Vein Visualization for Better Stick Outcomes

Ron Bucher, Director of Worldwide Customer Service at AccuVein, talked on “Mapping Vasculature for Better Outcomes” at www.bio2devicegrou.org event.

Many of us have experience with being poked more than once on account of the nursing professional not being able to find a vein immediately.  There are serious consequences of a missed poke.  Patient satisfaction goes down and with new changes in healthcare laws, patient satisfaction is becoming very important indicator, and is increasingly being tied to many incentives.  More attempts at poking patients also increase cost of supplies and equipment, and take up more staff time as different staff members have to be called after some unsuccessful attempts.  There is also increased potential for infection, as well as other complications, and potential delays in treatment, as well as possibility of compromise of optimal therapy.

Almost 3 million sticks per day take place in the US.  As high as 70% of medical decisions are made by blood tests, and IVs are used in 95% of hospital admissions, said Bucher.  Liabilities and challenges of missed sticks are particularly important in cases of more vulnerable populations; including pediatric patients, the elderly, among diabetic or obese patients, among chemotherapy patients, and the very sick.

English: Blood draw for genetic studies (Photo credit: Wikipedia)

AccuVein is a vein visualization product that increases the success rate with first stick by 350%.   This is a portable, non contact product that illuminates the veins, for easy stick, with first attempt.  Advantages of getting it right on first attempt are many, including increased patient satisfaction and reduction in pain related negative comments by patients, by 59%.  AccuVein use also leads to reduction in cost, reduced hospital stays, and reduction in time to complete a procedure.  Return on investment would be in less than a year’s time.  The percentage of procedures completed within 15 minutes, with AccuVein, went up to 97% from earlier 53%.  This also enhanced confidence among nursing staff.  Most nursing staff gets a bare minimum of 1 hour of training for venal puncture; often they learn on patients through trial and error, said Bucher.  AccuVein product is easy to use and requires minimum training and reduces escalations by 45%.  It is a point and click product that works in light and dark, works on all skin types and is non orientation sensitive. 

Bucher shared extremely high patient satisfaction data.  With high patient satisfaction, greatly reduced cost in terms of resources and time, and increased staff confidence, clearly AccuVein type product should become a standard of care in all healthcare facilities.  The talk was followed by Q&A.

“The Dog Lived and So Will I” by Teresa J. Rhyne — Book Review

“I was hideous.  Hideous.  In preparing for chemo I’d thought about the hair loss, of course, and concentrated on the fact that it would grow back.  I thought about losing my eyelashes and decided eye shadow and liner would work miracles.  I knew of the bloating weight gain the steroids could cause but told myself that was better than nausea and again it was temporary; after all, Seamus (dog) had gained 20 percent of his body weight and just as quickly was back in fighting shape.  Menopause would come, sure, but it was going to do that sooner or later anyway, and before it happened I was no more aware than anyone else of the true meaning of hot flashes and how you burn from the inside out, so that hadn’t bothered me either.  Somehow I had overlooked skin rashes as a side effect and never, never had I given thought to what these side effects would all be like together.  Not until that moment, face to mirrored face.  …….. How does one recover from this? Impossible. ……. I can’t do this.  I can’t”.

Heaven forbid and if one ever has to go through cancer treatment, having read this book not only would help one navigate the morass of health care system, but also giver clear hope that not only “it too shall pass” but it is worth waiting for the “cookie moment”.

Teresa poured her heart and soul (not to mention her hard earned money) to take her beagle, Seamus, survive through an aggressive form of cancer.  She cried buckets of tears, took him for his biopsy and chemo appointments, rushed him to the hospital when his white blood count dropped dangerously low, and stood up to the neglectful veterinarians, to get him the care he needed.  However, in one of life’s cruel ironies, before long she discovered that she had a lump in her breast and the biopsy showed it to be the one of the most aggressive forms of cancer, a triple negative breast cancer.   How does one survive such traumas?  The answer is “love”.

Some may consider this a story of surviving cancer, but this is a story about the rock, the glue, and the toast.  After being divorced twice, Teresa had a new boyfriend Chris, ten years younger, smart, funny, wise, and infinitely kind.  Little did they know that he would be the rock (the pack leader) on whom she would need to lean during both Seamus’s and her own illness and treatment.  When Teresa is completely dejected and feels she can’t do this anymore, he bakes her cookies at four in the morning, drives her to all her medical appointments, tries out wigs with her, and in solidarity as she looses her hair, he grows his hair, making a deal that he would only cut when she needed a cut, after the regrowth of her hair.

