Mrs. Australia Quest Finalist Veronica Cristovao Is Raising Ovarian Cancer Awareness “Down Under”

Mrs. Australian Quest Finalist Veronica Cristovao is raising ovarian cancer awareness “Down Under,” and she hopes to use the pageant as an international platform to further her ovarian cancer advocacy.

Did you know that February is national Ovarian Cancer Awareness Month in Australia?

Veronica Cristovao is a finalist in the Mrs. Australia Quest pageant which supports Ovarian Cancer Australia. Veronica hopes to use the pageant as an international platform for ovarian cancer awareness.

According to the Australian National Breast and Ovarian Cancer Centre, approximately 1,200 Australian women were diagnosed with ovarian cancer in 2010.  On average, three Australian women are diagnosed with ovarian cancer every day, while two Australian women die from the disease every day or one woman every twelve hours.  Ovarian cancer accounts for 55 percent of all Australian gynecological cancer deaths. By way of comparison, 88 out of every 100 Australian women diagnosed with breast cancer will be alive five years after diagnosis, whereas only 40 out of every 100 Australian women diagnosed with ovarian cancer will be alive during that same time period.

These statistics are alarming, and until effective prevention and early detection methods can be identified, awareness of the ovarian cancer early warning signs are critical. Promotion of ovarian cancer awareness and early detection underlie the charitable mission of the Mrs. Australia Quest pageant. The pageant’s mission is artfully expressed through its “beautiful awareness” motto.

Although February has come to an end, we had the pleasure of getting to know Veronica Cristovao, a Mrs. Australia Quest Finalist, earlier this month.  Because the Mrs. Australia Quest pageant supports ovarian cancer awareness through Ovarian Cancer Australia, we thought it was important to highlight Veronica’s ovarian cancer advocacy and participation in the pageant.  After reading Veronica’s story, you will discover what we already know; win, lose or draw in the final pageant competition, Veronica is already a winner given her amazing talents as an entrepreneur, ovarian cancer advocate, wife, and mother of two young children.

We would like to extend our fullest appreciation to Veronica and her family for allowing us to tell her ovarian cancer advocacy story.

“Character contributes to beauty. It fortifies a woman as her youth fades. A mode of conduct, a standard of courage, discipline, fortitude, and integrity can do a great deal to make a woman beautiful.”

– Jacqueline Bisset, English Actress & Golden Globe and Emmy Award Nominee

Mrs. Australia Quest Pageant

The Mrs. Australia Quest pageant selected Ovarian Cancer Australia as its designated 2011 charity. Ovarian Cancer Australia was founded by individuals directly affected by ovarian cancer, who wanted to raise awareness of the disease and support those who have been affected by it. This founder group includes:

  • Nicole Livingstone, a retired Australian swimmer and Olympic medal winner, television sports commentator and radio presenter, and recipient of the Order of Australia Metal, and her sister Karen, who lost their mother and aunt to the disease;
  • Simon Lee, whose wife Sheila was the driving force behind the Australian ovarian cancer awareness movement prior to her death in 2001;
  • Actress and comedian Lynda Gibson, who was diagnosed with ovarian cancer in 2000 and subsequently lost her battle to the disease in 2004; and
  • Journalist Tracey Curro, whose mother died from ovarian cancer.

Ovarian Cancer Australia is the country’s only national not-for-profit organization which (i) supports women with ovarian cancer, their families, friends and caretakers with compassionate support programs and practical resources; (ii) educates communities and individuals about the disease to increase their awareness of symptoms and the latest treatment, research and clinical trials from across Australia; and (iii) advocates to improve outcomes, treatment and quality of life for women with ovarian cancer.  In 2011, Ovarian Cancer Australia will be celebrating its 10th anniversary.

In support of Ovarian Cancer Australia, the Mrs. Australia Quest pageant is promoting awareness of the early signs and symptoms of ovarian cancer in an attempt to educate the women of Australia and beyond. The overarching goal is to save as many women’s lives as possible.

