroying existing tumor blood vessels and an anti-angiogenic agent that starves the tumor by preventing revascularization. This combined approach indicates a potential way forward in the ongoing clinical evaluation of vascular disrupting agents, a novel class of antitumor agents.”
“Publication of these important Phase 1 data is a significant milestone for OXiGENE, as these data laid the foundation for advancing ZYBRESTAT combined with bevacizumab into later stage clinical trials such as the ongoing Phase 2 ZYBRESTAT-bevacizumab combination trial in platinum-sensitive second-line and third-line advanced ovarian cancer patients, which is being conducted under the auspices of the Gynecologic Oncology Group (GOG),” said Peter Langecker, M.D., Ph.D., OXiGENE’s President and Chief Executive Officer. “We are looking forward later this year to seeing interim data from that study which could represent a potential clinical breakthrough in the approach to treating ovarian cancer with fewer side effects than typically seen with cytotoxic chemotherapy, and could potentially provide a roadmap to conducting a pivotal registration program in this indication.”
CA4P in combination with bevacizumab appeared to be well tolerated. Dose-limiting toxicities were one asymptomatic grade III atrial fibrillation and one grade IV liver hemorrhage in a patient with a history of hemorrhage. The most common toxicities were hypertension, headache, lymphopenia, pruritus, and pyrexia. Asymptomatic electrocardiographic changes were seen in five patients. There was no significant cardiovascular toxicity or new safety signals observed with the combination of CA4P and bevacizumab.
In summary, CA4P in combination with bevacizumab appeared to be safe and well tolerated with profound tumor vascular changes and early evidence of clinical activity. The company believes this combination warrants further study in later stage clinical trials.
About ZYBRESTAT (fosbretabulin)
ZYBRESTAT has been evaluated in a Phase 2/3 study of patients with anaplastic thyroid cancer and other clinical trials. OXiGENE believes that ZYBRESTAT is poised to become an important product in a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). Through interaction with vascular endothelial cell cytoskeletal proteins, ZYBRESTAT selectively targets and collapses tumor vasculature, thereby depriving the tumor of oxygen and causing death of tumor cells. In clinical trials in solid tumors, ZYBRESTAT has demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against anaplastic thyroid cancer, ovarian cancer and various other solid tumors.
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer. The Company's major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumor progression. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
Forward Looking Statements
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of advancement, outcomes, and regulatory guidance relative to our clinical programs, achievement of our business and financing objectives may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the inherent risks of drug development and regulatory review, and the availability of additional financing to continue development of our programs. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011.
CONTACT: Investor & Media
Cancer Prevention Pharmaceuticals, Inc. (CPP) today announced that it had completed a bridge financing round. As a result, the Company now has sufficient cash reserves for continuing operations into the first quarter of 2012. Geller Biopharm, a healthcare investment banking division of Financial West Group, was the exclusive placement agent.
Jeff Jacob, CEO, stated, "we are pleased to have successfully completed a bridge financing round with high quality investors. Among the participants in this round were the TRAC fund, managed by Mr. Richard Love and Dr. Daniel von Hoff, as well as former biotech and pharmaceutical executives." Mr. Jacob continued, "our choice of endpoints and subsequent positive advice from the European Medicine Agency have resulted in increased enthusiasm from our current investors, new investors, and potential partners. We are optimistic that completion of this bridge round will give us the runway to finalize a partnership and/or financing to complete two Phase III trials, familial adenomatous polyposis (FAP) and preventing recurrence in colon cancer survivors."
Cancer Prevention Pharmaceuticals, Inc. (CPP) is developing therapeutics that reduce the risk of cancer. CPP's approach has been used with great success in other disease categories such as cardiovascular, neurovascular and infectious disease. Agents that target pre-disease states have helped reduce death rates from these conditions by 50%-70% over the past 30 years. Just as these other prevention therapies represent the largest-selling drug classes on the market today (>$25 billion), CPP believes there is even more potential for therapies that reduce the risk of cancer. In addition to its Phase III FAP study, CPP is also collaborating on a large (n=1350) Phase III trial in colon cancer survivors (SWOG study S0820) expected to begin in the second half of 2011. Additional information on CPP is available at www.canprevent.com.
Forward Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the planned Phase III trial of the CPP-1X/sul combination therapy in FAP as well as the company's focus, collaborative partners, and independent and partnered product candidates. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
NEW YORK, April 30, 2010 (GLOBE NEWSWIRE)--Geller Biopharm, Inc. announced today that they have successfully advised BELLUS Health of LAVAL, Quebec, Canada in its transaction with Celtic Therapeutics with respect to Phase III investigational product candidate KIACTA(TM) (eprodisate) for the treatment of AA Amyloidosis. A news release presenting the details of the transaction was issued jointly by BELLUS Health and Celtic Therapeutics on April 29, 2010.
