CARY, NC (April 1, 2014).  Calvert Holdings, Inc. announced that Michael A. Recny, Ph.D., has been appointed Chief Executive Officer and has been elected a Director of the Company. He replaces Russ McLauchlan, who will become Executive Chairman and who will also now head the newly formed Executive Committee of Calvert Holdings, which will include Dr. Recny, Allan Reiss, President of Calvert Holdings, Inc., and Charles Spainhour, DVM, Ph.D, the Company’s Chief Scientific Officer. Dr. Recny will also continue to serve as President of Calvert Research, LLC.

Of these executive changes, Russ McLauchlan states “We founded Calvert Holdings, Inc. in 1996 with a vision to enter the service sector of the biopharmaceutical industry and to provide a platform to work with early stage companies as they navigate the regulatory path with their experimental drugs toward eventual commercialization. Our first acquisition, Calvert Laboratories, Inc., gave us that entry point. Over the years, we have added and modified several service offerings to the Calvert Labs base, and we intend to continue growing and diversifying the services we can offer to our clients. We have identified several specific opportunities to continue our expansion plans, and I feel now is the time to adjust our management structure to execute on our strategy. Dr. Recny is extremely qualified to lead our efforts going forward, and the creation of an Executive Committee will maximize our overall corporate strengths. I am very pleased to announce this move and look forward to the continued growth of the Company.”

“I am truly excited and honored to accept the role of Chief Executive Officer for Calvert Holdings” said Dr. Recny. “I’ve been working closely with Russ McLauchlan since 2007, and we share a common vision for where we want to take our Company over the next decade. I look forward to continuing to work closely with Russ and the other members of our Executive Committee to achieve our ambitious growth plans.”

About Calvert Holdings, Inc.

Formed in 1996, Calvert Holdings, Inc. is a privately-held company that provides vision, resources and business leadership for all of the companies we develop or acquire. Calvert Holdings (www.calvertholdings.com) is currently the parent company of Calvert Laboratories, Inc. (www.calvertlabs.com), Calvert Research, LLC, and Crescent Green Management Advisors, LLC (www.crescentgreenadvisors.com).

Media Contact:
Michael A. Recny, Ph. D.
Chief Executive Officer
Phone: 919.459.8669
Email: mrecny@calvertholdings.com

oncoceuticsCARY, NC (March 13, 2014): Calvert Research, LLC, a business unit of Calvert Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) recently accepted the Investigational New Drug (IND) application for the Phase I/II trial of ONC201, the lead experimental drug compound being developed by Oncoceutics, Inc., a Calvert Research portfolio company.  ONC201 will initially be studied in Phase I safety and dose ranging clinical studies in patients suffering from advanced cancer, including refractory solid tumors.

ONC201 is a first-in-class small molecule compound that has shown impressive efficacy in a wide range of very aggressive animal tumor models such as glioblastoma multiforme, prostate cancer, melanoma, sarcomas, and mantle cell lymphoma.  ONC201 exerts anti-cancer activity via inactivation of two of the most critical cancer “survival kinase” pathways, ERK and AKT, and employs TRAIL and one of its potent pro-apoptotic receptors, DR5, as apoptotic effectors.

Calvert Research and Oncoceutics previously executed an Investment Partnership Agreement in the third quarter of 2013 to support completion of IND enabling GLP animal pharmacology, toxicology, and pharmacokinetic testing of ONC201 by utilizing the extensive resources of Calvert’s CRO affiliate, Calvert Laboratories, Inc.  Calvert Research made a significant capital investment in Oncoceutics and several members of the Calvert Investment Group (CIG), Calvert’s angel investor network, also contributed capital to Oncoceutics under the same investment terms as Calvert Research.

“We are thrilled that Oncoceutics is now able to begin testing ONC201 in advanced cancer patients” said Dr. Michael A. Recny, President of Calvert Research. “The FDA’s acceptance of the IND application underscores the success of our investment thesis, which focuses on working with early stage biopharmaceutical companies who rely on our expertise and investment capital to help them advance their promising experimental drugs into the clinic.  We are also grateful to the members of CIG who co-invested in Oncoceutics alongside Calvert Research to help support this very exciting oncology compound.”