All Mrs. Australia Quest pageant entrants receive the opportunity to promote themselves, voice their opinions, get involved, network, fulfill personal goals, and most of all to have fun. Moreover, the experience at the Mrs. Australia Quest National Final, which will be held in Sydney during June 2011, promises to be very glamorous and entertaining for all of the women who participate. All participants will be judged based upon the following criteria:  personal interview & Q&A submission, photographic session, Evening Attire Competition, Swimwear Competition, Active Wear Competition, promotion of ovarian cancer awareness, and internet popularity voting.  Undoubtedly, the Mrs. Australia Quest National Final title winner will experience a life changing event that will open new doors of opportunity and create memorable moments.

The Mrs. Australia Quest national winner will go on to compete in the Mrs. International® pageant which will be held in Chicago, Illinois during July 2011. In this pageant, each contestant has the opportunity to select a platform of her choice, which she will spend the next year promoting. Husbands also play a direct role in this event.  Each husband will escort his wife in the Evening Gown competition, and the Mrs. International® pageant winner’s husband will crown his wife as the new titleholder.

Veronica Cristovao – Mrs. Australia Quest Finalist

The Mrs. Australia Quest pageant not only raises money for ovarian cancer, it also raises the profile of the disease by creating ambassadors of young wives in Australia. The pageant’s charitable ovarian cancer awareness mission is what motivated Veronica Cristovao to take part in the 2011 competition.

The Cristovao family celebrates Thomas' 3rd birthday. (Above: Duarte & Veronica Cristovao with their two children; Thomas, a 3-year old boy, and Samantha, an 18-month old girl)

Veronica is 33 years old and is married to her husband Duarte, who is property developer.  The couple has two children; Thomas, a 3-year old boy, and Samantha, an 18-month old girl.

After experiencing the effects of cancer so close to home, Veronica knows all too well the importance of awareness. Veronica’s family relatives have been affected by cancer of the stomach and the breast, as well as lymphoma.

Veronica completed her formal education with a major in Business/Marketing and Computer Science, although she started her work career in the areas of customer service, management and training.  Despite that fact, her life-long passion has always been real estate. In fact, before having children, Veronica worked as a real estate agent.  She also engaged in part-time modeling and commercials, and met many interesting people along the way.

While pregnant with her first child (Thomas), Veronica studied interior design and decoration. Given her husband’s real estate development expertise, Veronica believed that a background in interior design and decoration would allow her to work side-by-side with Duarte, thereby allowing the couple to share a common passion. Veronica has already completed four major interior design/decoration projects, while raising her young children at the same time.  And, her business and marketing background has proved quite helpful in recruiting new clients for her rapidly growing business, which include her brother who happens to be an architect.

Veronica has always been engaged in charitable activities throughout her life, including blood donation and volunteer activities in support of local charitable organizations and children in need.  While working and raising a family, Veronica has also been active in raising ovarian cancer awareness. She dedicates a great deal of time to distributing ovarian cancer awareness posters and informational pamphlets within her local community.  By all accounts, Veronica’s ovarian cancer awareness campaign has been extremely well received by her community.

This past month, Veronica utilized an Ovarian Cancer Australia awareness campaign called, “Afternoon Teal™.” Through this campaign, Ovarian Cancer Australia invites all Australians to support women diagnosed with ovarian cancer and their families by hosting an Afternoon Teal™ during the month of February.  This gathering allows a host, such as Veronica, to invite workmates, friends, and family members to the event with the goal of (i) raising funds to support programs for women touched by ovarian cancer and their families; and (ii) providing vital information regarding the early warning signs and symptoms of ovarian cancer. Veronica hosted several successful Afternoon Teal™ events, thereby raising much needed monies for ovarian cancer awareness.

“Beauty is how you feel inside, and it reflects in your eyes. It is not something physical.”

– Sophia Loren, Italian Film Actress & 1962 “Best Actress” Academy Award (Oscar) Winner

During a recent interview with a local Australian news reporter, Veronica said:  “Cancer is a horrible disease. I feel so fortunate that I am happy and healthy, I want to take this opportunity to give something back.” Veronica believes that learning to “give back” is a critical life lesson for her children, which is best taught by example. “I want my children to understand how important it is to help people in need. I want them to know just how lucky we are.”

