Category Archives: Novel Therapies

Small Phase I Study Reports 2 to 4 Year Ovarian Cancer Remission in 30% of Women Who Received a NY-ESO-1 Vaccine

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Three of nine patients (33%) remain in complete clinical remission at 25, 38, and 52 months, respectively.

The cancer-testis antigen NY-ESO-1 is expressed in greater than 40% of advanced epithelial ovarian cancers and represents a promising immunotherapeutic target. In a small Phase I (safety and immunogenicity) clinical trial conducted by Memorial Sloan-Kettering Cancer Center and Cornell University Medical College, nine “high-risk” epithelial ovarian cancer patients, who were in first clinical remission after primary surgery and chemotherapy, received NY-ESO-1b peptide and Montanide ISA-51 every 3 weeks in the form of five vaccinations. The “high risk” ovarian cancer patient criterion was defined as a patient who (i) received suboptimal primary debulking (remaining tumor masses with diameter of 1.0 cm or greater), or (ii) experienced a failure to normalize the CA 125 blood tumor marker by the end of the third cycle of first-line chemotherapy. In addition, each patient enrolled in the trial was required to test positive for (i) human leukocyte antigen 2A (HLA-2A) in the blood, and (ii) NY-ESO-1 or LAGE-1 tumor expression. NY-ESO-1 tumor expression was evaluated for each patient by immunohistochemistry (IHC). LAGE-1 tumor expression was evaluated for each patient by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis. For each patient, NY-ESO-1 specific humoral immunity (ELISA), T-cell immunity (tetramer and ELISPOT), and delayed-type hypersensitivity were assessed pre-vaccination and at week #1, week #4, week #7, week #10, week #13, and week #16 of the vaccination period.

The nine patients experienced treatment-related adverse events including: grade 1 fatigue, anemia, pruritus, myalgias, and hyperthyroidism; and grade 2 hypothyroidism. There were no grade 3/grade 4 adverse events. The results of the Phase I trial are set forth below.

  • Three of four patients (75%) with NY-ESO-1-positive tumor showed T-cell immunity.
  • Four of five patients (80%) with NY-ESO-1-negative tumor showed T-cell immunity.
  • At median follow-up of 11.3 months, six of nine patients (67%) have recurred, with a median progression-free survival (PFS) of 13 months.
  • Three of nine patients (33%) remain in complete clinical remission at 25, 38, and 52 months, respectively.

At the end of the Phase I trial, the trial investigators concluded that vaccination of high-risk, HLA-A2-positive epithelial ovarian cancer patients with NY-ESO-1b and Montanide has minimal toxicity and induces specific T-cell immunity in patients with both NY-ESO-1-positive and NY-ESO-1-negative tumors. Also, the trial investigators noted that additional study is necessary. For a copy of the clinical trial protocol associated with this trial, click here.

[Source: “Safety and Immunogenicity Study of NY-ESO-1b Peptide and Montanide ISA-51 Vaccination of Patients with Epithelial Ovarian Cancer in High-Risk First Remission;” Diefenbach, C.S. et. al.; Clin Cancer Res. 2008 May 1;14(9):2740-2748.]

Comment: Prior cancer vaccines targeting NY-ESO-1 overexpression in ovarian cancer tumors produced moderate success in terms of an increase in PFS. This study is particularly provocative because patients who tested positive and negative for NY-ESO-1 tumor expression experienced T-cell immunity, and “high risk” patients (including suboptimally debulked patients) experienced PFS benefit.

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We Have Met the Enemy and He is Us* — But Not If Aethlon Medical Has Its Way!

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Why can’t the human body immune system prevent all cancers? Because the immune system generally does not identify ordinary human cells — an essential building block of the human body — as a threat to the body, notwithstanding that such cells may possess an uncontrolled level of proliferation. To the extent that the immune system recognizes that certain cancer cells are “suspicious,” solid cancer tumors (including ovarian) further inhibit the attack capability of the immune system by secreting so-called “exosomes.”

Normally, immune system cells known as “T-cells” are entrusted with killing foreign invaders that may be harmful to the body. Exosomes secreted by ovarian cancer cells prevent the “expression” or activation of two biological markers (i.e., Jak-3 kinase & CD3-zeta) which must be present as a prerequisite for T-cell activation. Generally, the biological markers Jak-3 kinase and CD3-zeta are highly expressed in activated T-cell lines. When T-cells are subjected to ovarian cancer ascites fluid, the critical Jak-3 kinase and CD3-zeta biological markers are consistently absent. In sum, the exosomes secreted by ovarian cancer cells produce immunosuppressive activity within the human body and allow the cancer cells to avoid destruction by causing T-cell inactivation. The immunosuppressive activity associated with ovarian cancer is known to correlate with disease progression and reduced long-term survival.

