preclinical related Press Releases

Novavax Announces Preclinical Study Demonstrating that a Virus-like Particle Vaccine Provided Protection Against H1N1 and H5N1

Calisha Myers — Thu, 16 Apr 2009 10:41:57 -0400

NOVAVAX Announces Publication of a Preclinical Study Demonstrating that a Virus-like Particle Vaccine Provided Protection Against Highly Pathogenic H1N1 and H5N1 Influenza Strains

H1N1 Virus-like Particle (VLP) Vaccine Candidate Based on the 1918 Spanish Influenza Strain Protected Mice and Ferrets Against the Spanish Flu and Highly Pathogenic H5N1 Bird Flu

ROCKVILLE, Md., April 14 /PRNewswire-FirstCall/ -- Novavax, Inc. (NASDAQ: NVAX) today reported preclinical study results showing that an investigational H1N1 virus-like particle (VLP) vaccine based on the 1918 Spanish influenza strain protected against both the Spanish flu and a highly pathogenic H5N1 avian influenza strain. The study, published in the March 25, 2009 online issue of the Journal of Virology, was conducted by scientists from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA and Novavax under a Collaborative Research and Development Agreement.

Novavax scientists designed and produced a recombinant VLP vaccine candidate against the 1918 H1N1 influenza strain. This 1918 influenza strain was responsible for more than 50 million deaths worldwide during the great Spanish flu pandemic. Mice and ferrets were vaccinated with VLPs by one of two routes: either by standard intramuscular injection or by administering a small drop of the VLP vaccine in the nose (intranasal immunization). All of the 1918 VLP-immunized animals were protected when exposed to a lethal dose of the 1918 influenza virus, regardless of the route by which the vaccine was administered. Remarkably, animals immunized by the intranasal route were also protected against a lethal dose of a contemporary, highly pathogenic avian influenza subtype H5N1 virus strain, isolated from a fatal human case in 2004 (A/Vietnam/1203/2004 strain).

The H1N1 VLP vaccine candidate was made up of the hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins from 1918 Spanish influenza virus strains. These proteins, which were produced in insect cells, formed three-dimensional structures that mimic the 1918 pandemic influenza virus but without the genetic material needed for replication. The mechanism of action by which this H1N1 VLP vaccine candidate provided broad cross-protection is under further study, but the scientists described preliminary evidence that antibody cross-reactivity between the HA and possibly NA proteins of the H1N1 and H5N1 influenza were important.

"Unlike other non-live influenza vaccines, the VLPs are uniquely positioned to stimulate immunity through multiple mechanisms," said Dr. Penny Heaton, Chief Medical Officer at Novavax. "First, they contain HA protein that is the same structure as the live virus, which may stimulate HA antibodies of several types that not only prevent the virus from attaching to cells but also prevent the virus from fusing with cells. Second, the VLPs contain NA which may stimulate production of antibody that prevents spread of the virus down the respiratory tract. Finally, the structure of the HA and NA proteins and the way in which they are embedded in lipids on the surface of the VLP may activate the innate immune system providing protection against both the H1N1 and H5N1 strains," said Dr. Heaton.

Although cross protection against influenza strains of the same hemagglutinin or HA type has been achieved through the use of vaccines with adjuvants (e.g., cross-protection against H5N1 A/Vietnam and A/Indonesia strains), protection against strains with different HA types, as shown in this study, has not been reported. Cross-protection against different HA types is highly desirable for pandemic influenza vaccine candidates because it is not possible to predict the strain that may be responsible for the next pandemic with today's technology. A broadly cross-protective vaccine would be ideal for stockpiling in that it could be administered during the first wave of the pandemic while waiting for manufacture of vaccine specific to the pandemic strain.

Dr. Gale Smith, Vice President of Vaccine Development at Novavax, said, "The discovery that a VLP-based influenza vaccine candidate created through cell-based recombinant technology has the potential to protect against diverse strains of influenza has significant implications for both pre-pandemic and pandemic preparedness. A broadly protective vaccine administered prior to and during the first wave of a pandemic could prevent widespread morbidity and mortality from a newly emerged pandemic influenza strain and allow time for the development of strain-specific vaccines."