In the Mrs. Australia Quest pageant final to be held in June, Veronica will compete with seven other wives for the opportunity to represent Australia at an international level. Veronica believes that winning the national title in June will give her the requisite international platform to raise awareness about the devastating effects of ovarian cancer. Veronica would also like to note that ovarian cancer is preventable through various means, but as with any cancer, recognizing the early warning signs and symptoms is vital. Because there is no reliable blood test to detect early stage ovarian cancer, Veronica looks forward to the day when such a test is readily available at all Australian medical centers.

As noted above, Veronica has already taken it upon herself to campaign hard for ovarian cancer awareness. That hard work has already resulted in her receipt of approximately 7,500 online votes, which represent 10 percent of the final judging score to determine the next Mrs. Australia Quest.  We should note that 50% of monies raised through online voting support Ovarian Cancer Australia.

If you would like to vote for Veronica online, please visit http://www.mrsaustraliaquest.com.au/ and click on the “View Finalists” tab, which is located on the left margin of the Mrs. Australia Quest homepage. All individual donors who vote $100 (AUD) or more will be acknowledged on the Mrs. Australia Quest website. Three business voting packages are also available, which provide an even higher level of donor acknowledgment.

We would like to thank the Cristovao family again for helping us in the preparation of this story, and we wish Veronica all the best with respect to the Mrs. Australia Quest pageant final competition in June 2011. In our humble opinion, Veronica is already a winner and an inspirational ovarian cancer advocate.

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*“Vox Populi,” a Latin phrase that means “voice of the people,” is a term often used in broadcast journalism to describe an interview of the “man (or woman) on the street.”

In the spirit of Vox Populi, Libby’s H*O*P*E*™ searches online for original writings and visual media created by ovarian cancer survivors, survivors’ family members, cancer advocates, journalists, and health care professionals, which address one or more aspects of ovarian cancer within the context of daily life. The written and visual media features that we discover run the gamut; sometimes poignant, sometimes educational, sometimes touching, sometimes comedic, but always honest. The Vox Populi feature may take the form of an essay, editorial, poem, letter, story, song or video picture montage.

It is our hope that the Vox Populi feature will allow our readers to obtain, in some small way, a better understanding of how ovarian cancer impacts the life of a woman diagnosed with the disease and her family. We invite all readers to submit, or bring to our attention, original writings and visual media suitable for publication as Vox Populi features.

FDA Awards $1.6M Orphan Drug Grant for Clinical Phase II Development of EGEN-001 for Treatment of Ovarian Cancer

EGEN, Inc. announced that the Food and Drug Administration (FDA) awarded the company a four-year grant of $1.6 million to assist in the phase II clinical development of EGEN-001, the company’s lead product. EGEN-001 is under clinical development for the treatment of advanced recurrent ovarian cancer.

EGEN, Inc. announced that the Food and Drug Administration (FDA) awarded the company a four-year grant of $1.6 million to assist in the phase II clinical development of EGEN-001, the company’s lead product. EGEN-001 is under clinical development for the treatment of advanced recurrent ovarian cancer.[1]

EGEN, Inc. is developing gene-based biopharmaceuticals that rely on proprietary delivery technologies such as TheraPlas™ (illustrated above). In preclinical studies, the application of this approach produced anti-cancer activity in the treatment of disseminated abdominal cancers, solid tumors and metastatic cancers. (Photo: EGEN, Inc.)

EGEN-001 was developed as an interleukin-12 (IL‑12) gene therapy for the treatment of disseminated epithelial ovarian cancer. It is a low concentration formulation composed of a human IL-12 plasmid formulated with a proprietary PPC delivery system. EGEN-001 is designed for intraperitoneal (IP) administration. The subsequent IL-12 protein expression is associated with an increase in immune system activity, including T-lymphocyte and natural killer (NK) cell proliferation, and cytotoxic activation and secretion of interferon gamma (IFN-g), which in turn, leads to tumor inhibition. Additionally, IL-12 inhibits angiogenesis and formation of tumor vascularization.