Camry the beagle (Photo credit: laRuth)

Teresa for her part is the glue that holds their family together.  She leans on him but gives him space.  She is infinitely grateful and brings her and Chris’s family into the fold, eventually bringing them to meet each other.  Seamus who loves toast, steals people’s hearts with his cuteness.  He brings much needed joyful respites to their little family.

I cry easily but this book did not make me cry.  I teared up often reading this touching tender story, but I also laughed a lot.  Deep grief is wrapped in smart, witty, humorous, funny anecdotes.  And then there is treasure trove of information about little questions that are hard to get answered.  Is it painful for the radioactive tracer to be injected in order to locate the tumor for a biopsy, how long it takes for a chemo treatment, how long does it take for radiation, and more.

And while majority of the health care personnel and physicians are compassionate, committed, and are deeply dedicated to the welfare of their patients, there are some who are clearly uninterested, detached, and neglectful.  Teresa stands up (unfortunately not always succeeding) for her right as a patient to get timely information and reasonable care.  One of the physicians who rarely sees her patients, leaving actual care in the hands of the nurses, assures Teresa (about her dangerous white blood count crash), these side effects are very common, and the nurses know how to deal with them.  We deal with this stuff all the time.”  Teresa points out, that the nurse did not have the answers on how to deal with them and says, “it’s not common to me.  I don’t deal with it all the time”.  Contrarily, she is enormously grateful and highly appreciative of the compassionate and thorough care she received at the UCLA cancer center and particularly Dr. Amer Karam.

This is an engaging, funny, sweet, uplifting, heartwarming story.  After all, who would not like to read about a cute dog’s hilarious antics?

 

Genetically Engineered Oncolytic Virus to Treat Glioblastoma

Glioblastoma or GBM is the most aggressive brain tumor for which currently there exists no cure.  Michelle Chen talked about targeted oncolytic virus therapy for these tumors.  These tumors are highly malignant because the cells reproduce quickly and they are supported by a large network of blood vessels.  There are approximately 25,000 new cases in Europe and US, each year.  Median survival in newly diagnosed patients who receive the best treatments is less than 14 months.  Most patients experience quick relapse and survival after 5 years is very dim.

Following the diagnosis, the current standard of care consists of surgery, radiotherapy, and chemotherapy with temozolomide.  FDA has recently also approved Avastin for recurrent GBM.  But new therapies for GBM are urgently needed.  There is a lot of activity in this space but currently active drugs have lot of safety concerns.

English: TAC_Brain_tumor_glioblastoma-Coronal_plane Italiano: Immagine TAC della zona cerebrale, identificando un tumore di tipo glioblastoma (Photo credit: Wikipedia)

DNX-2401 may be an elegant genetic engineered solution.  DNX-2401 is an engineered virus that is capable of selectively and effectively killing a broad range of tumor cells with defects in the retinoblastoma (Rb) pathway.  The virus enters cells by binding to specific types of integrins highly expressed on tumor cells and tumor endothelial cells.  Once it gets in, the virus replicates rapidly and the replicating viruses in turn kill host tumor cells.  Further cell killing is done by triggering of anti tumor immune response which is capable of eliciting tumor destruction.

DNX-2401 therapy has shown to improve survival in animal models.  Relapse of GBM is attributed to recurrence and persistence of tumor stem cells.  Is it possible that the virus kills the stem cells as well?  Indeed, results indicate that brain tumor stem cells are also susceptible to being killed by DNX-2401, said Chen.  Additionally, Delta 24 RGD + temozolomide seem to provide enhanced therapeutic benefit in combination therapy.

Early safety profile of DNX-2401 looks very good and early indication suggests it to be very efficacious and capable of selectively and effectively killing a broad range of tumor cells.  Expectations are that DNX-2401 will demonstrate therapeutic effects in a wide variety of cancers.  Currently DNX-2401 is delivered by direct injection into the tumor bed, guided by the MRI through the cranium or through surgical resection, into the walls of the resection cavity to kill residual tumor cells.

Chen went into more detailed explanation of the mechanism of action, and her talk was followed by Q&A.

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Other information and events below.

