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Let's hope so.
Looks like the ASK is moving in the right direction again.
2 weeks until next earnings. Lets see if we can knock it out of the park.
GLTA & JMO
Agree. Think we bottomed out. News and deals should take this back up.
Happy New Year to all shareholders.
2015 will be our year. And what a ride it should be. :)
GLTA & JMO
I am liking what I am hearing/reading.
And a manager of regulatory affairs is nothing to sneeze at. Is a nice addition.
Good things coming.
GLTA
They are positioning themselves for the future very well.
Wow.
“We are in the registration queue in another half dozen countries with more coming. And to support these efforts, we hired a full-time regulatory affairs manager this month with considerable experience in this area.”
Great things on the horizon here.
GLTA & JMO
BIOJECT RECEIVES MEDICAL DEVICE REGISTRATION IN NIGERIA
Tigard, OR – December 22, 2014 – Bioject Medical Technologies Inc. (OTC Pink: BJCT), a leading developer and manufacturer of needle-free injection therapy systems, announced that iHealthNet, LLC and its subdistributor in the Federal Republic of Nigeria have received registration approval covering all of Bioject’s commercial products.
“As we have achieved in the Philippines, Australia, Singapore and several other territories this year, the registration in Nigeria shows our commitment to making Bioject technology available throughout the world”, commented Mark Logomasini, Bioject’s President and CEO, “We are in the registration queue in another half dozen countries with more coming. And to support these efforts, we hired a full-time regulatory affairs manager this month with considerable experience in this area.”
Bioject Medical Technologies Inc., based in Tigard, Oregon, USA, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS works by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. Bioject is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies, as well as research, global health and government organizations.
For more information about Bioject, visit www.bioject.com
I fully expect Q42014 and Q12015 to be significantly higher.
Yes. I do believe the bottom is in from what I am seeing on L2. Now watch all those who sold buy back in after the 30day wash rule.
The upside here is remarkable. We just need to keep executing and growing distributorship and support our international markets.
GLTA & JMO
I think (hope) we saw bottom this week. Financials are improving so I expect 2015 to be a much better year.
Thanks.
Looks like the release went through regular media channels today.
This agreement could be HUGE with the progress the LAMP-vax continues to show.
:)
GLTA
Bioject and Immunomic Therapeutics Enter into an Agreement for License of Needle-Free Technology for LAMP-vax Vaccines
Immunomic Therapeutics, Inc., (ITI), and Bioject have entered into an agreement for ITI to use Bioject’s Biojector®-2000 needle-free injection device with its LAMP™ vaccine platform. This collaboration has the potential to further support acceleration of LAMP-vax product development.
.
“The right delivery is key to a well-designed vaccine approach,” said Teri Heiland, ITI VP of R&D.
Tigard, OR and Hershey, PA (PRWEB) December 19, 2014
Bioject Medical Technologies Inc. (OTC Pink: BJCT), a leading developer and manufacturer of needle-free injection technology, today announced that it has entered into an agreement with Immunomic Therapeutics, Inc. (“ITI”) for ITI to use the Bioject’s Biojector®-2000 needle-free injection device with its LAMP™ vaccine platform.
In the agreement, ITI receives an option for an exclusive Worldwide license to the Biojector®-2000 that triggers based on the achievement of certain clinical milestones. The agreement contains provisions for development rights and exclusive license of Bioject’s ID Pen intradermal injection system for various fields of use.
"Bioject’s needle-free intradermal injection devices have a strong track record of clinical benefit with DNA vaccines” said Mark Logomasini, President and CEO of Bioject. “These benefits have been demonstrated in several programs at ITI. This agreement establishes a framework for bringing these programs and their associated products to market. We are very much looking forward to continued work with the team at ITI.”
Bioject's advanced needle-free technology works by forcing liquid medication at high speed through a tiny orifice held against the skin. The diameter of the orifice is smaller than the diameter of a human hair. This creates an ultra-fine stream of medicine able to penetrate skin without use of a needle. Bioject's technology is available for use with a wide range of injectable drugs and has the ability to deliver medicine at a range of depths and injection volumes.
ITI is a rapidly growing biotechnology company pioneering breakthrough vaccines. Its LAMP-vax has been described as the missing link in enhancing the effectiveness of DNA vaccines. LAMP immunotherapy formulations have been safely applied and immunogenic for patients with prostate cancer, acute myeloid leukemia and melanoma.
ITI has made great progress over the past few years and has emerged with a new class of DNA-based allergy immunotherapeutic vaccines poised to transform the worldwide allergy market. The company believes Bioject’s novel delivery technologies hold promise to deliver LAMP-vax vaccines to the right populations of cells in the right part of the body and further strengthen the application of ITI core technology, first in allergies and in other immunotherapeutic areas.
“The right delivery is key to a well-designed vaccine approach,” said Teri Heiland, ITI VP of R&D. “In our hands, we have shown that LAMP-vax delivered with Bioject has the potential to enhance the right kind of immune response to our vaccines while providing a safe delivery method. I am excited about the potential of this collaboration to further support acceleration of our product development.”
About Bioject Medical Technologies, Inc.
Bioject Medical Technologies Inc., based in Tigard, Oregon, USA, is a developer and manufacturer of needle- free injection therapy systems (NFITS). NFITS works by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. Bioject is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies, as well as research, global health and government organizations. http://www.bioject.com
About Immunomic Therapeutics, Inc.