EGEN has successfully completed two Phase I trials of EGEN-001 in ovarian cancer patients.  In the first study, EGEN-001 was administered as monotherapy in platinum-resistant ovarian cancer patients[2] and in the second study in combination with carboplatin/docetaxel chemotherapy in platinum-sensitive ovarian cancer patients.[3] In both studies, EGEN-001 treatment resulted in good safety, biological activity and encouraging efficacy.[4-5] EGEN-001 received Orphan Drug Status from the FDA in 2005, and its first $1 million FDA orphan grant in 2005.

“This is a significant milestone and accomplishment for the company,” commented Dr. Khursheed Anwer, President and Chief Science Officer of EGEN. “We are pleased to receive this FDA support, which has been very useful in the advancement of our novel EGEN-001 product in the clinic for the treatment of recurrent ovarian cancer. The product utilizes the Company’s proprietary TheraPlas® delivery technology and is composed of interleukin-12 (IL-12) gene formulation with a biocompatible delivery polymer. IL-12 is a potent cytokine which works by enhancing the body’s immune system against cancer and inhibiting tumor blood supply.”

About EGEN, Inc.

EGEN, Inc. (EGEN), with laboratories and headquarters in Huntsville, Alabama, is a privately held biopharmaceutical company focused on developing therapeutics for the treatment of human diseases including cancer. The Company specializes in the delivery of therapeutic nucleic acids (DNA and RNAi) and proteins aimed at specific disease targets. The Company has a significant intellectual property position in synthetic carriers, their combination with DNA, and their therapeutic applications. EGEN’s research pipeline products are aimed at treatment of various cancer indications. In addition, the Company has its TheraSilence® delivery technology aimed at delivery of therapeutic siRNA for the treatment of human diseases. EGEN collaborates with outside investigators, biotech organizations, and universities on various projects in these areas.

References:

1/ A Phase II Evaluation of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer, Clinical Trial Summary, ClinicialTrials.gov (Identifier:  NCT01118052).

2/A Phase 1, Open Label, Dose Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer, Clinical Trial Summary, ClinicialTrials.gov (Identifier: NCT00137865).

3/A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer, Clinical Trial Summary, ClinicialTrials.gov (Identifier:  NCT00473954).

4/Kendrick JE, Matthews KS, Straughn JM, et. al.  A phase I trial of intraperitoneal EGEN-001, a novel IL-12 gene therapeutic, administered alone or in combination with chemotherapy in patients with recurrent ovarian cancer.  J Clin Oncol 26: 2008 (May 20 suppl; abstr 5572).

5/Anwar K, Barnes MN, Kelly FJ, et. al. Safety and tolerability of a novel IL-12 gene therapeutic administered in combination with carboplatin/docetaxel in patients with recurrent ovarian cancer.  J Clin Oncol 28:15s, 2010 (suppl; abstr 5045).

Source: FDA Awards EGEN, Inc. Orphan -Drug Grant for Clinical Development of EGEN-001 for Treatment of Ovarian Cancer, Press Release, EGEN, Inc., February 2, 2011.

Risk of Death Doubles For Early Stage Ovarian Cancer Patients Who Are Not Checked For Lymph Node Metastases

University of California Davis Cancer Center and California Cancer Registry researchers determined that the risk of death doubles for those women with apparent early stage ovarian cancer who are not checked for lymph node metastases.

Dr. Gary Leiserowitz, Chief of Gynecologic Oncology at the UC Davis Cancer Center & Rosemary Cress, Research Program Director at the California Cancer Registry, reported that early-stage ovarian cancer patients had nearly twice the risk of death if they were not tested for lymph node metastases.

A team of University of California (UC) Davis Cancer Center and California Cancer Registry researchers determined that more than a quarter of women with apparent early ovarian cancer do not receive lymph node biopsies, which have been shown to improve patient survival.

For the study, the researchers identified patients diagnosed with apparent early-stage epithelial ovarian cancer between 1998 and 2000 from cancer registries in New York and California, then collected detailed information from patient medical records on the types of surgical staging procedures performed on 721 of the patients.

The study set forth the critical findings below.