 

About Calvert Holdings

Formed in 1996, Calvert Holdings, Inc. is a privately-held company that provides vision, resources and business leadership for all of the companies we develop or acquire. Calvert Holdings is currently the parent company of Calvert Labs and Calvert Research.

 

About Calvert Laboratories, Inc.

Calvert Labs provides a wide array of preclinical services to help clients navigate their GLP testing needs prior to advancing their discoveries into clinical trials.  In addition to lead identification and lead optimization services, Calvert’s core service offerings include toxicology, pharmacology, safety pharmacology, ADME, immunotoxicology and immunology.

oncoceutics-logoCARY, NC and HUMMELSTOWN, PA (October 1, 2013). Calvert Research, LLC and Oncoceutics, Inc. announced the execution of an Investment Partnership Agreement to support completion of preclinical studies for ONC201, Oncoceutics’ experimental anti-cancer compound.

Under the terms of the Agreement, Calvert Research will utilize the extensive resources of its CRO affiliate, Calvert Laboratories, Inc., to complete animal pharmacology, toxicology, and pharmacokinetic testing and conduct bioanalytical studies on ONC201 to support the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) by the end of 2013. In conjunction with performing these studies, Calvert Research has made a significant investment in Oncoceutics in the form of a Convertible Promissory Note that can be converted into equity in Oncoceutics under certain terms and conditions.

ONC201 is a small molecule that has shown potent anti-tumor effects in multiple mouse models of human cancer, including brain, colon, breast, lung, and other tumors. ONC201 elevates the expression of TRAIL (TNF-related apoptosis-inducing ligand) and its death receptor DR5 on the surface of tumor cells to trigger a tumor-specific cytotoxic response. ONC201’s exclusive ability to stimulate expression of both the death receptor and TRAIL leads to an increased spectrum of anti-tumor activity, which may offer a meaningful therapeutic benefit to cancer patients in numerous clinical settings.

“We are pleased to add Oncoceutics to our investment portfolio” said Dr. Michael Recny, President of Calvert Research. “This deal represents another outstanding example of how we implement our investment thesis by sharing both capital and development risk with early stage companies that have novel, highly promising experimental drugs. Our partners benefit from our extensive drug development expertise and ability to leverage the world-class capabilities of our affiliate, Calvert Laboratories into a meaningful capital investment in their company.”

“We are delighted that Calvert invested in Oncoceutics to help us advance ONC201 toward human testing” remarked Dr. Wolfgang Oster, CEO of Oncoceutics. “This investment partnership is indicative of Calvert’s entrepreneurial spirit as well as our aligned interests, and it validates the compelling data with ONC201 that have already been generated.”

 

About Oncoceutics, Inc.

Oncoceutics, Inc. is a drug discovery and development company, run by a leadership team with an outstanding track record of success in drug development that seeks to develop and commercialize novel anti-cancer therapeutics. The company investigates small molecule compounds to overcome dysfunctional p53 and related pathways, the most frequently mutated in human cancers. The most advanced of these molecules, ONC201, is the subject of a $1.3M grant from the Pennsylvania Department of Health that will be used to complete the preclinical and administrative components of an IND application, obtain IND and IRB clinical protocol approval, and conduct the first Phase I/II trial in humans. Oncoceutics is on track to file an IND application by the end of 2013.

Oncoceutics Contact:
Lee Schalop, M.D.
Chief Business Officer
lee.schalop@oncoceutics.com

 

About Calvert Laboratories, Inc.

Calvert Labs provides a wide array of preclinical services to help clients navigate their GLP testing needs prior to advancing their discoveries into clinical trials.  In addition to lead identification and lead optimization services, Calvert’s core service offerings include toxicology, pharmacology, safety pharmacology, ADME, immunotoxicology and immunology.

About Calvert Holdings, Inc.

Formed in 1996, Calvert Holdings, Inc. is a privately-held company that provides vision, resources and business leadership for all of the companies we develop or acquire. Calvert Holdings is currently the parent company of Calvert Labs and Calvert Research.