Immunomic Therapeutics, Inc. (ITI) is a privately held clinical stage biotechnology company headquartered in Lancaster, PA with lab facilities in Rockville, MD. ITI is developing next generation vaccines based on the patented LAMP Technology. Our LAMP-Vax platform significantly increases the effectiveness of the immune response to nucleic acid vaccines while simplifying overall vaccine design and delivery, yielding safer, more cost-effective human and animal therapies. Our LAMP constructs have been validated in human clinical trials for cancer and have been applied to a wide breadth of targets including allergy, cancer and infectious diseases. For more information about ITI and LAMP Technology please visit http://www.immunomix.com.
http://www.prweb.com/releases/2014/12/prweb12406970.htm
Thanks for staying on top of this Junk. Busy with CUBA. Averaged down today on BJCT
BIOJECT RECEIVES MEDICAL DEVICE REGISTRATION IN THE PHILIPPINES
Tigard, OR – December 18, 2014 – Bioject Medical Technologies Inc. (OTC Pink: BJCT), a leading developer and manufacturer of needle-free injection therapy systems, announced that its distributor in the Republic of the Philippines, Elba Pharmaceuticals has received a Certificate of Product Registration for Bioject’s ZetaJet™ injector system. Elba Pharmaceuticals is now able to market the full line of Bioject’s commercial products in the Philippines.
Stated Mark Logomasini, Bioject’s President and CEO, “We appreciate the efforts of Dr. Baura and Elba Pharmaceuticals to make the ZetaJet available to this growing customer base. It is another example of our continuing progress in expansion in international markets.”
Bioject Medical Technologies Inc., based in Tigard, Oregon, USA, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS works by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. Bioject is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies, as well as research, global health and government organizations.
Bioject (OTC Pink: BJCT) trades on the OTC Pink tier of the OTC market. Investors can find Real-Time quotes and market information for the Company on www.otcmarkets.com.
For more information about Bioject, visit www.bioject.com
Yes, definitely not an easy task. I've done foreign patents and licensing before. Never easy, even when both parties are on the same page.
Establishing foreign distributorship involves understanding device regulations and associated processes in those countries. Then after finding/establishing a suitable distributor they need to train the distributor properly.
If we can raise our awareness and positioning abroad it will exponentially snowball into more sales/revenue.
Mark has a good grasp of things and is a shrewd business man from what I gather. He understands all the dynamics that need to come together here and I know he wants to make this one a winner sooner than later.
Keeping my ear to the ground.
GLTA & JMO
I would agree with that assessment. If they can license their products to more distributors that will increase revenue and drastically decrease operating costs.
I believe they just amended it. The original was released Nov 12.
The amendment included an additional page.
2015 should reap some rewards and hopefully will turn us cash flow positive.
GLTA
Just went on otcmarkets.com and noticed they reported 3rd quarter financial results.
http://www.otcmarkets.com/otciq/ajax/showNewsReleaseDocumentById.pdf?id=12853
If it's not bottom I think it's definitely close.
I believe the share price is artificially depressed due to tax loss selling which happens this time of year.
Welcome to the board. :)
Ive been watching bjct silently and have thought about maybe taking a position im wondering if u also think this could be the bottom?
Here is an article on the new DNA vaccine platform by Immunomic.
The Next Generation of DNA Vaccines Is Poised to Transform the Healthcare Landscape
By Teri Heiland
October 13, 2014 | Contributed Commentary | Over the last several decades, the advent of biotechnology has enabled a brand new class of “third generation” vaccines, including nucleic acid (DNA and RNA) vaccines. These nucleic acid vaccines deliver a DNA or RNA sequence into tissue, where the cells that take up the sequence synthesize the encoded protein within the cell. The result is an antigen protein, derived from the viruses, bacteria, parasites, or tumors targeted by the vaccine, which offers protective immunity from the pathogenic agent from which the DNA or RNA was derived.1
Nucleic acid vaccines have the potential to change the vaccination landscape through easier, more scalable, less expensive and logistically simpler vaccines that better prevent infectious disease. What’s more, immunotherapies are being developed to treat and mitigate diseases that have never before been addressed in this way, including allergies, cancer and autoimmune disorders. Previously, technical challenges have stood as obstacles to safely administering these vaccines while delivering a strong level of effectiveness.
In recent years, however, new technologies are emerging that may help DNA vaccines achieve greater efficacy and meet their true potential. Delivery devices like electroporation and needle-free jet injectors aim to increase the amount of gene transfer into the cells, attempting to achieve higher antigen expression.
For example, the Biojector-2000 (B2000) and Biojector ID Pen by Bioject Medical Technologies, Inc., are needle-free jet injection systems intended to deliver vaccines intramuscularly, subcutaneously and intradermally. The belief is that delivery to particular parts of the body can focus the delivery of DNA to chosen cell types. In the case of DNA plasmids delivered intradermally by the Bioject devices, vaccines are directly presented to antigen presenting cells. Some researchers believe these delivery advances correlate to improved humeral and cellular immunity in humans and animals.
The Impact of Biotechnology
In addition to novel delivery methods, there have been real advances in plasmid backbone and antigen design. Optimal vector design, aided by bioinformatics systems, includes elements that enhance antigen expression and duration, including codon optimization, and can direct antigen presentation to particular parts of the immune system by combining the key nucleic acid antigen sequence with an immunomodulatory sequence. Modern vector design can also address regulatory concerns about antibiotic selection markers by using non-coding RNA selection markers, all while improving manufacturing yield and quantity using advanced plasmid manufacturing methods.2
At ITI, we are working with Lysosomal Associated Membrane Protein (LAMP), a glycoprotein found on the lysosomal membrane, as the preferred immunomodulatory sequence included in all of our DNA vaccines. LAMP is used as a nucleic acid coding sequence which diverts the synthesized protein products of DNA and RNA-based vaccines to the lysosome in antigen-presenting cells, stimulating helper T cells, which leads to production of antibodies and Th1 cytokines, while also activating CD8+ cytotoxic T cells. Other third generation vaccines companies are pursuing other strategies to direct antigens to key cell structures in the immune system. For instance, Immune Design makes vaccines that use a synthetic molecule, Glucopyranosyl Lipid A, to direct tumor antigens to the TLR4 receptors of dendritic cells in the skin.
