IPSOGEN acquires rights for new cancer biomarkers

IPSOGEN SA (Alternext: ALIPS), a majority-owned subsidiary of QIAGEN N.V. (Nasdaq: QGEN), has reported that it has acquired the worldwide exclusive rights to testing for mutations of the IDH1 and IDH2 genes for diagnostic purposes from Baltimore, Maryland-based Personal Genome Diagnostics (PGDx). IDH1 (isocitrate dehydrogenase 1) and IDH2 are enzymes and the mutations in IDH1 and IDH2 genes, discovered in 2008 by the founders of PGDx, are frequently found in brain cancers, including early stage and late-stage gliomas. Subsequent studies have implicated IDH1/IDH2 mutations in acute myelogenous leukemia (AML) and other cancers.

Biomarkers and depression

In a paper published in the journal Molecular Psychiatry, a team including Massachusetts General Hospital (MGH) researchers reports that a test analyzing levels of nine biomarkers accurately distinguished patients diagnosed with depression from control participants without significant false-positive results.  The test developed by Ridge Diagnostics measures levels of nine biomarkers associated with factors such as inflammation, the development and maintenance of neurons, and the interaction between brain structures involved with stress response and other key functions.

Signal Genetics acquires ChipDX

Signal Genetics has reported signing an agreement with New York based ChipDX LLC, under which Signal will acquire all of the assets of ChipDX, including patents for prognostic tests in lung, breast, and colon cancers. As part of the transaction, Signal will acquire BreastGeneDX, ColonGeneDX, and LungGeneDX, all diagnostic and prognostic tests in development by ChipDX. Signal says it believes that these genetic tests represent novel products or improvements over other products currently on the market in these cancer types. Signal will also acquire ChipDX’s web-based interface, which will be used to enhance Signal’s physician web portal and allow for remote interpretation of test algorithms. Ryan VanLaar, Ph.D., CEO and Founder of ChipDX, will join Signal as the Head of BioInformatics. Financial details of the transaction were not disclosed.

Agreement struck to produce custom nucleic acids

Synthetic Genomics, Inc. (SGI) and Integrated DNA Technologies, Inc. (IDT) have jointly announced that they have entered into an agreement to manufacture, market, and commercialize small synthetic gene products. SGI and IDT will work together to construct custom, synthetic, double-stranded nucleic acids up to 5 kb. IDT will use its custom oligonucleotide manufacturing expertise, including its recently launched gBlocks Gene Fragments product line, in combination with SGI’s proprietary technologies to efficiently assemble small gene constructs. The financial details of the agreement were not disclosed.

FDA approves test from Roche

Roche says that the FDA has provided 510(k) clearance to the cobas® CT/NG Test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self -collected vaginal swabs.  A polymerase chain reaction (PCR)-based multiplex dual probe assay, the test for chlamydia and gonorrhea runs on the automated cobas 4800 System, complementing the cobas HPV (Human Papillomavirus)Test that received FDA approval in April.

Diagnostics industry veteran joins Life Technologies

Ronnie Andrews, former CEO at Clarient and Segment Leader, GE Molecular Diagnostics, has joined Life Technologies as President, Medical Sciences. Mr. Andrews has more than 25 years of experience in the diagnostics industry, including leadership positions at companies such as Abbott Diagnostics and Roche Diagnostics. He will apply his expertise to expand Life’s presence in the diagnostics and personalized medicine space through strategies including short and long term partnerships.

-Peter Winter

Click to see slide presentation

Click below to hear live audio interview with Thomas Moore, CEO.

PRINCETON, N.J., Jan. 25  — Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, reported preliminary data on the safety and clinical benefit of ADXS-HPV from an ongoing randomized Phase 2 trial of ADXS-HPV with or without cisplatin in Indian women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. Dr. John Rothman, Advaxis Executive Vice President of Science and Operations, presented the preliminary data at the World Cancer Immunotherapy Conference in San Diego, California on Wednesday, January 25, 2012.