Aethlon Medical, Inc., a pioneer in developing medical devices to treat infectious disease, developed a device known as the “Hemopurifier®” which is capable of removing immunosuppressive exosomes from ovarian cancer cell fluid, thereby allowing proper activation of immune system T-cells that are capable of killing cancer cells. In follow-on studies, Dr. Douglas Taylor at the University of Louisville demonstrated that the capture of exosomes by the Hemopurifier(R) resulted in reversing immunosuppressive activity (i.e., eliminate exosomes). Throughout the course of the studies, the Aethlon Hemopurifier® completely removed the immunosuppressive activity normally found in the ascites fluid of ovarian cancer patients.

Prior to conducting the follow-on studies mentioned above, Dr. Taylor documented that 60% of circulating exosomes were removed from the blood of ovarian cancer patients during the first pass (approximately 10-minutes) through a small scale Hemopurifier®. The capture data was consistent over the course of five different studies. Exosomes are released by solid tumors, lymphomas, and leukemia. Because exosomes induce T-cell apoptosis (programmed cell death), and block T-cell signaling, proliferation, and cytokine production, high concentrations of circulating exosomes correlate with reduced T-cell production and tumor progression in cancer patients. The ability to reduce the presence of circulating exosomes could reverse immune suppression and increase patient responsiveness to both immunotherapy and chemotherapy. As such, Aethlon believes that the Hemopurifier(R) addresses a significant unmet medical need in cancer care.

Dr. Taylor is a recognized authority on the causative effects of immune suppression in cancer patients. He is credited with the initial characterization of exosomes and is a leading peer reviewed author on the subject. Aethlon disclosed that Dr. Taylor did not receive nor request any compensation for conducting the research studies mentioned above.

“Based on emerging data, we envision the Hemopurifier(R) will become a treatment standard that enhances the benefit of therapies administered to those who suffer from cancer,” stated James A. Joyce, Chairman and CEO of Aethlon Medical.

Aethlon Medical Company Background

“Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device to treat infectious disease. The Hemopurifier® addresses the largest opportunity in infectious disease, the treatment of drug and vaccine resistant viruses. The Hemopurifier(R) is a single use extracorporeal device that converges hollow-fiber filtration technology with immobilized affinity agents to capture viruses and soluble glycoproteins from the blood. The device has been designed to mimic the natural immune response of clearing infectious viruses and immunosuppressive proteins from circulation. Regulatory and commercialization initiatives in the United States are focused on bioterror threats, while international initiatives are directed towards naturally evolving pandemic threats, and chronic infectious disease conditions including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Collaborative studies to demonstrate utility of the Hemopurifier(R) are being conducted with researchers at the Government of India’s National Institute of Virology (NIV), The U.S. Centers for Disease Control and Prevention (CDC), The United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and The Southwest Foundation for Biomedical Research (SFBR). Aethlon recently demonstrated safety of the Hemopurifier(R) in a 24-treatment human study and is now conducting follow-on safety studies at the Fortis Hospital in Delhi, India. The Company has also submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) related to advancing the Hemopurifier(R) as a broad-spectrum treatment countermeasure against category “A” bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier(R) technology can be accessed online at www.aethlonmedical.com.”

[Post Source and Quoted Post Source: “The Aethlon Hemopurifier(R) Reverses Immune Suppression in Cancer,” Aethlon Medical, Inc. News Release dated November 19, 2007].

*[Post Title Source: The “foreword” chapter of The Pogo Papers, written by Walt Kelly and published by Simon & Schuster (Paper) (June 1953). The complete Kelly foreword chapter quote (which is a paraphrase of a message sent in 1813 from U.S. Navy Commodore Oliver Hazard Perry to Army General William Henry Harrison after The Battle of Lake Erie stating “We have met the enemy, and they are ours”) is “There is no need to sally forth, for it remains true that those things which make us human are, curiously enough, always close at hand. Resolve then, that on this very ground, with small flags waving and tinny blast on tiny trumpets, we shall meet the enemy, and not only may he be ours, he may be us.” Walt Kelly first used the abbreviated quote “We Have Met The Enemy and He Is Us” on a poster for Earth Day in 1970.]