Calvert Contact:
Dr. Michael A. Recny
EVP and Chief Investment Officer, Calvert Holdings, Inc.
President, Calvert Research, LLC
(919) 459-8669
mrecny@calvertholdings.com

Agreement to Advance Pharmaceutical Applications for Agile Sciences’ technology

Raleigh, NC. (October 4, 2011).  Agile Sciences, Inc. and Calvert Research, LLC, a business unit of Calvert Holdings, Inc., announced today that they have signed a strategic Research Collaboration to support the preclinical evaluation of Agile Sciences’ proprietary Agilyte™ small molecule compound library.  The Agilyte™ compounds were created by co-founders Dr. Christian Melander and Dr. John Cavanagh at North Carolina State University (“NCSU”) and are designed to treat a wide range of antibiotic resistant bacterial infections.  Rights to develop and commercialize these novel small molecule compounds were exclusively licensed to Agile Sciences by NCSU in 2007.

Hospital acquired bacterial infections are responsible for an estimated 100,000 deaths in the United States each year.  Many of these new infections are resistant to multiple conventional antibiotics, and few new treatment options are being developed.  In laboratory studies, Agilyte™ compounds have been shown to overcome antibiotic resistance in many different multi-drug resistant bacterial strains through a new mechanism which re-sensitizes these drug resistant bacteria to conventional antibiotics.

Under the terms of the Research Collaboration, Calvert Research will invest its management expertise and extensive preclinical development resources via its CRO affiliate, Calvert Laboratories, Inc., to test the ability of selected Agilyte™  compounds to successfully treat certain drug resistant bacterial infections (such as Methicillin Resistant Staphylococcus aureus, or “MRSA”) in mouse models.  Calvert Research and Calvert Laboratories may also evaluate the in vivo safety and pharmacology profile of Agilyte™ compounds to determine their suitability for further pharmaceutical development.  Based on the Research Collaboration study results, Agile Sciences and Calvert may elect to create and jointly own a new corporate entity that would hold the product development and commercialization rights to the Agilyte™ compound library for all human therapeutic and diagnostic uses.

Agile Sciences’ Chief Executive Officer, Mr. Keith Stoneback, stated, “This Collaboration leverages the impressive preclinical drug development capabilities of Calvert Research and facilitates Agile Sciences’ ability to more effectively advance the promise of our technology in human therapeutic applications”.

“We are very pleased to be working with Agile Sciences to evaluate the in vivo properties of the Agilyte™  compounds, which have the potential to revolutionize the treatment of life-threatening, drug resistant bacterial infections” commented Michael A. Recny, Ph.D., President of Calvert Research.  “Our investment in this Collaboration represents another key example of our strategy to utilize our extensive drug development expertise and capabilities to help emerging biopharmaceutical companies create substantial value by advancing their discovery stage drug candidates closer to human testing.”

About Agile Sciences:
Agile Sciences is headquartered on North Carolina State University’s Centennial Campus. The company was founded in 2007 to provide commercial solutions to those industries plagued by the effects of biofilms. The company’s proprietary Agilyte™ compounds have been shown to be effective in overcoming bacterial resistance mechanisms.  For additional information, please visit: http://www.Agilesci.com.

About Calvert Research:
Calvert Research, a business unit of Calvert Holdings of Cary, N.C., is pioneering a new way to work with early stage biopharmaceutical companies and academic institutions to help them advance their novel drug candidates from a promising discovery to the first stage of human testing.  Calvert Research leverages its extensive drug development expertise by combining it with a wide range of preclinical services offered by its CRO affiliate, Calvert Laboratories, to design and execute customized, risk-sharing drug development partnership programs with its corporate and academic partners. For more information, please visit http://calvert-research.com.