The way that nucleic acid vaccines are being used in the context of different vaccination regimens has also advanced, as researchers are now more aware of optimal dosing, timing, and ways to combine nucleic acid vaccines with other elements, such as adjuvants or peptides. One leading approach, the “prime-boost” methodology, involves “priming” or vaccinating first with a DNA vaccine, which is believed to activate antigen specific memory T cells and, in some cases, in turn activate antigen specific B cells. “Boosting,” or following with a recombinant protein or peptide-based vaccination, re-exposes the immune system to the antigen in a different form, as a protein. Circulating antigen-presenting cells can take up this protein and travel to the lymph nodes or spleen where they elicit the activation of these memory cells and B cells, resulting in a stronger immune response. Such methodologies have been pioneered by thought leaders in DNA vaccines, including Dr. Shan Lu, M.D., Ph.D., of the University of Massachusetts Medical School.3
With these new advances and techniques, DNA vaccines are currently under development for infectious disease, cancer, autoimmune and allergy indications and are now closer than ever to entering clinical use.
Recent Successes in Nucleic Acid Vaccines
The industry is showing renewed interest in DNA and RNA nucleic acid vaccines through strategic alliances forged between Roche/Inovio and Sanofi/Curevac, as well as positive clinical trial results, including encouraging Phase II data in HPV by Inovio Pharmaceuticals.4
DNA and RNA vaccines have also shown some success in cancer immunotherapies. In contrast to chemotherapy regimens often associated with severe side effects, cancer immunotherapy stimulates the body’s immune system and natural resistance to cancer. This year, Boehringer Ingelheim will pay mRNA drug developer CureVac $45 million for an RNA vaccine in early clinical development to treat lung cancer, paving the way for up to $556 million in future payments. Meanwhile, Inovio is developing a technology platform to discover and develop “synthetic” DNA vaccines, and has partnered with Roche on several candidates.
Use of these therapies in the clinic continues to grow, as the market for cancer immunotherapies alone is expected to reach over $9 billion by 2020. Nucleic acid vaccination has the potential to play a large part in this.
Next Steps for Nucleic Acid Vaccines
Even with this progress, there are still barriers and misconceptions to overcome. These include long-held impressions about poor human immunogenicity, and concerns among European and Asian regulators over safety issues related to DNA vaccine integration into the host genome — in stark contrast to the regulatory authorities in the US, who have already issued affirmative statements regarding the safety of DNA vaccines.
It is the job of nucleic acid vaccine companies and the scientific community to engage with the appropriate regulatory authorities, and lead working groups to overcome these misgivings. Unfortunately, there appears to be a shrinking group of DNA and RNA vaccine scientists and less collaboration across technologies, at a time when an increased exchange of ideas regarding design, assays, and combinations of technology can greatly enhance their success. Therefore, researchers working in DNA and RNA vaccines and surrounding technologies must band together and collaborate to ensure that the outside world has knowledge of the key advances, progress and potential of this groundbreaking class of new vaccines.
Dr. Teri Heiland is currently the Vice President of Research and Development at ITI. She is an experienced molecular biologist and holds multiple patents in the field of genomics. Prior to ITI, Dr. Heiland led multiple research teams at Capital Genomix, Inc. developing and validating GeneSystem320 and applying this technology to identify biomarkers associated with cancer. Prior to joining Capital Genomix, Dr. Heiland worked as a senior scientist in R&D at Kirkegaard & Perry Labs (KPL) where she spent four years as a project leader.
Link: http://www.bio-itworld.com/2014/10/13/next-generation-dna-vaccines-poised-transform-healthcare-landscape.html
Bioject and Immunomic Therapeutics Enter into an Agreement for License of Needle-Free
Technology for LAMP-vax Vaccines
TIGARD, Oregon and Hershey, Pennsylvania December 15, 2014
TIGARD, Ore., December 15, 2014 /PRNewswire/ -- Bioject Medical Technologies Inc. (OTC
Pink: BJCT), a leading developer and manufacturer of needle-free injection technology, today
announced that it has entered into an agreement with Immunomic Therapeutics, Inc. (“ITI”) for
the use of Bioject’s Biojector®-2000 needle-free injection device with its LAMP™ vaccine
platform. In the agreement, ITI receives an option for an exclusive Worldwide license to the
Biojector®-2000 that triggers based on the achievement of certain clinical milestones. In
addition, the agreement contains provisions for development rights and exclusive license of
Bioject’s ID Pen intradermal injection system for various fields of use.
"Bioject’s needle-free intradermal injection devices have a strong track record of clinical benefit
with DNA vaccines” said Mark Logomasini, President and CEO of Bioject.” These benefits have
been demonstrated in several programs at ITI. This agreement establishes a framework for
bringing these programs and their associated products to market. We are very much looking
forward to continued work with the team at ITI.”
Bioject's advanced needle-free technology works by forcing liquid medication at high speed
through a tiny orifice held against the skin. The diameter of the orifice is smaller than the
diameter of a human hair. This creates an ultra-fine stream of medicine able to penetrate skin
without use of a needle. Bioject's technology is available for use with a wide range of injectable
drugs and has the ability to deliver medicine at a range of depths and injection volumes.
Immunomic Therapeutics (ITI) is a rapidly growing biotechnology company pioneering
breakthrough vaccines. ITI’s LAMP-vax has been described as the missing link in enhancing the
effectiveness of DNA vaccines. LAMP immunotherapy formulations have been safely applied
and immunogenic for patients with prostate cancer, acute myeloid leukemia and melanoma.