Jobs: There is a huge uptick in JOBS.  Check out new jobs posted for May at http://bit.ly/1o85CTM .

TiEcon: If you are a professional  in #healthIT, #digital health,  #internetofthings, #cloud, #bigdata or related, I would say this is the conference, you don’t want to miss – It gives fabulous opportunity to network with 4000+ professionals. Check out great agenda, top notch speakers & panelists at www.tiecon.org.  Register for #TiEcon (May 16 & 17 at Santa Clara Convention Center) at link http://tinyurl.com/kr2hkcw  as my guest & enter promo code tievalue to get $100 discount.

Healthtechnology conference & Code-a-thon http://www.healthtechnologyforum.com, focused on exploring pathways to sustainable health, is on May 20 in SF. Please register for the conference as my friend, with the discount code “HTF14-FriendOfOrganizer” and send me your first & last name at wd_darshana at hotmail dot com, to get $150 off the price of the ticket. There are $20K+ in prizes at the code-a-thon.

Dr. Sarvajna Dwivedi, founder of Pearl Therapeutics will talk on Tuesday, May 6.  Notice venue change & pre-register at  http://www.eppicglobal.org . Pearl Therapeutics was acquired by Astra Zeneca last year, for $1.15 B and was a winner of TiEcon’s TiE50 awards, two years in a row. It will likely be sold out event, so please pre-register.

http://www.bio2devicegroup.org meets every Tuesday in Sunnyvale, CA.  Morning meetings are free, wealk-ins welcome. Dr. Alan Jacobs, Founder & CEO, PerceptiMed will talk on “Preventing Drug-Related Patient Injury and Death With Advanced, Cost-Effective Technology Systems“.

Feel free to send me an email for any of these events at wd_darshana at hotmail dot com and you can follow my updates on Twitter @DarshanaN.

Novel Approaches to Immune Therapy & Monitoring for non-Hodgkins Lymphoma

Dr. Russell Pachynsky, co-founder and CSO at CombImmune, spoke about their unique approach to immune therapy and monitoring for aggressive non-Hodgkins lymphoma patients, at www.bio2devicegroup.org event.  One of the clinical pain points with large B cell lymphomas, also called DLBCL is patients often do poorly after chemotherapy and current methods to identify high risk patients often lead to variations in patient outcomes, said Pachynsky.  Currently the standard method used is the IPI or International Prognostic Index but it is far from perfect where clinical outcomes are often discordant to risk prognosis. The IPI  is based on clinical assessments during the initial work-up of the patient which include age, Ann Arbor Stage, Serum LDH level, number of extranodal sites of the disease, and performance status.  Based on these, a patient receives the total score and higher the total score, higher the chances of them being at great risk of relapse and disease reoccurrence.  The challenge however is that the IPI does not capture the molecular heterogeneity of DLBCL.

English: Monoclonal antibodies for cancer. ADEPT, antibody directed enzyme prodrug therapy; ADCC, antibody dependent cell-mediated cytotoxicity; CDC, complement dependent cytotoxicity; MAb, monoclonal antibody; scFv, single-chain Fv fragment. (Photo credit: Wikipedia)

CombImmune offers a unique molecular diagnostic test that accurately identifies high risk patients.  After running FFPE tumor tissue through rt-PCR and based on certain algorithms the assay can identify patients who may be in need of more aggressive treatment.  Currently, first line therapy that is generally administered is R-CHOP therapy.  About 75% of patients with DLBCL respond to the standard R-CHOP therapy.  However, 50% of patients with non-Hodgkin’s lymphoma patients die despite receiving the therapy.  And there is nothing approved for maintenance therapy, for DLBCL patients.  Standard second line therapy consists of R-DHAP or R-ICE therapy and those who do not respond to that may go for bone marrow transplant.  Although it is more toxic, the Dose adjusted EPOCH or DA-R-EPOCH chemotherapy is currently in a Phase III CALGB trial 5303 (http://www.cancer.gov/clinicaltrials/search/view?cdrid=433265&version=HealthProfessional) vs R-CHOP in newly diagnosed DLBCL patients. If more found to be more efficacious, DA-R-EPOCH may offer DLBCL patients another option for first line therapy. There are also other combination therapies with R-CHOP in Ph2 and Ph3 trials including lenalidamide, bortezomib, GA-101, ibrutinib, idelalisib, and many others. According to Dr. Pachynski, there are over 100 programs currently evaluating new DLBCL therapies and it will be important to understand which patients will become Rituxan refractory and relapse earlier in their disease. All patients do not require this aggressive treatment and a molecular diagnostic assay will minimize the unneeded additional therapies and over treatment.