 

Public-Private Partnership Is New Model For State To Attract Business, Encourage Exports
RESEARCH TRIANGLE PARK, N.C. – The N.C. Department of Commerce, the North Carolina Biotechnology Center, Longistics, the North Carolina China Center (NCCC), the China Investment Promotion Agency (CIPA), Calvert Research, LLC and The Hamner Institutes for Health Sciences, under its new Hamner-China Biosciences Center, have announced their joint participation in the N.C. China Global Gateway Platform for Investment and Economic Development (the “Platform”) to promote job creation and trade in North Carolina and China. The partners will cooperate in the development of a new model to attract investment to the state, as well as support and bolster the foreign competitiveness of N.C. exports with a process that can be replicated among many economic sectors statewide. Goals for this public-private partnership include developing an easily understandable and functional Platform that increases economic development and job creation, accelerating life science development in North Carolina and China, and establishing a showcase Platform for global life sciences, technology, business and economic development.
The Platform is part of a comprehensive effort by Gov. Bev Perdue’s administration, which has spent two years encouraging more trade and investment with China. Important activities have included a business delegation visit to China by the governor, and Commerce Secretary Keith Crisco; a delegation visit from other state leaders and government officials; the creation of the China Advisory Council, a group of North Carolina leaders who provide guidance on how the state can best build productive relationships with Chinese government officials as well as business and industry; adding capacity to the existing investment and trade office in Shanghai.   The Obama administration has publicly stated a goal of doubling U.S. exports by 2015, which could realize up to 2 million trade-related jobs. Chinese Premier Wen Jiabao has endorsed this concept.
The duties of the parties involved in the Platform will include:
– The N.C. Department of Commerce and the North Carolina Biotechnology Center will facilitate investment/export opportunities, provide resources to support the operation as well as represent the public’s interest to see that the final Platform developed can be replicated by North Carolina business sectors.
– The North Carolina China Center (NCCC), started by Longistics creators Duane and Pat Long, will have Luke Treloar serve as its executive officer in Beijing and act as an independent representative of the NCCC for North Carolina. He will serve as a liaison between the N.C. partners and the China partners during the project and provide a detailed feasibility and opportunity analysis. Treloar will research, establish and define which benefits the Platform will provide all partners, then submit the plan to China to review and create visible investment projects there. NCCC works on promoting relations in business and academia between North Carolina and the greater China region.
– Longistics and The Hamner-China Biosciences Center, both based in Research Triangle Park, are participating to expand their business models into the China region. Longistics, a global logistics solution with extensive knowledge of the Chinese import and export business, will provide an in-kind donation of office space and consulting support for new businesses enter the China market. Longistics recently expanded into the China market with the launch of its new Suzhou Industrial Park International Commodities Exhibition Center and joint partnership with Chinese logistics company SeAll. The Hamner will have Treloar as its center’s manager when in the United States.
– Calvert Research, based in Cary, N.C., is the initial North Carolina company involved in the Platform and is providing financial assistance to cover a portion of the Platform’s initial operating costs. Calvert Research is a strategic advisory and investment firm that establishes drug development partnerships with biopharmaceutical companies to help them advance their preclinical stage drug candidates toward human testing. Treloar will concentrate on ways in which Calvert Research can expand its business model into China, focusing specifically on Good Laboratory Practice (GLP) training programs that Chinese scientists may need to successfully conduct preclinical animal testing on drug candidates according to the U.S. Food and Drug Administration guidelines.
– CIPA, a division of the Chinese Ministry of Commerce that organizes and promotes inbound and outbound foreign investment, will apply policy and incentives to the Platform being written. CIPA depends on private sector partnerships to actualize the Platform financially, while it provides consulting and guidance of Chinese government policies and regulations.
QUOTES:

“China is North Carolina’s second largest trading partner and continues to grow,” said Commerce Secretary Keith Crisco.  “The establishment of this Global Gateway Partnership will lead to more jobs, increased exports, and new business opportunities.  This innovative approach can pay big dividends to all participants in the long run.”

“With this Platform, we hope to attract additional campus development funding, expand existing life science partnerships in China and gain access to novel life science technologies developed by Chinese companies associated with the Platform,” said Dr. William Greenlee, president and CEO of The Hamner. “It is a major element of our global initiative plans that can benefit many Americans and Chinese in the process.”

