Clinical Studies

Association Of Senior Professors Of Sun Yat-sen University

NGPDT TREATMENT RESULT OBSERVATIONS ON DIGESTIVE CANCERS
Observation Object

From 2009 Oct to 2011 May, a total of 15 patients were treated specifically with NGPDT. Seven were diagnosed with Esophageal Cancers, 4 with Colon Cancers and 4 with Rectal Cancers; 8 males and 7 females at the age of 45-76 years (an average of 55 years old) made up the test group. All 15 patients had received chemotherapy before and were deemed not suitable or were not willing to have surgery.

Medical Device and Agent

NGPDT (PASPDT-063), multi frequency output device. Oral and Inhalation administration of NGPDT Agent (NGPDT Agent does not need to be intraveneouly administered)

Treatment Procedure

A PETCT scan was conducted on each patient prior treatment to locate the area, size and depth of the tumor.

  • DAY 1 : Orally administered 80mg of NGPDT Agent, 20mg inhaled.
  • DAY 2 : First light treatment is performed 24 hours after administration of the agent. Treatment Session time of 40-60 minutes.
  • DAY 3 : Oral administration of 30mg and inhalation administration of 20mg of NGPDT Agent.
  • DAY 4 : Second light treatment session.
  • DAY 5 : Oral administration of 30mg and inhalation administration of 20mg of NGPDT Agent.
  • DAY 6 : Light treatment session.
  • DAY 7 : Orally administered 50mg of NGPDT Agent.
  • DAY 8 : Final light treatment is performed.
  • DAY 9 : NGPDT treatment course is complete.

Patients received traditional Chinese medicine as vitamin supplemented recovery program.

Result Evaluation Standard

According to the result evaluation standard set by the China PDT conference:

  1. complete effectiveness: tumor disappear and last for over a month;
  2. obvious effectiveness: the diameter of the tumor has shrunk 50% or more;
  3. slightly effectiveness: the diameter of the tumor has shrunk less than 50%;
  4. no effect: the tumor has not increased or decreased in size.
Result - Symptoms

After 1-3 courses of NGPDT treatment, Esophageal Cancer patients who had obstructions and/or difficulties swallowing before the treatment have all experienced different extents of improvement. All Rectal Cancer patients had a cessation of bleeding from the intestines after the first light treatment session; Two patients who experienced stool bleeding of over 0.5 litres/day reported a cessation of bleeding after two light treatments. All the patients who had difficulties with bowl movement reported different extent of improvement after completed treatment course.

Tumors

Tumor tissue in patients was observed to have different levels of necrosis two days after the treatment, tumour surface changed to a grey and white colour. Endoscopy checkup four weeks after treatment showed all tumours had disappeared or had shrunk in size. From the 15 patient trial group, 4 have shown complete effectiveness; 8 have shown obvious effectiveness; two have shown slight effectiveness with one patient showing no effect. Total Effective Rate is 93.4%.

Side Effects

One Esophageal Cancer patient had hematemesis and dark red colour of stool a week after the treatment. Gastroscopy showed that the bleeding was due to tumour festering after treatment. Blood Transfusion and other methods to stop bleeding were attempted but failed, patients family disagreed to emergency surgery, the patient died two weeks after treatment. PDT Treatment Complication rate of 5%.

Object

All patients had condition confirmed via biopsy or scan. 10 male, 3 female; Aged between 62-81 years old with an average of 71.63. All were diagnosed from 4-11 months. One with upper esophageal cancer, 9 with lower part of esophageal cancer; two with cardia cancer; one with gastric cancer;

Method

All patients submitted blood test, stool and urine samples, and ECG, CT scan etc after checked in. They were given IV drips for nutrition and alkaline balance. After their general health condition was stabilized, patients started NGPDT treatment. Device: NGPDT (PASPDT-063), multi frequency output device; Orally and/or inhaled NGPDT Agent.

Result Standard
  • CR : Swallowing difficulties disappear; able to consume solid food
  • PR : FSwallowing difficulties partly resolved; able to consume liquid and soft foods
  • NR : no improvement
Treatment Result

Of the patients treated, 7 were present with CR, 6 were present with PR. The total effective rate for NGPDT – 100%. On 7th and 14th days after the treatment, patients submitted new blood, urine, and stool tests, ECG, PET all of which showed no abnormal symptoms.

Case study 1

Patient XX, male, 81yo, had eating obstruction for two months, diagnosed with Esophageal Squamous Cell Carcinoma. The obstruction relapsed 3 months after radiation and as a result the patient could only consume liquid food. Patient received NGPDT treatment in 2009, was able to consume food five days after treatment. Currently still alive.

Case study 2

Patient Jiang Hao, Male, 43yo, Nasopharyngeal Carcinoma, Medical history summary: Patient has suffered with Nasopharyngeal Carcinoma for 6 years. Had chemotherapy and radiation multiple times. Clinical diagnosis confirmed he was at late stage of cancer and that he was not suitable for chemotherapy or radiation treatments. Nasopharyngoscopy Report: Right nasal cavity blocked by tumour, bleeds easily when touched. Inside nasal cavity and on wall of the nasal cavity are partly blocked. 10 days after NGPDT treatment, dead tumour cells present in the left nasal cavity, inside and the upper part of nasal cavity. Biopsy confirmed most of the tumour tissue is necrotic. Nose no longer unobstructed. Patient now is in recovery with Natural Herbal Therapy.