About Novavax

Novavax, Inc. is a clinical-stage biotechnology company creating novel vaccines to address a broad range of infectious diseases worldwide using advanced proprietary VLP technology. The company produces these VLP based, potent, recombinant vaccines utilizing new, and efficient manufacturing approaches. The Company has VLP vaccine candidates against seasonal influenza and potential pandemic influenza strains in phase II clinical development.

This report describes the second of two preclinical studies of Novavax's investigational H5N1 pandemic influenza vaccine announced this year that have shown different approaches to achieving broad protection against diverse influenza strains. As announced in February, a VLP vaccine with an HA based on several H5 strains showed broad cross-protection against different H5 strains. In the current study, an alternative route of administration resulted in cross-protection against different HA types. Novavax has shown in clinical trials that an H5N1 VLP candidate vaccine given by intramuscular injection is well tolerated and immunogenic in humans. Preclinical research on alternative pandemic influenza VLP vaccine approaches is expected to continue.

Additional information about Novavax is available at www.novavax.com and in the company's various filings with the Securities and Exchange Commission.

Forward Looking Statement

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, safety, efficacy and potency of our vaccines, and supply availability are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to commencing clinical trials and their outcome; risks relating to the supply and commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrolment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

ReNeuron announces positive pre-clinical data with lead stem cell line in peripheral arterial disease

Calisha Myers — Mon, 06 Apr 2009 11:51:02 -0400

ReNeuron announces positive pre-clinical data with lead stem cell line in peripheral arterial disease

06/04/09

Guildford, UK, 6 April 2009: ReNeuron Group plc (LSE: RENE.L) today announces positive pre-clinical efficacy data with its lead CTX stem cell line in a model of peripheral arterial disease (PAD).This is a chronic and debilitating disease that progressively restricts blood flow in the limbs, causing cramping, chronic pain and in extreme cases, loss of limb. PAD is commonly associated with other conditions such as diabetes, obesity and stroke. At least 1 in 20 people over the age of 55 have some degree of PAD and it becomes more common with increasing age.

The research was conducted by Professor Paolo Madeddu, Chair of Experimental Cardiovascular Medicine and colleagues at the Bristol Heart Institute, Bristol, UK. The researchers tested ReNeuron's CTX stem cell line, via intramuscular injection, in a recognised murine hind limb ischaemia model. The cells were seen to generate significant recovery of blood flow in the ischaemic limb and tissue perfusion was shown to improve through increased revascularisation of the damaged tissue, as measured by increased capillary and arteriole density.

The results of the study are being presented at the UK National Stem Cell Network Second Annual Scientific Conference, taking place on 6-8 April at the University of Oxford Examination Schools, Oxford, UK. Further information concerning this conference may be found at www.uknscn.org/meetings/meetings09.

ReNeuron is continuing its research collaboration with Professor Madeddu and his colleagues with the aim of generating further pre-clinical data sufficient to translate these initial findings into a clinical programme within the next two years. In the meantime, the Company intends to commence an initial clinical trial in the UK this year in disabled stroke patients, where the same CTX stem cell line forms the basis of the Company's ReN001 therapy in this indication. UK regulatory approval for this trial was granted in January of this year.

Commenting on the results of the study, Professor Madeddu said:

"The results of this initial study are very promising and compare very favourably with other cell types that are being tested in models of peripheral ischaemia. We look forward to continuing to test the potential of the CTX cell line in further pre-clinical studies over the coming months."

Dr John Sinden, Chief Scientific Officer of ReNeuron, said:

"The results of this study further demonstrate the potency of our lead CTX stem cell line when applied in ischaemic disease settings. We are excited by the apparent utility of this cell line in both the ischaemic brain and muscle. The CTX cell line is extremely well-characterised and has already been scaled up and extensively tested as part of our ReN001 programme for stroke. This work will therefore give us a significant advantage as we look to move this cell line forward to the clinic as a non-patient-specific therapeutic candidate for peripheral arterial disease."