“We are excited about this partnership and the opportunities it will provide for our state’s biotechnology and life-science companies,” said Norris Tolson, president and CEO of the North Carolina Biotechnology Center. “A facilitated introduction between companies in North Carolina and China is a significant advantage for companies in both locations.”

“Having been a proponent of more trade with China for several years, I know this is the right step for North Carolina to take,” said Duane Long, chairman of Longistics. “This Platform can help North Carolina lead the nation in investing and doing business with China.”

“As our mission is to create bridges of understanding between businesses and cultural and educational institutions in North Carolina and China, we enthusiastically endorse this Platform,” said Tom Martineau, president of the North Carolina China Center. “It fulfills the needs of everyone involved.”

“We are very pleased to be part of the launch of this Platform,” said Dr. Michael A. Recny, president of Calvert Research, LLC. “We believe that Chinese companies can gain valuable knowledge and expertise from Calvert’s preclinical drug development service offerings and GLP training programs. This Platform presents an ideal opportunity to help accelerate life sciences development in China by expanding our reach into this important international market.”

ABOUT THE N.C. DEPARTMENT OF COMMERCE:

The N.C. Department of Commerce works with local, regional, national and international companies to improve the economic well-being and quality of life for all North Carolinians by serving existing business and industry, including providing international trade assistance, and recruiting new jobs and domestic and foreign investment, among other responsibilities. For more information, visit http://www.nccommerce.com/en.

ABOUT THE NORTH CAROLINA CHINA CENTER:

The North Carolina China Center has a mission of creating of bridges of understanding between businesses, as well as cultural and educational institutions, in North Carolina and the greater China region including Mainland China, Hong Kong, and Taiwan. For more information, visit http://www.ncchinacenter.org.

ABOUT THE NORTH CAROLINA BIOTECHNOLOGY CENTER:

The North Carolina Biotechnology Center supports biotechnology research, business and education to create jobs statewide. Located in Research Triangle Park, it is the nation’s first state-sponsored biotechnology initiative. For more information, visit http://www.ncbiotech.org

ABOUT LONGISTICS:

Located in Research Triangle Park, N.C., Longistics is a full-service provider of global logistics solutions that specializes in cold-chain logistical support and problem solving services for a broad range of pharmaceutical manufacturers and distributors of high value, high security products. A leading provider of third-party logistics, Longistics has a worldwide reach and growing presence in China and other emerging world markets. For more information, visit http://www.longistics.com.

ABOUT CALVERT RESEARCH:

Calvert Research, a division of Calvert Holdings of Cary, N.C., is pioneering a new way to work with early stage biopharmaceutical companies and academic institutions to help them advance their novel drug candidates from a promising discovery to the first stage of human testing. Calvert Research leverage its extensive drug development expertise by combining it with a wide range of preclinical services offered by its CRO affiliate, Calvert Laboratories, to design and execute customized, risk-sharing drug development partnership programs with its corporate and academic partners. For more information, visit http://calvert-research.com.

ABOUT THE HAMNER INSTITUTES FOR HEALTH SCIENCES:

The Hamner Institutes for Health Sciences is a nonprofit research organization located in the heart of Research Triangle Park (RTP), N.C. Its two flagship institutes, the Institute for Chemical Safety Sciences and the Hamner-UNC Institute for Drug Safety Sciences, build upon 35 years of preeminent research in toxicology and human health research to develop and validate new cutting-edge tools for safety assessment. For more information, visit http://www.thehamner.org.

Contact: Jeff Tippett

919.459.8662

 

Cary, NC–November 11, 2010–Calvert Research, LLC announced today that one of the Company’s therapeutic development programs (T1-1081) qualified to receive federal grant funding totaling approximately $245,000 under the Patient Protection and Affordable Care Act of 2010 (“The ACT”), which will be used to help advance T1-1081 toward an IND application filing.
The Act created a $1.0 billion federal program to provide grants or tax credits to help support certain “Qualifying Therapeutic Discovery Projects” that have been designated by the Department of Health and Human Services using the following criteria: (a) the potential to create a novel therapy to treat unmet medical needs; (b) the potential to reduce long-term health care costs in the U.S., and (c) be among those projects with the greatest potential to create and sustain jobs and increase U.S. competitiveness.