ITI has made great progress over the past few years and has emerged with a new class of DNAbased
allergy immunotherapeutic vaccines poised to potentially transform the worldwide allergy
market. The company believes that Bioject’s novel delivery technologies hold promise to deliver
LAMP-vax vaccines to the right populations of cells in the right part of the body and further
strengthen the application of ITI core technology, first in allergies and in other
immunotherapeutic areas.
“The right delivery is key to a well-designed vaccine approach. In our hands, we have shown that
LAMP-vax delivered with Bioject has the potential to enhance the right kind of immune
response to our vaccines while providing a safe delivery method. I am excited about the potential
of this collaboration to further support acceleration of our product development,” said Teri
Heiland, ITI VP of R&D.
LOL.
Someone is definitely looking to maximize tax loss and shopping for tinsel.
Almost time to grab a few K more. :)
GLTA
Looks like folks desperate for Christmas shopping money...
My thoughts, exactly. Average down a bit.
Thanks, I still like the concept and the company. I just got used to steady progress. Good time to buy some more I suppose.
Just tax loss selling in my opinion.
Same as many OTC stocks I have been watching that have flattened out a bit lately.
Anyone have any thoughts on why this stock appears to be languishing here lately?
LOL.
Nice. Thanks for the post. :)
Upwards and onwards!
GLTA
Latest patent filing - something set to rise!
Patent applications are held confidential for 18 months from the initial filing (either as a provisional or a utility before they are published, so no knowing what has been filed since the beginning of the year.
Here's the latest filing from 12-13-2013
WO/2014/0938 and US2014017191, published 06/19/2014
USE OF A NOVEL SUBCUTANEOUS NEEDLE-FREE TECHNIQUE TO DELIVER TESTOSTERONE IN HYPOGONADAL MEN
Embodiments herein are directed to methods for increasing testosterone levels in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of testosterone by needle-free injection to an injection site. Some embodiments are further directed to a method of increasing testosterone levels in a subject in need thereof, by administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of testosterone and a pharmaceutically acceptable carrier by needle-free injection. Some embodiments are directed to a method of minimizing fluctuations in testosterone levels in a subject diagnosed with hypogonadism, comprising serially administering to the subject a therapeutically effective amount of testosterone by needle-free injection to an injection site.
Hopefully, the stock rises as well!
Have you spotted any new-ish ones?
Still in a bit of a holding pattern as we row towards profitability.
Another distributor or two and we should see some value get unlocked.
GLTA & JMO
Bioject patent portfolio. I did a patent search and BJCT has a total of 188 issued patents and/or pending applications in the U.S., Europe, and worldwide (PCT applications only). I put them (with abstracts) in a spreadsheet, but at 108 pages, too long to list here.
Thanks for posting. Just catching up on this one. Increased revenues and decreased loss is a good sign and the right direction.
BIOJECT REPORTS UNAUDITED THIRD QUARTER 2014 FINANCIAL RESULTS
Tigard, OR – November 12, 2014 – Bioject Medical Technologies Inc. (OTC Pink: BJCT), a developer and manufacturer of needle-free injection therapy systems, today reported unaudited financial results for the third quarter ended September 30, 2014. The financial results are unaudited and actual results may vary.
Bioject reported revenues of $458,000 for the quarters ended September 30, 2014 and 2013. Operating expense was $581,000 for the third quarter of 2014, compared to $732,000 in the third quarter 2013. The Company reported an operating loss of $123,000 in the third quarter of 2014, compared to an operating loss of $274,000 in the third quarter of 2013. Net loss allocable to common shareholders for the third quarter of 2014 was $189,000, compared to $320,000 in the comparable 2013 period.
Operating results were negatively affected by unexpected delays at the Company’s contract manufacturing site, resulting in $108,000 less in revenues than forecasted and associated operating expenses of $45,000. The Company has put in place procedures to avoid this issue in the future.
Basic and diluted net loss per share allocable to common shareholders for the quarter ended September 30, 2014 was $0.01 per share on 32.4 million weighted average shares outstanding compared to a net loss of $0.02 per share on 18.9 million weighted average shares outstanding for the same period in 2013.
For the nine months ended September 30, 2014, Bioject reported revenues of $1,312,000, compared to revenues of $1,146,000 in the comparable period of 2013. Operating loss for the nine months ended September 30, 2014 was $657,000, compared to $1,237,000 in the comparable period of 2013. Net loss allocable to common shareholders was $836,000, or $0.03 per share on 25.7 million weighted average shares outstanding, in the nine-month period ended September 30, 2014 compared to $1,349,000, or $0.07 per share on 18.9 million weighted average shares outstanding, in the comparable period of 2013. New share transactions that occurred in the first and second quarters of 2014 were described in prior 8-K filings.
Bioject Medical Technologies Inc., based in Tigard, Oregon, USA, is a developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS works by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. Bioject is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies, as well as research, global health and government organizations.
A Needle Could Make For Pain-Free Flu Shots
http://www.smithsonianmag.com/innovation/needle-could-make-for-pain-free-flu-shots-180953141/?no-ist
Bioject cited in article
Agreed. Nice to see some discussion here.
Open to all DD. BJCT has the tech and the model to make itself into a very significant player if not the leader in needle-free tech. Once the distribution is established world-wide the sales will follow. We just need some good marketing and to get current when the time is right.
Lots of upside.. the spread being wide can deter investors but when they buy the PPS jumps. Most of the shares are under institutional lockdown so the float is tight.
GLTA & JMO
Board is finally feeling more active. Lots of dd behind the scenes will start coming out
Thanks. I'll be doing a deeper dive into their technology and relationships. I'll note this on the Obamacare Stock Portfolio Recovery Room board.
BJCT is indeed a nice find and I'm glad I followed you here to take a look. I think this one has buck plus written all over it and it won't take that long too get there.