Enquiries:

Michael Hunt, Chief Executive Officer - ReNeuron +44 (0) 1483 302560
Dr John Sinden, Chief Scientific Officer - ReNeuron

Jonathan Birt, Susan Quigley Financial Dynamics +44 (0) 20 7831 3113

Stewart Wallace, Adam Cowen Collins Stewart +44 (0) 20 7523 8350

About ReNeuron

ReNeuron is a leading, UK-based stem cell business. Its primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need.

ReNeuron has received UK regulatory approval for an initial clinical trial with its lead ReN001 stem cell therapy for disabled stroke patients, and expects to commence this study in the second quarter of 2009. In addition to its stroke programme, ReNeuron is developing stem cell therapies for a number of other conditions, including peripheral arterial disease and diseases of the retina.

ReNeuron has also developed a range of stem cell lines for non-therapeutic applications, its ReNcell® products for use in academic and commercial research. The Company's ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by USA-based Millipore Corporation.

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.

Alkermes Presents Positive Preclinical Data on Molecule Designed to Improve Outcomes for Patients Taking Opiod Analgesics

Calisha Myers — Mon, 17 Nov 2008 09:05:33 -0500

Alkermes Presents Positive Preclinical Data on Novel, Proprietary Molecule Designed to Improve Outcomes for Patients Taking Opioid Analgesics

Second New Program Disclosed During Calendar 2008

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS) today announced positive preclinical results for its proprietary small molecule candidate, RDC-1036, which emerged from a library of novel opioid modulators. The data demonstrated RDC-1036 was effective in reversing opioid effects on gastrointestinal motility. Data also showed that oral administration of RDC-1036 had greater efficacy at a lower dose and for an extended period of time compared to an active comparator, methylnaltrexone. The data were presented at the 38th Annual Meeting of the Society for Neuroscience in Washington, D.C.

According to IMS Health, 200 million prescriptions were written for opioids in 2007 in the United States. Many studies indicate that a high percentage of patients receiving opioids are likely to experience side effects affecting gastrointestinal motility.

"While opioids are a common and effective treatment for managing chronic pain, the side effects of these medications can be debilitating and may diminish patient adherence to pain medication," stated Daniel Deaver, Ph.D., vice president, non-clinical development of Alkermes. "We are encouraged by these preclinical results as they suggest that the unique, oral formulation of RDC-1036 may enable the use of pain medications without inhibiting gastrointestinal motility."

The study results presented included efficacy and sustainability data of RDC-1036 compared to methylnaltrexone administered orally and parentally in a well-characterized rodent model of gut motility. Data showed that treatment with oral RDC-1036 blocked opioid-induced side effects for up to four hours at a dose three-fold lower than oral methylnaltrexone. Additionally, oral RDC-1036 had a faster onset of action compared to methylnaltrexone and maintained sustained efficacy for at least eight hours, compared to four hours with methylnatrexone. These data suggest oral RDC-1036 may be effective in reducing gastrointestinal side effects associated with opioid use.

"We are pleased to present these data on RDC-1036 as an example of our emerging proprietary pipeline," said Elliot Ehrich, M.D., chief medical officer of Alkermes. "These preclinical results are encouraging and suggest that we can successfully leverage our biological and chemical expertise to advance candidates from discovery to development."

About Alkermes

Alkermes, Inc., a biotechnology company committed to developing innovative medicines to improve patients' lives, manufactures RISPERDAL® CONSTA® for schizophrenia and developed and manufactures VIVITROL® for alcohol dependence. Alkermes' robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has research and manufacturing facilities in Massachusetts and Ohio.

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to the potential therapeutic value of RDC-1036 and Alkermes' plans to continue development of RDC-1036. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the company's business is subject to significant risk and uncertainties and there can be no assurance that its actual results will not differ materially from its expectations. For further information with respect to factors that could cause the company's actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or financial expectations contained in this release.

VIVITROL® is a registered trademark of Cephalon, Inc.; RISPERDAL® CONSTA® is a registered trademark of Janssen-Cilag group of companies.