CNN Reports On the Hemopurifier®

NOV-002 and Carboplatin Slow Disease Progression of Platinum Drug Resistant Ovarian Cancer

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“Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced continued encouraging results in an ongoing Massachusetts General Hospital Cancer Center and Dana-Farber/Harvard Cancer Center (DF/HCC) Phase 2 trial of NOV-002 in combination with carboplatin in platinum-resistant ovarian cancer patients. Fifteen patients have now been enrolled and, to date, 60% (9) have had slower than expected disease progression. NOV-002 was well-tolerated, further extending the excellent safety profile NOV-002 has demonstrated in previous studies. Detailed results of this trial will be presented as a poster at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO) taking place May 30 – June 3 in Chicago, Illinois.

‘I am encouraged by these results in platinum-resistant ovarian cancer, with NOV-002 (in combination with carboplatin) apparently slowing disease progression in over half of the treated patients. Most women who have failed three lines of chemotherapy would be expected to progress in about eight weeks. I am excited to present the trial results at ASCO,’ said Dr. Carolyn Krasner, medical oncologist at the Massachusetts General Hospital Cancer Center and the Principal Investigator. ‘We look forward to working closely with Dr. Krasner, the Massachusetts General Hospital Cancer Center, Dana-Farber/Harvard and other institutions on designing and implementing a larger NOV-002 trial for this indication,’ said Harry Palmin, President and CEO of Novelos. ‘Our objective is to commence the next Phase 2 trial in platinum-resistant ovarian cancer in early 2009.’

According to the American Cancer Society, in 2007 approximately 22,000 U.S. women were diagnosed with ovarian cancer and 15,000 women were expected to die from it. There is a lack of effective treatment, particularly in the case of platinum-resistant patients. Once a woman’s ovarian cancer is defined as platinum-resistant the chance of having a partial or complete response to further platinum therapy is typically less than 10% and only 10-20% with other available agents. Thus, there is a major unmet medical need for this indication. …”

[Source: “Novelos Therapeutics Announces Continued Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dan-Farber/Harvard Cancer Center;” Novelos Therapeutics, Inc. Press Release dated March 31, 2008.]

Yale Researchers Indicate That Novogen Compound NV-128 Induces Cell Death in Chemo-Resistant Ovarian Cancer Cells

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“An abstract for an oral presentation to be given at the Annual Meeting of the American Association for Cancer Research, April 12 – 16, in San Diego, Calif., is now available (abstract number 4926) at http://www.aacr.org. The abstract, describing work undertaken by Professor Gil Mor and colleagues at the Yale University School of Medicine, indicates that the compound NV-128, developed by Novogen Limited (ASX: NRT) (NASDAQ: NVGN), may be useful for the maintenance of remission in chemo-resistant ovarian cancer.NV-128 is able to induce cell death through the inhibition of the mTOR pathway [mTOR pathway diagram] in cancer cells. NV-128 inhibition of the mTOR pathway results in caspase-independent apoptosis and autophagy. Only a few other compounds are in the mTOR antagonist class, providing an alternative to drug candidates reliant on caspase dependent cell death as their mechanism of action.

At the annual meeting of the Society for Gynecological Oncology in Tampa, earlier this month, several key speakers addressed the significance of mTOR antagonists in cancer therapeutics.

mTOR is a key intracellular kinase, integrating proliferation and survival pathways. In cancer cells, mTOR signals enhance tumour growth and may be associated with resistance to conventional therapy. Inhibition of mTOR may shut down many of these survival pathways, including the proteins protecting the mitochondria. It is believed that NV-128 affects the catalytic dynamics of mTOR in order to achieve apoptosis.

NV-128 works differently from therapies that are dependent on caspases to trigger apoptosis. Through the inhibition of mTOR, NV-128 is capable of triggering a cascade of events that leads to mitochondrial damage and cell death. Interestingly, since NV-128-induced cell death is completely caspase-independent, it could be effective on cancer cells characterised by high resistance to cell death and representative of late stage chemorefractory disease.”

Quoted Source: [ “Yale researchers to present data indicating that NV-128 uses mTOR pathway to induce cell death,” Novogen Limited News Release dated March 25, 2008.]