CombImmune’s unique assay the Two Gene Score or TGS has been validated in 692 DLBCL patients.  One of them is a measure of the tumor (LMO2) and one is a measure of immune response (CD137).  LMO2 and CD137 are robust, independent, and prognostic determinants of DLBCL.  This technology has come out of work at Ron Levy’s lab, at Stanford.  Compared to TGS the IPI captured only 7% of high risk patients, while the validation cohort, the TGS captured 28.5% of high risk patients.  Based on this test, high risk patients can be administered more aggressive first line of treatment, while wait and watch approaches can be taken with low risk patients.

Additionally, CombImmune’s TGS test is useful in monitoring and enhancing immune response to cancer.  Energizing the immune system to illicit a more robust response can be a key to more efficacy of treatment.  It is already known that new DLBCL patients have impaired immune mediated NK cell cytotoxicity and lower CD137 expression.  DLBCL patients have a compromised immune system, at the time of the diagnosis.  It is also known that increased tumor infilterating leukocytes are prognostic and predictive.  Clinical outcomes are generally good with increased counts, and poor, when lower.  It is also known that active monitoring of patient immune system may improve clinical outcomes.  The TGS diagnostic test and PF05082566 (anti CD137 mAB) can capture true high risk patients who are Rituximab non-responders.  Rx may play synergistic role with antibodies to stimulate CD137 expression in NK/T cells.  Sequential dosing of co-stimulatory agents have anti-cancer synergy.  Currently, there are a number of pathways and co-inhibitation therapeutics under investigation.  Many of them will likely increase CD137 expression.  Dr. Pachynski said, TGS is a powerful way to monitor immune response of the tumor.  The event was followed by Q&A.

 

 

Novel Cell Based Therapies as Treatment for Chemotherapy and Radiation

Dr Ram Mandalam, CEO of Cellerant Therapeutics (www.cellerant.com) talked about Cellerant’s portfolio of products based on the regulation of the hematopoietic (blood-forming) system at www.bio2devicegroup.org event.

 

Cellerant is developing a novel, cell based medicine (Myeloid Progenitors/ CLT-008) as a treatment for chemotherapy and radiation induced neutropenia.  Neutopenia is a common side effect of chemotherapy or acute radiation that results in a decreased level of a type of white blood cells called neutophils.  These type of white blood cells protect us from bacterial and fungal infections.  Current mode of treatment to boost the immune system is through administration of G-CSF to help the bone marrow recover its ability to produce white blood cells but it is not without challenges.

 

CLT-008 consists of myeloid progenitor cells of the blood forming system that do not have the stem cell ability to self-renew and are restricted to creating mature myeloid cells, that include neutrophils, red blood cells and platelets.  Additionally, CLT-008 does not contain any detectable T-cells and hence GVHD is not expected.  Once infused, they can differentiate into mature cells and is expected to last for 2-3 weeks.  This is an off-the-shelf, cryopreserved product that can be potentially used for the treatment of chemotherapy and radiation induced neutropenia.  It is administered to patients who do not have an active immune system.  The cells have been shown to prevent fungal infections, enhance engraftment and protect from radiation in pre-clinical models.  Cellerant is developing CLT-008 for the treatment of neutropenia in AML patients and for the treatment of victims when they are exposed to radiation.  Mandalam shared pre-clinical data demonstrating that the myeloid progenitors can be administered 5-7 days post exposure to lethal levels of radiation and increase survival.  It is expected that in the event of mass casualty, it would be required to have a drug that can be administered at least 2 days post exposure as access to the victims in the first 24 hours may be difficult.  CLT-008 administration is expected to be via the intravenous route and would require minimal infrastructure.

 

Mandalam shared data on IND-enabling pre-clinical studies indicating the product to be safe and showing efficacy (increased survival) among mice suffering high levels of radiation.  He shared details on the ongoing clinical studies and also discussed the company’s financial status.  Cellerant has received two rounds of funding from BARDA, the Biomedical Advanced Research and Developmental Authority.  Mandalam also discussed the company’s product pipeline, including the antibody program targeting cancer stem cells in AML.  The program was followed by Q&A.