Ardea Biosciences's MEK Inhibitor, RDEA119, Demonstrates Synergy with Other Anti-Cancer Agents in Multiple Tumor Types

Calisha Myers — Fri, 24 Oct 2008 09:23:22 -0400

Ardea Biosciences Presents Preclinical Data on its Lead MEK Inhibitor, RDEA119, Demonstrating Synergy with Other Anti-Cancer Agents in Multiple Tumor Types

October 24, 2008--SAN DIEGO--(BUSINESS WIRE)--Ardea Biosciences, Inc. (Nasdaq: RDEA) announced today that it presented preclinical data on its lead mitogen-activated ERK kinase (MEK) inhibitor at the 20th European Organisation for Research and Treatment of Cancer (EORTC) -- National Cancer Institute (NCI) -- American Association for Cancer Research (AACR) symposium on 'Molecular Targets and Cancer Therapeutics' in Geneva, Switzerland.

In preclinical studies, RDEA119 has demonstrated synergistic activity when used in combination with multiple anti-cancer agents in a wide range of tumor cell lines. Additionally, RDEA119 has demonstrated the ability to produce significant tumor cell death when administered in combination with sorafenib (Nexavar®; Onyx Pharmaceuticals, Bayer HealthCare) in cancer cells that had developed resistance to sorafenib.

Doses being evaluated in an ongoing Phase 1 study of RDEA119 as a single agent in patients with advanced cancer have achieved systemic exposure consistent with active doses in animal models of human tumors, without drug-related toxicity. A Phase 1/2 study in combination with Nexavar in patients with advanced cancer has been recently initiated.

"The preclinical data presented today formed the rationale for our Phase 1/2 study of RDEA119 in combination with Nexavar," commented Barry D. Quart, PharmD, Ardea's president and chief executive officer. "RDEA119's potential to enhance the activity of current cancer therapies and its broad activity against both K-ras and B-raf mutations makes RDEA119 a very promising product candidate to improve the current standard-of-care across multiple cancer indications. We are pleased with the progress that we have made with RDEA119 thus far and look forward to working with a partner in the future to bring this important potential therapy to patients."

The poster is available on the Company website (http://www.ardeabio.com) under the title, "RDEA119: A Potent and Highly Selective MEK Inhibitor for the Treatment of Cancer."

About RDEA119

RDEA119, a non-ATP competitive, highly-selective MEK inhibitor for the treatment of inflammatory diseases and cancer is the Company's lead compound from its MEK inhibitor research and development program. RDEA119 has shown potential as a potent inhibitor of MEK, which is believed to play an important role in inflammation, as well as cancer cell proliferation, apoptosis and metastasis. Preclinical and clinical results suggest that RDEA119 has favorable properties, including oral dosing, excellent selectivity and limited retention in the brain, which, in turn, may result in a reduced risk of central nervous system (CNS) side effects.

About Nexavar

Nexavar, a small-molecule drug, is being developed and marketed by Onyx Pharmaceuticals, Inc., in collaboration with Bayer HealthCare Pharmaceuticals, Inc. Nexavar is currently approved for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

About Ardea Biosciences, Inc.

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, gout, cancer and inflammatory diseases. We have five product candidates in clinical trials and others in preclinical development and discovery. Our most advanced product candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which has successfully completed a Phase 2a study for the treatment of patients with HIV. We have evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in a human micro-dose pharmacokinetic study and have selected it for clinical development. RDEA594, our lead product candidate for the treatment of hyperuricemia and gout, is being evaluated in a Phase 1 clinical trial and is believed to be an inhibitor of the URAT1 transporter in the kidney, which is responsible for regulation of uric acid levels. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1/2 study in combination with sorafenib (Nexavar®; Onyx Pharmaceuticals, Bayer HealthCare) and as a single agent in a Phase 1 study, both in advanced cancer patients, and have completed a Phase 1 study in normal healthy volunteers as a precursor to trials in patients with inflammatory diseases. Lastly, we have evaluated our second-generation MEK inhibitor for the treatment of cancer and inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study and have selected it for clinical development.