The advanced cervical cancer study is being conducted at 17 sites in India, and as of January 25, 2012, 87 out of a planned 110 patients have been enrolled in the study. To be enrolled in the study, all patients must have been previously treated with radiation, and/or chemotherapy, and the cancer must have resumed growth and in most cases has metastasized, as confirmed by CT or radiologic scan. Because data are available to Advaxis in “real time”, the Company is reporting preliminary data on a periodic basis. The initial safety and objective response data for this ongoing study were presented at the AACR New Horizons in Cancer Research: Biology to Prevention to Therapy conference Gurgaon, Delhi (NCR), India on December 14, 2011.

The objectives of this Phase 2 trial are to assess the safety and efficacy of ADXS-HPV (1×109 cfu) with and without cisplatin (40 mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. As of January 20, 2012, 87 patients have received 195 doses of ADVS-HPV. 34% of patients (a total of 30) have experienced a ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events that were transient, comprised of non-cumulative flu-like symptoms that responded to symptomatic treatment, or resolved on their own; and 1 Grade 3 event.

The primary efficacy endpoint of this Phase 2 trial is overall survival. As of January 25, 2012, the percentage of patients alive at 6 months is 62% (34/55); at 9 months is 41% (15/37) and at 1 year is 40% (6/15). Clinical responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) documented to date, which expands on the preliminary data presented at the AACR meeting in December that reported 1 complete response and 3 partial responses. “These data will change, as the study is ongoing and still enrolling. However, we are encouraged by the preliminary safety, tumor response, and survival data,” commented Dr. Rothman.

The slide presentation is available on the Advaxis website at http://www.advaxis.com/.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.

Advaxis’ most advanced construct, ADXS-HPV, is being evaluated in 4 Phase 2 clinical trials for HPV-associated diseases: CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), recurrent/refractory cervical cancer (India), and head & neck cancer (CRUK study) with over 150 patients receiving over 360 doses to date. Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, and others.

“Thousands of people are killed or seriously injured in U.S. hospitals each year when they receive the wrong IV medicine or wrong dosage. S.E.A. Medical is doing something that has never been done before: instantly identifying the actual contents of any IV,” said Michael Weickert, CEO and co-founder of S.E.A. Medical. “We are delighted to have the support of JK&B Capital who understand the power and potential of our technology solution to address patient safety issues and revolutionize medical care.”

“S.E.A. Medical Systems has demonstrated the potential for a novel and dramatic advance in IV medicine,” stated David Kronfeld, Chairman of JK&B Capital. “The company is well positioned to provide disruptive products that improve safety and cost effectiveness of medical care in the coming years.”

“Drug errors are a very serious problem in medicine and it is exciting to finally see a technology that can address some that could not previously be prevented in a new and decisive way,” said David Bates, MD. Dr. Bates is a leading authority on adverse drug events, the mistakes with medicines that injure or kill patients, and is also a member of the S.E.A. Medical board of directors.

About JK&B Capital (www.jkbcapital.com)

Founded in 1996, JK&B Capital is a Chicago-based venture capital firm with more than $1.1 billion under management which focuses on Information Technologies, healthcare and communications. A key to JK&B’s success has been its ability to leverage its substantial technology domain expertise to identify, analyze and access the most promising emerging technologies and the companies behind them. JK&B then provides these companies with financial support, strategic guidance and most importantly technical guidance to help them grow and prosper.

About S.E.A. Medical Systems, Inc. (www.seamedical.com)

S.E.A. Medical Systems Inc. is a private healthtech company that pioneers smart solutions for the safe manufacture, preparation, delivery, and disposal of intravenous and other liquid medications. The Company is developing medical devices to catch life-threatening IV drug errors before they harm patients. S.E.A. Medical’s unique technology identifies drugs, concentrations, and diluents in IV fluids, and simultaneously measures flow rate and cumulative dose during IV administration. The Company is also developing its proprietary technology for other medical applications. Based in Santa Clara, CA, the company has been supported by strategic funding and Series A investors including Quantum Technology Partners, New Biology Ventures, and private investors.