T1-1081 is currently undergoing preclinical evaluation as a potentially more effective treatment for the wet form of Age-related Macular Degeneration (AMD), which is a major cause of significant vision loss in people over age 50 affecting millions worldwide.  T1-1081 was specifically designed to affect multiple factors that lead to vision loss by targeting and destroying unwanted blood vessels in the back of the eye that cause this disease, by blocking formation of new blood vessels, and by reducing inflammation that damages retinal cells.  T1-1081 also has the potential to treat other serious ocular diseases such as diabetic retinopathy, and the dry form of AMD

“We are very pleased to have been awarded the maximum amount from this competitive grant program, which will be used to help advance T1-1081 toward human clinical studies” said Dr. Michael A. Recny, President of Calvert Research.  “We licensed rights to develop and commercialize T1-1081 from Tulane University in 2009, and it represents a key component of our strategy to assemble a diverse portfolio of novel preclinical stage therapeutic compounds that we can advance quickly and efficiently toward human studies by leveraging our extensive in-house preclinical development expertise together with our preferred network of contract service partners”.

About Calvert Holdings, Inc.

Formed in 1996, Calvert Holdings, Inc. (www.calvertholdings.com) is a privately-held company consisting of a diverse portfolio of companies including Calvert Labs, Calvert Research, Calvert Corporate Funding, and Calvert Creative.

Calvert Holdings is a company of people who are passionately engaged in contributing to the future well being of the planet we live on. By analyzing how emerging discoveries and current trends will affect future global needs, we position resources and apply our skills to meet them.

About Calvert Labs

As a global service provider, Calvert Labs’ core offerings include toxicology (acute through chronic & carcinogenicity plus reproductive and developmental), pharmacokinetics & ADME, pharmacology, safety pharmacology, immunotoxicology and immunology.

About Calvert Corporate Funding

Calvert Corporate Funding has emerged from its parent, Calvert Holdings, Inc., to address the needs of small and mid-sized companies seeking an alternative source of capital from traditional banking and lending institutions. Recent economic challenges, financial reform, and bank credit restrictions have created a need for viable options to be made available to business owners and operators.

In addition to its extensive network of non-bank lenders, Calvert Corporate Funding is a direct representative of the Global Finance Group, whose network includes a consortium of seventeen non-bank lenders. This array of investors specializes in lending to credit-worthy business owners/operators using creative financial packages.  Due to our extensive banking and asset-based lending experience, we are able to identify the optimum lender/company match.

About Calvert Creative
Calvert Creative powers online and offline marketing by helping companies push their brand to the next level. Utilizing various marketing platforms, Calvert Creative develops strategies, executes campaigns, and optimizes results to reach the target market and drive traffic.

Cary, North Carolina April 8, 2010

Calvert Holdings, Inc. announced today a restructuring of executive responsibilities within in its Calvert Research, LLC business unit, effective April 1st, 2010.

Michael A. Recny, Ph.D. has been appointed as President of Calvert Research, LLC, assuming the position currently held by Russ McLauchlan, Chairman & Chief Executive Officer of Calvert Holdings, Inc.

“Michael and I have now worked together for several years, and I have come to appreciate that he is a highly competent individual who has a keen ability to balance his skills as an experienced scientist and successful drug developer with appropriate business insight and discipline” said Russ McLauchlan.  “Together we formed Calvert BioCapital, a new venture fund that would focus on acquiring and developing early stage drug candidates licensed from major universities.  While fundraising for the venture fund has now been terminated, we continue to believe the fundamental strategy we set is sound and viable. Our history of working with University technology transfer offices and young biopharmaceutical companies to develop and then identify clinical development partnerships gives us confidence our business model is sustainable. The changes in management responsibilities are designed to accelerate the pace of our portfolio development.”

Dr. Recny will be responsible for building an internal portfolio of clinical stage drug candidates within Calvert Research utilizing the same core elements of the investment strategy that he and Russ McLauchlan formulated in 2007.