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our plans and goals, the expected properties and benefits of RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds, and the timing and results of our preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, costs associated with our drug discovery and development programs, and risks related to the outcome of our business development activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Vaxart Demonstrates Efficacy of Oral Avian Flu Vaccine in Preclinical Studies

Fri, 24 Oct 2008 07:20:25 -0400

Vaxart Demonstrates Efficacy of Oral Avian Flu Vaccine in Preclinical Studies

SAN FRANCISCO, Oct. 24 /PRNewswire/ -- Vaxart Inc., a biotechnology company focused on the development of oral vaccines, today announced positive efficacy results from preclinical studies of the company's oral avian flu vaccine. Sean Tucker, PhD, Vaxart founder and vice president of research, presented data from animal models demonstrating that an orally administered flu vaccine was protective against lethal exposure to H5N1 influenza. Tucker presented the data this morning at the Modern Mucosal Vaccines, Adjuvants & Microbicides (MMVAM) international conference in Porto, Portugal.

Delivery of flu vaccine via a capsule rather than an injection offers critical advantages, particularly in the case of a pandemic. The Vaxart vaccine formulation can withstand ambient temperatures, enabling emergency distribution methods that avoid the transmission risks associated with centralized vaccination clinics. In the developing world, where medical providers and supplies are scarce, oral vaccination will reduce costs, as well as needle reuse and consequent cross-infection.

The data presented today are from studies measuring the effectiveness of an orally-administered avian flu vaccine designed by Vaxart scientists using the company's proprietary modular platform. The Vaxart vaccine (ND1) comprises a non-replicating chimeric adenovirus-5 vector, or delivery vehicle, engineered to express avian flu hemaggluttinin (HA) and a TLR3 ligand as a vaccine adjuvant.

"Injected vector-based vaccines that deliver a target pathogen protein have shown excellent potency in animal models, but their application has been limited in humans because the immune system typically responds to the vector rather than the target," said Dr. Tucker. "By using oral delivery of a non- replicating vector with a potent adjuvant, we achieve a robust immune response that is focused on the targeted pathogen rather than the delivery vehicle. This approach addresses the problems that have plagued vector-based vaccination and also allows us to create different vaccines simply by switching out the antigen."

In the recent study, Vaxart tested the ND1 vaccine using oral administration to ferrets, widely recognized as the most predictive animal model for influenza research. Researchers administered vaccine at the start of the study and at 4 weeks. At 8 weeks, researchers measured antibody responses, then monitored survival following direct nasal exposure of 10 times the median lethal dose of H5N1 avian influenza virus. Seventy-five percent (6 of 8) of oral vaccinated ferrets developed antibody levels of 1:200 or greater, survived the challenge and were healthy as demonstrated by weight gain after challenge, while all 12 control ferrets either died (67 percent) or became very ill (33 percent). These results, if confirmed in human immunogenicity studies, compare well to the approved, injectable avian flu vaccine that achieved protective antibody levels in 45 percent of human subjects.

In a previous study conducted in mice, 6 of 6 mice vaccinated orally with ND1 survived H5N1 avian flu challenge, while 8 of 8 unvaccinated mice died. Based on these results, Vaxart plans to proceed to an investigational new drug application (IND) and begin clinical studies of the avian flu vaccine in 2009. The company is also developing an annual flu vaccine.

"To date, efforts to develop a broadly-applicable oral vaccine platform have not been successful, but the advantages of a modular approach for vaccine development are compelling, particularly for influenza," said Mark Backer, PhD, Vaxart CEO. "We can provide a vaccine that matches a new outbreak strain months faster than current approaches."

"These results are encouraging. An oral vaccine for pandemic flu would be a great help in rapid distribution to large numbers of people," said Dr. Arnold Monto, professor of epidemiology at University of Michigan. "The availability of an oral vaccine for annual influenza would also likely improve vaccination compliance and help reduce the rates of hospitalization and death that are associated with flu every year."

The Vaxart Approach

Vaxart has developed a proprietary, modular approach to vaccine development that will reduce the time and expense needed to bring new vaccines to market. The key to Vaxart's efforts is a unique adjuvant (an adjuvant is the vaccine component that enhances immune response to a foreign protein). Vaxart uses an adjuvant that works through a "toll-like receptor" (TLR). Vaxart determined that TLR3 is much more active in the gut than other TLR pathways that have been used for injected vaccines, making this the only TLR adjuvant approach likely to work well for oral vaccines. The company has demonstrated both the induction of mucosal immunity and the stimulation of antigen-specific cell-based immunity following oral administration of its vaccines; these features may provide a performance advantage over injected protein vaccines.