About Series A investors

Quantum Technology Partners (www.quantumtp.com) invests in early stage life sciences and technology companies. New Biology Ventures (www.newbiologyventures.com) is an early stage life science investor and venture capital incubator accelerator.

Source

Click below to hear audio interview with Dr. Craig Dees, CEO of Provectus.

Provectus is seeking consensus on a design that will qualify for Special Protocol Assessment and supports approval of PV-10 for its melanoma indication. The Company intends to pursue the SPA path, which would represent an agreement from the FDA that the Phase 3 study design endpoints, statistical analyses and other components of the planned clinical trials are acceptable to support approval of the product.

Craig Dees, Ph.D., CEO of Provectus said, “Following our third meeting with the Agency in October, we believed that significant progress had been achieved in defining the threshold the FDA will require for approval in melanoma, which is a rapidly evolving therapeutic area. Using recommendations of senior FDA officials from that meeting, including those related to patient population and primary endpoint, we intend to request SPA review of our protocol, which we expect will be submitted before the end of the first quarter. While SPA can occur over as little as 45 calendar days, it is important to note that this is frequently an iterative process, and could take longer as we work with the Agency to reach ultimate agreement on study design.”

Dr. Dees continued, “We also continue to assess whether a second Phase 3 RCT, tailored to meet the regulatory requirements of Australia, would be helpful in accelerating approval in that important market, and whether emerging results from ongoing immunologic mechanism of action studies can be used to support accelerated approval in the U.S. We are fortunate to have the necessary resources to allow sufficient flexibility in our development plan to maximize likelihood of approval in the major melanoma markets in the U.S., Australia and the European Union.”

More information about the Special Protocol Assessment is contained in the Appendix to this press release.

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. Its dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed Phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

Clinical trial initiated for Trisomy 21 test

Hologic to purchase Barcoded Magnetic Beads
Applied BioCode reports that it has signed a license and supply agreement with Hologic that allows them to purchase the company’s Barcoded Magnetic Beads (BMB) with digital multiplex capabilities. Hologic says that it plans to use the BMBs in conjunction with its Invader® chemistry to create nucleic acid based tests for the agriculture market.

Health Discovery and NeoGenomics collaborate
Health Discovery (OTCBB: HDVY) and NeoGenomics (OTCBB: NGNM) say that they have entered into a licensing agreement for the development of laboratory developed tests (LDT’s) in the field of hematopoietic and solid tumor cancers excluding breast cancer, which was previously licensed to Quest Diagnostics (NYSE:DGX) and Smart Personalized Medicine and excluding cancer of the retina, which was previously committed to Retinalyze, LLC. HDC will retain all rights to in-vitro diagnostic test kit development in cancer. NeoGenomics has paid $1 million in cash and issued 1,360,000 common shares to HDC in upfront licensing fees. In addition, NeoGenomics will make milestone payments, in cash or stock, based on sublicensing revenue and revenue generated from products and services developed as a result of the collaboration.

In Brief…
Agilent Technologies and Integrated Diagnostics say that they have struck a strategic partnership to develop assays that detect major human diseases at very early stages to improve treatment outcomes. The partnership will develop high-throughput automated workflows to include sample preparation and LC MS/MS analysis. The technology opens the possibility of screening for several hundred biomarkers in a single assay, in a very high-throughput and quantitative fashion, according to Agilent.

Exagen Diagnostics has announced the launch of its Avise SLE, which aids in the diagnosis of lupus. Avise SLE is a 5-marker panel that includes testing of ANA, dsDNA, Avise MCV, EC4d and BC4d. The Avise SLE diagnostic differentiates itself by using cell-bound complements because of their increased performance over soluble complements.