Comment: NV-128 represents a novel intracellular kinese inhibitor that disrupts chemo-resistant ovarian cancer cells. V-128 is an analogue of Novogen’s lead anti-cancer agents triphendiol (triphendiol), and phenoxodiol (NV-06). Phenoxodiol has demonstrated efficacy as a monotherapy and as a chemosensitizer against cancer cell lines representative of non-small cell lung carcinoma (NSCLC). Phenoxodiol is also currently being used in the OVArian TUmor REsponse (OVATURE) clinical trials for recurrent ovarian cancer being conducted in the U.S., Europe and Australia. Proof of concept xenograft studies have confirmed that orally delivered NV-128 retards NSCLC tumor proliferation. Efficacy studies are in progress in pre-clinical in vitro studies against late stage colorectal, breast, and gastric cancers and hepatocellular carcinoma, both as a monotherapy and in combination with current standard of care drugs.

Liposomal siRNA — Genetic On/Off Switches That Target Ovarian Cancer Through the Trojan Horse Effect

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Use of Liposomal siRNA to Target Ovarian Cancer Protein Known as “Interleukin-8 (IL-8)”

“A protein that stimulates blood vessel growth worsens ovarian cancer, but its production can be stifled by a tiny bit of RNA wrapped in a fatty nanoparticle, a research team led by scientists at The University of Texas M. D. Anderson Cancer Center reports in the Journal of the National Cancer Institute.

The protein IL-8 is a potential therapeutic target in ovarian cancer,’ said senior author Anil Sood, M.D., professor in the M. D. Anderson Departments of Gynecologic Oncology and Cancer Biology.

The paper demonstrates that high IL-8 expression in tumors is associated with advanced tumor stage and earlier death for ovarian cancer patients. Lab experiments and research in a mouse model show that short interfering RNA (siRNA) can cut IL-8 expression, reducing tumor size by attacking its blood supply.

‘This comprehensive analysis – with human data, animal data and lab experiments to highlight the molecular mechanisms involved – helps us develop the new targets needed for a more effective approach against ovarian cancer,’ Sood said.

Interleukin-8 is overexpressed in many types of cancer and has previously been shown to promote tumor growth, new blood vessel growth known as angiogenesis, and metastasis, the spread of cancer to other organs. ‘In the long run, this research will have applications in other cancers as well,’ Sood said.

His research focuses on ovarian cancer, for example, while senior co-author Menashe Bar-Eli, Ph.D., professor in M. D. Anderson’s Department of Cancer Biology, examines IL-8’s role in melanoma.

Impact on survival

Ovarian cancer is often detected in late stages. Initial treatment includes surgery and taxane- or platinum-based chemotherapy regimens that keep the cancer at bay for a time in most patients. Recurrence is common and often lethal.

To examine IL-8’s role in ovarian cancer, the researchers analyzed tumors from 102 patients diagnosed and treated between 1988 and 2006 at M. D. Anderson and the University of Iowa. Of those, 43 had tumors with high levels of IL-8 and 59 had low levels. The median survival of those with high IL-8 tumors was 1.62 years, compared with 3.79 years for those with low expression of the protein.

All 43 tumors with high expression of IL-8 were of high grade and 42 of 43 were advanced, either stage III or IV tumors. By comparison, 10 of 59 tumors with low IL-8 expression were early stage tumors and six were of low grade.

Shrinking tumors

Genes transcribe single strands of RNA that in turn are ‘read’ by ribosomes to produce proteins. siRNAs are short, double-stranded bits of RNA capable of halting that process. The team confirmed in a lab experiment that a specific siRNA silences IL-8 and then tested it against two lines of ovarian cancer in a mouse model.

Sood, Gabriel Lopez-Berestein, M.D., professor in M. D. Anderson’s Department of Experimental Therapeutics, and colleagues are building an arsenal of siRNAs capable of silencing genes that produce cancer-promoting proteins. They packaged siRNA that stymies IL-8 into a small ball of fat known as a liposome, a combination they developed to overcome a problem – siRNA is hard to deliver to tumors.

Tumors shrank by a median of 32 percent and 52 percent in the two cancer lines among mice that received injections of the IL-8 siRNA liposome compared to those receiving control siRNA or empty liposomes.

Mice that got both the IL-8 siRNA plus the taxane-based chemotherapy drug docetaxel [Taxotere®] had median tumor weight reduction of 90 percent and 98 percent in the two cell lines. Mice with control siRNA plus docetaxel saw reductions of 67 and 84 percent.

Finally, they tested the approach in mice with an ovarian cancer cell line known to be resistant to taxane-based drugs such as docetaxel. IL-8 siRNA alone reduced the size of these tumors by 47 percent, and when combined with docetaxel reduced tumor size by 77 percent, suggesting that the combination re-sensitizes a resistant tumor to taxanes.