Another key feature of the Vaxart platform is the ability to employ the same vector (delivery vehicle) across all vaccines. Typically an injected vector can only be used once, because antibodies build up against the vector proteins after initial exposure. Subsequent vaccines are less effective, because the body neutralizes the vector before a response can be mounted against the disease target. Vaxart has overcome this obstacle and demonstrated that strong immune responses can be generated against multiple diseases following a series of different oral vaccines. Vaxart will be able to produce new vaccines through a standardized and low-cost process, and safety data from one vaccine will be supportive for others created through the platform.

About Vaxart

Vaxart (http://www.vaxart.com) is a privately held biotechnology company focused on the development of oral vaccines. Vaxart's proprietary approach is ideally suited for modular creation of vaccines, enabling the company to reduce development risk. Vaxart intends to apply its platform to develop a first-in-class vaccine for pandemic influenza, as well as creating oral alternatives to current vaccines such as annual influenza and HPV. The company expects to begin clinical testing of its pandemic flu vaccine in 2009.

SOURCE Vaxart Inc.

PRESS RELEASE: Hollis-Eden Pharmaceuticals Presents HE3235 Update at ASCO Breast Cancer Symposium

Maureen Martino — Fri, 07 Sep 2007 10:58:48 -0400

Hollis-Eden Pharmaceuticals Presents HE3235 Update at ASCO Breast Cancer Symposium

Preclinical Data Show Lasting Anti-Tumor Effect of Novel Drug Candidate

SAN DIEGO -- Hollis-Eden Pharmaceuticals, the leader in the development of a new class of small molecule compounds based on endogenous steroid hormones, today reported on its progress with HE3235, its investigational oral drug candidate for the treatment of cancer. Data being presented today at The 2007 ASCO Breast Cancer Symposium, being held September 7-8 in San Francisco, California, demonstrate that HE3235, as previously reported, significantly inhibited the incidence of new tumors and stopped the growth of existing tumors in a preclinical model of breast cancer. Updated data presented at this conference indicate that existing tumors in the HE3235-treated animals from this preclinical model had still not progressed and no new tumors were reported during the five weeks of observation after dosing stopped, in contrast to the vehicle-treated animals in which tumors continued to proliferate. Additionally, the Company reported that when animals with existing tumors were dosed at one half the strength of the lowest dose previously tested, HE3235 stopped tumor progression in these animals.

The new data indicating that the anti-tumor benefit of HE3235 was sustained for five weeks after dosing stopped are striking in light of the fact that approved breast cancer treatments lose activity once treatment is discontinued. The Company plans to file an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2008 in order to initiate a planned Phase I/II clinical trial with HE3235 for the treatment of cancer.

The previously reported data being presented at the Breast Cancer Symposium are from an animal model in which rats were given the potent carcinogen N-methyl-N-nitrosourea to induce multiple breast tumors. Animals with detected tumors were randomized to receive one of two strengths of HE3235 or assigned to a placebo control group. Treatment with HE3235 resulted in a reduced tumor burden for existing tumors that were present before treatment commenced compared to placebo-treated animals (p less than 0.001). In addition, after the treatment period began, all placebo control treated animals developed one or more additional tumors, while not a single new tumor arose in the animals treated with HE3235. This preventive action of HE3235 on the occurrence of new tumors also reached statistical significance (p less than 0.01).

â€œThe effect of HE3235 to inhibit new tumor growth and stop tumor progression in this model was impressive, but what was unexpected and exciting was that the compound appeared to have a lasting effect even after dosing was stopped,â€ stated Dr. Rajkumar Lakshmanaswamy, Assistant Professor, Department of Pathology, Texas Tech University Health Sciences Center, who conducted the study and reported on the findings at the ASCO symposium.