  • Approximately 90 percent of patients had removal of the omentum and evaluation of the bowel serosa and mesentery.  In contrast, only 72 percent of patients with presumed early-stage disease had lymph nodes from the pelvis and abdomen tested for signs of cancer spread, despite the existence of published, professional guidelines for proper staging of the disease.
  • Only lymph node assessment (as well as node assessment combined with washings and omentectomy) had a statistically significant association with improved survival.
  • The five-year survival for women with early-stage disease who had the node biopsies was 84 percent, compared with 69 percent of those who did not have the tests.
  • Patients who did not have lymph node assessment had nearly twice the risk of death as those who did.
  • Stratification of patients based upon receipt of chemotherapy revealed that lack of lymph node sampling had an effect only on patients who also received no chemotherapy.  Thus, only when patients did not have the lymph nodes tested did chemotherapy improve survival, a finding the researchers attribute to the role chemotherapy likely plays in killing cancer cells that have spread beyond the ovaries.
  • Gynecologic oncologists were nearly six-and-a-half times more likely to perform lymph node biopsies than other surgical specialists, and nearly four times more likely to perform all recommended staging biopsies. (See “Additional Information” below for prior medical study findings, regarding the importance of gynecologic oncologists in the evaluation and treatment of ovarian cancer.)

The study results were published online last week in the journal Gynecology Oncology and will be published in the journal’s April print edition.

“Early-stage patients had nearly twice the risk of death if they didn’t have the lymph nodes tested,” said Rosemary Cress, who is an epidemiologist and research program director at the California Cancer Registry, associate adjunct professor in the Department of Public Health Sciences at UC Davis, and the study’s lead author. “Hopefully, this should raise the awareness among physicians that it’s really important to do lymph node biopsies in these patients.”

Why some surgeons don’t remove lymph nodes during ovary surgery for early-stage cancer patients is a matter of speculation, said Gary Leiserowitz, M.D., chief of Gynecologic Oncology at the UC Davis Cancer Center, who is the senior author of the study. But the tests are important, he said, because patients with positive lymph nodes are given a more advanced stage diagnosis and prescribed follow-up chemotherapy treatment.

“Depending on the knowledge and expertise of the surgeon doing the operation, they may not know they need to do all the biopsies,” said Dr. Leiserowitz. “The literature is pretty consistent in showing that the people who have specialized knowledge in this – gynecological oncologists – are much more likely to follow the guidelines.”

Another reason some surgeons may not perform the lymph node biopsies, he said, is that they don’t believe the patient would benefit, either because of advanced age or because they have other serious illnesses, or both.

“If we have a patient who is medically unsuitable because of their age or medical conditions and is not a candidate for chemotherapy, you wouldn’t do all the staging biopsies,” said Dr. Leiserowitz. “But for a woman, say in her 40’s who is otherwise healthy, it turns out to be critical, because chemotherapy could be lifesaving.”

Leiserowitz said he hopes the results of the study will help educate the medical community and patients about the value of appropriate cancer treatment.

“If you are going to treat someone with a cancer, you really have an obligation to understand what the published practice guidelines are, and adhere to them as well as you can, or refer the patient to someone else who will,” he said.

The study was paid for with a grant from the U.S. Centers for Disease Control and Prevention.

About University of California Davis Cancer Center

University of California (UC) Davis Cancer Center is the only National Cancer Institute- designated center serving the Central Valley and inland Northern California, a region of more than 6 million people. Its top specialists provide compassionate, comprehensive care for more than 9,000 adults and children every year, and offer patients access to more than 150 clinical trials at any given time. Its innovative research program includes more than 280 scientists at UC Davis and Lawrence Livermore National Laboratory. The unique partnership, the first between a major cancer center and national laboratory, has resulted in the discovery of new tools to diagnose and treat cancer. Through the Cancer Care Network, UC Davis is collaborating with a number of hospitals and clinical centers throughout the Central Valley and Northern California regions to offer the latest cancer-care services. For more information, visit cancer.ucdavis.edu.