The team gauged the impact of IL-8 siRNA on tumor blood supply by measuring the density of blood vessels in the tumor. The IL-8 siRNA alone reduced blood vessel density by 34 percent and 39 percent in two cancer lines.

Clinical Prospects

‘These are encouraging results. We want to move one of our siRNA agents into the clinic to test its potential for therapy,’ Sood said, ‘and then in the longer term, we’ll consider moving additional siRNA agents into the clinical arena.’

The IL-8 siRNA liposome is the third developed by Sood’s and Lopez-Berestein’s team. Two others target the oncoproteins FAK and EphA2. The EphA2 siRNA liposome is closest to Phase I clinical trial, with required toxicology studies nearly complete. A clinical trial could begin within a year.

Methods used to inject siRNA in high volumes for research purposes are impractical for human therapy. Sood and Lopez-Berestein developed the liposomal approach to ensure that the siRNA reaches the cell intact so it can silence the targeted gene. Their research has shown that the liposome penetrates deeply into cells to deliver its siRNA.

Research reported in JNCI was funded by grants from the National Cancer Institute of the National Institutes of Health, including M. D. Anderson’s Specialized Program of Research Excellence in Ovarian Cancer; the Ovarian Cancer Research Fund, Inc.; and the Zarrow Foundation.”

Quoted Source: [“Researchers Identify and Shut Down Protein that Fuels Ovarian Cancer, M. D. Anderson-led team pinpoints blood vessel promoter’s role and targets it with siRNA,” M.D Anderson News Release, dated February 26, 2008]. See also “Effect of Interleukin-8 Gene Silencing With Liposome-Encapsulated Small Interfering RNA on Ovarian Cancer Cell Growth;” Merritt,W.M., Lin,Y.G., Spannuth,W.A., Fletcher,M.S., Kamat,A.A., Han,L.Y., Landen,C.N., Jennings,M., Geest,K., Langley,R.R., Villares,G., Sanguino,A., Lutgendorf,S.K., Lopez-Berestein,G., Bar-Eli,M.M., Sood, A.K.; Journal of the National Cancer Institute 2008 100(5):359-372.

Use of Liposomal siRNA to Target Ovarian Cancer Protein Known as “Focal-Adhesion Kinase (FAK)”

Recent work reported in October 2006 by Dr. Anil Sood at M.D. Anderson involved the use of a targeted “siRNA” liposome in mice to identify and correct defective ovarian cancer cells. M. D. Anderson researchers used siRNA (which acts as a genetic “on/off” switch) to target an ovarian cancer protein known as focal-adhesion kinase (FAK), which is present in all ovarian cancer cells. FAK helps ovarian cancer cells survive and spread. The siRNA was rolled into a liposome – a ball of fat so small that its dimensions are measured in nanometers (billionths of a meter). Because of their tiny size, these liposomes have no problem traveling through the blood supply into cells that make up tumors through the so-called “Trojan Horse” effect. To test how well it worked, mice that were implanted with human ovarian tumors were given injections of the therapy for three to five weeks. The mice ovarian tumors experienced a 44% to 72% reduction in weight. Adding chemotherapy to the treatment boosted tumor weight reduction to the 94% to 98% range. The next step for the FAK siRNA liposome is testing for toxicity prior to studies in human patients.

Source: [ “Novel Therapy Shrinks Ovarian Tumors in Mice, Genetic Fragments Turn Off Cancer Growth Switch,” Cancer Newsline, October 2006, M.D. Anderson Cancer Center, University of Texas.]

Use of Liposomal siRNA to Target the Ovarian Cancer Kinase Known as “EphA2”

In an earlier in vitro studies, Anil Sood, M.D. et. al. demonstrated that when EphA2-targeting siRNA was combined with paclitaxel [Taxol®], tumor growth was dramatically reduced compared with treatment with paclitaxel and a nonsilencing siRNA. These studies show the feasibility of siRNA as a clinically applicable therapeutic modality.

Source: [“Therapeutic EphA2 Gene Targeting In vivo Using Neutral Liposomal Small Interfering RNA Delivery;” Landen,C.N., Chavez-Reyes, A., Bucana, C., Schmandt, R., T. Deavers, M., Lopez-Berestein, G. and Sood, A.K., The University of Texas M.D. Anderson Cancer Center, Houston, Texas; Cancer Research 65, 6910-6918, August 1, 2005.