“I am very pleased to assume this new leadership role within Calvert Research,” said Dr. Recny.  “We will continue to focus on implementing our capital efficient, virtual drug development model to create clinical stage assets that will be attractive acquisitions candidates for pharmaceutical and biotechnology partners.  Our current drug candidate  consists of a novel, patented compound we licensed from Tulane University in 2009 for the potential treatment of the wet form of age-related macular degeneration that is currently being evaluated in preclinical studies, and we look forward to expanding our portfolio with additional assets in the near future.”

Sam C. Tetlow, MBA will assume a new role as Vice President of Business Development for Calvert Research.  In this position, Mr. Tetlow will be instrumental in setting the strategic direction of the compounds and technologies housed within the Calvert Research portfolio while cultivating relationships with corporate partners interested in collaborating and acquiring rights to portfolio technologies as they advance toward human clinical trials.

“Sam first joined Calvert BioCapital shortly after we formed the fund, and we quickly learned that he improved our ability to interface with the investment community with his  operational and strong investment experience,” said Russ McLauchlan.  “In his new role within Calvert Research, Sam will be instrumental in helping to execute our business model, as well as contributing to other important business initiatives within Calvert Holdings, Inc.”

Andy Burch, Vice President of Calvert Research, will continue to lead the direct involvement of Calvert Research with University Technology Transfer offices and will add to his role as President of Carolina Securities LLC, a wholly owned business unit of Calvert Holdings, Inc. Mr. Burch will also assume additional responsibilities for new business initiatives within Calvert Holdings, Inc.

“Andy is a valued member of the Calvert organization and we look to him to drive the implementation of many initiatives we have put into our longer term strategic plan,” said Mr. McLauchlan. “We know that Andy has been key to our success in multiple sectors of our businesses, and we want to deploy his efforts across several other areas of our company.”

About Calvert Holdings, Inc.

Formed in 1996, Calvert Holdings, Inc. is a privately held company consisting of a diverse portfolio of companies including the following: Calvert Laboratories, Calvert Research, Calvert Creative, and Carolina Securities.

Calvert Holdings is a company of people who are passionately engaged in contributing to the future well being of the planet we live on. By analyzing how emerging discoveries and current trends will affect future global needs, we position resources and apply our skills to meet them.

CARY, North Carolina (June 9, 2009). Calvert Research today announced the execution of a license agreement with Tulane University granting Calvert Research (through its wholly owned subsidiary, Calvert T1, LLC) certain rights to issued patents and patent applications covering a technology platform and novel compounds which have the potential to treat a debilitating eye disease known as Age-related Macular Degeneration (AMD).  The patented compounds and technology licensed by Calvert T1 were developed in the laboratory of Dr. David H. Coy and his team at the Peptide Research Laboratory at Tulane University.

AMD is a leading cause of blindness in the elderly, affecting millions worldwide and results from the progressive deterioration of the macula, which are the light-sensitive cells of the central retina at the back of the eye.  AMD is characterized by two types: a dry (atrophic) and wet (exudative) form.  Wet AMD occurs when abnormal blood vessels behind the retina begin to grow under the macula, often leaking blood and fluid that can lead to visual distortions, a decrease or loss of central vision, and eventual blindness.

The preclinical stage compounds licensed by Calvert T1 combine the known anti-proliferative effects of a somatostatin peptide analog with a cytotoxic drug chemically linked to the peptide, resulting in a dual mechanism drug candidate designed to specifically target and kill abnormal blood vessels found in wet AMD patients.

The lead compound from this technology platform has shown activity in an animal model of AMD.  Calvert T1 intends to advance it further through additional preclinical studies using its network of preferred pharmaceutical development service providers including Calvert Laboratories, Inc., a leading contract laboratory offering toxicology, pharmacology, immunology, pharmacokinetic and other preclinical services to the biotechnology and pharmaceutical industry.