â€œThese data hold the promise that HE3235, if successfully developed, could offer a new treatment option for women with breast cancer,â€ stated Richard B. Hollis, Chairman and Chief Executive Officer of Hollis-Eden. â€œThe lasting anti-tumor effect of HE3235 reported in this animal model of breast cancer suggests the compound is causing tumor cells to undergo apoptosis, or die. Therefore, the compound may act through a novel mechanism of action that could make it useful in treating multiple types of cancer. Due to this potential and the previously reported activity with HE3235 in prostate cancer models, we are aggressively pursuing the mechanism of action and the activity of the drug candidate in other models of cancer. HE3235 represents yet another novel pharmaceutical drug candidate developed out of our hormone signaling technology platform and yields a program in cancer to augment our expanding drug development pipeline in metabolic disorders and diseases of inflammation, such as type 2 diabetes and rheumatoid arthritis.â€

Currently the leading approved drug treatments for prostate or breast cancer focus on blocking the effects of testosterone or estrogen and generate annual sales ranging from approximately $500 million to $2 billion.

Hollis-Eden Pharmaceuticals

Hollis-Eden Pharmaceuticals, Inc. is a world leader in the development of a proprietary class of adrenal steroid hormones as novel pharmaceuticals for human health. Through its Hormonal Signaling Technology Platform, Hollis-Eden is developing a new series of small molecule compounds that are metabolites or synthetic analogs of endogenous hormones derived by the adrenal glands from the bodyâ€™s most abundant circulating steroid. These steroid hormones, designed to restore the biological activity of cellular signaling pathways disrupted by disease and aging, have been demonstrated in humans to possess several properties with potential therapeutic benefit -- they regulate innate and adaptive immunity, reduce nonproductive inflammation and stimulate cell proliferation. The Companyâ€™s clinical drug development candidates include HE3286, a next-generation compound currently in a clinical trial for the treatment of type 2 diabetes and being prepared for potential clinical trials in rheumatoid arthritis, and HE3235, a next-generation compound selected for cancer. In addition to these clinical development candidates, Hollis-Eden has an active research program that is generating additional new clinical leads that are being further evaluated in preclinical models of a number of different diseases. For more information on Hollis-Eden, visit the Companyâ€™s website at www.holliseden.com.

This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, the potential and prospects of the Company's drug discovery program and its drug candidates. Any statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause the Company's actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in the Company's business, including, but not limited to: the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to obtain regulatory approval for HE3286, HE3235 or any other investigational drug candidate; the Company's future capital needs; the Company's ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual property rights of others; the development of competitive products by other companies; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.

PRESS RELEASE: FermaVir Announces Positive Data from Recent Preclinical Studies of FV-100

Wed, 08 Aug 2007 12:52:18 -0400

FermaVir Announces Positive Data from Recent Preclinical Studies of FV-100

FermaVir Pharmaceuticals, Inc. today announced positive results from preclinical studies evaluating FV-100, a highly potent, orally bioavailable bicyclic nucleoside analogue for the treatment of herpes zoster infection (shingles). In the preclinical toxicology studies, the compound was generally safe and well tolerated in animals at dose levels that are expected to exceed a therapeutically relevant dose. In addition, preclinical pharmacokinetic studies indicated that single oral doses of FV-100 can produce prolonged plasma concentrations over twenty-four hours, suggesting the potential for a once-a-day dosing regimen.

"This encouraging data builds on prior published preclinical data demonstrating the antiviral activity of FV-100 against varicella zoster and its potential to further reduce the symptoms associated with shingles, such as acute pain and post-herpetic neuralgia ("PHN")," stated Geoffrey Henson, Ph.D., chief executive officer of FermaVir. "Importantly, the data reinforces our belief that FV-100 has the potential to be a more potent treatment option for shingles with the advantage of a favorable safety profile and once-a-day dosing regimen as compared to currently-available therapies, and provides a path forward for filing an Investigational New Drug ("IND") Application in the near future and commencing the clinical development of FV-100."

In the preclinical studies, FV-100 was administered as a single oral dose at 100 mg, 500 mg, or 2,000 mg/kg in both rats and dogs. Following a 14-day observation period, toxicity data from both species revealed no mortalities or significant adverse events. Additionally, genotoxicity and phototoxicity studies were also negative.