Comment: The ultimate use of siRNA to treat ovarian cancer in humans holds future promise. Ovarian cancer survivors should monitor the development of this liposomal siRNA form of treatment because its use in human clinical trials could occur in the near future, assuming that pre-clinical trial toxicity tests demonstrate safety. Anil Sood, M.D. has developed the liposomal siRNA for IL-8, FAK, and EphA2. It is reported that human clinical trials with respect to the EphA2 siRNA treatment will begin within 12 months.

SNS-595 Shows Promise For Platinum-Resistant Ovarian Cancer Patients

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“Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small-molecule therapeutics, announced positive interim data from the company’s ongoing Phase 2 clinical trial of its lead product candidate, SNS-595, in platinum-resistant ovarian cancer patients.

In this Phase 2 clinical trial, single agent SNS-595 has demonstrated disease control (defined as stable disease, partial response or complete response) in 31 of 35 patients evaluable for best response using GOG-RECIST criteria. Of these 31 patients, one patient had a complete response, four patients had partial responses (two unconfirmed) and 26 patients had a best response of stable disease. All patients enrolled in the trial have previously failed treatment with platinum-containing regimens, and fourteen of the 35 patients have also failed prior treatment with doxorubicin HCl liposome injection (Doxil(R)). Both platinum-resistant and Doxil-resistant patients in the Phase 2 clinical trial have responded to SNS-595 therapy.

‘Recurrence rates among ovarian cancer patients remain high, and the majority of refractory patients are resistant to platinum-based therapies. Based on these interim data, SNS-595 appears to be a promising, active agent in a difficult-to-treat ovarian cancer patient population,’ said William P. McGuire, M.D., Medical Director of the Harry and Jeanette Weinberg Cancer Institute at Franklin, and a lead investigator for the Phase 2 trial.

Among forty-five patients with sufficient follow-up to yield safety data, SNS-595 was generally well tolerated at a dose level of 48mg/m2 administered once every three weeks. The most common adverse events reported thus far include nausea, fatigue, vomiting and alopecia. There was a low rate of febrile neutropenia or other Grade 3/4 adverse events, and manageable Grade 1/2 nausea or vomiting.

Based on the indications of clinical activity and the acceptable tolerability profile demonstrated to date among this patient population, the dose of SNS-595 in this trial has been increased to 60 mg/m2 over twenty-eight days. Patient accrual at this dose level is ongoing.

‘We are pleased by the strong signal of activity emerging from our Phase 2 clinical trial of SNS-595 at the 48mg/m2 dose level. Based on the drug’s observed safety profile and recommendations from advisors, we are exploring a higher dose of SNS-595 in this trial. Enrollment has begun at 60 mg/m2 and we expect to enroll approximately 30 patients at this dose by the third quarter of this year,’ said Daniel C. Adelman, M.D., Senior Vice President, Development and Chief Medical Officer of Sunesis. ‘Enthusiasm for SNS-595 among our clinical investigators is growing and enrollment in this trial has been accelerating. We expect to present further data from this Phase 2 clinical trial this year.’

The interim clinical results are being presented in a poster, “A Phase 2 Trial of SNS-595 in Women with Platinum-Refractory Epithelial Ovarian Cancer” (Abstract # 290), at the 39th Annual Meeting on Women’s Cancer hosted by the Society of Gynecologic Oncologists (SGO) in Tampa, Fla. through March 12, 2008.”

About SNS-595

SNS-595 is a novel naphthyridine analog, structurally related to quinolones, a class of compounds which has not been used previously for the treatment of cancer. SNS-595 is a specific DNA intercalator and topoisomerase II poison, causing replication-dependent site-selective double strand DNA damage, irreversible G2 arrest and rapid apoptosis. In non-clinical evaluations, SNS-595 demonstrates broad and potent activity in xenograft, syngeneic and drug-resistant models. In addition to the Phase 2 clinical trial in ovarian cancer patients, SNS-595 is currently being evaluated in combination with cytarabine in a Phase 1b acute leukemia clinical trial. In clinical trials conducted to date, SNS-595 has been generally well tolerated and has shown objective responses in both solid and hematologic tumor types.”

Quoted Source: [“Sunesis Pharmaceuticals Reports Positive Interim Data for SNS-595 Single-Agent Activity in Platinum-Resistant Ovarian Cancer”, MedicalNewsToday.com, March 11, 2008. (Emphasis added by posting author)].

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