Russ C. McLauchlan, Chairman and CEO of Calvert Holdings commented: “We are very pleased to enter into this agreement with Dr. Coy and his colleagues at Tulane to further develop this very promising technology for the treatment of wet AMD.  This disease is of growing concern to millions of people as our population ages.  Calvert has a strong commitment to work with research universities such as Tulane to advance these research efforts.”  He added: “Calvert T1 is a continuation of investments in a range of technologies over the last several years.  Other investments include the following: CureDM (Lankenau Institute) for diabetes, Auburn University for targeted drug delivery, Pinnacle Pharmaceuticals (University of Virginia) for wound healing, and AcSentient II (now owned by Ista Pharmaceuticals, Inc.) for ocular hypertension/open-angle glaucoma.

About  Tulane University
Tulane University is one of the nation’s leading educational and research institutions. Founded in 1834 in New Orleans, Tulane has ten schools and colleges offering degrees in architecture, business, law, liberal arts, medicine, public health and tropical medicine, the sciences and engineering, and social work.

About Calvert Holdings, Inc.
Formed in 1996, Calvert Holdings, Inc. (www.calvertholdings.com) is a privately-held company consisting of a diverse portfolio of companies including the following: Calvert Laboratories, Inc.; Calvert Research, LLC; Calvert Creative, LLC; Carolina Securities, Inc. and Calvert Cafe.

Calvert Holdings is a company of people who are passionately engaged in contributing to the future well being of the planet we live on. By analyzing how emerging discoveries and current trends will affect future global needs, we position resources and apply our skills to meet them.

Calvert Research and CureDM Sign Collaborative Agreement

by Jeff Tippett on February 19, 2009

Calvert Research announced today the signing of a collaborative agreement with CureDM to continue the preclinical development of CureDM’s HIP2B peptide.  Calvert and CureDM have been working together for the past two years to identify a lead candidate in the CureDM portfolio. Calvert and CureDM will now work toward preparing an IND submission by the end of 2009.

Located on the Lankenau Institute Medical Research campus in Wynnewood, Pennsylvania, CureDM is developing a humanized peptide, HIP2B, which has promise to regenerate insulin-producing islet cells and stimulate differentiation of adult pancreatic progenitor cells, a potential benefit to type 1 and 2 patients with diabetes. “This could be a true breakthrough for diabetes because it addresses the underlying deficiency of pancreatic islets,” according to CureDM’s Chief Medical Officer, Claresa Levetan, MD.  Calvert has invested in CureDM on a number of fronts including preclinical studies at Calvert Laboratories (a Calvert Holdings unit), project management services, and corporate identity development.

Dr. Dana Minnick, Director of Project Management, will oversee Calvert activities supporting the preclinical development of HIP2B. According to Dr. Minnick: “HIP2B is a novel technology with the potential to treat all forms of diabetes.  Early preclinical studies support the proposed mechanism of action and suggest an exciting new target for diabetes treatment complementary to current therapies.”

Dr. Dana Minnick Joins Calvert Research

by Jeff Tippett on December 17, 2008

Calvert Research is pleased to announce the hiring of Dr. Dana Minnick as Director of Project Management. Earning a PhD, MS, and BA from Case Western Reserve University in Cleveland, Ohio, Dr. Minnick pursued post-doctoral studies at the National Institute of Environmental Health Science, Research Triangle Park, NC.  In 2006, Dr. Minnick received the GlaxoSmithKline Excellence in Science award.

Bringing almost a decade of pharmaceutical experience in preclinical drug discovery and development, Dr. Minnick stated: “I am excited to be joining Calvert Research. I look forward to being a part of this talented team committed to bridging the gap between drug discovery and clinical development.”

Established in 2003 to work with early-stage companies to advance their lead candidate biopharmaceuticals, Calvert Research has further evolved to working closely with technology transfer executives of major universities across the country to identify, license, and develop novel compounds. Mr. Russ McLauchlan, CEO, noted: “Dr. Minnick’s professional experiences fit perfectly into our organization. She brings the skills to advance our group’s capabilities as we continue to identify technologies we expect to license and develop and a personality that reflects our corporate image. We’re glad she has joined us and we all look forward to working with her.”