Pharmacokinetic analysis indicated at the lowest dose level, a single oral dose of FV-100 resulted in plasma levels at 24 hours of CF-1743, the active form of FV-100, which exceeded the amount required to inhibit 90% (EC90) of the replication of varicella zoster virus. The EC90 is a measure of the amount of a compound which inhibits 90% of the virus in vitro. Taken together, FV-100 appears to be safe and well tolerated in rats and dogs over the ranges and duration of exposure examined.

Published in vitro studies demonstrate that FV-100, a prodrug of CF-1743, is the most potent compound among antivirals in development or approved for the treatment of shingles. Further, based on its exceptional ability to rapidly enter cells and quickly inhibit viral replication, FV-100 has the potential to further reduce all shingles-related symptoms, including the incidence and the severity of acute pain and post-herpetic neuralgia (PHN), a painful condition caused by damage to the nerves during the active viral infection.

About FermaVir

FermaVir Pharmaceuticals, Inc. is a biotechnology company focused on the development of important antiviral drugs in underserved segments of the pharmaceutical development marketplace. FermaVir's most advanced program is FV-100, a compound currently being developed for the treatment of shingles. FermaVir is also developing a series of compounds that could improve the treatment of Cytomegalovirus (CMV) infection, a currently incurable viral disease that can threaten eyesight as well as cause severe morbidity and mortality mostly in the immunosuppressed. FermaVir's Intellectual Property portfolio includes a number of patent applications and a worldwide exclusive license for potential new drug treatments of infectious diseases. On April 10, 2007, FermaVir announced that it has entered into a definitive agreement to merge with Inhibitex, Inc., which is expected to close in September 2007. For additional information about FermaVir, please visit www.fermavir.com.

Additional Information about the Merger and Where to Find It

In connection with the proposed merger, Inhibitex and FermaVir have filed relevant materials with the Securities and Exchange Commission (SEC), including a registration statement on Form S-4 that contains a prospectus and a joint proxy statement. The registration statement has not yet been declared effective by the SEC. Investors and security holders of Inhibitex and FermaVir are urged to read these materials when they become available because they will contain important information about Inhibitex, FermaVir and the merger. The proxy statement, prospectus and other relevant materials (when they become available), and any other documents filed by Inhibitex and FermaVir with the SEC, may be obtained free of charge at the SEC's web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Inhibitex by directing a written request to: Inhibitex, 9005 Westside Parkway, Alpharetta, GA 30004, Attention: Investor Relations; and documents filed with the SEC by FermaVir by directing a written request to FermaVir, 420 Lexington Avenue, Suite 445, New York, N.Y. 10170, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the merger.

Participants in the Solicitation

Inhibitex and FermaVir and their respective directors, executive officers and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Inhibitex and FermaVir in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger transaction will be included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of Inhibitex is also included in Inhibitex's Amendment No. 1 to the Annual Report on Form 10-K for year ended December 31, 2006. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at Inhibitex at the address set forth above. Additional information regarding the directors and executive officers of FermaVir is also included in FermaVir's Annual Report on Form 10-KSB for the year ended April 30, 2007. This document is available free of charge at the SEC's web site (www.sec.gov) and from Investor Relations at FermaVir at the address set forth above.

Safe Harbor Statement

Some of the statements included in this press release are forward-looking statements that involve a number of risks and uncertainties, including, but not limited to: statements regarding the proposed acquisition, future market opportunity and future financial performance. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Important factors may cause our actual results to differ materially, including, but not limited to, the satisfaction of the conditions to the closing of the pending merger transaction with Inhibitex, including approvals by the stockholders of both corporations, the Board of Directors of neither FermaVir nor Inhibitex withdrawing its support for the pending merger transactions, uncertainties associated with product development, the risk that FermaVir will not obtain approval to market its products, the risk that FermaVir technology will not gain market acceptance, the risks associated with dependence upon key personnel, the need for additional financing; and other cautionary statements contained elsewhere herein and in FermaVir's Annual Report on Form 10-KSB for the year ended April 30, 2007, as filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.