Dako reports that it will develop a companion diagnostic test for an Amgen cancer drug candidate targeted for a rare and deadly cancer.

The G2 Molecular Diagnostics Conference will be held in Boston April 17-19, 2012. Details: www.mdxconference.com-Peter Winter

Their main technology is called the PISCO® (Pressure-Controlled Coronary Sinus Occlusion) Impulse System and it is designed to improve blood flow in the heart tissue, which improves the overall heart function after a severe heart attack. Three million patients are treated for restricted coronary blood flow every year. More than 350,000 of these patients still have poor heart tissue blood flow even after successful balloon angioplasty or stent placement.

This system is CE-marked and can be used during coronary revascularization procedures following a heart attack or other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system. Currently, the technology is only approved for investigative purposes in the United States.

How It Works

During a heart attack, one or more arteries are blocked by plaque build-up, which limits blood flow to the heart tissue. About 1.8 million patients per year globally will suffer permanent heart damage. They typically receive a Percutaneous Coronary Intervention (PCI) such as balloon angioplasty or stent placement to prevent further damage and to support circulation. However, they do not typically receive therapy for the damaged heart tissue.

That’s where PISCO comes in. The Impulse Catheter is inserted on the venous side of the heart and intermittently inflated to increase blood pressure in the heart muscle. This pressure build-up causes a redistribution of flow into the damaged area of the heart.

Initial Outlook

In the initial round of clinical trials, Professor Jan Piek, MD and his group at the Academic Medical Center in Amsterdam performed 10 successful PISCO procedures on stable angina patients.

Professor Piek reported that even when a patient receives a successful initial PCI such as ST-segment elevation myocardial infarction (STEMI), the patient still has limited blood flow in about 30 percent of cases. “Our study demonstrates that PISCO significantly increased the redistribution of blood into ischemic myocardium.”

While these results are limited, the mortality and morbidity following a PCI procedure remains sizable, reports Miracor. More trials are underway.

To learn more about Miracor’s PISCO system, please visit www.miracormedical.com. Miracor presented its products and technologies at OneMedForum SF 2012, on January 9 – 12.

Their most recent project was documented in a paper published in the December 2011 issue of Cancer Discovery. The paper showcased research performed by collaborators from the University of Texas MD Anderson Cancer Center on the cytokeratin, which is a protein biomarker for epithelial cells (the tissue that lines body cavities and flat surfaces in the body). The research indicates not all CTCs have epithelial properties.

To date, most CTC capture and detection technologies have not been able to recognize the cytokeratin negative (CK‐) CTCs. In the paper, researchers explore how Biocept’s Cell Enrichment and Extraction (CEETM) platform allows for the capture of these CK- cells as well as CK+ CTC phenotypes in patient samples and animal models.

The researchers determined that CK- CTCs may be as prevalent as CK+ CTCs at different stages of a patient’s cancer in many types of cancer. The benefit of capturing both types of these cells is to gain useful information about the cancer such as whether the CK- CTCs have undergone the epithelial-to-mesenchymal transition (EMT), which is believed to be a key process for metastasis (cancer’s transfer from one organ to another).

“New technologies, and new ways of looking at a problem, often bring advances in understanding cancer biology, which may translate into better patient care. We are at the beginning of characterizing CTCs, and different CTC populations, as well as their roles in different cancers, or stages of cancer. We believe that the Biocept CEETM platform holds great potential in advancing towards this goal,” said Anil Sood, MD and lead author of the paper in a recent press release.

OncoCEE-BRTM™ – Advancing Breast Cancer Research

Currently, Biocept has one test commercially available – the OncoCEE-BRTM test for breast cancer. The test allows for CTC enumeration (higher CTC numbers may be an indicator of poor treatment outcomes) and the determination of HER2 status of the CTCs via a technique called fluorescence in situ hybridization (FISH). The FISH HR2 test predicts whether the patient is eligible for treatments such as Herceptin®. This drug is used to treat patients with HER2+ breast cancers, which is considered an aggressive cancer. A higher number of HER2 protein markers indicate that the cancer will spread quickly.