"We are pleased to have advised BELLUS Health in successfully finding a partner for Kiacta for AA Amyloidosis. It has been an excellent experience, working closely with the outstanding management team of BELLUS Health," said Matthew Geller, PhD, President of Geller Biopharm. "This is an ideal partnership for BELLUS Health. It provides validation of their highly promising phase III product candidate, KIACTA(TM), while at the same time contributing to strengthen their financial position."
Mr. Roberto Bellini, President and Chief Executive Officer of BELLUS Health, stated, "We are pleased to deliver on what has been a major priority of our Company and announce this partnership with Celtic Therapeutics to develop KIACTA(TM) to its fullest potential. We are grateful to Geller Biopharm for having introduced us to Celtic Therapeutics. Geller Biopharm's expertise and counsel has certainly been very useful in successfully closing this transaction," he concluded.
KIACTA(TM) is an investigational product candidate for the treatment of AA Amyloidosis. KIACTA(TM) has received Orphan Drug Status designation in the United States and Orphan Medicinal Product designation in Europe and is now advancing to a second Phase III confirmatory clinical trial in the second half of 2010.
KIACTA(TM) was investigated in a landmark international, randomized, double-blind, placebo-controlled, and parallel-designed clinical trial in which 183 AA Amyloidosis patients were enrolled at 27 sites around the world. The results of the Phase II/III clinical trial for KIACTA(TM) demonstrate that this product candidate offers important clinical benefits to patients by reducing the progression of AA Amyloidosis-associated renal disease. These results were published in the June 7, 2007 issue of the New England Journal of Medicine.
About BELLUS Health
BELLUS Health is a global health company focused on the research and development of products to provide innovative health solutions to address critical unmet medical needs. For further information, please visit www.bellushealth.com.
About Geller Biopharm
Geller Biopharm is a healthcare advisory firm based in NYC that has extensive experience and is actively engaged in licensing, mergers, acquisitions and consulting assignments for biotech, pharmaceutical and medical device companies. All securities and investment advisory services, including financial raises, provided by Geller Biopharm's members are offered through Financial West Group (FWG), member FINRA/SIPC. Geller Biopharm and FWG are not affiliated.
Forward Looking Statements
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks include but are not limited to: the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Group does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, that actual results may vary once the final and quality-controlled verification of data and analyses has been completed, as well as other risks disclosed in public filings of BELLUS Health Inc. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These statements speak only as of the date made and BELLUS Health Inc. is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see the Annual Information Form of BELLUS Health Inc. for further risk factors that might affect the BELLUS Health Group and its business.
CONTACT: Geller Biopharm Matthew Geller, PhD, President (212) 315-0600 ext 201 Mobile (917) 509-6062 email@example.com
NEW YORK, Oct. 6, 2009 (GLOBE NEWSWIRE) -- Geller Biopharm, a healthcare investment banking division of Financial West Group, has co-led a $35 million Private Equity Offering for Threshold Pharmaceuticals, Inc. (Nasdaq:THLD). Geller Biopharm has also served as an advisor to Threshold Pharmaceuticals since September of 2008. On October 5, 2009, Threshold completed a private placement of Threshold common stock and warrants with a select group of investors that includes Federated Kaufmann Fund, Frazier Healthcare Ventures and Great Point Partners, LLC. Threshold sold approximately 18.3 million shares of its common stock and warrants to purchase up to approximately 7.3 million shares of its common stock for gross proceeds of approximately $35 million. Each unit, consisting of one share of common stock and a warrant to purchase 0.4 of a share of common stock, has been sold at a purchase price of $1.91, which is equal to the consolidated closing bid price of the common stock as reported on the Nasdaq Capital Market on September 29, 2009, plus $0.05.
"Geller Biopharm is proud to have worked closely with Threshold. Threshold's lead product, TH-302, has shown encouraging positive results in the treatment of a broad variety of solid tumors and has the potential to be a breakthrough cancer treatment. Geller Biopharm has worked closely with Threshold's outstanding management over the past year in assisting them in positioning and presenting their story and is greatly pleased that they now have the financial resources to bring this product closer to the market," said Dr. Geller, President of Geller Biopharm.
About Geller Biopharm
Geller Biopharm is a healthcare advisory firm based in NYC that is actively engaged in licensing, mergers, acquisitions and consulting assignments for biotech, pharmaceutical and medical device companies. All securities and investment advisory services offered through Financial West Group, Member FINRA/SIPC. Geller Biopharm is a healthcare investment banking division of Financial West Group.Ę
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold's product candidates and approach to developing new product candidates, clinical trials and anticipated results, potential therapeutic uses and benefits of our product candidates and financial results, estimates, projections and requirements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to attract and retain employees, commence, enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which was filed with the Securities Exchange Commission on August 6, 2009 and is available from the SEC's website (www.sec.gov) and on Threshold's website (www.thresholdpharm.com) under the heading "Investors." Threshold undertakes no duty to update any forward-looking statement made in this news release.
CONTACT: Geller Biopharm Matthew Geller, Ph.D., President 212-315-0600