About the California Cancer Registry

The California Cancer Registry (CCR) is a program of the California Department of Public Health’s Cancer Surveillance and Research Branch (CSRB), and works in collaboration with the Public Health Institute, regional cancer registries, health care providers, cancer registrars, and cancer researchers throughout California and the nation. CSRB collects, analyzes, and disseminates information on cancer incidence and mortality. The statewide population-based cancer surveillance system monitors the incidence and mortality of specific cancers over time and analyzes differential cancer risks cancer by geographic region, age, race/ethnicity, sex, and other social characteristics of the population. It gathers cancer incidence data through CCR, and conducts and collaborates with other researchers on special cancer research projects concerning the etiology, treatment, risk factors, and prevention of specific cancers. In addition, the system is designed to monitor patient survival with respect to the type of cancer, extent of disease, therapy, demographics, and other parameters of prognostic importance. In general, data generated from CCR are utilized as set forth below.

  • Monitor the amount of cancer and cancer incidence trends by geographic area and time in order to detect potential cancer problems of public health significance in occupational settings and the environment, and to assist in their investigation.
  • Provide information to stimulate the development and targeting of resources to benefit local communities, cancer patients, and their families.
  • Promote high-quality epidemiologic and clinical research by enabling population-based studies to be performed that can provide better information for cancer control.
  • Inform health professionals and educate citizens regarding specific health risks, early detection, and treatment for cancers known to be elevated in their communities.
  • Respond to public concerns and questions about cancer.

For more information, visit http://www.ccrcal.org/.

Sources:

Additional Information — The Role of Gynecologic Oncologists and Their Impact on Survival:

Novel Cancer-Targeting “Cornell Dot” Nanoparticle Approved for First-In-Human Clinical Trial

“Cornell Dots” — brightly glowing nanoparticles — may soon be used to light up cancer cells to aid in diagnosing and treating cancer. The U.S. Food and Drug Administration (FDA) has approved the first clinical trial in humans of the new technology. It is the first time the FDA has approved using an inorganic material in the same fashion as a drug in humans.

“Cornell Dots” (or “C dots”) — brightly glowing nanoparticles — may soon be used to light up cancer cells to aid in diagnosing and treating cancer. The U.S. Food and Drug Administration (FDA) has approved the first clinical trial in humans of the new technology. It is the first time the FDA has approved using an inorganic material in the same fashion as a drug in humans.

Michelle Bradbury, M.D., Ph.D., Clinician-Scientist, Neuroradiology Service, Memorial Sloan-Kettering Cancer Center; Assistant Professor, Radiology, Weill Cornell Medical College; Lead Study Investigator

Researchers at Memorial Sloan-Kettering Cancer Center’s Nanotechnology Center, along with collaborators at Cornell University and Hybrid Silica Technologies, have received approval for their first Investigational New Drug Application (IND) from the FDA for an ultrasmall silica inorganic nanoparticle platform for targeted molecular imaging of cancer, which may be useful for cancer treatment in the future. Center researchers are about to launch their first-in-human clinical trial in melanoma patients using this first-of-its-kind inorganic nanoparticle to be approved as a drug. “This is a very exciting and important first step for this new particle technology that we hope will ultimately lead to significant improvements in patient outcomes and prognoses for a number of different cancers,” said Michelle Bradbury, M.D., Ph.D., a clinician-scientist on Memorial Sloan-Kettering’s Neuroradiology Service and an assistant professor of radiology at Weill Cornell Medical College, who is the lead investigator of the study, along with Snehal Patel, M.D., a surgeon on Memorial Sloan-Kettering’s Head and Neck Service, who is a co-principal investigator.

“This is a very exciting and important first step for this new particle technology that we hope will ultimately lead to significant improvements in patient outcomes and prognoses for a number of different cancers.”

– Michelle Bradbury, M.D., Ph.D., lead investigator of the study and clinician-scientist on Memorial Sloan-Kettering’s Neuroradiology Service and an assistant professor of radiology at Weill Cornell Medical College

C dots were initially developed as optical probes at Cornell University, Ithaca, by Ulrich Wiesner, Ph.D., a professor of materials science and engineering who, along with Hybrid Silica Technologies, the supplier of C dots, has spent the past eight years precisely engineering these particles. C dots are silica spheres less than 8 nanometers in diameter that enclose several dye molecules. (A nanometer is one-billionth of a meter, about the length of three atoms in a row.) The silica shell, essentially glass, is chemically inert and small enough to pass through the body and out in the urine. For clinical applications, the dots are coated with polyethylene glycol so the body will not recognize them as foreign substances.