According to BreastCancer.org, more than 230,000 cases of invasive breast cancer would be diagnosed in American women by the end of 2011. Additionally, more than 57,000 cases of non-invasive breast cancer were expected to be diagnosed in 2011.

This year, Biocept’s OncoCEE-BRTM test will include determination of the estrogen and progesterone receptors (ER and PR, respectively) status via immunocytochemical staining, which is yet another indicator of the status of the patient’s disease.

The test is currently available through Biocept’s CLIA lab. In the near future, the test will be marketed and sold commercially via collaboration with Clarient, Inc. (a GE Healthcare company). Biocept’s breast cancer CTC test is the first commercially available test to include the analysis of a specific treatment-associated biomarker.

Biocept, Inc. presented its products and technologies OneMedForum SF 2012, on January 9 – 12.

Currently, seven million people in the western world use Warfarin to treat blood coagulation (clotting) disorders such as atherosclerosis and deep vein thrombosis. The U.S. Food and Drug Administration estimates that nearly 1 million patients will be prescribed the drug each year. In order to ensure they receive the correct dosage of the drug, patients must have regular blood tests at their doctor’s office. The drug requires this testing because everyday activities and foods can affect dosages levels.

According to a recent study at the University of Oxford in the UK, patients who monitor their own blood coagulation levels and Warfarin dosages can reduce their risk of blood clots by half.

Microvisk’s CoagMax® & CoagLite®

Microvisk’s two devices – the CoagMax® and CoagLite® tests allow patients and healthcare professionals a new testing technology to provide the Prothrombin time or INR (international normalized ratio), which is the internationally recognized standard in measuring blood coagulation. All of the currently available tests use the same approach to find the INR – taking a blood sample from the patient and measuring the clotting factor on a test strip. However, most available devices use optical analysis or chemical reactions.

The Microvisk uses micro electro mechanical sensors (MEMS) to measure blood clotting speed. The real difference in this SmartStrip® is that it allows patients to accurately measure their blood clotting levels at home with a single drop of blood and a handheld reader displays the results, much like a blood glucose monitor. The small testing sample is less intrusive and effectively removes the need for a laboratory.

The coagulation status (clotting speed) of the patient’s blood is measured by tiny multi-layered paddles on the surface of the strip and a memory chip ensures the device is calibrated to provide the highest levels of accuracy. The MEMS technology, which was originally developed as a movement system for nano-robots is also used in devices such as the iPhone and Nintendo Wii. This technology is cost-effective and allows for high volumes of the Microvisk devices to be manufactured at a low cost.

Currently, only three companies have developed a blood coagulation testing system approved for use in a doctor’s office. Although these devices are also certified for home use, Microvisk’s research shows that doctors feel they are “too robust” and “too complex” for home use.

The Microvisk devices are currently undergoing clinical trials in the UK and in Germany. Product launches are planned for these two countries in early 2012. In addition, U.S. clinical trials are ongoing in major medical centers in Florida; and the U.S. product launch is scheduled for later in the year.

A key finding in the pilot trials is that nine of 10 patients have expressed a preference for the Microvisk devices due to the small test sample needed.

Microvisk’s devices were named “Healthcare Project of the Year” at the prestigious BioNow Biomedical Awards, a showcase of the leading biomedical companies in northwest England in December.

Microvisk presented its products and technologies at OneMedForum SF 2012, on January 9 – 12.

Manufactured and marketed by Chagrin Falls, Ohio-based Cervilenz, Inc., the device measures the vaginal cervical length and quickly identifies women at high risk for premature birth. Premature birth is the leading cause of death for newborns in the United States, and cervical length is considered the single best indicator for premature birth risk. To date, measurements have been made with transvaginal ultrasound (TVU).