Will do. Thanks!
Time to strike while the iron is hot and make a name for ourselves in pockets that can benefit from our technology the most. Its all about distribution first.. sales will follow.
GLTA & JMO
If you google Vical and Bioject, you'll see that they have been working together at least since 2006 and Vical has licensed Bioject's needle-free technology for it's vaccines and clnical trials.
Also found this excerpt. Notice the delivery method states needless delivery. Bioject has working agreements with the NIH so could very well be the Biojector 2000.
Excerpt Here:
Ebola DNA vaccine produces immune responses in all fully vaccinated volunteers in Phase 1 trial Vical Incorporated (Nasdaq:VICL) announced today that an Ebola vaccine candidate administered using Vical's proprietary DNA delivery technology was safe and well tolerated, and produced both antibody and T-cell Ebola-specific responses in all healthy volunteers who received the full 3 doses of vaccine. The Phase 1, randomized, placebo-controlled, dose-escalation study, the first human trial for any Ebola vaccine, was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and conducted at the NIH Clinical Center. The data were presented at the American Society for Microbiology (ASM) 2006 Biodefense Research Meeting in Washington, D.C., by Julie E. Martin, D.O., a trial investigator and research scientist at NIAID's Dale and Betty Bumpers Vaccine Research Center (VRC), which developed the vaccine. The DNA vaccine used in the Phase 1 trial incorporates genetic material encoding core and surface proteins from two strains of Ebola. Vical has secured a nonexclusive license from the NIH to proprietary gene sequences used in the vaccine.
"The high rates of immune responses at all dose levels in this initial human Ebola vaccine study support continued development of this vaccine and further evaluation of our technology for potential additional biodefense and emerging disease applications," said David C. Kaslow, M.D., Vical's Chief Scientific Officer, "particularly where antibody responses may be protective. Our processes allow rapid development and manufacturing of vaccines without handling potentially dangerous pathogens."
The vaccine used in the Phase 1 trial vaccine included three plasmids (closed loops of DNA), one each encoding the surface glycoprotein (GP) from the Zaire strain of Ebola, GP from the Sudan/Gulu strain, and the internal nucleoprotein (NP) from the Zaire strain. Subjects received three doses of vaccine or placebo at one-month intervals via intramuscular needleless injection. Three cohorts tested progressively higher doses of the vaccine at 2 mg (5 subjects), 4 mg (8 subjects), or 8 mg (8 subjects – with 6 receiving the full three doses). Each cohort included two additional subjects who received placebo instead of active vaccine.
The vaccine was well tolerated, with no severe adverse reactions to the vaccine reported at any of the doses tested. Ebola-specific antibody responses against at least one of the encoded antigens were detected in all vaccine recipients. GP-specific antibody and T-cell responses were detected in all recipients who received the full three doses at all dose levels.
An older study from April last year but speaks to the efficacy of the NFIT from Bioject (Biojector 2000) as a better alternative when compared to needle injection.
DNA Vaccine Delivered by a Needle-Free Injection Device Improves Potency of Priming for Antibody and CD8+ T-Cell Responses after rAd5 Boost in a Randomized Clinical Trial
Published: April 08, 2013DOI: 10.1371/journal.pone.0059340
Abstract
Background
DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared to delivery by needle and syringe and evaluated for safety and immunogenicity.
Methods
Forty adults, 18–50 years, were randomly assigned to intramuscular (IM) vaccinations with DNA vaccine, VRC-HIVDNA016-00-VP, (weeks 0, 4, 8) by Biojector® 2000™ or needle and syringe (N/S) and boosted IM at week 24 with VRC-HIVADV014-00-VP (rAd5) with N/S at 1010 or 1011 particle units (PU). Equal numbers per assigned schedule had low (=500) or high (>500) reciprocal titers of preexisting Ad5 neutralizing antibody.
Results
120 DNA and 39 rAd5 injections were given; 36 subjects completed follow-up research sample collections. IFN-? ELISpot response rates were 17/19 (89%) for Biojector® and 13/17 (76%) for N/S delivery at Week 28 (4 weeks post rAd5 boost). The magnitude of ELISpot response was about 3-fold higher in Biojector® compared to N/S groups. Similar effects on response rates and magnitude were observed for CD8+, but not CD4+ T-cell responses by ICS. Env-specific antibody responses were about 10-fold higher in Biojector-primed subjects.
Conclusions
DNA vaccination by Biojector® was well-tolerated and compared to needle injection, primed for greater IFN-? ELISpot, CD8+ T-cell, and antibody responses after rAd5 boosting.
Link: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0059340
Was just going to post that! At least two of us are on top of the news.
The Next Generation of DNA Vaccines Is Poised to Transform the Healthcare Landscape
By Teri Heiland
October 13, 2014
Over the last several decades, the advent of biotechnology has enabled a brand new class of “third generation” vaccines, including nucleic acid (DNA and RNA) vaccines. These nucleic acid vaccines deliver a DNA or RNA sequence into tissue, where the cells that take up the sequence synthesize the encoded protein within the cell. The result is an antigen protein, derived from the viruses, bacteria, parasites, or tumors targeted by the vaccine, which offers protective immunity from the pathogenic agent from which the DNA or RNA was derived.1
Nucleic acid vaccines have the potential to change the vaccination landscape through easier, more scalable, less expensive and logistically simpler vaccines that better prevent infectious disease. What’s more, immunotherapies are being developed to treat and mitigate diseases that have never before been addressed in this way, including allergies, cancer and autoimmune disorders. Previously, technical challenges have stood as obstacles to safely administering these vaccines while delivering a strong level of effectiveness.