C dots were subsequently modified at Memorial Sloan-Kettering for use in PET (positron emission tomography) imaging. C dots are tiny silica spheres that contain dye that glows three times more brightly than simple free dyes when excited by light of a specific wavelength. C dots can “light up” cancer cells, and act as tumor tracers for tracking the movement of cells and assisting in the optical diagnosis of tumors near the skin surface. The attachment of a radioactive label produces a new generation of multimodal (PET-optical) particle probes that additionally enable deeper detection, imaging, and monitoring of drug delivery using three-dimensional PET techniques.

Ulrich Wiesner, Ph.D. (left), a Cornell University Professor of Materials Science & Engineering, works with graduate students Jennifer Drewes & Kai Ma to characterize the size & brightness of C dots in their Bard Hall lab. (Photo: Jason Koski/University Photography)

C dots can be tailored to any particle size. Previous imaging experiments in mice conducted by the Memorial Sloan-Kettering team showed that particles of a very small size (in the 5 to 7 nanometer range) could be retained in the bloodstream and efficiently cleared through the kidneys after applying a neutral surface coat. More recently, the research team molecularly customized C dots to create a new particle platform, or probe, that can target surface receptors or other molecules expressed on tumor surfaces and that can be cleared through the kidneys.

Using PET scans, C dots can be imaged to evaluate various biological properties of the tumors, including tumor accumulation, spread of metastatic disease to lymph nodes and distant organs, and treatment response to therapy. The information gained from imaging tumors targeted with this multimodal platform may also assist physicians in defining tumor borders for surgery, and improving real-time visualization of small vascular beds, anatomic channels, and neural structures during surgery.

The purpose of this trial is to evaluate the distribution, tissue, uptake, and safety of the particles in humans by PET imaging. This study will provide data that will serve as a baseline to guide the design of future surgical and oncologic applications in the clinic. “The use of PET imaging is an ideal imaging technology for sensitively monitoring very small doses of this new particle probe in first-in-human trials,” added Steven Larson, M.D., Chief of Memorial Sloan-Kettering’s Nuclear Medicine Service.

Memorial Sloan-Kettering nanochemist Oula Penate Medina, Ph.D., notes that “this is an important trial in that it will help to answer a number of key questions regarding future potential applications of this multimodal system. Once the door has been opened, new and emerging fields, such as targeted drug delivery, can be investigated. We expect that these particles can be adapted for multiple clinical uses, including the early diagnosis and treatment of various cancers, as well as for sensing changes in the microenvironment.”

“This clinical trial is the culmination of a longstanding collaborative effort with our colleagues at Cornell and Hybrid Silica Technologies, as well as a testament to our own institutional colleagues here at the Center,” Dr. Bradbury said. “With the support of many, in particular the Office of Clinical Research, we’ve pushed to translate the C dots from a laboratory idea to our first FDA IND-approved inorganic nanomedicine drug product to be tested in the clinic,” Dr. Bradbury said.

The work was funded in part by the Clinical and Translational Science Center, Weill Cornell Medical College, the Cornell Nanobiology Center, and the National Institutes of Health (NIH) Small-Animal Imaging Research Program (SAIRP). In addition to Drs. Bradbury, Penante-Medina, Larson, Patel, and Wiesner, the following Memorial Sloan-Kettering investigators contributed to and/or supported this work: Pat Zanzonico, Ph.D.; Heiko Schöder, M.D.; Elisa De Stanchina, Ph.D.; Hedvig Hricak, M.D., Ph.D., Chair of the Department of Radiology; as well as Hooisweng Ow, Ph.D., of Hybrid Silica Technologies, Inc.; Memorial Sloan-Kettering’s Office of Clinical Research; and the Cyclotron Core.

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