The CerviLenz device’s advantage is that it can be used by any healthcare practitioner trained to perform a speculum exam in any healthcare setting. The disposable, single-use device is cost-effective and allows the physician or midwife to begin treatment more quickly.

Both clinical studies were presented as part of the “Prevention of Prematurity and Care of the Premature” scientific session at the 10^th World Congress of Maternal and Neonatal Health in Rome in December 2011.

Premature birth, which affects 13 million babies globally each year, has been named a public health epidemic and was the sole topic of the session. In this session, Gian Carlo Di Renzo, MD, PhD and president of the Congress, addressed the condition’s risk factors and introduced the CerviLenz device as a cost-effective innovation with potential to improve maternity care worldwide.

Dr. Di Renzo declared that the device shows “great promise to identify patients at risk for preterm delivery as well as those in real preterm labor” and shared data from his recent clinical evaluation. At each of the 50 patients’ mid-gestation pre-natal visits, cervical length was checked with the traditional transvaginal ultrasound (TVU) and the CerviLenz device. Each test was performed by two different examiners blinded to the other result.

“Our data show 100 percent agreement,” Dr. Di Renzo, said in a press release. “Both TVU and CerviLenz measurements identified all of the patients with a cervical length of less than 30 millimeters (3 centimeters) and the correlation coefficient was excellent. I am very pleased with the performance of this new device to identify high risk patients so they can be treated appropriately with progesterone therapy to prevent preterm delivery.”

Another study presented at the Congress comes from Justin Lavin, MD and professor emeritus of obstetrics and gynecology at Northeast Ohio Medical University, evaluated pregnant women with regular contractions between 22 and 34 weeks gestation.

This study, which took place at Akron General Medical Center in Akron, Ohio, followed 144 pregnant women presenting with regular contractions in the late second and early third trimesters. The CerviLenz device was used to measure cervical length and if a patient measured 25 millimeters (2.5 cm) or more ruled out delivery within seven days with 100 percent accuracy and delivery before 34 weeks with 97 percent accuracy.

“These data show similar results to published data with transvaginal ultrasound assessment of cervical length to rule out suspected premature labor,” Dr. Lavin said in a press release. “The CerviLenz device holds great promise as a tool to help physicians make decisions in this challenging clinical situation.”

Cervilenz, Inc. presented its products and technologies at OneMedForum SF 2012.

A recent product of note is the BlackLight® Sepsis Kit, which is currently under clinical evaluation. The sepsis detection kit has been extensively tested on real hospital samples, which have led to recognition of both common and rarer pathogens. Sepsis is a condition that occurs when there is a system inflammatory response to a microbial infection. According to the Sepsis Alliance (a charitable organization dedicated to combating sepsis), American hospitals spend approximately $20 billion each year combating the deadly condition, which is often linked to infections such as appendicitis or pneumonia. Currently, about 40 percent of patients diagnosed with a serious case of sepsis do not survive. Nearly 1,400 people worldwide die each day from this toxic condition.

According to BlackBio, the increased sepsis rates can be attributed to an increase in organ transplants and other surgeries that require suppression of the immune system. Additionally, a growing elderly population and the overuse of antibiotics has created drug-resistant bacteria are other reasons for the increase in sepsis.

Early detection is considered the best chance for sepsis survival, and BlackBio seeks to help increase this early detection with their early detection kit.

How It Works

With a minimal sample size and diagnosis completed in less than four hours, the cost-competitive, easy-to-use kit is designed to identify the species of bacteria by generating sequences covering three regions of the 16S ribosomal DNA. When these sequences are compared with the kit’s included database, the microorganism causing the infection can be identified in a timely manner. This early detection could reduce sepsis death by half proper treatment is administered within 48 hours.

To learn more about BlackBio’s BlackLight Sepsis detection kit and their other technologies, please visit www.blackbio.eu. BlackBio presented its products and technologies at OneMedForumSF January 9-12.