In recent years, however, new technologies are emerging that may help DNA vaccines achieve greater efficacy and meet their true potential. Delivery devices like electroporation and needle-free jet injectors aim to increase the amount of gene transfer into the cells, attempting to achieve higher antigen expression.
For example, the Biojector-2000 (B2000) and Biojector ID Pen by Bioject Medical Technologies, Inc., are needle-free jet injection systems intended to deliver vaccines intramuscularly, subcutaneously and intradermally. The belief is that delivery to particular parts of the body can focus the delivery of DNA to chosen cell types. In the case of DNA plasmids delivered intradermally by the Bioject devices, vaccines are directly presented to antigen presenting cells. Some researchers believe these delivery advances correlate to improved humeral and cellular immunity in humans and animals.
The Impact of Biotechnology
In addition to novel delivery methods, there have been real advances in plasmid backbone and antigen design. Optimal vector design, aided by bioinformatics systems, includes elements that enhance antigen expression and duration, including codon optimization, and can direct antigen presentation to particular parts of the immune system by combining the key nucleic acid antigen sequence with an immunomodulatory sequence. Modern vector design can also address regulatory concerns about antibiotic selection markers by using non-coding RNA selection markers, all while improving manufacturing yield and quantity using advanced plasmid manufacturing methods.2
At ITI, we are working with Lysosomal Associated Membrane Protein (LAMP), a glycoprotein found on the lysosomal membrane, as the preferred immunomodulatory sequence included in all of our DNA vaccines. LAMP is used as a nucleic acid coding sequence which diverts the synthesized protein products of DNA and RNA-based vaccines to the lysosome in antigen-presenting cells, stimulating helper T cells, which leads to production of antibodies and Th1 cytokines, while also activating CD8+ cytotoxic T cells. Other third generation vaccines companies are pursuing other strategies to direct antigens to key cell structures in the immune system. For instance, Immune Design makes vaccines that use a synthetic molecule, Glucopyranosyl Lipid A, to direct tumor antigens to the TLR4 receptors of dendritic cells in the skin.
The way that nucleic acid vaccines are being used in the context of different vaccination regimens has also advanced, as researchers are now more aware of optimal dosing, timing, and ways to combine nucleic acid vaccines with other elements, such as adjuvants or peptides. One leading approach, the “prime-boost” methodology, involves “priming” or vaccinating first with a DNA vaccine, which is believed to activate antigen specific memory T cells and, in some cases, in turn activate antigen specific B cells. “Boosting,” or following with a recombinant protein or peptide-based vaccination, re-exposes the immune system to the antigen in a different form, as a protein. Circulating antigen-presenting cells can take up this protein and travel to the lymph nodes or spleen where they elicit the activation of these memory cells and B cells, resulting in a stronger immune response. Such methodologies have been pioneered by thought leaders in DNA vaccines, including Dr. Shan Lu, M.D., Ph.D., of the University of Massachusetts Medical School.3
With these new advances and techniques, DNA vaccines are currently under development for infectious disease, cancer, autoimmune and allergy indications and are now closer than ever to entering clinical use.
Recent Successes in Nucleic Acid Vaccines
The industry is showing renewed interest in DNA and RNA nucleic acid vaccines through strategic alliances forged between Roche/Inovio and Sanofi/Curevac, as well as positive clinical trial results, including encouraging Phase II data in HPV by Inovio Pharmaceuticals.4
DNA and RNA vaccines have also shown some success in cancer immunotherapies. In contrast to chemotherapy regimens often associated with severe side effects, cancer immunotherapy stimulates the body’s immune system and natural resistance to cancer. This year, Boehringer Ingelheim will pay mRNA drug developer CureVac $45 million for an RNA vaccine in early clinical development to treat lung cancer, paving the way for up to $556 million in future payments. Meanwhile, Inovio is developing a technology platform to discover and develop “synthetic” DNA vaccines, and has partnered with Roche on several candidates.
Use of these therapies in the clinic continues to grow, as the market for cancer immunotherapies alone is expected to reach over $9 billion by 2020. Nucleic acid vaccination has the potential to play a large part in this.
Next Steps for Nucleic Acid Vaccines
Even with this progress, there are still barriers and misconceptions to overcome. These include long-held impressions about poor human immunogenicity, and concerns among European and Asian regulators over safety issues related to DNA vaccine integration into the host genome — in stark contrast to the regulatory authorities in the US, who have already issued affirmative statements regarding the safety of DNA vaccines.
It is the job of nucleic acid vaccine companies and the scientific community to engage with the appropriate regulatory authorities, and lead working groups to overcome these misgivings. Unfortunately, there appears to be a shrinking group of DNA and RNA vaccine scientists and less collaboration across technologies, at a time when an increased exchange of ideas regarding design, assays, and combinations of technology can greatly enhance their success. Therefore, researchers working in DNA and RNA vaccines and surrounding technologies must band together and collaborate to ensure that the outside world has knowledge of the key advances, progress and potential of this groundbreaking class of new vaccines.
Dr. Teri Heiland is currently the Vice President of Research and Development at ITI. She is an experienced molecular biologist and holds multiple patents in the field of genomics. Prior to ITI, Dr. Heiland led multiple research teams at Capital Genomix, Inc. developing and validating GeneSystem320 and applying this technology to identify biomarkers associated with cancer. Prior to joining Capital Genomix, Dr. Heiland worked as a senior scientist in R&D at Kirkegaard & Perry Labs (KPL) where she spent four years as a project leader.
.1651 x .35
Now that is the widest the spread has been for a long time
Really nice. Had day off and was working outside yesterday. Pleasant surprise this morning.
Yep. Saw that.
Someone took out all the .25 and under shares.
All buys today. Are we in a float lock situation?
http://ih.advfn.com/p.php?pid=trades&symbol=BJCT
Hoping we get some news this week to bring in real volume and see the spread tighten up.