Case study 3

Patient Huang XX, male, Vocal Cord Cancer, 63yo. Patient experienced hoarseness of the throat since 2008 Dec, nothing abnormal was found by CT. A Bronchus check failed due to non-stop coughing. Natural Therapies didn’t relieve patients symptoms. 2009 April, Laryngoscope found a node in patients right Vocal Cord . Biopsy in 2009 May confirmed Differentiated Squamous Cell Carcinoma. 2009 Dec, patient treated with NGPDT. Checkup two months after treatment, the tumour has completely disappeared, normal tissue replaced the tumor site. Patients vocal cords are intact and patient can talk normally. This patient’s tumor was on the right of the vocal cord, suggested surgery would have removed the patients vocal cords. Treating this patient with NGPDT has resulted in a full recovery while leaving essential organs intact. NGPDT has repeatedly proven to be the best therapy for early stage Vocal Cord Cancers in our clinical studies.

NGPDT For Advanced Non-small Cell Lung Cancer

Abstract

Objective: To investigate the clinical efficacy of the Next Generation Photodynamic Therapy (NGPDT) (www.ngpdt.com) against advanced lung cancer.

Methods: Through pathology or cytology diagnosis, 66 cases of advanced non-small cell lung cancer patients were selected and divided into two groups. The Next Generation Photodynamic Therapy (NGPDT) group had 32 patients. Photosensitizer was administered on a dosage of 2mg per kilogram of body weight, wherein two-thirds via ultrasonic atomization inhalation and one-third via oral intake. After the irradiation target(s) were determined, optical fiber for laser treatment purposes was guided into lung tumor(s) via interstitial, percutaneous puncture under precious laser navigation, irradiation light intensity was 200J/cm2, irradiation power was 1000mw, activation was then started and last for 8 to 10 minutes, laser irradiation into tumor was 2-5cm in length, irradiation could be performed phase by phase (sub-paragraph treatment) based on tumor size or irradiations could be performed repeatedly. While in the mean time in the chemotherapy/radiotherapy group (external beam radiotherapy + whole body chemotherapy) 34 cases were observed, 15MV X ray radiation therapy irradiation field covers primary lung tumor lesion(s) and mediastinal lymphatic drainage area, dosage was 65-70Gy, on every first day in a week of radiotherapy, 20mg cisplatin was administered via intravenous application.

Result: In the Next Generation Photodynamic Therapy (NGPDT) group and simultaneous radiotherapy/chemotherapy group, 1 and 2 years survival rate were 93.75%, 70.60% and 68.75, 32.35% respectively (P < 0.05). The complete remission rate and partial remission rate were 56.20% and 21.30%, rate of the Next generation PDT group was significantly higher than that of the corresponding radiotherapy and chemotherapy group, the difference was statistically significant (P < 0.05).

Conclusion: The Next Generation Photodynamic Therapy (NGPDT) can prolong survival in patients with advanced NSCLC, improving their quality of life; it proved to be the most effective measure for advanced non-small cell lung cancer treatment of the treatments tested in this study.

Effects Of Duteroporphyrin, Photosoft & 5-ALA

Abstract

Objective: To observe and evaluate the effects of the photodynamic therapy( PDT) mediated by three different photosensitizer namely Duteroporphyrin, Photosoft and 5-ALA on mouse S180 sarcoma and explore their antitumor mechanisms.

Methods: Kunming mice with subcutaneous S180 sarcoma were randomly divided into four groups: ( A) the Duteroporphyrin group ( 10 mg /kg) ,( B) Photosoft group ( 20 mg /kg) ,( C) 5-ALA group ( 100 mg /kg) and ( D) blank control group. The mice in Group AC were given PDT after tail vein injection of photosensitizers,whereas those in Group D didn't receive any treatment. After the treatment, tumor changes both in appearance and size were observed. The necrosis and apoptosis of tumor cells were quantified with flow cytometry technology. The pathological sections of the tumor tissues were observed via HE staining.

Result: The tumor size was smaller in the PDT groups than in the control group on the 21st day after the therapy ( P < 0. 05). As to the three PDT groups,the tumor size was smaller in the Photosoft group than in the 5-ALA group ( P < 0. 05). The tumor inhibition rates in the Duteroporphyrin,Photosoft and 5-ALA group were 62.68%,75.35% and 37.17% respectively. Compared with the control group, the proportion of necrotic and apoptotic cells in the PDT groups increased significantly 24 hours after the treatment ( P < 0. 01). The pathological changes of tumor tissues in the PDT groups 24 hours after the treatment included: a wide range of tumor necrosis, tumor vascular disruption and neutrophil infiltration.

Conclusion: Tumor growth inhibition was observed in each PDT group. The effect was stronger in the Photosoft group than in the 5- ALA group, while the Photosoft group and Duteroporphyrin group being similar in this respect (see percentages above). The effect of tumor cell necrosis and apoptosis was remarkable in each PDT group, but some mice weren’t fully cured. The reason behind is subject to further exploration based on animal experiments.