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Bioject Medical Technologies Inc.
Bioject Medical Technologies Inc. (OTCBB: BJCT) is an emerging drug delivery company developing the world's leading technology for needle-free injection of liquid medications.
Bioject's technology works by forcing liquid medication at high speed through a tiny orifice held against the skin. This creates an ultra-fine stream of fluid that penetrates the skin, delivering medication in a fraction of a second. Bioject's systems are designed to deliver injected medications comfortably, accurately, and quickly - without the use of a needle. Bioject was founded in 1985 to develop needle-free injection systems to improve the comfort and safety of routine injections. Since then, Bioject has developed a broad technology platform for delivering many different types of medications and vaccines to the subcutaneous and intramuscular depths. The company is currently developing systems and is in clinical trials for intradermal injections.
Bioject has developed a portfolio of injection systems based on its core technology. These include durable devices designed for heavy use in a professional healthcare environment, and small, lightweight injectors designed for home use. With partners, Bioject is also developing an inexpensive, pre-filled, disposable injection systems. Bioject's strategy is to form strategic partnerships with leading pharmaceutical, biotechnology, and animal health companies. The company seeks to develop mutually beneficial agreements with these partners to develop customized injection systems to enhance the delivery of the partner's injected medication or vaccine. Bioject has alliances with leading pharmaceutical, biotechnology, and animal health companies.
Bioject Medical Technologies Inc.
20245 SW 95th Avenue
Tualatin, OR 97062
Phone: 503-692-8001
Fax: 503-692-6698
E-mail: investorrelations@bioject.com
Web: www.bioject.com
Bioject Medical Technologies Inc.is a fully reporting OTCBB stock: www.otcmarkets.com/pink/quote/quote.jsp
The company has recently confirmed that the share structure from the latest 10Q (3rd Quarter 2009) is still accurate: www.otcmarkets.com/edgar/GetFilingPdf
A/S: 100,000,000
O/S: 17,679,111 (confirmed by T/A on 4th March 2010)
Float: 13,800,000
The company has stated that at the current time they do not have any plans to dilute, as they recently closed a financing agreement with their largest shareholder. In the event they do need to dilute they would do it as a private placement which is usually done in the form of restricted shares that can not convert to common for 6 months, so we do not need to worry about dilution.
Transfer Agent
American Stock Transfer & Trust Company, LLC
59 Maiden Lane
Plaza Level
New York, NY 1003
Tel: (800) 937-5449 or (718) 921-8124
Web: www.amstock.com
Estimated Market Cap: $3,345,872 as of Mar 2, 2010
The Form 8K filed with the SEC for the company's financial year ending December 31st 2009 can be viewed here: http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=7133612
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April 7th 2010: Bioject announces that it has met the final milestone under its Development Agreement with Merial Limited ("Merial") by delivering devices with auto-disable nozzles to Merial for its next generation spring-powered companion animal vaccination device. Bioject's President and Chief Executive Officer, Ralph Makar said "Merial has been an excellent partner and we appreciate the confidence Merial has in our needle-free technology. We are pleased to have completed this final milestone and look forward to using our new platform technology in its first commercial application". Full press release www.businesswire.com/portal/site/home/permalink/
March 17th 2010: Bioject published 4th Quarter and End of Year 2009 financials showing that the operating loss and net loss allocatable to common shareholders has decreased by 65% over the previous financial year. Bioject's President and Chief Executive Officer, Ralph Makar said "Recent positive events, such as the announcement of our strategic alliance with MPI Research, the elimination of our existing debt and the additional cash infusion, are encouraging as we strive for a better future and to increase shareholder value". Full press release http://www.marketwatch.com/story/bioject-reports-december-31-2009-results-2010-03-17?reflink=MW_news_stmp
February 22nd 2010: Bioject announced in a PR approval from the Swedish Medical Products Agency to conduct a phase I clinical trial evaluating an HIV/DNA vaccine in collaboration with the Karolinska Institutet (KI) and the Swedish Institute for Infectious Disease Control (SMI) to be delivered to healthy volunteers by ZetaJet® Full press release www.businesswire.com/portal/site/home/permalink/
February 16th 2010: Bioject announced in a PR full USDA license approval for Oncept canine melanoma vaccine, to be administered via a Canine Transdermal Device, which delivers the vaccine without the use of a needle. The device was developed in conjunction with Bioject, Inc. Full press release www.prnewswire.com/news-releases/merial-receives-full-license-approval-for-oncepttm-canine-melanoma-vaccine-84464667.html
January 5th 2010: Bioject announced that it has established a strategic alliance with MPI Research, a leading pre-clinical research organization with experience in the development of injectable therapeutics, which allows Bioject to gain access to a range of capabilities and resources needed for the company to explore drug+device opportunities, including access to pharmacologic, analytical, safety and other preclinical testing resources available at MPI Research. Full press release www.businesswire.com/portal/site/home/permalink/
December 21st 2009: Bioject announced it completed a Series G Preferred Stock financing with each of Life Sciences Opportunities Fund II, L.P., Life Sciences Opportunities Fund (Institutional) II, L.P. (collectively, the “LOF”), and Edward Flynn for the purchase of an aggregate of 92,448 shares of its Series G Convertible Preferred Stock at a price of $13.00 per share. Gross proceeds from the sale were $1,201,834, payable by payment of $500,000 in cash and the cancellation of the $600,000 outstanding principal amount of and $101,834 accrued interest. Full press release www.businesswire.com/portal/site/home/permalink/
April 6th 2009: Bioject announced that the U.S. Food and Drug Administration (FDA) has granted market clearance for the Zetajet™ Needle-Free Injection Therapy System. Bioject’s new ZetajetTM system is the latest advance in needle-free delivery systems, offering a significant array of unique product features and patient benefits that can provide highly competitive differentiation to a wide variety of injectables market segments. Full press release www.businesswire.com/portal/site/google/
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Results from a sequential phase I and II, controlled, double-blinded study to determine whether immune responses suggesting protection against influenza can safely be induced in young children. The study commenced in October 2006 and was completed in November 2009, with study completion date set for May 2010. Good results from this study could be amazing for BJCT investors.
Clinical trials information www.clinicaltrials.gov/ct2/show/NCT00386542
Bioject's needle-free injection technology works by forcing liquid medication at high speed through a tiny orifice that is held against the skin. The diameter of the orifice is smaller than the diameter of a human hair. This creates an ultra-fine stream of high-pressure fluid that penetrates the skin without using a needle.
Bioject's technology is unique because it delivers injections to a number of injection depths and supports a wide range of injection volumes. For instance, the Biojector 2000 can deliver intramuscular or subcutaneous injections up to 1 mL in volume. In addition, Bioject is developing a syringe for the Biojector 2000 that delivers intradermal injections that is currently in clinical trials.
Intradermal* injections are very shallow injections that deposit the medication between the layers of the skin. Many new DNA-based vaccines are delivered to the intradermal layer.
Subcutaneous injections are delivered to the adipose (fat) layer just below the skin. Many therapeutic proteins are delivered to the subcutaneous depth, such as human growth hormone.
Intramuscular injections are the deepest injection type, delivering the medication into the muscle tissue. Most vaccines are currently delivered to the intramuscular depth.
The Bioject research and development team has developed a new spring-powered injector known as the ZetajetTM, which is based on the design of the Biojector® 2000 (B2000) for performance but uses a spring for its power source. The pressure profile of the Zetajet has been documented by in vitro testing to be virtually the same as that of the B2000, which has given millions of injections. The B2000 is a needle-free jet injection device that provides up-to-date jet injection technology and eliminates or reduces complications associated with others previous devices (eg, cross-contamination from patient to patient, lacerations at the injection site, difficult device cleaning, cumbersome tanks, etc).1-12 The intended use of this device is to provide a low-cost, needle-free injection system that delivers SC, IM, or ID injections via a simple change of the syringe. There is no need to adjust the device or technique for different injection types. This new needle-free system offers an additional feature - an auto-disable syringe that prevents re-use of the syringe. The syringe may be used to perform reconstitution with manual movement of the syringe plunger; however, once the injection is given, the syringe is disabled with the plunger tip remaining in the syringe to prevent any possible re-use.
A study comparing the use of Zetajet was conducted at a clinical centre in 2009. After meeting all eligibility criteria, a total of 60 healthy subjects were enrolled in this study and were given three injections. After each injection, a subjective evaluation was made related to the injection site, and questions were asked regarding the patients’ perceptions of the injection. Immediately after each injection, the injection sites were evaluated by a trained healthcare professional and within 5 minutes after the injections, the degree of pain with each injection was elicited from the subjects. The injection sites were also evaluated immediately following for local reactions (bruising, redness, and wheal formation). The follow-up was completed 24 hours after the initial injection and consisted of injection site evaluations.
The study reconfirmed the capability of a spring-powered device to successfully provide three types of injection (SC, ID, IM) that was originally proven using the Vitavax, a precursor device that led to the development of the Zetajet. The device was well received by the clinical investigators and clinicians who used the device during the study. Comments received throughout the trial regarding the ease of winding, loading, and administering the injection by the clinical investigators was very positive. On the assessments by injection type, all three injection methods with Zetajet received very positive ratings with more than 96% overall receiving Extremely Favorable and Favorable ratings.
In conclusion, the results of this clinical trial indicate that the Zetajet needle-free injection system is preferred compared to a traditional needle and syringe system. It also demonstrated the subjective injection effectiveness of the Zetajet jet injection system for SC, ID, and IM injections.With these unique advances in delivery technology, the Zetajet is anticipated to provide the optimal injection therapy system for both developed and developing countries to provide a safer and more effective method for delivering their parenteral injectables.
The full study report can be downloaded here http://www.bioject.com/pdf/Zetajet%20DDT%20Article%20February%202009%20Low%20Res.pdf
The Biojector® 2000 is a durable, professional-grade injection system designed for healthcare providers. The Biojector® 2000 is the only needle-free system in the world cleared by the FDA to deliver intramuscular injections. The system can also deliver subcutaneous injections, and is being used for intradermal injections in clinical trials.
Cool.clickTM is a needle-free injection system designed for delivery of Saizen® recombinant human growth hormone. Serono, the manufacturer of Saizen, is the first company to offer a needle-free delivery system for human growth hormone injection that is cleared by the FDA.
SeroJetTM needle-free injection system designed for delivery of Serostim, Serono’s high-dose recombinant human growth hormone formulation that is the leading treatment for AIDS wasting. Serostim has been the most extensively tested in AIDS wasting and the only biotechnology-derived drug approved for AIDS wasting by the FDA in the USA, which has granted Serostim orphan drug status, and marketing exclusivity, in the United States until August 2003.
The Vial Adapter Drug Reconstitution Adapter Kit includes a blunt plastic device that replaces a fill needle for accessing medication vials, making syringe filling completely needle-free. The Vial adapter is designed to fit all standard syringes and all standard 13mm vials. The system is a convenient method for the withdrawal of medication and the transfer of diluents for reconstitution without the use of a needle.
The Bioject® needle-free drug reconstitution vial adapter is a non-sharp plastic device that replaces a fill needle for accessing medication vials making syringe filling completely needle-free. The vial adapter is designed to fit all standard syringes and fits on a drug vial with a 13 mm neck. The system is a convenient method for the withdrawal of medication and the transfer of diluents for reconstitution without the use of a needle.
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